WO2025212014A1

WO2025212014A1 - Systems and methods for diagnostic testing of an analyte in a sample

Info

Publication number: WO2025212014A1
Application number: PCT/SE2025/050290
Authority: WO
Inventors: Julia TREUTIGER; Malinda Linnea Kristina BLOMQVIST; Stina Juhlin; Per MÅNSSON; Eli Torbjörn BLAD
Original assignee: Apac Security Pty Ltd
Current assignee: Apac Security Pty Ltd
Priority date: 2024-04-03
Filing date: 2025-04-02
Publication date: 2025-10-09
Anticipated expiration: 2026-10-03

Abstract

The present invention relates to testing devices for collecting a sample and determining the presence of one or more analyte(s) in the sample. Methods of using the testing system for determining the presence of the analyte(s) in a sample is also described. The testing system comprises a sample collector and an analysis device. The analysis device is adapted for holding one or more test strips for lateral flow analysis. The testing system comprises a device activation means adapted to activate the oral fluid testing system, and an analysis initiation means for allowing a fluid in a mixing chamber to be applied to the test strips.

Description

Title

Systems and methods for diagnostic testing of an analyte in a sample

Field of the invention

The present invention relates to testing devices for collecting a sample and determining the presence of one or more analyte(s) in the sample, as well as methods of use of such testing devices.

Background

Lateral flow immunoassays (LFIA) are used in a variety of areas wherein quick testing of the presence of a specific analyte is required. The specific analyte can be a drug (for drug testing), a hormone (as in pregnancy tests) or specific microbes or parts of microbes, e.g. a virus component (for example in covid-19 tests). LFIA devices are especially useful for point- of-care tests, such as drug testing at customs checkpoints, law enforcement field tests and emergency hospital care. Examples of drugs that are commonly tested for are cocaine, benzodiazepines, opiates, amphetamines, methamphetamines, cannabis (e.g. tetrahydrocannabinol (THC)), ketamine and methadone.

Commonly known LFIA devices are strips with conjugate pads, i.e. pads with e.g. gold particles conjugated to a specific antibody specific for the analyte to be tested for. The strips use lateral flow through capillary action or wicking to move a sample along the different parts of the strip. Commonly, a sample, e.g. a saliva sample, is applied to a sample pad at one end of the strip, and the sample is drawn into an adjacent conjugate pad where any target analyte will bind to a gold-conjugated antibody. The fluid solution will continue to travel along the strip, past one or more test line(s), each supplied with an immobilized binding partner of the analyte of interest, such as a specific antibody, antigen or other molecule with high affinity for the analyte, to detect presence of a desired analyte in the sample. A control line, placed after the test line(s) will capture all remaining antibodies, and indicate that the sample has flown properly through the different parts if the strip.

WO 2013/131955A1 discloses an example of a such device for detecting analytes, comprising a test cartridge housing three test strips, and including a separate wiping element for obtaining and applying the sample to a sample zone. WO 2011/134946 discloses a microfluidic device for determining an analyte, comprising various regions arranged to be put into fluid connection with each other by a user, in order to control the timing of the different steps. AU2014200352B2 shows an example of saliva collector suitable for use with an LFIA test device. AU2015200466B2 discloses a sample preparation and testing system with a mixing container comprising an indicator element provided to show when a reaction mixture has been mixed sufficiently.

Saliva is a viscous fluid due to the presence of mucopolysaccharides and mucoproteins. Saliva viscosity is the measure of how thick or sticky saliva is, and can vary depending on many factors, such as hydration, mouth breathing, medication, and health conditions. Thick saliva can cause discomfort and difficulty swallowing, speaking, or breathing. It can also affect the accuracy and reliability of saliva-based analytical tests, such as those using LFIA.

Some problems of known LFIA devices include poor analyte sensitivity, the need for extensive dilution of samples, awkward handling etc.

The inventors of the present invention have identified a need for an improved oral fluid testing device, which provides for better test results and easy handling.

Summary

The above-mentioned objects are achieved by the present invention according to the independent claim. Preferred embodiments are set forth in the dependent claims.

In accordance with the present invention, a testing system for collecting a sample and determining the presence of one or more analyte(s) in the sample is disclosed. The testing systems disclosed herein are described in the context of the sample being a saliva sample, and the testing system thus being an oral fluid testing system. However, it is fully conceivable that the sample may be any sample that may can be obtained on a swab or pad of a sample collector as described herein. Non-limiting examples of samples and sample sites that may be applied to the testing systems herein include saliva obtained directly in a person’s mouth, saliva or other bodily fluids on a person’s body (such as hands, nose, mouth or face). Further examples of sample sites are surfaces such as surfaces inside or outside a vehicle, table- tops, furniture etc. The sample may be fluid or dry, depending on the type of sample collector used. Various sample collectors will be further detailed herein.

The testing system has a longitudinal axis A extending from a first end to a second end of the system and defining a proximal-distal direction. Herein the term proximal generally means in an direction towards a user and distally in a direction away from a user, during use. The testing system comprises a sample collector, an analysis device, a dried particle-antibody conjugate preparation arranged within the testing system, and an eluent solution provided within the system.

The analysis device comprises a mixing chamber and a proximally oriented first receiving opening configured to provide access of the sample collector to the mixing chamber. Further, the analysis device comprises a holding means for one or more test strips for lateral flow analysis. The analysis device is configured such that any test strips arranged in the holding means are initially arranged to have a first end of a test strip positioned such it is not in fluid connection with the mixing chamber. Details of how this may be achieved are described below.

The analysis device also comprises a viewing means for observing any results indicated on the test strips.

The testing system further comprises a device activation means adapted to activate the testing system for receiving the sample and performing the analysis of determining the presence of the analyte(s). The actuation of the device activation means causes or allows the dried particle-antibody conjugate preparation to come in contact with the eluent solution. Details of how this may be achieved are described below.

The testing system further comprises an analysis initiation means for allowing a fluid in the mixing chamber to be applied to the first end of the test strips in the holding means. Details of how this may be achieved are described below.

Further, a method of using a testing system for determining the presence of an analyte in a sample is disclosed herein. Such method is intended for use with a testing system, e.g. generally as disclosed herein, the testing system comprising an eluent solution, a dried particle-antibody conjugate preparation, a sample collector, a sample receiving unit and a test unit.

The method comprises the steps of activating a device activation means to activate the testing system for receiving the sample and performing the analysis of determining the presence of the analyte(s), wherein actuation of the device activation means allows said dried particle-antibody conjugate preparation to come in contact with the eluent solution, inserting the sample collector into a mixing chamber of the sample receiving unit in the testing system, such that an obtained sample is transferred into the mixing chamber, said step being performed before, simultaneously with or after the step of activating a device activation means, allowing the sample to react in the mixing chamber, activating an analysis initiation means to allow any fluid in the mixing chamber to be applied to first end of any test strips arranged in a holding means of the test unit. The present disclosure will become apparent from the detailed description given below. The detailed description and specific examples disclose preferred various aspects of the disclosure by way of illustration only. Those skilled in the art understand from guidance in the detailed description that changes and modifications may be made within the scope of the disclosure.

Hence, it is to be understood that the herein disclosed disclosure is not limited to the particular component parts of the device described or steps of the methods described since such device and method may vary. It is also to be understood that the terminology used herein is for purpose of describing particular embodiments only, and is not intended to be limiting. It should be noted that, as used in the specification and the appended claim, the articles "a", "an", "the", and "said" are intended to mean that there are one or more of the elements unless the context explicitly dictates otherwise. Thus, for example, reference to "a unit" or "the unit" may include several devices, and the like. Furthermore, the words "comprising", "including", "containing" and similar wordings does not exclude other elements or steps.

Brief description of the drawings

Figure 1 shows a first aspect of a testing system in perspective view.

Figure 2 shows the testing system of Figure 1 in cross-sectional view, with a sample collector partially inserted.

Figure 3 shows a perspective view of a sample collector for use in a testing system.

Figure 4 shows an exploded perspective view of a sample receiving unit in the testing system of Figure 1.

Figure 5 shows an exploded perspective view of a test unit in the testing system of Figure 1.

Figures 6a to 6f illustrate sequential steps of using the testing system of Figure 1.

Figures 7a to 7c illustrate cross-sectional views of the testing system corresponding to Figures 6c, 6e and 6f, respectively.

Figure 8 shows another aspect of a testing system in perspective view.

Figure 9 shows the testing system of Figure 8 in cross-sectional view, with a sample collector inserted. Figure 10a shows an exploded perspective view of a sample collector for use in a testing system of Figure 8.

Figure 10b shows a cross-sectional and exploded view of the sample collector of Figure 10a.

Figure 11 shows a perspective view of a sample receiving unit in the testing system of Figure 8.

Figure 12 shows an exploded perspective view of a test unit in the testing system of Figure 8.

Figures 13a to 13g illustrate sequential steps of using the testing system of Figure 8.

Figures 14a to 14e illustrate cross-sectional views of the testing system corresponding to Figures 13a, 13b, 13d, 13e and 13g, respectively.

Figure 15 shows a perspective view of yet another testing system.

Figures 16a and 16b illustrate a cross-sectional view of the testing system of Figure 15 in two different states.

Figures 17a, 17b and 17c illustrate a cross-sectional view of another aspect of a testing system.

Figures 18a, 18b and 18c illustrate a cross-sectional view of a further aspect of a testing system.

Figures 19a, 19b and 19c illustrate a cross-sectional view of yet another aspect of a testing system.

Figure 20 shows an exploded perspective view of the testing system of Figure 15.

Figure 21 shows an exploded side view of the testing system of Figure 15.

Figure 22 shows a top view of the distal end within the testing system of Figure 15.

Figure 23a shows a perspective view of a further testing system.

Figure 23b illustrates a cross-sectional view of the testing system of Figure 23a.

Figure 24 shows an exploded perspective view of the testing system of Figure 23a.

Figures 25a and 25b illustrate a cross-sectional view of the testing system of Figure 23a in two different states. Figure 26 shows an exploded perspective view of a sample collector in aa testing system of Figure 23a.

Figures 27a to 27h illustrate perspective views of sequential steps of using the testing system of Figure 23a.

Figures 28a to 28h illustrate perspective views of sequential steps of using the testing system of Figure 23a, wherein the housing has been removed for clarity.

Detailed description

In accordance with the present invention, various aspects of a testing system for collecting a sample and determining the presence of one or more analyte(s) in the sample are disclosed. It should be understood that various features described in regard to one aspect may often be combined with features of other aspects. Thus, the herein described different aspects are in no manner intended to be limiting to the specific combinations in regards to the present invention.

The systems disclosed herein are intended for use with customized lateral flow immunoassay strips. In traditional LFIA strips, a user commonly applies a fluid sample to a sample pad on the test strip, wherein the sample flows into a conjugate pad, to directly both react with the particle-antibody conjugate and initiate lateral flow towards a detection zone. However, in contrast, the presently disclosed devices provide a delayed reaction, for at least one analyte for which presence is being analysed, allowing sample and a particle-antibody conjugate to react before applying the mixture to a test trip for lateral flow. This results in highly improved efficiency and much improved test results overall.

Notably, herein the term “antibody” encompasses both entire antibody molecules as well as parts of antibodies, as long as the molecule chosen binds to the intended target. In a preferred aspect, the analyte for which presence is being analysed is THC, and a gold particle-THC antibody conjugate is used for the initial step, before application to the test strips. In other aspects, particle-antibody conjugates for two or more analytes are provided in the initial step.

A lateral flow test strip used in the present devices may thus preferably use the principle of immunochromatography. As described below for all the disclosed aspects herein, the sample and a particle-antibody conjugate for at least one analyte are mixed and allowed to react before being applied to the test strip. The test zone of a lateral flow test strip may be provided with one, two or multiple test lines. Each test line is provided with an immobilized specific binding partner to a desired analyte. A binding partner may be another antibody towards the same analyte, or an antigen or another suitable binding receptor.

In some aspects, if particle-antibody conjugates are provided for all analytes tested for on a particular test strip, before applying to the test strips, such test strips do not need to be provided with a separate conjugate pad. However, in some preferred aspects, particleantibody conjugates for one or a selected number of the analytes tested for are provided before application to the test strips, and the remaining particle-antibody conjugates may be provided in a dedicated conjugate pad on the test strip.

Various aspects of a testing system are disclosed herein, and comprise a sample collector, an analysis device, a dried particle-antibody conjugate preparation arranged within said oral fluid testing system, and an eluent solution provided within said testing system. The analysis device comprises a mixing chamber, a first receiving opening adapted to receive the sample collector and provide access of the sample collector to the mixing chamber, and holding means for one or more test strips for lateral flow analysis. The holding means are configured such that any test strips arranged in the holding means are initially arranged to have a first end of a test strip positioned such it is not in fluid connection with the mixing chamber. The holding means also comprises a viewing means for observing any results indicated on the test strips. The dried particle-antibody conjugate preparation is arranged within the testing system such that the particle-antibody conjugate preparation initially is not in contact with the eluent solution.

Furthermore, the testing system comprises a device activation means adapted to activate the testing system for receiving the sample and performing the analysis of determining the presence of the analyte(s). Actuation of the device activation means causes the dried particle-antibody conjugate preparation to come in contact with the eluent solution. Moreover, the testing system comprises an analysis initiation means for allowing a fluid in the mixing chamber to be applied to the first ends of the test strips in the holding means.

A first important feature is that when the disclosed testing systems are manufactured and transported to where they are to be used, the testing systems are thus in an inactive configuration, and require activation. Thus, when a user is ready to start the analysis of one or more analyte(s) in a sample, the user activates the device and initiates the procedure of taking a sample and performing the analysis. Another important feature of the devices disclosed herein is that, after a sample has been taken and allowed to react with a particleantibody conjugate in an eluent solution, the configuration requires actuation of the analysis initiation means by the user. This allows for effective reaction of the reaction mixture before lateral flow on the test strips is initiated. These features will be described in detail below and for each aspect disclosed herein.

The disclosed testing systems disclosed herein are thus delivered with a dried particleantibody conjugate preparation separated from an eluent, thus making the system easy to transport and suitable for long-term storage between manufacture and use of the device. Once a user is ready to perform a test the device is activated to efficiently dissolve a dried particle-antibody conjugate preparation. The device activation means is configured in various configurations in the different disclosed aspects herein, but all have in common that the actuation of the device activation means causes the eluent to come into contact with the provided dried particle-antibody conjugate preparation within the testing system. Notably, in some aspects, allowing the provided dried particle-antibody conjugate to completely dissolve, during a period of a few seconds to a few minutes, before coming into contact with the saliva sample appears to increase the effectiveness of the test procedure.

The sample to be tested may be a bodily fluid and/or tissue sample. The sample may be in dry or fluid form. Further, the sample may be obtained either directly from a person’s body, e.g. from within the mouth or on the hands. As an alternative a sample may be obtained from a surface, such as surfaces inside or outside a vehicle, table-tops, furniture etc. In preferred aspects, the sample is a saliva sample. Further, the testing systems disclosed herein are preferably used to directly collect the sample in a test subject’s oral cavity. For simplicity, the examples and aspect describe herein are described in the context of testing a saliva sample.

Once the saliva sample has been obtained, dissolved in the eluent and allowed to react with the particle-antibody conjugate in the mixing chamber, as will be described for each aspect in detail below, there is a built-in delay period, due to the analysis initiation means of the testing systems. Before actuation of the analysis initiation means by the user, the sample-conjugate mixture remains in the mixing chamber. In various configurations described in detail below for each disclosed testing system herein, the actuation of the analysis initiation means will cause the mixture in the mixing chamber to be applied to one end of the test strips in the holding means, initiating final stage of the testing procedure, as the reacted sample and conjugate is applied to the test strips and lateral flow towards a detection zone is initiated. Thus, the provision of the analysis initiation means, intended to be activated by the user, ensures that the sample fully reacts with the particle-antibody conjugate before being allowed to come in contact with the test strips.

The inventors have found that testing systems provided with a configuration that causes a delay between reaction of the saliva sample with the gold-antibody conjugate preparation and the application of the sample to a lateral flow assay strip greatly improves the quality and consistency in testing results. The results are further enhanced by providing two separate steps of device activation and analysis activation.

Another advantage of the disclosed systems is that a relatively small volume of saliva is required, due to that the majority of the taken sample is effectively used for the testing procedure.

Figure 1 shows a first aspect of an oral fluid testing system in perspective view. The testing system 100 has a longitudinal axis A extending from a first end 101 visual indicator o a second end 20 of the system and defining a proximal-distal direction. The oral fluid testing system 100 is preferably adapted to be used, at least in some of the steps, in an orientation wherein the longitudinal axis A is essentially vertical. Figure 2 shows the oral fluid testing system of Figure 1 in cross-sectional view along the longitudinal axis A of Figure. Figure 1 illustrates the configuration as supplied to a user, i.e. before initiating use. In Figure 2, a sample has been obtained and the sample collector is being inserted into the device. The specific steps of use will be described further herein.

The testing system 100 has an overall shape to be able to stand vertically, i.e. with longitudinal axis A in a vertical direction, on a horizontal surface, and is adapted to be used in an upright orientation. The shape is further preferably adapted to be comfortably held in a user’s hand during use. The testing system comprises a sample collector 110 and an analysis device 150, wherein the analysis device 150 comprises a sample receiving unit 120, and a test unit 140. Figure 3 to 5 illustrate the sample collector 110, the sample receiving unit 120, and the test unit 140, respectively, in exploded views. The test unit 140 is configured to be joined together with the sample receiving unit 120, e.g. by inserting at least part of the sample receiving unit 120 into the test unit 140, as will be detailed further below. The sample collector 110 may initially be provided separately from the sample receiving unit 120 and the test unit 140.

One aspect of a sample collector 110 is illustrated in Figure 3. The sample collector 110 has a generally elongated body 111 , with a proximal end 112 and a distal end 113. The sample collector 110 is adapted to be inserted into the sample receiving unit 120 such that the distal end 113 reaches into the mixing chamber 122 during use. The distal end 113 is preferably provided with a sample collection element 114, adapted to collect e.g. a saliva sample from a user’s mouth. The sample collection element 114 may be any suitable shape and material for collecting at least 25-100 pl of saliva by wiping the collection element 114 inside a subject’s mouth. For instance, sample collection element 114 may be a rounded or squared loop, such that a sample may be captured within a through-going hole. As an alternative, the sample collection element 114 may comprise a suitable absorbent pad made of any suitable porous material capable of absorbing and releasing a sample of e.g. saliva from a subject. Regardless of material, the sample collection element 114 should preferably not comprise a material that would bind any of the intended target substances to any extent that would hinder the efficiency of the analysis.

Thus, the oral fluid testing system 100 comprises a sample collector 110, an analysis device 150, and a dried particle-antibody conjugate preparation and an eluent solution, both arranged within the system. The analysis device 150 comprises a mixing chamber 122 and a proximally oriented first receiving opening 123 configured to provide access of the sample collector 110 to the mixing chamber 122. Further, the analysis device 150 comprises holding means 143 for one or more test strips 148 for lateral flow analysis. The analysis device 150 is configured such that any test strips arranged in the holding means 143 are initially arranged to have a first end of a test strip 148 positioned such it is not in fluid connection with the mixing chamber 122. Details of how this may be achieved are described below.

The analysis device 150 also comprises a viewing means 144 for observing any results indicated on the test strips 148.

The oral fluid testing system 100 further comprises a device activation means adapted to activate the oral fluid testing system 100 for receiving the sample and performing the analysis of determining the presence of the analyte(s). The actuation of the device activation means allows the dried particle-antibody conjugate preparation to come in contact with the eluent solution. Details of how this may be achieved are described below.

The oral fluid testing system 100 further comprises an analysis initiation means for allowing a fluid in the mixing chamber 122 to be applied to the first end of the test strips 148 in the holding means 143. Details of how this may be achieved are described below.

As seen in e.g. Figure 4, the sample receiving unit 120 comprises a first housing element 121 and a mixing chamber 122, where the mixing chamber 122 is preferably attached to the first housing element 121 , e.g. by a snap fit or adhesive. As an alternative, the first housing element 121 and a mixing chamber 122 may be integrally formed. The first housing element 121 further comprises a proximally oriented receiving opening 123, adapted to receive the sample collector 110, wherein the receiving opening 123 is configured to provide access of the sample collector 110, and specifically the distal end 113 of the sample collector, to the interior of the mixing chamber 122. The mixing chamber 122 is pre-filled with eluent solution before use. In some aspects, the first housing element 121 is provided with an elongated interior access channel 129 extending into the sample receiving unit 120 from the receiving opening 123. The inner volume of the mixing chamber 122 is initially sealed from the test unit 140, i.e. in a distal end of the mixing chamber 122.

In some aspects, a device activation means comprises a breakable seal 127 and a cutting element 128. In one aspect, the sample receiving unit 120 comprises a breakable seal 127, such as a membrane or weakened wall, somewhere between the receiving opening 123 and the mixing chamber 122, e.g. at a distal end of the interior access channel 129. This breakable seal 127 is adapted to break when the sample collector 110 is inserted into the receiving opening 123 to reach the mixing chamber 122. The breakable seal 127 ensures that the eluent initially provided in the mixing chamber 122 is contained until the system is to be used.

In some aspects, the sample receiving unit 120 comprises a cutting element 128, slidingly mounted within the interior access channel 129. As best seen in Figure 2, the cutting element 128 is initially placed a distance from the breakable seal 127. The cutting element 128 is adapted to be pushed towards the breakable seal 127 by an inserted saliva collector 110, such that the cutting element 128 will rupture the breakable seal 127 and the distal end of the saliva collector, with the sample collection element 114, enters into the mixing chamber 122 (see e.g. Figure 7b). Thus, any saliva sample in the sample collection element 114 will be mixed into the eluent solution present in the mixing chamber 122.

Furthermore, a dried particle-antibody conjugate preparation 119 is provided at a suitable location such that it is initially not in contact with the eluent solution. For example, the dried particle-antibody conjugate preparation 119 may be provided anywhere within the interior access channel 129, e.g. on the inner wall and/or on a pad placed within the interior access channel 129.

In one aspect, the particles in the particle-antibody conjugate preparation 119 comprises gold particles. Alternatively, the particles may be any suitable metal, latex or carbon particles, as long as the particles are capable of conjugating with the chosen antibody. Depending on the chosen particle, a color band may result when using test strips for lateral flow immunoassay. In other aspects, colouring reagents may be necessary. For ease of description, the aspects herein are described as utilizing gold particles, but these may be substituted for any suitable particle.

In one aspect, a dried gold particle-antibody conjugate preparation 119 is provided on the surface of the cutting element 128, such that when the cutting element 128 cuts through the breakable seal 127 and is pushed into the mixing solution, also the dried gold particleantibody conjugate preparation 119 is dissolved into the eluent and sample mixture. Thus, by shaking or mixing the entire oral fluid testing system 100, or simply leaving for a specified time period, such as 30, 60 or 90 seconds, the saliva sample and the gold particle-antibody conjugate preparation are allowed to react in the mixing chamber 122. Further details of the method of use will be described further on.

As mentioned, the antibodies of the gold particle-antibody conjugate preparation are selected to react against the desired analyte to be detected in the oral fluid testing system, conjugated with gold nanoparticles and dried according to standard practice. The dried gold particleantibody conjugate preparation 119 comprises one or more types of antibodies against the desired analyte(s). The preparation is prepared by drying the gold particle-antibody conjugate, preferably with suitable stabilizing agents and/or agents to make it readily soluble.

Examples of analytes that may be tested for are cocaine, benzodiazepines, opiates, amphetamines, methamphetamines, cannabis (THC), ketamine and methadone and other narcotic or non-narcotic pharmaceutical substances or ingredients.

The test unit 140 comprises a second housing element 141 arranged to receive the sample receiving unit 120 and to enclose at least a lower end of the mixing chamber 122. As seen in Figure 2, when the sample receiving unit 120 is joined with the test unit 140, e.g. by being is inserted into a top opening 147, the second housing element 141 surrounds the mixing chamber 122, and also at least part of the interior access channel 129 of the sample receiving unit 120.

Referring to Figures 2 and 5, the latter showing an exploded view of the test unit, the second housing element 141 further forms a test strip application receptacle 142 distally of the mixing chamber 122. In other words, the test strip application receptacle 142 is positioned below, i.e. in a bottom end, opposite from the end that the sample receiving unit 120 is inserted into. When the sample receiving unit 120 is joined with the test unit 140, the test strip application receptacle 142 will thus be located below and outside the mixing chamber 122 (Figure 2).

As best seen in Figure 5, the second housing element 141 further comprises holding means 143 for one or more test strips 148 for lateral flow analysis. The holding means 143 are configured such that any test strips 148 arranged in the holding means 143 are arranged to have a first end of a test strip positioned in the receptacle 142.

Lateral flow test strips are preferably provided in the holding means 143. More specifically, the test strips 148 are preferably mounted vertically in slots forming the holding means 143, with the ends of the strips bent in an L-shape, such that one end is arranged along at least part of the bottom of the receptacle 142. The lateral flow analysis strips 148 are provided with a sample application zone, an optional conjugate pad, one or more test zones and a control zone, as described above. The sample application zone, i.e. first end of a test strip, is arranged in the receptacle 142, and strips may be bent at an angle to be arranged in e.g. lengthwise open slots, forming the holding means 143. Holding means 143 may be adapted to hold one, two, three, four or more strips simultaneously in the holding means 143. Notably, before actuation of the analysis activation means, described further below, the analysis device 150 is thus configured such that any test strips arranged in the holding means 143 are initially arranged to have a first end of a test strip 148 positioned such it is not in fluid connection with the mixing chamber 122.

The second housing element 141 further comprises viewing means 144, arranged in connection with the holding means 143, for observing any results indicated on the test strips 148 from the outside of the testing device. The viewing means may be open slots along at least part of the holding means 143, adapted to view the strips at least at the test zone and the control zone.

Further, the test unit 140 is joined together with the sample receiving unit 120 such that the two units are able to rotate relative to each other around the longitudinal axis A,. Such rotation will actuate the analysis initiation means, such that any fluid in the mixing chamber 122 is applied to the first end of any test strips 148 arranged in the holding means 143. The rotational actuating means thus allows a fluid in the mixing chamber 122 to be released into the test strip application receptacle 142. Thereby the fluid is applied to a first end of any test strips in the holding means 143, and the lateral flow assay is initiated.

The fluid applied to the sample zone of the test strips 148 will thus travel along the strip, past one or more test line(s) in a test zone, each supplied with an immobilized specific antibody, antigen or other binding receptor against the analyte to detect presence of a desired analyte in the sample. A control line, placed after the test line(s), will capture all antibodies, and indicate that the sample has flown properly through the different parts of the strip.

As understood from e.g. Figure 1 , 2 and 5, the sample receiving unit 120 may be configured to be inserted into a top opening 147, and adapted to rotate within the test unit 140 and the top opening 147. The shapes of especially any interacting parts of the sample receiving unit 120 and the test unit 140 may be configured to rotate a specific angular distance when pushed into each other, and or rotated by a user. This will guide a user through the operational steps as described further below.

Referring to Figures 2 and 4, in some aspects, the sample receiving unit 120 further comprises a penetrable portion 125 in the lower end of the mixing chamber 122. In such an aspect, the rotational actuating means comprises a penetrating element 145 arranged in the test unit 140, wherein the penetrating element 145 is adapted to penetrate the penetrable portion 125 when the first housing element 121 is rotated relative to the second housing element 141 around the longitudinal axis A (also seen when comparing Figures 7b and 7c). The penetration of the penetrable portion 125 results in any fluid present in the mixing chamber 122 being allowed to flow out of the mixing chamber 122 and into the test strip application receptacle 142 located below (distally of) the mixing chamber 122. As illustrated in Figures 2 and 4, the penetrable portion 125 may be a membrane or breakable seal provided as a bottom of the mixing chamber 122.

Figures 6a to 6f illustrate perspective views of sequential steps of using the oral fluid testing system. Figures 7a to 7c illustrate cross-sectional views of the oral fluid testing system corresponding to Figures 6c, 6e and 6f, respectively. In aspects comprising a penetrating element 145 in the test unit 140 and a penetrable portion 125 forming part of the mixing chamber 122, rotation of the first housing element 121 relative to the second housing element 141 causes the penetrating element 145 to move towards and through at least part of the penetrable portion 125, creating an opening or rupture in the bottom of mixing chamber 122, allowing fluid to flow out of the mixing chamber 122 and into the test strip application receptacle 142 located below the mixing chamber 122. This may be achieved by adapting the shapes of especially any interacting parts. For example, guiding grooves and protrusions may be adapted such that a 90 degree rotation of first housing element 121 relative to the second housing element 141 executes the penetration of the penetrable portion 125 forming the bottom of the mixing chamber 122.

As an alternative, or performed in combination with, the sample receiving unit and test unit may be configured such that rotation of the first housing element 121 relative to the second housing element 141 causes a penetrable portion 125 of the mixing chamber 122 to move towards a penetrating element 145, such that the penetrable portion 125 is cut open or ruptured, allowing fluid to flow out of the mixing chamber 122 and into the test strip application receptacle 142 located below the mixing chamber 122.

In some aspects, the first housing element 121 further comprises a first outer gripping surface 126, and the second housing element 141 comprises a second outer gripping surface 146. The analysis initiation means may thus be activated by a user by gripping the first and second gripping surfaces and thereby rotating the sample receiving unit 120 and test unit 140 relative to each other around the longitudinal axis A. The first and second gripping surfaces may be provided with a suitable coating or surface profile adapted to a good grip by a user. In some aspects, as shown in e.g. Figure 5, the second housing element 141 comprises two main parts, a first portion 141a and a second portion 141b, together forming the main structure of the test unit. One advantage of dividing up the housing 141 into two parts is for manufacturing and mounting reasons, as it gives access to the test strip holding means during assembly. The first portion 141a comprises the holding means 143 for one or more test strips and forms the test strip application receptacle 142. The second portion 141b comprises the receiving opening 147 for receiving the sample receiving unit. The first portion 141a and second portion 141b of the second housing element 141 are thus preferably adapted to tightly attach to each other to form the main body of the test unit 140.

Another aspect of an oral fluid testing system is shown in Figure 8, in perspective view. The testing system 200 has a longitudinal axis A extending from a first end 10 to a second end 20 of the system and defining a proximal-distal direction. The oral fluid testing system 200 is preferably adapted to be used, at last in some of the steps, in an orientation wherein the longitudinal axis A is essentially vertical. Figure 9 shows the oral fluid testing system of Figure 8 in cross-sectional view along the longitudinal axis A of Figure 8. Generally, the features and aspects described above for Figures 1 to 5 also apply to the following aspects, unless otherwise stated.

The testing system 200 has an overall shape to be able to stand vertically, i.e. with longitudinal axis A in a vertical direction, on a horizontal surface, and is adapted to be used in an upright orientation. The shape is further preferably adapted to be comfortably held in a user’s hand during use. The testing system comprises a sample collector 210 and an analysis device 250, wherein the analysis device 250 comprises a sample receiving unit 220, and a test unit 240. Figure 10a - 10b, 11 and 12 illustrate the sample collector 210, the sample receiving unit 220, and the test unit 240, respectively, in exploded views. The test unit is configured to be joined together with the sample receiving unit, e.g. by inserting at least part of the sample receiving unit 220 into the test unit 240, as will be detailed further below.

One aspect of a sample collector 210 is illustrated in Figure 10a, in an exploded view and in Figure 10b, in a cross-sectional view of the collector in Figure 10a. Even though sample collector 210 herein is described in context of oral fluid testing system 200, the skilled person would understand that sample collector 210 could also be utilized together with any of the other oral fluid testing systems disclosed herein. The sample collector 210 has a generally elongated body along a longitudinal axis B, with a proximal end 212 and a distal end 213. The sample collector 210 comprises a barrel shaped eluent preparation chamber 211 extending along the longitudinal axis B, and comprising a distal opening 215 for allowing fluid to flow through.

A sample collection pad 214 is arranged adjacent the distal opening 215 of the eluent preparation chamber 211 and in fluid communication with the eluent preparation chamber 211 through the opening 215. The sample collection pad 214 is arranged with an outwardly exposed pad surface for obtaining a sample. Such a sample may be obtained by inserting the end of the sample collector with the sample collection pad 214 into a person’s mouth and moving it around, by e.g. wiping or rolling it against the inner surfaces of the cheeks or tongue, for a specified time.

The sample collector 210 is further provided with a piston element 216 arranged to be applied from a proximal end 212 of and into the eluent preparation chamber 211. The piston element 216 is adapted to be slidingly moved back and forth within the eluent preparation chamber. Furthermore, the piston element 216 is adapted to fit snugly, at least in a distal end, within the eluent preparation chamber 211. This may be achieved by providing a distal end of the piston element 216 with a flexible O-ring or similar, to provide an essentially fluid tight seal of the piston element and the eluent preparation chamber 211. The piston element 216 is thus configured to pull or push fluid, such as liquid or gas, e.g. air, in and out of the eluent preparation chamber 211 through the distal opening 215 and the sample collection pad 214.

The sample collector 210 further comprises a handle element 217 connected to the piston element 216 and arranged for operating the piston element 216 within the eluent preparation chamber 211.

A fluid testing system with a sample collector 210 is preferably configured such that the device activation means is actuated when the handle element 217 of the sample collector 210 is pulled proximally or pushed distally, to allow the dried particle-antibody conjugate preparation 219 to come in contact with the eluent solution. This may be achieved in several different manners.

On one aspect, the dried particle-antibody conjugate preparation 219 may be provided within the eluent preparation chamber 211. In other aspects, the dried particle-antibody conjugate preparation 219 may be provided in the mixing chamber 222.

In one aspect, the particles in the particle-antibody conjugate preparation 219 are gold particles. Alternatively, the particles may be any suitable metal, latex or carbon particles. Depending on the chosen particle, a color band may result when using test strips for lateral flow immunoassay. In other aspects, colouring reagents may be necessary. For ease of description, the aspect herein are described as utilizing gold particle, but these may be substituted for any suitable particle.

As mentioned earlier, the antibodies are selected to react against the desired analyte to be detected in the oral fluid testing system, conjugated with gold nanoparticles and dried according to standard practice. The dried gold particle-antibody conjugate preparation 219 comprises one or more types of antibodies against the desired analyte(s). The preparation is prepared by drying the gold particle-antibody conjugate, preferably with suitable stabilizing agents and/or agents to make it readily soluble.

The dried gold particle-antibody conjugate preparation 219 is thus adapted to be dissolved in an eluent solution, for example within the eluent preparation chamber 211 or in the mixing chamber 222, when the sample collector 210 is activated for use in taking a sample, prior to sample application in an oral fluid testing system. To allow the gold particle-antibody conjugate preparation to fully dissolve in an applied eluent before the saliva sample is added provides for increased efficiency of the test reaction. This is contrast to known lateral flow immunoassay strips and devices, where sample is commonly allowed direct access to a conjugate pad, or applied at the same time as dissolving a gold particle-antibody conjugate preparation in an eluent solution. The presently disclosed system and method ensures complete dissolution and distribution of the gold particle-antibody conjugate preparation before introducing the saliva sample.

Notably, when the dried gold particle-antibody conjugate preparation 219 is indicated in the Figures herein, it is actually the location of where the dried substance is initially provided in the illustrated product, as the dried substance is not illustrated in itself in the Figures. In some aspects, the dried gold particle-antibody conjugate preparation 219 is provided on an inner wall of the eluent preparation chamber 211 , e.g. as a dried spot on an inner wall. In other aspects, the dried gold particle-antibody conjugate preparation 219 may be provided in a recessed portion of an inner wall of the eluent preparation chamber 211. In a preferred aspect, the gold particle-antibody conjugate preparation 219 is provided in an opening in the wall of the eluent preparation chamber 211, as seen in e.g. Figures 10b and 14b , and wherein such opening is sealed from the outside of the wall by e.g. an adhesive film, membrane or other structure. In other aspects, the particle-antibody conjugate preparation 219 may also be provided in the mixing chamber 222.

Thus, oral fluid testing system 200 comprising the sample collector 210 is adapted to be initially provided to a user in a non-activated state, wherein the gold particle-antibody conjugate preparation 219 is in a dried preparation, not exposed to eluent solution. Activation of the oral fluid testing system 200 entails exposing the gold particle-antibody conjugate preparation 219 to a suitable eluent solution and dissolving the dried preparation in the eluent. The activation is performed before the solution is mixed with a sample, such as a saliva sample.

In aspects comprising a dried particle-antibody conjugate preparation 219 arranged within the eluent preparation chamber 211 , a sample collector may be activated by immersing the distal opening 215 and the sample collection pad 214 directly in an eluent solution, and drawing in eluent into the eluent preparation chamber 211 by pulling back on the piston element 216.

However, when using the sample collector 210 in an oral fluid testing system as described herein, it is advantageous to provide the sample collector 210 already at least partly inserted into a sample receiving unit 220, as illustrated in Figures 8 and 9. At least the sample collection pad 214 may be initially placed within a mixing chamber 222. An eluent solution may be provided within a distal portion of the eluent preparation chamber 211 , distally of the piston element 216.

For reference of sequential steps when using the oral fluid testing system, Figures 13a to 13g illustrate perspective views of such steps. Further, figures 14a to 14e illustrate cross- sectional views of the oral fluid testing system corresponding to Figures 13a, 13b, 13d, 13e and 13g, respectively. Figures 13a and 14a illustrate the oral fluid testing system as provided to a user, before initiation of the testing procedure.

Interacting surfaces of the sample collector and the sample receiving unit 220 may be adapted such that when a user pulls back on the handle element 217 to withdraw the sample collector 210 from the sample receiving unit 220, the piston element 216 is also pulled back within the eluent preparation chamber 211. Accordingly, in some aspects, illustrated in the difference between Figures 14a and 14b, the sample collector 210 may be activated by removal, e.g. pulling back, the sample collector out of a sample receiving unit, thus pulling back the piston element 216 within the eluent preparation chamber 211. The dried gold particle-antibody conjugate preparation 219, e.g. initially provided proximally of the distal end of the piston element 216, i.e. “behind” the end of the piston element 216, is then exposed to the eluent to dissolve the conjugate within the eluent preparation chamber 211. Further, the action of retracting the piston element 216 within the eluent preparation chamber 211 also causes air to be drawn into the eluent preparation chamber 211 through the distal opening 215, creating turbulence, which will enhance dissolution and dissolving of the gold particleantibody conjugate preparation 219 in the eluent solution.

Thus, in some aspects, the sample collector 210 is provided for use with the piston element 216 positioned within the eluent preparation chamber 211 such that the dried gold particleantibody conjugate preparation 219 is initially located proximally of the distal end of the piston element 216. Preferably, the dried gold particle-antibody conjugate preparation 219 may be provided in an opening or recess in the wall of the eluent preparation chamber 211 , as described above, behind the distal end of the piston element 216, such as illustrated in Figure 14b.

In aspects where the dried particle-antibody conjugate preparation 219 is initially provided in the mixing chamber 222, the device activation means may be actuated when the handle element 217 of the sample collector 210 is instead pushed distally, to allow the dried particleantibody conjugate preparation 219 in the mixing chamber 222 to come in contact with the eluent solution provided in the eluent preparation chamber 211.

As further understood from Figures 1a and 1b, the handle element 217 may be provided with an outer casing 218 configured to slide along at least a part of an outer surface of the eluent preparation chamber 211 when the piston element 216 is moved within the eluent preparation chamber 211. The outer casing 218 stabilizes the eluent preparation chamber 211 and provides an outer surface that may be provided with surface profiles to function as interacting surfaces with corresponding interacting surfaces in the sample receiving unit 120, to promote activation of the sample collector, and also to actuate various further steps, as will be detailed further below. For instance, in an oral fluid testing system 200, interacting surfaces, such as protrusions, ridges and/or grooves, on the outer casing 218 and inner surfaces of the sample receiving unit 120 may bias the various steps of activation of the sample collector 210 and/or the delivery of the sample from the sample collector 210 to the sample receiving unit 220.

The sample collector 210 may further comprise a sample pad mounting element 260, as seen in Figure 10a and 10b. The sample pad mounting element 260 is arranged to fluidly connect to the distal opening 215 of the eluent preparation chamber 211. In this aspect, the sample collection pad 214 may be provided on an outer perforated surface 261 of the sample pad mounting element 260. This perforated surface 261 is in fluid connection with the distal opening 215. In other words, there is a fluid connection from the eluent preparation chamber 211 via the distal opening 215 and through the sample collection pad 214, when assembled. The sample pad mounting element 260 may be attached, either reversibly or permanently, to the eluent preparation chamber 211 at the distal opening 215.

As illustrated in Figure 10a, the outwards facing surface of the sample collection pad 214 may arranged with an essentially flat exposed surface and parallel to or arranged along the longitudinal axis B. The sample collection pad 214 and its corresponding outer perforated surface 261 may be any suitable shapes, such a square, rectangular, round or oval. However, it is advantageous that the sample collection pad 214 and the outer perforated surface 261 are of the same or similar shape and size. A suitable size of the sample collection pad 214 may be in the range of 0,5 to 2.0 cm².

The sample collection pad 214 may be made of any suitable porous material capable of absorbing and releasing a sample of e.g. saliva from a subject. The material should also preferably be one with good recovery of the analytes to be tested for, such as cocaine, benzodiazepines, opiates, amphetamines, methamphetamines, cannabis (THC), ketamine and methadone and other narcotic or non-narcotic pharmaceutical substances or ingredients. Non-limiting examples of materials for the sample collection pad 214 are porous sintered plastics or glass, sponges, cotton, various synthetic materials, etc.

The sample collector 210 is further preferably provided with a pierceable element 270 arranged to initially close the distal opening 215. The pierceable element 270 may be a membrane or weakened material portion, provided either within the sample pad mounting element 260 and/or covering the distal opening 215. When the pierceable element 270 is pierced or broken, any fluid within the eluent preparation chamber 211 may be pushed out from the eluent preparation chamber 211 through the distal opening 215 and through the sample collection pad 214 by operating the piston element 216.

As is understood from the above, and seen in Figure 9, the sample collector 210 is adapted to be inserted into a sample receiving unit 220 such that the distal end 213 reaches into a mixing chamber 222. Figure 9 illustrates an oral fluid testing device in a configuration as provided to a user, i.e. before initiation of a testing procedure.

As already described, the oral fluid testing system 200 comprises a sample collector 210, an analysis device 250, and a dried particle-antibody conjugate preparation and an eluent solution, both arranged within the system. The analysis device 250 comprises the mixing chamber 222 and a proximally oriented first receiving opening 223 configured to provide access of the sample collector 210 to the mixing chamber 222. Further, the analysis device 250 comprises holding means 243 for one or more test strips 248 for lateral flow analysis. The analysis device 250 is configured such that any test strips arranged in the holding means 243 are initially arranged to have a first end of a test strip 248 positioned such it is not in fluid connection with the mixing chamber 222. Details of how this may be achieved are described below.

The analysis device 250 also comprises a viewing means 244 for observing any results indicated on the test strips 248.

As is previous aspects, the oral fluid testing system 200 further comprises a device activation means adapted to activate the oral fluid testing system 200 for receiving the sample and performing the analysis of determining the presence of the analyte(s). The actuation of the device activation means allows the dried particle-antibody conjugate preparation 219 to come in contact with the eluent solution. Details of how this may be achieved are described below.

The oral fluid testing system 200 further comprises an analysis initiation means for allowing a fluid in the mixing chamber 222 to be applied to the first end of the test strips 248 in the holding means 243. Details of how this may be achieved are described below.

As shown in e.g. Figure 11 , the sample receiving unit 220 comprises a first housing element 221 and a mixing chamber 222, where the mixing chamber 222 is preferably integrally attached to the first housing element 221. Alternatively, the mixing chamber 222 may be made separately, and attached to the first housing element 221 during assembly, e.g. by a snap fit or adhesive. The first housing element 221 further comprises a receiving opening 223, adapted to receive the sample collector 210, wherein the receiving opening 223 is configured to provide access of the sample collector 210 to the mixing chamber 222.

Specifically, the distal end 213 of the sample collector, i.e. the sample collection pad 214 and the distal opening 215, is provided access to the interior of the mixing chamber 222 when the sample collector 210 in inserted into the receiving opening 223. In some aspects, the first housing element 221 is provided with an elongated interior access channel 229 extending into the sample receiving unit 220 from the receiving opening 223 to the mixing chamber 222. The inner volume of the mixing chamber 222 is initially sealed from the test unit 240, i.e. in a distal end of the mixing chamber 222.

The test unit 240, as seen in Figure 12 in an exploded view, comprises a second housing element 241 arranged to receive the sample receiving unit 220 and to enclose at least a lower end of the mixing chamber 222. As seen in Figure 9, when the sample receiving unit 220 is joined with the test unit 240, e.g. by being is inserted into a proximal receiving opening 247, the second housing element 241 surrounds the mixing chamber 222, and also at least part of the interior access channel 229 of the sample receiving unit 220. Further, when the sample receiving unit 220 is joined with the test unit 240, the pierceable element 270 of the sample collector 210 is initially mounted above a piercing protrusion 280 in the bottom of the mixing chamber 222.

The second housing element 241 further forms a test strip application receptacle 242 distally of the mixing chamber 222. In other words, the test strip application receptacle 242 is positioned below, i.e. in a bottom end, opposite from the end that the sample receiving unit 220 is inserted into. When the sample receiving unit 220 is joined with the test unit 240, the test strip application receptacle 242 will thus be located below and outside the mixing chamber 222 (Figure 9).

As best seen in Figure 12, the second housing element 241 further comprises holding means 243 for one or more test strips 248 for lateral flow analysis. The holding means are configured such that any test strips arranged in the holding means 243 are arranged to have a first end of a test strip 248 positioned in the receptacle 242.

Lateral flow test strips are preferably provided in the holding means 243. More specifically, the test strips 248 are preferably mounted vertically in slots forming the holding means 243, with the ends of the strips bent in an L-shape, such that one end is arranged along at least part of the bottom of the receptacle 242. The lateral flow analysis strips 248 are provided with a sample application zone, an optional conjugate pad, one or more test zones and a control zone, as described above. The sample application zone, i.e. first end of a test strip, is arranged in the receptacle 242, and strips may be bent at an angle, as illustrated in Figure 12, to be arranged in e.g. lengthwise open slots, forming the holding means 243. Holding means 243 may be adapted to hold one, two, three, four or more strips simultaneously in the holding means 243. Notably, before actuation of the analysis activation means, described further below, the analysis device 250 is thus configured such that any test strips arranged in the holding means 243 are initially arranged to have a first end of a test strip 248 positioned such it is not in fluid connection with the mixing chamber 222.

The second housing element 241 further comprises viewing means 244, arranged in connection with the holding means 243, for observing any results indicated on the test strips from the outside of the testing device. The viewing means may be open slots along at least part of the holding means 243, adapted to view the strips at least at the test zone and the control zone.

Further, the test unit 140 is joined together with the sample receiving unit 120 such that the two units are able to rotate relative to each other around the longitudinal axis A,. Such rotation will actuate the analysis initiation means, such that any fluid in the mixing chamber 122 is applied to the first end of any test strips 148 arranged in the holding means 143. The rotational actuation thus allows a fluid in the mixing chamber 222 to be released into the test strip application receptacle 242. When released from the mixing chamber 222, the fluid is applied to a first end of any test strips in the holding means 243, and the lateral flow assay is initiated.

The fluid applied to the sample zone of the test strips 248 will thus travel along the strip, past one or more test line(s) in a test zone, each supplied with an immobilized specific antibody, antigen or other binding receptor against the analyte to detect presence of a desired analyte in the sample. A control line, placed after the test line(s), will capture all antibodies, and indicate that the sample has flown properly through the different parts of the strip.

As understood from e.g. Figure 8, 9 and 12, the sample receiving unit 220 may be configured to be inserted into a proximal receiving opening 247, and adapted to rotate within the test unit 240 and the receiving opening 247. The shapes of especially any interacting parts of the sample receiving unit 220 and the test unit 240 may e.g. be configured to rotate a specific angular distance when pushed into each other. In other aspects, rotation of the sample receiving unit 220 and the test unit 240 may cause longitudinal movement of the two units relative to one another, in further aspects, rotation and/or pushing or pulling may actuate subsequent steps of the procedure, such as initiating application to lateral flow immunoassay strips. These “semi-automatic” or triggered actions will guide a user through the operational steps as described further below, making the test procedure easier to perform.

In some aspects, the sample receiving unit 220 further comprises a penetrable portion 225 in the lower end of the mixing chamber 222. An example is shown in Figure 11. In such an aspect, the rotational actuating means may comprise a penetrating element 245 arranged in the test unit 240, as seen in Figure 12, wherein the penetrating element 245 is adapted to penetrate the penetrable portion 225 when the first housing element 221 is rotated relative to the second housing element 241 around the longitudinal axis A. The penetrating element 245 may be one, two or multiple such protrusions. The penetrating element 245 may be a sharp or pointed protrusion or hook. The penetration of the penetrable portion 225 results in any fluid present in the mixing chamber 222 being allowed to flow out of the mixing chamber 222 and into the test strip application receptacle 242 located below the mixing chamber 222. As seen in Figures 9 and 11, the penetrable portion 225 may be a weakened portion in the wall of the mixing chamber 222, e.g. around at least a part of the circumference of the lower end of the mixing chamber 222. Alternatively, a penetrable portion 225 may be a membrane or breakable seal provided as the bottom and/or sides of the mixing chamber 222. In aspects comprising a penetrating element 245 in the test unit 240 and a penetrable portion 225 forming part of the mixing chamber 222, rotation of the first housing element 221 relative to the second housing element 241 causes the penetrating element 245 to create an opening or rupture in the mixing chamber wall, allowing fluid to flow out of the mixing chamber 222 and into the test strip application receptacle 242 located below the mixing chamber 222. This step is illustrated when comparing Figures13f and 13g or Figures 14d and 14e. Notably, these figures do not show any liquid transfer, however the function may be understood. In some aspects, the penetrating element 245 is configured with a sharp edge or hook, adapted to cut into the penetrable portion 225.

In some aspects, the rotational movement will result in the penetrating element 245 to move towards and through at least part of the penetrable portion 225. This may be achieved by adapting the shapes of especially any interacting parts.

As an alternative, or performed in combination with the above, the sample receiving unit and test unit may be configured such that rotation of the first housing element 221 relative to the second housing element 241 causes a penetrable portion 225 of the mixing chamber 222 to move towards a penetrating element 245, such that the penetrable portion 225 is cut open or ruptured, allowing fluid to flow out of the mixing chamber 222 and into the test strip application receptacle 242 located below the mixing chamber 222.

As a further alternative, not illustrated in the Figures, to a penetrating element 245 in the test unit 240 and a penetrable portion 225 forming part of the mixing chamber 222, other fluid releasing mechanisms are conceivable within the scope of the present disclosure. For instance, the bottom of the mixing chamber 222 may be provided as a releasable bottom, i.e. configured to separate from the rest of the mixing chamber 222, when the sample receiving unit 220 and the test unit 240 are rotated relative one another. This may be achieved by using interacting surfaces, such as protrusions and grooves in the two units, wherein the bottom of the mixing chamber may e.g. be separated or released from the rest of the mixing chamber 222 upon rotation.

In some aspects, the first housing element 221 further comprises a first outer gripping surface 226, and the second housing element 241 comprises a second outer gripping surface 246, as seen in e.g. Figure 8 and 13a. The analysis initiation means may thus be activated by a user by gripping the first and second gripping surfaces and thereby rotating the sample receiving unit 220 and test unit 240 relative to each other around the longitudinal axis A. The first and second gripping surfaces may be provided with a suitable coating or surface profile adapted to enable a good grip by a user. In some aspects, as shown in e.g. Figure 12, the second housing element 241 comprises two main parts, a first portion 241a and a second portion 241b, together forming the main structure of the test unit. One advantage of dividing up the housing 241 into two parts is for easier manufacturing and for mounting reasons, as it gives access to the test strip holding means during assembly. The first portion 241a preferably comprises the holding means 243 for one or more test strips and forms the test strip application receptacle 242. The second portion 241b preferably comprises the receiving opening 247 for receiving the sample receiving unit. The first portion 241a and second portion 241b of the second housing element 241 are thus preferably adapted to tightly attach to each other to form the main body of the test unit 240.

A further aspect of an oral fluid testing system is shown in Figure 23a, in perspective view. The testing system 400 has a longitudinal axis A extending from a first end 10 to a second end 20 of the system and defining a proximal-distal direction. The oral fluid testing system 400 is preferably adapted to be used, at last in some of the steps, in an orientation wherein the longitudinal axis A is essentially vertical. Figure 23b shows the oral fluid testing system of Figure 23a in cross-sectional view along the longitudinal axis A of Figure 23a. Generally, the features and aspects described above for previous aspects, at least those illustrated in Figures 1 to 5, 8, 9 and 12, also apply to the following aspects, unless otherwise stated.

The testing system 400 has an overall shape to be able to stand vertically, i.e. with longitudinal axis A in a vertical direction, on a horizontal surface, and is adapted to be used in an upright orientation. The shape is further preferably adapted to be comfortably held in a user’s hand during use. The testing system comprises a sample collector 410 and an analysis device 450. Figure 24 illustrates the analysis device 450 in an exploded view. The analysis device 450 comprises a sample receiving unit 420 and a test unit 440. The test unit 440 is configured to be joined together with the sample receiving unit 420, e.g. by inserting at least part of the sample receiving unit 420 into the test unit 440, as will be detailed further below. Figure 26 illustrates the sample collector 410 in an exploded view. The sample collector 410 may initially be provided separately from the analysis device 450.

One aspect of a sample collector 410 is illustrated in exploded view in Figure 26. Even though sample collector 410 herein is described in context of oral fluid testing system 400, the skilled person would understand that sample collector 410 could also be utilized together with any of the other oral fluid testing systems disclosed herein. The sample collector 410 has a generally elongated body 411 along a longitudinal axis C, with a proximal end 412 and a distal end 413. The sample collector 410 is adapted to be inserted into the sample receiving unit 420 along longitudinal axis A such that the distal end 413 of the sample collector 410 reaches into the mixing chamber 422 during use. The distal end 413 is provided with a sample collection element 414, adapted to collect e.g. a saliva sample from a user’s mouth. For example, a sample may be obtained by inserting the end of the sample collector 410 with the sample collection element 414 into a person’s mouth and moving it around, by e.g. wiping or rolling it against the inner surfaces of the cheeks or tongue, for a specified time. As an alternative, a sample may be obtained by wiping the sample collection element 414 along a surface to be tested, or on the test subject hands or face.

The sample collection element 414 may be any suitable shape and material for collecting at least 25-100 pl of saliva by wiping the collection element 414 inside a subject’s mouth. For instance, sample collection element 414 may a sponge, a cotton swab or other absorbent material. In some aspects, the sample collection element 414 may comprise a material suitable to collect a dry or semi-dry sample from e.g. a surface. Regardless of material, the sample collection element 414 should preferably not comprise a material that would bind any of the intended target substances to any extent that would hinder the efficiency of the analysis. In other words, the material, shape and positioning of the sample collection element

414 is preferably adapted to be able to absorb enough sample to produce a reliable result when testing in the disclosed testing systems, and further preferably adapted to also release the sample from the sample collection element 414 when rinsed with an eluent, such as that of the testing system. The sample collection element 414 is arranged with an outwardly exposed surface for obtaining a sample.

In some aspects, the sample collector 410 is provided with a sample detection means for confirming that a predetermined amount of sample is obtained, the predetermined amount being a sufficient amount for a complete testing procedure to be performed. An example of such sample detection means is shown in Figure 26. The sample collector 410 has at least a partly hollow part, forming an opening directed towards the distal end 413 of the elongated body 411, wherein a detection strip holder 416 may be arranged. Further, a detection strip

415 may be arranged within the detection strip holder 416 and proximally of the sample collection element 414. The detection strip may be a strip of paper or similar material capable of absorbing fluid. The sample collection element 414 is arranged to be in fluid connection with the detection strip 415, such that when the sample collection element 414 is sufficiently wetted with a fluid sample, a small volume of the fluid sample will be pulled into the detection strip 415 by capillary force. The detection strip 415 is preferably provided with a visual indictor 415a, such as a color indicator, configured to change color when the detection strip 415 becomes filled with fluid, i.e. the sample fluid. The color indicator may be e.g. a strip across the detection strip 415, wherein the strip is adapted to change color when wetted. Other visual indicator configurations are also possible. The color indicator may be viewed through a detection viewing window 417 arranged on one side of the elongated body 411.

The sample collector 410 is adapted for taking a sample and thereafter inserting it into the analysis device 450 to deposit the fluid sample within a mixing chamber 422. The configuration and role of the mixing chamber 422 will be further detailed below, however at this stage it is sufficient to note that the mixing chamber 422 is where the sample is intended to react with a particle-antibody conjugate dissolved in an eluent solution. In some aspects, the sample collected in the collection element 414 will simply mix with the surrounding solution as the collection element is immersed in eluent solution. In other aspects, the mixing chamber 422 is provided with a suitable sample releasing element, configured to enhance release of the sample from the collection element 414. This may be e.g. a protrusion or a small net or perforated element that the collection element 414 is pressed against in the mixing chamber to press out the sample from the collection element 414 into a solution within the mixing chamber 422. In further aspects, the shape or configuration of the mixing chamber 422 and optionally any access channel, and/or the sample collector 410 itself, is adapted such that the act of inserting the sample collector 410, or more specially the collection element 414, into the mixing chamber will cause turbulence or movement in the fluid in the mixing chamber, such that the sample in the collection element 414 is more effectively rinsed out into the surrounding eluent solution.

Thus, the oral fluid testing system 400 comprises a sample collector 410, an analysis device 450, as well as a dried particle-antibody conjugate preparation 419 and an eluent solution, both arranged within the system. As may be seen in e.g. Figure 24, the analysis device 450 comprises a mixing chamber 422 and a proximally oriented first receiving opening 423 configured to provide access of the sample collector 410 to the mixing chamber 422. Further, the analysis device 450 comprises holding means 443 for one or more test strips 448 for lateral flow analysis. Holding means 443 may comprise a securing part 443a, adapted to hold test strips 448 in place by securing the test strips 448 in the holding means 443. This may be achieved by e.g. a snap-fit to attach the securing part 443a into place adjacent the holding means 443. The analysis device 450 is configured such that any test strips arranged in the holding means 443 are initially arranged to have a first end of a test strip 448 positioned such it is not in fluid connection with the mixing chamber 422. Details of how this may be achieved are described below.

The analysis device 450 also comprises a viewing means 444 for observing any results indicated on the test strips 448, as best illustrated in Figures 23a and 23b. The oral fluid testing system 400 further comprises a device activation means adapted to activate the oral fluid testing system 400 for receiving the sample and performing the analysis of determining the presence of the analyte(s). The actuation of the device activation means allows the dried particle-antibody conjugate preparation 419 to come in contact with the eluent solution. Details of how this may be achieved are described below.

The oral fluid testing system 400 further comprises an analysis initiation means for allowing a fluid in the mixing chamber 422 to be applied to the first end of the test strips 448 in the holding means 443. Details of how this may be achieved are described below.

As mentioned, Figure 24 shows an exploded view of the analysis unit 450 of the testing device shown in Figure 23a. As seen in Figures 24, the sample receiving unit 420 comprises a first housing element 421 and a mixing chamber 422, where the mixing chamber 422 is preferably attached to the first housing element 421, e.g. by a snap fit or adhesive. As an alternative, the first housing element 421 and a mixing chamber 422 may be integrally formed. The first housing element 421 further comprises the proximally oriented receiving opening 423, adapted to receive the sample collector 410, wherein the receiving opening 423 is configured to provide access of the sample collector 410, and specifically the distal end 413 of the sample collector 410, to the interior of the mixing chamber 422. In some aspects, the first housing element 421 is provided with an elongated interior access channel 429 extending into the sample receiving unit 420 from the receiving opening 423. The inner volume of the mixing chamber 422 is initially sealed from the test unit 440, i.e. in a distal end of the mixing chamber 422.

The test unit 440, as seen in the exploded view of Figure 24, comprises a second housing element 441 arranged to receive the sample receiving unit 420 and to enclose at least a lower end of the mixing chamber 422. As understood from Figure 24, when the sample receiving unit 420 is joined with the test unit 440, e.g. by being is inserted into a proximal receiving opening 447, the second housing element 441 surrounds the mixing chamber 422, and also at least part of the interior access channel 429 of the sample receiving unit 420.

One aspect of a configuration of a device activation means of an oral fluid testing device 400 is illustrated in Figures 25a and 25b. The cross-sectional views shown in Figures 25a and 25b are arranged along the longitudinal axis A of the testing device shown in Figure 23a. Notably, the cross-sectional view plane in Figures 25a and 25b is a plane perpendicular to the cross-sectional plane shown in Figure 23b, wherein the two planes are arranged along the same longitudinal axis A. Figure 25a shows a cross-sectional view of the device 400 before activation, and Figure 25b shows a corresponding view of the device 400 after activation. The oral fluid testing device 400 is in this aspect provided with an eluent chamber 491 , which may be arranged adjacent or to one side and slightly proximal to the mixing chamber 422. The eluent solution may initially be provided in the eluent chamber 491. The eluent chamber 491 has a proximal end 492 and a distal end 493, and a distal opening 495 for allowing fluid to flow through. An eluent piston 496 is arranged within the eluent chamber 491 and is configured to be slidingly moved back and forth within the eluent chamber 491 and thus push or pull fluid in the eluent chamber 491 through the distal opening 495. Furthermore, the piston element 496 is adapted to fit snugly, at least at a distal end, within the eluent chamber 491. This may be achieved by providing a distal end of the piston element 496 with a flexible O-ring or similar, to provide an essentially fluid tight seal of the piston element 496 and the eluent chamber 491. The distal opening 495 is arranged in fluid connection with the mixing chamber 422, such as via a channel leading into the mixing chamber from one side.

In a preferred aspect, as illustrated in Figures 25a and 25b, the oral fluid testing device 400 further has a piston actuator 497 connected to the eluent piston 496 and arranged for operating the eluent piston 496 within the eluent chamber 491. The piston actuator 497 is operatively arranged such that a longitudinal movement of the sample collector 410 relative to the analysis device 450 will actuate the eluent piston 496 to push fluid in the eluent chamber 491 through the distal opening 495 into the mixing chamber 422. As understood when comparing Figures 25a and 25b, this may be achieved by providing the actuator 497 as an extending arm from the proximal end of the eluent piston 496, where the end of the extending arm is adapted to slide along the elongated body 411 of the sample collector 410 when inserted into the analysis device 250. The outside surface of the elongated body 411 may be provided with a protrusion 411a of a suitable dimension to push against the piston actuator 497, such that the action of pushing in the sample collector 410 into the analysis device 250 will cause the eluent piston 496 to move distally in the eluent chamber 491. Other manners of arranging the piston actuator 497 are also conceivable.

Preferably, the eluent chamber 491 is provided with a pierceable element 470 arranged to initially close the distal opening 495. This ensures that the eluent solution will be contained within the eluent chamber 491 until the oral fluid testing device 400 is activated. In such aspect, the eluent piston 496 may be provided with a piercing element 471 at its distal end, pointing towards the distal opening 495. When the eluent piston 496 is actuated, the piercing element 471 will pierce the pierceable element 470, and any fluid within the eluent chamber 491 will be pushed out from the eluent chamber 491 through the distal opening 495 and into the mixing chamber. The dried particle-antibody conjugate preparation 419 is preferably provided in the mixing chamber 422. However, it may also be provided in the channel between the distal opening 495 of the eluent chamber 491 and the mixing chamber 422, or any other location where it can be kept dry before activating the device. Thus, actuation of the device activating means by pushing the eluent solution into the mixing chamber 422 will allow the particle-antibody conjugate preparation 419 to dissolve in the eluent solution in the mixing chamber 422.

When using the oral fluid testing device 400 illustrated in Figure 23a to 25b, the action of moving the sample collector 410 distally such that the sample is released in the mixing chamber 422 is essentially simultaneous to dissolving the particle-antibody conjugate preparation 419 in the eluent solution. Thus, the sample will reach the mixing chamber 422 and be dissolved in the eluent solution at the same time or very shortly after the eluent solution is released into the mixing chamber 422.

Returning to Figure 23b and 24, the second housing element 441 further forms a test strip application receptacle 442 distally of the mixing chamber 422. In other words, the test strip application receptacle 442 is positioned below, i.e. in a bottom or distal end 20, opposite from the end that the sample receiving unit 420 is inserted into. When the sample receiving unit 420 is joined with the test unit 440, the test strip application receptacle 442 will thus be located below and outside the mixing chamber 422.

The second housing element 441 further comprises the holding means 443 for one or more test strips 448 for lateral flow analysis. The holding means 443 are configured such that any test strips arranged in the holding means 443 are arranged to have a first end of a test strip 448 positioned in the receptacle 442.

Lateral flow test strips are preferably provided in the holding means 443. More specifically, holding means 443 are preferably configured such that the test strips 448 are mounted vertically in slots forming the holding means 443, with the ends of the strips bent in an L- shape or curved shape, such that one end is arranged along at least part of the bottom of the receptacle 442. The lateral flow analysis strips 448 are provided with a sample application zone, an optional conjugate pad, one or more test zones and a control zone, as described above. The sample application zone, i.e. first end of a test strip, is arranged in the receptacle 442, and strips may be bent at an angle, as illustrated in e.g. Figures 23b and 24, to be arranged in e.g. lengthwise open slots, forming the holding means 443. Holding means 443 may be adapted to hold one, two, three, four or more strips simultaneously in the holding means 443. Notably, before actuation of the analysis activation means, described further below, the analysis device 450 is thus configured such that any test strips arranged in the holding means 443 are initially arranged to have a first end of a test strip 448 positioned such it is not in fluid connection with the mixing chamber 422. The second housing element 441 further comprises viewing means 444, arranged in connection with the holding means 443, for observing any results indicated on the test strips from the outside of the testing device. The viewing means may be open slots or clear windows along at least part of the holding means 443, adapted to view the strips at least at the test zone and the control zone.

Further, the test unit 440 is joined together with the sample receiving unit 420 such that the two units are able to rotate relative to each other around the longitudinal axis A. Such rotation will actuate the analysis initiation means, such that any fluid in the mixing chamber 422 is applied to the first end of any test strips 448 arranged in the holding means 443. The rotational actuation thus allows a fluid in the mixing chamber 422 to be released into the test strip application receptacle 442. When released from the mixing chamber 422, the fluid is applied to a first end of any test strips in the holding means 443, and the lateral flow assay is initiated.

In some aspects, as shown in e.g. Figure 24, the second housing element 441 comprises two main parts, a first portion 441a and a second portion 441b, together forming the main structure of the test unit. One advantage of dividing up the housing 441 into two parts is for easier manufacturing and for mounting reasons, as it gives access to the test strip holding means during assembly. The first portion 441a preferably comprises the holding means 443 for one or more test strips and forms the test strip application receptacle 442. The second portion 441b preferably comprises the receiving opening 447 for receiving the sample receiving unit. The first portion 441a and second portion 441b of the second housing element 441 are thus preferably adapted to tightly attach to each other to form the main body of the test unit 440.

One aspect of an analysis initiation means and its operation may be understood from Figure 24, illustrating an exploded view of the different parts of a testing device 400, and from Figures 27a-27h and 28a-28h, illustrating the different stages of operation of the testing device 400.

As seen in Figure 24, the oral fluid testing system 400 may further comprise a support element 485 arranged to support and partially enclose a distal part of the mixing chamber 422. The support element 485 is provided in a fixed relationship with the test unit, such as by latching or hooking onto the housing part 441a containing the receptacle 442. The support element 485 comprises a first side opening 486. Further, the mixing chamber 422 comprises a second side opening 487, preferably arranged near a bottom or distal end of the mixing chamber 422. In the illustrated testing device 400, mixing chamber 422 preferably has a cylindrical shape with a partial cutout forming side opening 487. Further, the support element 485 has a matching cylindrical shape, also with a partial cutout forming side opening 486. The inner surface circumference of the support element 485 is slightly larger than the outer surface circumference of the mixing chamber 422, such that the mixing chamber is able to slidingly rotate within the support element 485.

The first and second side openings 486, 487 may initially be arranged in a first position relative to each other, e.g. before actuation of the analysis initiation means, wherein the first and second side openings 486, 487 do not overlap each other, such that any fluid within the mixing chamber 422 is contained to the mixing chamber 422. Thus, when the two side openings do not overlap, there is a fluid tight seal between the mixing chamber 422 and the support element 485. Furthermore, the two side openings 486, 487 are configured to be moved to a second position relative each other, e.g. after actuation of the analysis initiation means, wherein the two side openings 486, 487 at least partly overlap each other. In other words, the two openings 486, 487 are arranged such that actuation of the analysis initiation means, e.g. by rotating the sample receiving unit 420, and thus the mixing chamber 422 around the longitudinal axis A, in relation to the test unit 440, and thus the support element 485, will cause the two side openings 486, 487 to at least partly overlap. The second position opens up the mixing chamber to the receptacle 442 below it and allows any fluid present in the mixing chamber 422 to flow through the first and second side openings 486, 487. The complete steps of operation of the testing device 400 are illustrated in Figures 27a-27h and 28a-28h, and will be further detailed below. As mentioned previously, after the oral fluid testing device 400 has been activated and the sample added, the mixing chamber 422 contains the reaction mixture. Upon actuation of the analysis initiation means as described, this reaction mixture will flow from the mixing chamber 422 into the receptacle 442 and be applied to the first end of any test strips 448 arranged in the holding means 443. Hence, as in previous aspects, the rotation of the sample receiving unit 420 and the test unit 440 in relation to each other will actuate the analysis initiation means.

The fluid applied to the sample zone of the test strips 448 will thus travel along the respective strip, past one or more test line(s) in a test zone, each supplied with an immobilized specific antibody, antigen or other binding receptor against the analyte to detect presence of a desired analyte in the sample. A control line, placed after the test line(s), will capture all antibodies, and indicate that the sample has flown properly through the different parts of the strip.

As described above, the sample receiving unit 420 may be configured to be inserted into a proximal receiving opening 447, and adapted to rotate within the test unit 440 and the receiving opening 447. The shapes of especially any interacting parts of the sample receiving unit 420 and the test unit 440 may e.g. be configured to rotate a specific angular distance when pushed into each other. In other aspects, rotation of the sample receiving unit 420 and the test unit 440 may cause longitudinal movement of the two units relative to one another, in further aspects, rotation and/or pushing or pulling may actuate subsequent steps of the procedure, such as initiating application to lateral flow immunoassay strips. These “semiautomatic” or triggered actions will guide a user through the operational steps as described further below, making the test procedure easier to perform.

In some aspects, the first housing element 421 further comprises a first outer gripping surface 426, and the second housing element 441 comprises a second outer gripping surface 446, as seen in e.g. Figures 23a, 23b and 24. The analysis initiation means may thus be activated by a user by gripping the first and second gripping surfaces and thereby rotating the sample receiving unit 420 and test unit 440 relative to each other around the longitudinal axis A. The first and second gripping surfaces may be provided with a suitable coating or surface profile adapted to enable a good grip by a user.

Notably, in yet another aspect, not specifically illustrated in the Figures, a testing system may comprise a sample collector similar to that of sample collector 210, as described in connection with Figures 10a and 10b, together with an analysis unit similar to that of the analysis unit 450, as described in connection with Figures 23a, 23b and 24. Such a sample collector would be provided with the eluent in an eluent chamber in the sample collector itself, and a sample would be rinsed into the mixing chamber 422 directly from the sample collector after insertion into the analysis device. The dried particle-antibody conjugate preparation could be provided either in the mixing chamber 422, or in the sample collector, e.g. as described for sample collector 210. Thus, such a testing device would not need a separate eluent chamber 491 in the analysis unit. The mixing chamber 422 could in this aspect be arranged with the support element 485 and first and second side openings 486, 487 as described above.

Methods of using an oral fluid testing system for determining the presence of an analyte in a sample is further disclosed herein. Such method is intended for use with an oral fluid testing system, e.g. generally as disclosed herein, the oral fluid testing system comprising an eluent solution, a dried particle-antibody conjugate preparation, a sample collector, a sample receiving unit and a test unit. Steps of the method are illustrated for the various devices described herein e.g. in Figures 6a-6f, 7a-7c, 13a-13g, 14a-14e, 16a-16b, 17a-17b, 27a-27h, and 28a-28h, each described in detail elsewhere herein. For all testing systems 100, 200, 300, 400 described herein, a common method of use may be applied. A method of using an testing system for determining the presence of an analyte in a sample comprises the steps of activating a device activation means to activate the testing system for receiving the sample and performing the analysis of determining the presence of the analyte(s), wherein actuation of the device activation means allows said dried particle-antibody conjugate preparation to come in contact with the eluent solution, inserting the sample collector into a mixing chamber of the sample receiving unit in the testing system, such that an obtained sample is transferred into the mixing chamber, said step being performed before, simultaneously with or after the step of activating a device activation means, allowing the sample to react in the mixing chamber, activating an analysis initiation means to allow any fluid in the mixing chamber to be applied to first end of any test strips arranged in a holding means of the test unit.

Methods of use will now further be described in the context of testing system 400, referring to Figures 27a-27h, and 28a-28h. Methods in the context of other testing systems disclosed herein are described elsewhere herein.

Various steps of the intended test procedure have been described above. Figures 27a to 27h illustrate perspective views of sequential steps of using the oral fluid testing system 400. Figures 28a to 28h illustrate perspective configurations of the testing system 400, each in corresponding steps to Figures 27a to 27h, but with the housing removed for illustrative purposes. It should be noted that even though each of Figures 27a to 27h correspond to the respective Figures 28a to 28h of corresponding designating letter, the viewing angle is not always the same, in order to properly illustrate the relative positions of different parts of the testing system 400.

The oral fluid testing device is delivered to the user in an inactive state, as shown in Figures 27a and 28a. The details of different parts of the testing device 400 have been described in connection to e.g. Figures 23a, 23b and 24. As a first step, the user retracts and removes the sample collector 410 (Figures 27b and 28b). As an alternative, the sample collector may be delivered separately. Figures 27c and 28c illustrate that the sample collector before and after a sample has been taken, as previously described. The sample collection element 414 thus carries the sample, and the change in color of an indicator may be viewed through a detection viewing window 417. A device activation means is thereafter actuated. Once a sample has been obtained, the sample collector 410 is pushed into the top opening of the analysis unit (Figure 27d). As previously described in connection to Figures 25a and 25b, and further illustrated in Figure 28d, this will release the eluent solution from the eluent chamber 491 by actuation of the piston actuator 497, such that eluent flows into the mixing chamber 422 and dissolve the particle-antibody conjugate preparation. In some aspects, the user is thereafter instructed to wait a few minutes, e.g. between 1 to 5 minutes (Figures 27e and 28e). In other aspects, it may not be necessary to wait until proceeding. The sample collection element 414 will be immersed in the eluent solution and will react with the particleantibody conjugate in the mixing chamber 422.

Thereafter, to activate the analysis initiation means, the user rotates the top housing 421 around the longitudinal axis in relation to the bottom housing 441 , as shown in Figure 27f. As seen in the corresponding view of Figure 28f, this will cause the mixing chamber 422 to rotate within the support element 485, such that the side opening 486 of the support element 485 becomes aligned with the side opening 487 of the mixing chamber 422. The reacted mixture is then allowed to flow into the receptacle 442 (see Figure 24) and is applied to the test strips 448 (Figures 27g and 28g). Lateral flow is thus initiated, and once a specified time period is allowed to pass, the results can be seen in the viewing window (Figures 27h and 28h). The view in Figure 28h is seen from the opposite side of the testing device compared to Figures 28a-b, and 28d-g.

Other aspects of methods of using an oral fluid testing system as disclosed herein are described below. Some steps below are exemplary, and depend on the configuration of the system used, as detailed above.

Figures 6a-f and 7a-c illustrate the different steps of the method of use of an oral fluid testing system 100. Figure 6a illustrates the configuration as supplied to a user, i.e. before initiating use. Referring to Figure 6a-f and 7a-c, as well as Figures 3 to 5 for specific parts of the system, a method of using oral fluid testing system 100 may be initiated by holding the sample collector 110 and wiping or rolling the sample collection element 114 on the inside surfaces of a test subject mouth to collect saliva. Thereafter the sample collector 110 is inserted into the receiving opening 123 such that cutting element 128, or other suitable element, provided with the dried gold particle-antibody conjugate preparation 119, is pushed down by the sample collector and pierces the breakable seal 127 (Figure 7a and 7b).

Thereby, both the gold particle-antibody conjugate preparation 119 and the saliva sample on the sample collection element 114 are applied to an eluent solution present in the mixing chamber 122. A device activation means is thereby actuated. Alternatively, the dried gold particle-antibody conjugate preparation 119 may initially be provided in other locations, such as on the breakable seal 127, on a pad within the interior access channel 129, or in another location above the mixing chamber, as long as insertion of the sample collector provides access of an eluent in the mixing chamber 122 to the gold particle-antibody conjugate. It is also conceivable that the distal end of the sample collector may be configured to cut the breakable seal 127, and thus obviate the need for a separate cutting element.

The sample collector 110 and the sample receiving unit 120 are preferably configured such that a user pushes the sample collector 110 fully into the sample receiving unit 120, such that sample collector no longer protrudes from the top of the sample receiving unit 120, as seen in Figures 6d to 6f. Such an aspect may be achieved by adapting size and interacting surfaces between the sample collector 110 and the sample receiving unit 120. This provides confirmation to a user that sample collector 110 has been inserted far enough, and also prevents the user from accidently or intentionally pulling the sample collector 110 back out.

The oral fluid testing system 100 is thereafter held firmly in a user’s hand and shaken a specified time to dissolve the gold particle-antibody conjugate properly in the eluent and thereafter allowing it to react with the saliva sample (Figure 6d). Notably, the fact that the mixture, i.e. saliva sample and gold particle-antibody conjugate, is allowed to react for a specified amount of time before application to lateral flow test strips results in vastly improved results compared to traditional lateral flow test systems.

According to another aspect, when using the sample collector 210 as described above, in the oral fluid testing system 200, the effectiveness and usability of the test is greatly improved by first assuring that the dried gold particle-antibody conjugate preparation is properly dissolved in the eluent solution, and adding a delay in time before exposing it to the saliva sample. In addition, a further controlled delay after mixing the reaction mixture and before application to lateral flow test strips allows the saliva sample and gold particle-antibody conjugate mixture to react more completely application to lateral flow test strips. Thus, the results of the tests are very much improved using the disclosed sample collector and oral fluid testing system.

Figures 13a-g and 14a-e illustrate the different steps of a method of use of an oral fluid testing system 200. Referring to Figure 13a-g and 14a-e, as well as Figures 10a to 12 for specific parts of the system, a method of using the oral fluid testing system 200 is described. Figure 13a illustrates the configuration as supplied to a user, i.e. before initiating use. The oral fluid testing system 200 is preferably supplied to a user with the sample collector 210 inserted into the receiving opening 223. An eluent solution is provided in the front part of the eluent preparation chamber 211. A user may initiate sample taking by pulling out the sample collector 210 by the handle element 217 (Figures 13b and 14b). This will pull back the piston element 216 within the eluent preparation chamber 211 , exposing a dried gold particleantibody conjugate preparation to the eluent solution (as seen when comparing Figure 14a and 14b). A device activation means is thereby actuated. The user action of taking a saliva sample from a test subject’s mouth using the removed sample collector 210 (Figure 13c) generally allows enough time and movement to dissolve the gold particle-antibody conjugate preparation in the eluent. In some aspects, a user may dissolve the gold particle-antibody conjugate preparation in the eluent by shaking the sample collector 210 for a specified time. In other aspect, simple allowing a short amount of time to pass will dissolve the gold particleantibody conjugate preparation in the eluent.

Thus, once the sample collector 210 has been prepared, the sample collection pad 214 may be wiped or rolled on the inside surfaces of a test subject mouth to collect saliva. Thereafter the sample collector 210 is inserted into the receiving opening 223 (Figures 13d and 14c) such that the sample collection pad 214 is positioned within the mixing chamber 222. The user thereafter continues to press the handle into the sample receiving unit 220 coupled to the test unit 240 (Figures 13e and 14d). This will cause piercing protrusion 280 to break pierceable element 270, allowing fluid to flow from the eluent preparation chamber 211 into the mixing chamber 222 (as seen when comparing Figures 14c and 14d). Further, the piston element 216 continues to move forward, distally, in the eluent preparation chamber 211 , pushing the gold particle-antibody conjugate and eluent solution through the sample collection pad 214, thus rinsing out the saliva sample into the mixing chamber 222. This ensures an effective release of the saliva sample into the reaction mixture.

When providing the sample collector 210 with a sample pad mounting element 260 comprising an outer perforated surface 261 for arranging the sample collection pad 214, pushing the gold particle-antibody conjugate and eluent solution through perforated surface 261 and the sample collection pad 214 creates effective mixing of the components with the saliva sample through turbulence in the mixing chamber 222. Thus, no or very little manual shaking may be needed for mixing. However, the mixture is preferably allowed to react for a specified amount of time, before application to lateral flow test strips.

Furthermore, as there almost always will be a small amount of air trapped within the eluent preparation chamber 211 , when pushing out the eluent-conjugate solution using the piston element 216, especially when holding the system essentially upright, the air pocket is also emptied through the sample collection pad 214. This both enhances mixing in the mixing chamber and ensures releasing as much of the sample as possible from the sample collection pad 214 into the mixing chamber. Thus, very little amounts of the sample is left in the sample collection pad 214 or in the eluent preparation chamber 211 .

As illustrated in figures 6a-f, 7a-c, 13a-g and 14a-e, and described for different aspects above, using either oral fluid testing system 100 or 200, the saliva sample and gold particleantibody conjugate mixture is allowed to react a specified amount of time in a mixing chamber 122, 222 before application to lateral flow test strips. The application to lateral flow test strips is thereafter activated by a rotational actuating means.

Using the oral fluid testing systems 100, 200 described herein, rotational actuating means are activated to allow any fluid in the mixing chamber 122, 222 to be released into a test strip application receptacle 142, 242 of the test unit 140, 240 and thereby applied to a first end of any test strips arranged in a holding means 143, 243 of the test unit.

Hence, activating a rotational actuating means comprises rotating the sample receiving unit 120, 220 and test unit 140, 240 relative to each other around a longitudinal axis A.

In further aspects, activating a rotational actuating means, e.g. by rotating the sample receiving unit 120, 220 and test unit 140, 240 relative to each other around a longitudinal axis A, comprises actuating a penetrating element 145, 245 to penetrate a penetrable portion 125, 225 between the mixing chamber 122, 222 and the test strip application receptacle 142, 242 (Figures 7b-c and 14d-e). As detailed above, this causes an opening or rupture in the penetrable portion 125, 225 of the mixing chamber 122, 222, such that any fluid present in the mixing chamber 122, 222 is allowed to flow into the test strip application receptacle 142, 242.

As previously described, premounted test strips for lateral flow immunoanalysis are positioned with a sample application zone in the test strip application receptacle 142, 242. The lateral flow phase of the test is initiated by actuating the rotational actuating means, e.g. by rotating the two units in relation to each other. The actuating is further enabled by arranging adapted interacting surfaces on each unit, such as grooves, protrusions and various surface profiles. As an example, the sample receiving unit 120, 220 may be provided with a protrusion at a suitable point in the outer surface, and the test unit 140, 240 may be provided with a corresponding spirally arrange groove, such that on rotation, the two units also move longitudinally against each other.

Figure 15 shows yet another aspect of an oral fluid testing system 300 in perspective view.

The testing system 300 has an elongated shape and a longitudinal axis A, extending from a first end 10 to a second end 20 of the system and defining a proximal-distal direction. The overall shape of the system 300 is preferably adapted to lie flat on a surface, but may also be adapted to be comfortably held in a user’s hand. Thus, the oral fluid testing system is preferably adapted to be used in an orientation wherein the longitudinal axis A is essentially horizontal. For orientation purposes, the first end 10 may also be referred to as the proximal end, and the second end 20 referred to as the distal end herein. However, the device may be used in any orientation in relation to a user. Figures 15 shows a perspective view of one aspect of an oral fluid testing device 300, and Figure 16a shows a cross-sectional view of the device in an initial state of the system when provided for use.

Corresponding to previous aspects, the oral fluid testing system 300 comprises a sample collector, an analysis device 350, and a dried particle-antibody conjugate preparation 309 and an eluent solution, both arranged within the system. The analysis device 350 comprises the mixing chamber 307 and a first receiving opening 314 configured to provide access of the sample collector to the mixing chamber 307. Further, the analysis device 350 comprises holding means 311 for one or more test strips 316a for lateral flow analysis. The analysis device 350 is configured such that any test strips arranged in the holding means 311 are initially arranged to have a first end 316a of a test strip positioned such it is not in fluid connection with the mixing chamber 307. Details of how this may be achieved are described below.

The analysis device 350 also comprises a viewing means 303 for observing any results indicated on the test strips.

As is previous aspects, the oral fluid testing system 300 further comprises a device activation means adapted to activate the oral fluid testing system 300 for receiving the sample and performing the analysis of determining the presence of the analyte(s). The actuation of the device activation means allows the dried particle-antibody conjugate preparation 309 to come in contact with the eluent solution. Details of how this may be achieved are described below.

The oral fluid testing system 300 further comprises an analysis initiation means for allowing a fluid in the mixing chamber 307 to be applied to the first end 316a of the test strips in the holding means 311. Details of how this may be achieved are described below.

Figures 16a and 16b shows the oral fluid testing system 300 of Figure 15 in cross-sectional view along the longitudinal axis A of Figure, wherein Figure 16a depicts an initial state of the system when provided for use. Figures 17a-c, 18a-c and Figures 19a-c depict various cross- sectional views of aspects of specific features of an oral fluid testing system 300, however the overall configuration of an oral fluid testing system 300 disclosed herein is similar in any corresponding aspects not specifically described as being different.

For example, referring to Figure 16a, the oral fluid testing system 300 comprises an eluent preparation chamber 305, a mixing chamber 307, and an eluent channel 308 configured to fluidly connect the eluent preparation chamber 305 with the mixing chamber 307. The oral fluid testing system 300 further comprises a device activation means adapted to activate the oral fluid testing system 300 for receiving the sample and performing the analysis of determining the presence of the analyte(s). In all aspects disclosed in connection to Figures 15 to 21, an eluent reservoir 306a, 306b, 306c, 306d is arranged within or adjacent the eluent preparation chamber 305. The eluent reservoir 306a, 306b, 306c, 306d comprises the eluent solution, and is configured to release the eluent solution into the mixing chamber 307 upon actuation of the device activation means. When provided to a user, the eluent reservoir 306a, 306b, 306c, 306d is sealed, which ensures that the eluent initially provided in the eluent reservoir 306a, 306b, 306c, 306d is contained, and the dried particle-antibody conjugate preparation 309 kept dry, until the system is to be used.

According to the aspects disclosed in connection to Figures 15 to 21, the dried particleantibody conjugate preparation 309 is arranged anywhere within one or more of the eluent preparation chamber 305, the mixing chamber 307, and the eluent channel 308. When an oral fluid testing system 300 is provided to a user, the particle-antibody conjugate preparation 309 is provided as a dried preparation, and initially not in in contact with the eluent solution. In a preferred aspect, the particle-antibody conjugate preparation 309 is arranged on the bottom of mixing chamber 307, as will be described further below, and further detailed in Figures 15 to 22. However, several other placements are conceivable, such as in the eluent preparation chamber 305 and/or the eluent channel 308, as long as it is arranged such that it is initially separated from the eluent, i.e. before actuation of the device activation means.

The device activation means preferably comprises an actuator configured to activate release of the eluent solution from an eluent reservoir into the eluent preparation chamber. Various alternative arrangements of device activation means will be detailed herein, however all are compatible with and may be combined with any oral fluid testing system 300 as described herein. Some of the various arrangements of device activation means are illustrated in Figures 16a-b, 17a-c, 18a-c, and 19a-c. In one aspect, as illustrated in Figure 16a, the eluent reservoir 306a may be a sealed blister, or similar pierceable container, arranged above one or more piercing protrusions 317a arranged in the eluent preparation chamber 305. An activation push-button 302a is configured to activate release of the eluent solution from the blister 306a into the eluent preparation chamber 305 by pressing the eluent blister 306a against one or more piercing protrusions 317a provided within the eluent preparation chamber 305.

A top view of an eluent preparation chamber 305 with piercing protrusions 317a is seen in Figure 22, wherein the eluent blister 306a and activation push-button 302a have been removed for clarity.

Thus, when user is ready to use the oral fluid testing system 300, the user presses down on activation push-button 302a, which breaks the blister and the eluent solution flows into the eluent preparation chamber 305, thereafter into the eluent channel 308 and further into the mixing chamber 307. Figure 16a illustrates an oral fluid testing system 300 before activating the system, and Figure 16b illustrates the system once a user has pressed down the activation button 302a, as shown by the dashed arrow. Figure 16b also shows an actuated manual analysis initiation means 313, which will be further detailed below.

The activation push-button 302a is shown in Figures 16a and 16b to be an essentially cylindrical shape, and the eluent preparation chamber 305 is also an essentially cylindrical shape. However, any cross-sectional shape of the activation push-button 302a and eluent preparation chamber 305 are conceivable, as long as they are matching shapes, to ensure effective pressing against the blister 306a. Further, the fit between the activation push-button 302a and the eluent preparation chamber 305 is preferably such that fluid cannot escape out of the device, e.g. past the button 302a. In some aspects, a fluid tight seal may be applied between the activation push-button 302a and the eluent preparation chamber 305.

In another aspect, illustrated in Figures 17a, 17b and 17c, a device activation means comprises a rotary knob 302b for activation of the oral fluid testing system 300. Also in this aspect, the eluent reservoir 306b may be a sealed blister, or similar pierceable container, arranged above one or more piercing protrusions 317b arranged in the eluent preparation chamber 305. A rotary knob 302b is configured to be rotated by a user and thus activate release of the eluent solution from the eluent reservoir 306b into the eluent preparation chamber 305 by pressing the eluent reservoir 306b against the one or more piercing protrusions 317b.

In another aspect, illustrated in Figures 18a, 18b and 18c, a device activation means comprises a rotary knob 302c for activation of the oral fluid testing system 300. Figure 18a illustrates a distal half of an oral fluid testing system 300 before activating the system, and Figure 18b illustrates the system in a semi-activated state. Figure 18c illustrates the same oral fluid testing system 300 as seen from a distal direction, once a user has fully actuated the rotary knob 302c. In this aspect, rotary knob 302c comprises the eluent reservoir 306c within the rotary knob 302c itself, i.e. the eluent reservoir 306c is a hollow space within the rotary knob 302c. The bottom of the eluent reservoir 306c is preferably a suitable pierceable element 320, such as a membrane or weakened layer of material. The pierceable element 320 is arranged above one or more piercing protrusions 317c arranged in the eluent preparation chamber 305.

In some aspects, e.g. as shown in Figures 17a, 17b, and 17c, or in Figures 18a, 18b and 18c, a rotary knob 302b, 302c preferably has an essentially cylindrical shape, and the eluent preparation chamber 305 is also an essentially cylindrical shape, to allow easy rotation of the knob within the chamber. Further, the fit between the rotary knob 302b, 302c and the eluent preparation chamber 305 is preferably such that fluid cannot escape out of the device, e.g. past the rotary knob 302b, 302c. In some aspects, a fluid tight seal may be applied between the two parts.

The rotation of rotary knob 302b, 302c causes the knob to move a specified distance further into the eluent preparation chamber 305, i.e. along a central axis of the cylindrical knob. This may be, as seen in Figures 17a, 17b and 17c, or in Figures 18a, 18b and 18c, actuated by providing e.g. a protrusion 318a on the rotary knob 302b, 302c, along the outer sides of the cylindrical knob. The protrusion 318a is adapted to interact with a corresponding spirally arranged groove 318b in the sidewall of the eluent preparation chamber 305, such that rotation also causes axial movement of the rotary knob 302b, 302c. Other arrangements of interacting surface profiled may be used, such as threads etc.

Thus, when user is ready to use the oral fluid testing system 300, the user rotates activation rotary knob 302b, 302c, which breaks the blister 306b or pierceable element 320, respectively, and the eluent solution flows into the eluent preparation chamber 305, thereafter into the eluent channel 308 and further into the mixing chamber 307.

A further aspect of a device activation means is illustrated in Figures 19a, 19b, and 19c. This aspect has many similarities to the previous aspects. A rotary knob 302d is provided for activation of the oral fluid testing system 300. Figure 19a illustrates a distal half of an oral fluid testing system 300 before activating the system, and Figure 19b illustrates the system in a semi-activated state. Figure 19c illustrates the same oral fluid testing system 300 as seen from a distal direction, once a user has fully actuated the rotary knob 302d. In this aspect, rotary knob 302d comprises the eluent reservoir 306d within the rotary knob 302d itself, i.e. the eluent reservoir 306d is a hollow space within the rotary knob 302d. In this aspect, a bottom wall 322 is provided for initial containment of the eluent in the eluent reservoir 306d. Either the bottom wall 322 itself or a bottom part of the cylindrical sidewalls of the eluent reservoir 306d are provided with a weakened circumferential or semi-circumferential tearable portion 321, such as a membrane or weakened layer of material. The eluent preparation chamber 305 is provided with corresponding penetrating or tearing protrusions 317d. Tearing protrusions 317d mat e.g. be sharp and/or pointed, or comprise a hook shape, such that rotation of rotary knob 302d within the eluent preparation chamber 305 will cause rupture of the tearable portion 321, allowing the eluent to flow out into the eluent preparation chamber 305.

Similar to previous aspects, e.g. as shown in Figures 19a, 19b and 19c, the rotary knob 302d preferably has an essentially cylindrical shape, and the eluent preparation chamber 305 is also an essentially cylindrical shape, to allow easy rotation of the knob within the chamber. Further, the fit between the rotary knob 302d and the eluent preparation chamber 305 is preferably such that fluid cannot escape out of the device, e.g. past the rotary knob 302d. In some aspects, a fluid tight seal may be applied between the two parts.

The rotary knob 302d may initially be provided in an essentially fully inserted position within the eluent preparation chamber 305, as shown in Figure 19a. As an alternative, the rotary knob 302d may be provided in a semi-inserted position within the eluent preparation chamber 305, and/or such that a bottom wall 322 is positioned a distance above the bottom of the eluent preparation chamber 305. As mentioned, rotation of rotary knob 302d within the eluent preparation chamber 305 will cause rupture of the tearable portion 321.

Thus, when user is ready to use the oral fluid testing system 300, the user rotates activation rotary knob 302d, which breaks the tearable portion 321, and the eluent solution flows into the eluent preparation chamber 305, thereafter into the eluent channel 308 and further into the mixing chamber 307.

In the aspects disclosed in connection to Figures 15 to 21 comprising a rotary knob, the rotary knob 302b, 302c, 302d may preferably be provided with a gripping handle 319, for the user to grip and rotate. As an example of the procedure, Figure 17b, 18b and 19b shows aspects when the knob 302b, 302c, 302d, respectively, has been rotated 90 degrees from the initial position in Figure 17a, 18a, or 19a, respectively. In some aspects, the rotary knob 302b, 302c has moved partly down into the eluent preparation chamber 305. In other aspects, the rotary knob 302d has not moved axially within the eluent preparation chamber 305, as the activation of the system, i.e. the release of the eluent into the mixing chamber, is actuated by side penetration, instead of penetration from the bottom direction.

Figure 17c, 18c, 19c shows when the knob 302b, 302c, 302d has been rotated a further distance in each respective aspect. The specific rotational angle needed to execute release of the eluent may be varied in different aspects. In some aspects, the rotary knob 302b, 302c has thus moved fully into the eluent preparation chamber 305, as seen in Figures 17c and 18c, and the eluent reservoir 306b, 306c has been opened by piercing. In the case of the aspect of Figure 19c, the rotation of the rotary knob 302d has caused tearing protrusions 317d to break open the tearable portion 321. Thus, in all three aspects, the eluent reservoir 306b, 306c, 306d has been opened, allowing fluid to flow out into the eluent preparation chamber 305, into the eluent channel 308 and further into the mixing chamber 307.

Further, the rotary knob 302b, 302c, 302d, respective eluent reservoir 306b, 306c, 306d and the eluent preparation chamber 305 may be arranged such that a specified angle of rotation of the knob is needed for release of the eluent. For example, as seen in each illustrated sequence of events, as seen in Figures 17a-c, Figures 18a-c, or Figures 19a-c, a total of approximately 180 degree rotation of the rotary knob 302b, 302c, 302d may move the rotary knob essentially to a position in the eluent preparation chamber 305 wherein the initially sealed eluent reservoir 306b, 306c, 306d has been ruptured. The activation means may be configured such that this corresponds to the knob reaching the bottom of the eluent preparation chamber 305, or, for example, that specific stop protrusions in the chamber or on the rotary knob are provided. The user is then provided with a clear indication that the eluent reservoir 306b, 306c is emptied and the system properly activated.

In addition to the illustrated and above described aspects of a device activation means, it is also conceivable to arrange a device activation means in another orientation, e.g. such that it may be actuated from the distal and second end 20 of the oral fluid testing system, or from one or the other sides of the oral fluid testing system. For example, a suitable actuator, such as a rotary or push-activated knob, button or lever, may be arranged on the distal and second end 20 of the oral fluid testing system, i.e. protruding in a direction along the longitudinal axis A. Such an actuator may be arranged to pierce or break an eluent reservoir, similar to the examples of Figures 16a to 19c, or otherwise release an eluent from an eluent reservoir.

In preferred aspects of an oral fluid testing system disclosed in connection to Figures 15 to 21 , a dried gold particle-antibody conjugate preparation 309 may be arranged on the bottom of mixing chamber 307. Referring to e.g. Figures 15-18, once the device activation means has been activated by the user, the released eluent will flow into the mixing chamber 307, and the particle-antibody conjugate preparation 309 will dissolve in the eluent. The dried particle-antibody conjugate preparation 309 is thus adapted to be dissolved in an eluent solution within the eluent preparation chamber 305, when the device activation means is activated, and prior to sample application in an oral fluid testing system. To allow the particleantibody conjugate preparation to fully dissolve in an applied eluent, before the saliva sample is added, provides for increased efficiency of the test reaction and improved results. This is contrast to known lateral flow immunoassay strips and devices, where sample is commonly allowed direct access to a conjugate pad containing a particle-antibody conjugate, or applied at the same time as dissolving a gold particle-antibody conjugate preparation in an eluent solution. The presently disclosed system and method ensures complete dissolution and distribution of the particle-antibody conjugate preparation before introducing the saliva sample. To further illustrate the different parts of an oral fluid testing system, Figure 20 shows an exploded view of the oral fluid testing system of Figure 15, e.g. before use. Figure 21 shows an exploded side view of the oral fluid testing system of Figure 15. As seen in e.g. Figures 15-21 , the oral fluid testing system 300 further comprises a sample collector channel 310 configured to hold a sample collector 330, e.g. a swab, such that a distal sample end of the swab is positioned in the mixing chamber 307. For clarity, the sample collector 330 itself is only illustrated in Figures 20 and 21. The proximally oriented first receiving opening 314 provides access of the sample collector 330 to the sample collector channel 310 and thus to the mixing chamber 307. A sample collector 330 may be any suitable collector swab comprising an absorbent swab or pad made of any suitable porous material capable of absorbing and releasing a sample of e.g. saliva from a subject. Regardless of material, the sample collector 330 should preferably not comprise a material that would bind any of the intended target substances to any extent that would hinder the efficiency of the analysis. As will be further detailed later, the sample collector 330, once inserted fully into the oral fluid testing system 300, will immerse the distal absorbent swab or pad in the eluent containing particle-antibody conjugate preparation in the mixing chamber 307.

In some aspects disclosed in connection to Figures 15 to 21 , the oral fluid testing system 300 is provided to the user with a sample collector 330 adapted for collection of a saliva sample and insertion into said sample collector channel 310.

A sample collector 330 is preferably adapted to effectively be twirled or spun once inserted into the mixing chamber 307, to enhance the release of a sample on the swab into a fluid in the mixing chamber 307. For instance, the elongated portion of a sample collector 330 could be made in a robust but flexible material and preferably with a proximal end adapted to be easily spun between a user’s fingers. Further, in some aspects disclosed in connection to Figures 15 to 21 , the mixing chamber 307 could be provided with one or more protrusions (not illustrated) to create turbulence when a swab is spun within the mixing chamber 307, enhancing the release of the sample into a fluid in the mixing chamber 307.

It is also conceivable that a sample collector channel or insertion opening in general may be configured with other orientations in relation to the device, as long as a sample collector 330 can be inserted such that a distal sample end of the swab is positioned in the mixing chamber 307. For example, the oral fluid testing system could be configured such that the sample collector is inserted from a side, from the top or even from any acute angle in relation to the longitudinal axis A of the elongated device. Other parts of the device might have to be repositioned to obtain the intended functions and analysis procedure described herein. The oral fluid testing system 300 further comprises a test strip compartment 311, configured to hold one or more test strips 316 for lateral flow analysis such that a sample zone end 316a of such test strips 316 is initially positioned adjacent and outside of the mixing chamber 307.

Lateral flow test strips 316 are preferably provided in the test strip compartment 311. In some aspects disclosed in connection to Figures 15 to 21 , the oral fluid testing system 300 is provided to the user with one or more test strips 316 for lateral flow analysis already arranged in the test strip compartment 311. The test strip(s) 316 are then positioned such that a sample zone end 316a of the test strips 316 are initially positioned adjacent and outside of the mixing chamber 307, as illustrated in e.g. Figures 16a, 17a, 18a, 19a. As may be understood for the figures, test strips would initially be arranged essentially flat within the test strip compartment 311, with the distal sample zone end(s) 316a hanging free above the mixing chamber 307. This is illustrated for instance in Figures 20 and 21 , which show exploded views of an oral fluid testing system 300 according to the aspects of Figures 15 and 16.

In other aspects disclosed in connection to Figures 15 to 21 , a user may insert test strips 316 into the test strip compartment 311 via an insertion opening before use (not illustrated).

The lateral flow analysis strips 316 are provided with a sample application zone 316a, an optional conjugate pad, one or more test zones and a control zone, as described above. The sample application zone is initially arranged above the mixing chamber 307.

As mentioned, in the aspects disclosed in connection to Figures 15 to 21, a dried particleantibody conjugate preparation 309 may be arranged anywhere within one or more of the eluent preparation chamber 305, the mixing chamber 307, and the eluent channel 308. In one aspect, the dried particle-antibody conjugate preparation 309 is provided in the mixing chamber 307, as illustrated in e.g. Figures 16a, 18a, 19a, 20a. However, it may also be supplied on a wall or bottom of the eluent preparation chamber 305 and/or eluent channel 308, on a pad or as a granulate within any of the chambers or eluent channel, as long as a released eluent will effectively dissolve the preparation on activation of the system. The particle-antibody conjugate preparation 309 is provided such that it is initially not in in contact with the eluent solution. As mentioned, the eluent solution is initially provided, i.e. prior to activation, in an eluent reservoir 306a, 306b, 306c, 306d arranged within or adjacent the eluent preparation chamber 305.

In preferred aspects, the particle-antibody conjugate preparation 309 comprises gold particles. Alternatively, the particles may be any suitable metal, latex or carbon particles, as long as the particles are capable of conjugating with the chosen antibody. Depending on the chosen particle, a color band may result when using test strips for lateral flow immunoassay. In other aspects, colouring reagents may be necessary. For ease of description, the aspects herein are described as utilizing gold particles, but these may be substituted for any suitable particle.

As mentioned, the antibodies of the particle-antibody conjugate preparation are selected to react against the desired analyte to be detected in the oral fluid testing system, conjugated with nanoparticles and dried according to standard practice. The dried particle-antibody conjugate preparation comprises one or more types of antibodies against the desired analyte(s). The preparation is prepared by drying the particle-antibody conjugate, preferably with suitable stabilizing agents and/or agents to make it readily soluble.

Further, the oral fluid testing system 300 comprises manual analysis initiation means. When actuated by a user, the analysis initiation means moves the sample zone ends 316a of the one or more test strips 316 from the initial position adjacent and outside of the mixing chamber 307 into a position wherein the sample zones are located in the mixing chamber 307. This is illustrated in e.g. the difference between Figure 16a and 16b, or Figure 17b and 17c.

The fluid applied to the sample zone 316a of the test strips will thus travel along the strip, i.e. towards a proximal end 10 of the system, past one or more test line(s) 316b in a test zone, each supplied with an immobilized specific antibody, antigen or other binding receptor against the analyte to detect presence of a desired analyte in the sample. A control line 316c, placed after (proximally of) the test line(s) 316b, will capture all antibodies, and indicate that the sample has flown properly through the different parts if the strip.

In some aspects, the manual analysis initiation means comprises an analysis initiation actuator 313, adapted to move the sample zone end 316a of any one or more test strips 316 present in the test strip compartment 311 into the mixing chamber 307. Examples of an actuated analysis initiation actuator 313 is seen in Figures 16b and 17c. The actuator 313 may be provided as a suitable button, knob, toggle switch, etc. Further, it may be provided as a hinged section of the housing, as seen in Figures 16b and 17c.

As is understood from comparing e.g. Figures 16a and 16b, if one or more test strip(s) 316 are provided in the test strip compartment 311 , and a user presses down on the hinged section forming an analysis initiation actuator 313, the distal sample zone end 316a of the of the test strip(s) will be pushed into the mixing chamber 307. Thus, any fluid in the mixing chamber 307 is applied to such test strip 316, and lateral flow along the test strip is initiated.

As is further understood from the above, and illustrated in the figures, the oral fluid testing system 300 is preferably adapted to be used in an orientation wherein the longitudinal axis A is essentially horizontal, and wherein the eluent preparation chamber 305 is located near the second end 20. The sample collector channel 310 is provided with an opening 314 configured for insertion of a sample collector from the first end 10. The mixing chamber 307 is thus positioned such that the sample collector channel 310 is arranged on an essentially opposite side of the mixing chamber 307 from said eluent channel 308. This allows easy insertion of a sample collector 330 through the sample collector channel 310 such that a distal swab end of the sample collector 330 enters into the mixing chamber 307 on a separate side of the mixing chamber 307 in relation to the eluent channel 308.

The oral fluid testing system 300 comprises viewing means 303 for observing any results indicated on any test strips 316 positioned in the test strip compartment 311. Such viewing means may be any suitable window or opening, as long as the test lines 316b and control line 316c are visible from the outside of the system. For example the viewing means 303 may an open window in a housing, as illustrated in Figures 15, 16a-b, 17a-c, 18a-c, 19a-c or 20, or as an alternative, slots along at least part of a housing (not illustrated). In other aspects, the viewing means 303 may be a transparent part of a housing, such as a transparent window in an otherwise non-transparent housing.

Further, in aspects disclosed in connection to Figures 15 to 21, the mixing chamber 307 is preferably provided with a pierceable cover 312, as seen in Figures 16a and 16b. In such aspects, when initially providing the oral fluid testing system 300 to a user, the test strip compartment 311 is configured to hold the one or more test strips 316 such that a sample zone 316a of such test strips 316 is initially positioned adjacent, i.e. above, the pierceable cover 312 and thus outside and shielded from the mixing chamber 307. The analysis initiation actuator 313 comprises a piercing element 315 configured to both push the test strips down and pierce or cut the pierceable cover 312 when the analysis initiation actuator 313 is actuated.

As seen in e.g. Figures 15-20, an oral fluid testing system 300 further preferably comprises a housing 301 adapted to enclose at least the eluent preparation chamber 305, the mixing chamber 307, and the test strip compartment 311. The housing may also form other parts of the system, such as the analysis initiation actuator 313 described above. As shown in Figures 20 and 21 , illustrating perspective and side views of an exploded view of the oral fluid testing system 300, the housing 301 may be formed of two or more customized parts, e.g. a lid portion 301a, a middle portion 301b and a base portion 301c. The different housing portions are adapted to attach to each other, such that when assembled, the eluent preparation chamber 305, the mixing chamber 307, the sample collector channel 310 and the test strip compartment 311 are all formed by the assembled housing portions 301a, 301b, 301c.

A method of using an oral fluid testing system 300 for determining the presence of an analyte in a sample is further disclosed herein. Such method may preferably be used with an oral fluid testing system generally as disclosed herein. One advantage of using the disclosed systems and methods is that a relatively small volume of saliva is required, due to the delay between reaction of the saliva sample with the gold-antibody conjugate preparation and the application of the sample to a lateral flow assay strip. Further, essentially the entire taken sample is effectively used for the testing procedure.

A method of using an oral fluid testing system for determining the presence of an analyte in a sample comprises the steps of activating an oral fluid testing system by actuating a device activating means to release an eluent solution from an eluent reservoir into an eluent preparation chamber, allowing the eluent solution to flow through an eluent channel from the eluent preparation chamber to the mixing chamber, allowing a particle-antibody conjugate preparation to dissolve in the eluent solution, inserting a sample collector into a sample collector channel such that a distal sample end of said sample collector is positioned in the mixing chamber, allowing any sample on the sample collector to react in the mixing chamber with the particle-antibody conjugate and eluent solution, actuating a manual analysis initiation means, such that sample zone ends of any one or more test strips present in a test strip compartment are moved from an initial position adjacent and outside of the mixing chamber into a position wherein the sample zones are positioned in the mixing chamber, thereby initiating a lateral flow analysis on the one or more test strips.

The method disclosed is preceded by a sample taking step, which depends on the sample collector used. Various further aspects of methods of using an oral fluid testing system as disclosed herein are described below. As described previously, the particle-antibody conjugate preparation 309 is preferably provided in the mixing chamber 307. However, it may also be provided in the eluent preparation chamber 305 and/or the eluent channel 308. In some aspects, once the system has been activated by releasing the eluent, a user may be instructed to wait for a short period of time to allow full dissolution of the particle-antibody conjugate preparation 309. Thereafter, the sample collector 330 with a saliva sample is inserted and mixed with the eluent and particle-antibody conjugate preparation in the mixing chamber 307. An advantage if the system is to allow the eluent to fully dissolve the particle-antibody conjugate preparation before adding the saliva sample.

Further, the system allows for the saliva sample to react fully before applying the mixture to the strip(s). In some aspects, once the sample has been added via the sample collector, a user may be instructed to wait for a short period of time before actuating the manual analysis initiation means. For instance, a user may be instructed to wait for a specified time period, such as 30, 60 or 90 seconds, allowing the saliva sample and the gold particle-antibody conjugate preparation to react.

As previously described, premounted test strips for lateral flow immunoanalysis are positioned with a sample application zone 316a initially above the mixing chamber. The lateral flow phase of the test is initiated by actuating the manual analysis initiation means. The lateral flow phase of the test is finished once the control lines are visible on the test strip(s).

Once the lateral flow phase of the test has been allowed to occur, the user may view the results of the lateral flow analysis on the one or more test strips 316 through a viewing means 303 for observing any results indicated on the test strips 316 positioned in the test strip compartment 311.

As described previously, actuating the manual analysis initiation means may comprise moving a piercing element 315 to pierce or cut a pierceable cover 312 separating the one or more test strips 316 and the mixing chamber 307, and thereby press the sample zone ends 316a of the one or more test strips 316 into a position wherein the sample zones are positioned in the mixing chamber 307.

The herein described oral fluid testing systems 100, 200, 300, 400 have many features in common, and are based on the same general principle of use. The configuration of the various units and the analysis initiation means provide an easy to use system that guides the user through the steps, and provides quick and reliable results even for someone not experienced in these types of tests. One advantage of the disclosed systems is that a relatively small volume of saliva is required, due to both that the entire taken sample is effectively used for the testing procedure, and the delay between reaction of the saliva sample and the gold-antibody conjugate preparation and the application of the sample to a lateral flow assay strip. A further advantage when using device activation means is that the dried particle-antibody conjugate preparation is allowed to efficiently dissolve after activation of the oral fluid testing device, and in connection with the step of taking a sample form a subject’s mouth. Yet another advantage when using e.g. the sample collector 210 or 410 is the efficient rinsing of the saliva sample from the sample collector and simultaneous mixing of the sample in the mixing chamber. The present invention is not limited to the above-described preferred embodiments. Various alternatives, modifications and equivalents may be used. Therefore, the above embodiments should not be taken as limiting the scope of the invention, which is defined by the appending claims.

Claims

1. A testing system (100, 200, 300, 400), for collecting a sample and determining the presence of one or more analyte(s) in said sample, said testing system (100, 200, 300, 400) having a longitudinal axis A extending from a first end (10) to a second end (20) of the system and defining a proximal-distal direction, said testing system (100, 200, 300, 400) comprising a sample collector (110, 210, 330, 410), an analysis device (150, 250, 350, 450), a dried particle-antibody conjugate preparation (219, 309, 419) arranged within said testing system (100, 200, 300, 400), an eluent solution provided within said testing system (100, 200, 300, 400), wherein said analysis device (150, 250, 350, 450) comprises a mixing chamber (122, 222, 307, 422), a first receiving opening (123, 223, 314, 423) adapted to receive said sample collector (110, 210, 410), said first receiving opening (123, 223, 314, 423) configured to provide access of the sample collector (110, 210, 310, 410) to the mixing chamber (122, 222, 307, 422), a holding means (143, 243, 311, 443) for one or more test strips (148, 248, 316, 448) for lateral flow analysis, the analysis device (150, 250, 350, 450) being configured such that any test strips arranged in said holding means (143, 243, 311 , 443) are initially arranged to have a first end of a test strip (148, 248, 316a, 448) positioned such it is not in fluid connection with said mixing chamber (122, 222, 307, 422), a viewing means (144, 244, 303, 444) for observing any results indicated on said test strips (148, 248, 316, 448), wherein said dried particle-antibody conjugate preparation (219, 309, 419) is arranged within said testing system (100, 200, 300, 400) such that said particle-antibody conjugate preparation (219, 309, 419) initially is not in contact with said eluent solution, wherein said testing system (100, 200, 300, 400) further comprises a device activation means adapted to activate said testing system (100, 200, 300, 400) for receiving the sample and performing the analysis of determining the presence of the analyte(s), wherein actuation of the device activation means causes said dried particle-antibody conjugate preparation (219, 309, 419) to come in contact with the eluent solution, and wherein said testing system (100, 200, 300, 400) further comprises an analysis initiation means for allowing a fluid in said mixing chamber (122, 222, 307, 422) to be applied to said first end of the test strips (148, 248, 316a, 448) in said holding means (143, 243, 311 , 443).

2. A testing system (100, 200, 400), according to claim 1, wherein the analysis device (150, 250, 450) comprises a sample receiving unit (120, 220, 420), and a test unit (140, 240, 440), said test unit (140, 240, 440) configured to be joined together with the sample receiving unit (120, 220, 420), wherein said test unit (140, 240, 440) is joined together with said sample receiving unit (120, 220, 420) such that the sample receiving unit (120, 220, 420) and test unit (140, 240, 440) are able to rotate relative to each other around the longitudinal axis A, to actuate said analysis initiation means, such that any fluid in said mixing chamber (122, 222, 307, 422) is applied to said first end of any test strips (148, 248, 316a, 448) arranged in said holding means (143, 243, 311 , 443).

3. The testing system (100, 200, 400) according to any preceding claim, wherein said sample receiving unit (120, 220, 420) comprises a first housing element (121, 221 , 421) comprising said first receiving opening (123, 223, 423), adapted to receive said sample collector (110, 210, 410), said first receiving opening (123, 223, 423) configured to provide access of the sample collector (110, 210, 410) to the mixing chamber (122, 222, 422), said first receiving opening (123, 223, 423), being proximally oriented, wherein said test unit (140, 240, 440) comprises a second housing element (141 , 241 , 441) comprising a proximally oriented second receiving opening (147, 247, 447) arranged to receive said sample receiving unit (120, 220, 420) and to enclose at least a lower end of said mixing chamber (122, 222, 422), said second housing element (141, 241 , 421) further forming a test strip application receptacle (142, 242, 442) distally and outside of said mixing chamber (122, 222, 422), wherein said second housing element (141, 241 , 441) further comprising said holding means (143, 243, 443) for one or more test strips (148, 248, 448) for lateral flow analysis, said holding means (143, 243, 443) configured such that any test strips arranged in said holding means (143, 243, 443) are arranged to have a first end of a test strip (148, 248, 448) positioned in said receptacle (142, 242, 442), wherein said second housing element (141, 241 , 441) further comprises said viewing means (144, 244, 444) for observing any results indicated on said test strips (148, 248, 448), and wherein said analysis initiation means comprises rotational actuating means for allowing a fluid in said mixing chamber (122, 222, 422) to be released into said test strip application receptacle (142, 242, 442) and thereby applied to a first end of any test strips (148, 248, 448) arranged in said holding means (143, 243, 443).

4. The testing system (400) according to any preceding claim, wherein said device activation means is provided in that the testing system (400) is further provided with an eluent chamber (491) wherein said eluent solution is initially provided, said eluent chamber (491) comprising a proximal end (492) and a distal end (493), said eluent chamber (491) comprising a distal opening (495) for allowing fluid to flow through, an eluent piston (496) arranged within said eluent chamber (491), the eluent piston (496) being configured to pull or push fluid in said eluent chamber (491) through the distal opening (495), a piston actuator (497) connected to said eluent piston (496), arranged for operating said eluent piston (496) within said eluent chamber (491).

5. The testing system (400) according to claim 4, wherein said piston actuator (497) operatively arranged such that a longitudinal movement of said sample collector (410) relative to the analysis device (450) will actuate said eluent piston (496) to push fluid in said eluent chamber (491) through the distal opening (495) into said mixing chamber (422).

6. The testing system (400) according to claim 4 or 5, wherein said eluent chamber (491) is provided with a pierceable element (470) arranged to initially close said distal opening (495), and said eluent piston (496) is provided with a piercing element (471) at its distal end, arranged such that when said eluent piston (496) is actuated, said piercing element (471) will pierce said pierceable element (470), and any fluid within said eluent chamber (491) will be pushed out from said eluent chamber (491) through said distal opening (495).

7. The testing system (400) according to any preceding claim, wherein said analysis initiation means is provided in that said testing system (400) further comprises a support element (485) arranged to support and partially enclose a distal part of said mixing chamber (422), wherein the support element (485) comprises a first side opening (486), wherein said mixing chamber (422) comprises a second side opening (487), preferably arranged near a bottom or distal end of said mixing chamber (422), wherein said first and second side openings (486, 487) are adapted to be arranged in a first position relative to each other, wherein the first and second side openings (486, 487) do not overlap each other, and wherein any fluid within the mixing chamber (422) is essentially contained within said mixing chamber (422), wherein said first and second side openings (486, 487) are further adapted to be moved to a second position relative to each other, wherein the first and second side openings (486, 487) at least partly overlap each other, and wherein actuation of the analysis initiation means causes the first and second side openings (486, 487) to move from the first position to the second position.

8. The testing system (100, 200, 300, 400) according to any preceding claim, wherein said sample collector (410) is elongated along a longitudinal axis C and comprises a proximal end (412) and a distal end (413), said sample collector (410) further comprising a sample collection element (414) provided at the distal end (413) and arranged with an outwardly exposed surface for obtaining a sample, a sample detection means for confirming that a predetermined amount of sample is obtained, said sample detection means comprising a detection strip (415) comprising a visual indicator, wherein said sample collection element (414) is arranged to be in fluid connection with said detection strip (415), such that when the sample collection element (414) is sufficiently wetted with a predetermined volume of fluid sample, a small volume of the fluid sample is pulled from the sample collection element (414) into the detection strip (415) by capillary force, and the visual indicator activated to indicate that a sufficient volume of fluid sample is obtained.

9. The testing system (100, 200) according to claim 3, wherein said analysis initiation means is provided in that said sample receiving unit (120, 220) further comprises a penetrable portion (125, 225) in said lower end of said mixing chamber (122, 222), and wherein said analysis initiation means comprises rotational actuating means comprising a penetrating element (145, 245) arranged in said test unit (140, 240) and adapted to penetrate said penetrable portion (125, 225) when said first housing element (121 , 221) is rotated relative to said second housing element (141, 241) around said longitudinal axis A, and wherein the penetration of the penetrable portion (125, 225) results in any fluid present in the mixing chamber (122, 222) being allowed to flow into said test strip application receptacle (142, 242).

10. The testing system (100, 200, 400) according to any of claims 3 to 9, wherein said first housing element (121 , 221 , 421) further comprises a first outer gripping surface (126, 226, 426), and said second housing element (141 , 241 , 441) comprises a second outer gripping surface (146, 246, 446), and said analysis initiation means is configured to be activated by a user by gripping said first and second gripping surfaces and rotating said sample receiving unit (120, 220, 420) and said test unit (140, 240, 440) relative to each other around the longitudinal axis A.

11. The testing system (100, 200, 400) according to any of claims 3 to 10, wherein said second housing element (141, 241 , 441) comprises a first portion (141a, 241a, 441a) comprising the holding means (143, 243, 443) for one or more test strips (148, 248, 448) and forming the test strip application receptacle (142, 242, 442), and a second portion (141b, 241b, 441b) comprising the second receiving opening (147, 247, 447) for the receiving the sample receiving unit (120, 220, 420), said first portion (141a, 241a, 441a) and second portion (141b, 241b, 441b) of the second housing element (141 , 241 , 441) are adapted to attach to each other to form the test unit (140, 240, 440).

12. The testing system (100) according to any of claims 3 to 11 , wherein said first housing element (121) of sample receiving unit (120) comprises an elongated interior access channel (129) extending into the sample receiving unit (120) from said first receiving opening (123), and said first housing element (121) further comprising a breakable seal

(127), arranged anywhere within the sample receiving unit (120) such that said elongated interior access channel (129) is initially sealed from the mixing chamber (122).

13. The testing system (100) according to claim 12, further comprising a cutting element

(128), slidingly mounted within said interior access channel (129), configured to be pushed towards and break said breakable seal (127).

14. The testing system (100, 200, 300, 400) according to any preceding claim, wherein said sample collector (210) is elongated along a longitudinal axis B and comprises a proximal end (212) and a distal end (213), said sample collector (210) further comprising a barrel shaped eluent preparation chamber (211) extending along said longitudinal axis B, and comprising a distal opening (215) for allowing fluid to flow through, a sample collection pad (214), arranged adjacent the distal opening (215) of said eluent preparation chamber (211) and in fluid communication with said eluent preparation chamber (211) through said distal opening (215), and wherein the sample collection pad (214) is arranged with an outwardly exposed pad surface for obtaining a sample, a piston element (216) arranged to be applied from a proximal end (212) of and into said eluent preparation chamber (211), wherein said piston element (216) is further adapted to be slidingly moved back and forth within said eluent preparation chamber (211), and configured to pull or push fluid in said eluent preparation chamber (211) through the distal opening (215) and through the sample collection pad (214), a handle element (217) connected to said piston element (216), arranged for operating said piston element (216) within said eluent preparation chamber (211), wherein the testing system (100, 200, 300, 400) is configured such that the device activation means is actuated when the handle element (217) of the sample collector (210) is pulled proximally or pushed distally, to allow said dried particle-antibody conjugate preparation (219, 309, 419) to come in contact with the eluent solution.

15. The testing system (100, 200, 300, 400) according to claim 14, wherein said dried particle-antibody conjugate preparation (219) is provided within the eluent preparation chamber (211) and in a location proximal of the distal end of the piston element (216) before the device activation means is actuated, such that activation of said device activation means comprises retraction of the piston element (216) in a proximal direction, exposing the particle-antibody conjugate preparation (219, 309, 419) to the eluent solution.

16. The testing system (100, 200, 300, 400) according to claim 15, wherein the dried particle-antibody conjugate preparation (219) is provided in a recessed portion or opening of an inner wall of the eluent preparation chamber (211).

17. The testing system (100, 200, 300, 400) according to any of claims 14 to 16, further comprising a pierceable element (270) arranged to close said distal opening (215), such that when pierced, any fluid within said eluent preparation chamber (211) may be pushed out from the eluent preparation chamber (211) through said distal opening (215) and through the sample collection pad (214) by operating the piston element (216).

18. The testing system (300) according to claim 1, further comprising an eluent preparation chamber (305), an eluent channel (308) configured to fluidly connect said eluent preparation chamber (305) with said mixing chamber (307), an eluent reservoir (306) arranged within or adjacent said eluent preparation chamber (305), said eluent reservoir (306) comprising said eluent solution, and wherein said eluent reservoir (306) is configured to release said eluent solution into said mixing chamber (307) upon actuation of said device activation means, a sample collector channel (310) configured to hold a sample collector (330) such that a distal sample end of said sample collector (330) is positioned in said mixing chamber (307), said holding means (311) being a test strip compartment (311) configured such that a sample zone end (316a) of such test strips (316) is positioned adjacent and outside of said mixing chamber (307) before actuation of said analysis initiation means, said dried particle-antibody conjugate preparation (309) being arranged anywhere within one or more of said eluent preparation chamber (305), said mixing chamber (307), and said eluent channel (308), said particle-antibody conjugate preparation (309) initially not being in contact with said eluent solution, wherein said analysis initiation means is configured such that, when actuated by a user, the sample zone ends (316a) of any said one or more test strips (316) present in said test strip compartment (311) are moved from the initial position adjacent and outside of the mixing chamber (307) into a position wherein the sample zones are positioned in said mixing chamber (307).

19. The testing system (300) according to claim 18, wherein the testing system (300) is adapted to be used in an orientation wherein the longitudinal axis A is essentially horizontal, wherein the sample collector channel (310) is provided with an opening (314) configured for insertion of a sample collector from the first end (10), and wherein the eluent preparation chamber (305) is located near the second end (20), and the mixing chamber (307) is positioned such that the sample collector channel (310) is arranged on an essentially opposite side of said mixing chamber (307) from said eluent channel (308).

20. The testing system (300) according to any of claims 18 to 19, wherein the device activation means comprises an actuator configured to activate release of said eluent solution from said eluent reservoir (306a, 306b, 306c, 306d) into said eluent preparation chamber (305).

21. The testing system (300) according to any of claims 18 to 20, wherein the device activation means comprises an activation push-button (302a) arranged to move axially within said eluent preparation chamber (305) for activation of said testing system (300), and one or more piercing protrusions (317a) arranged within said eluent preparation chamber (305), wherein said activation push-button (302a) is configured to activate release of said eluent solution from said eluent reservoir (306a) into said eluent preparation chamber (305) by pressing said eluent reservoir (306a) against said one or more piercing protrusions (317a).

22. The testing system (300) according to any of claims 18 to 20, wherein the device activation means comprises a rotary knob (302b, 302c, 302d) arranged to rotate within said eluent preparation chamber (305) for activation of said testing system (300), and one or more piercing or tearing protrusions (317b, 317c, 317d) arranged in said eluent preparation chamber (305), wherein said rotary knob (302b, 302c, 302d) is configured to activate release of said eluent solution from said eluent reservoir (306b, 306c, 306d) into said eluent preparation chamber (305) by rupturing said eluent reservoir (306b, 306c, 306d) against said piercing or tearing protrusion (317b, 317c, 317d), when said rotary knob (302b, 302c, 302d) is rotated.

23. The testing system (300) according to any of claims 18 to 22, wherein the analysis initiation means comprise an analysis initiation actuator (313), adapted to move the sample zone end of the one or more test strips (316) positioned in said test strip compartment (311) into said mixing chamber (307), such that any fluid in said mixing chamber (307) is applied to such test strip (316).

24. The testing system (300) according to claim 23, wherein said mixing chamber (307) is provided with a pierceable cover (312), and said test strip compartment (311) is configured to hold the one or more test strips (316) such that a sample zone end of such test strips (316) is initially positioned adjacent said pierceable cover (312) and outside said mixing chamber (307), and wherein said analysis initiation actuator (313) comprises a piercing element (315) configured to pierce or cut said pierceable cover (312) when said analysis initiation actuator (313) is actuated.

25. The testing system (100, 200, 300, 400) according to any preceding claim, wherein the particle-antibody conjugate preparation (219, 309, 419) comprises gold particles.

26. The testing system (100, 200, 300, 400) according to any preceding claim, wherein the dried particle-antibody conjugate preparation (219, 309, 419) is provided in said mixing chamber (122, 222, 307, 422).

27. The testing system (100, 200, 300, 400) according to any preceding claim, further comprising one or more test strips arranged in said holding means (143, 243, 311, 443) and said test strips are initially arranged to have a first end of a test strip (148, 248, 316a, 448) positioned such it is not in fluid connection with said mixing chamber (122, 222, 307, 422).

28. A method of using a testing system for determining the presence of an analyte in a sample, the testing system comprising an eluent solution, a dried particle-antibody conjugate preparation, a sample collector, a sample receiving unit and a test unit, said method comprising the steps of - activating a device activation means to activate said testing system for receiving the sample and performing the analysis of determining the presence of the analyte(s), wherein actuation of the device activation means allows said dried particle-antibody conjugate preparation to come in contact with the eluent solution, inserting the sample collector into a mixing chamber of the sample receiving unit in the testing system, such that an obtained sample is transferred into the mixing chamber, said step being performed before, simultaneously with or after the step of activating a device activation means, allowing the sample to react in the mixing chamber, activating an analysis initiation means to allow any fluid in said mixing chamber to be applied to first end of any test strips arranged in a holding means of the test unit.