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WO2022218457A1 - Dispositif d'essai et procédé d'essai pour essais rapides et automatiques - Google Patents

Dispositif d'essai et procédé d'essai pour essais rapides et automatiques Download PDF

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Publication number
WO2022218457A1
WO2022218457A1 PCT/DE2022/000041 DE2022000041W WO2022218457A1 WO 2022218457 A1 WO2022218457 A1 WO 2022218457A1 DE 2022000041 W DE2022000041 W DE 2022000041W WO 2022218457 A1 WO2022218457 A1 WO 2022218457A1
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WO
WIPO (PCT)
Prior art keywords
scan code
test
test device
display window
code
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/DE2022/000041
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German (de)
English (en)
Inventor
Wilfried Ehmer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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Filing date
Publication date
Priority claimed from DE102021001941.5A external-priority patent/DE102021001941A1/de
Application filed by Individual filed Critical Individual
Publication of WO2022218457A1 publication Critical patent/WO2022218457A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/54—Labware with identification means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/54—Labware with identification means
    • B01L3/545—Labware with identification means for laboratory containers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/021—Identification, e.g. bar codes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/023—Sending and receiving of information, e.g. using bluetooth
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0627—Sensor or part of a sensor is integrated
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • G01N2021/8488—Investigating reagent band the band presenting reference patches
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00732—Identification of carriers, materials or components in automatic analysers
    • G01N2035/00742—Type of codes
    • G01N2035/00782—Type of codes reprogrammmable code

Definitions

  • the invention relates to a test device and a test method for determining a concentration and/or a threshold value of a substance, and to a manufacturing method for a test device.
  • the test device according to the invention is used for the optical display of a threshold value, in particular of germs and/or measurable messengers thereof, such as the rapid and self-tests that are used to detect a viral load and/or antibodies.
  • a threshold value in particular of germs and/or measurable messengers thereof, such as the rapid and self-tests that are used to detect a viral load and/or antibodies.
  • rapid test and rapid and self-test are used synonymously.
  • This test device comprises a first side (top) and further sides,
  • confirmation copy - at least one reaction and indication unit by means of which a follow-up reaction is triggered depending on the test substance applied and at least one labeling is initiated depending on a threshold value (due to use).
  • a threshold value due to use.
  • These are usually one or more dark bars that appear in the viewing window and can be interpreted by the user on a marking attached to the side of the viewing window.
  • At least one display window is thus also included, in which the at least one identifier can be displayed after the subsequent reaction.
  • the marking thus shows the respective test result, in particular after a defined waiting time, by appearance or non-appearance.
  • the application window is not meant to be limiting here and can be formed as any application and/or contact surface, a recess, a nozzle, a tube or in any other way that allows the substance to be tested to reach the reaction and indication unit directly or indirectly.
  • user should be understood to mean both the person to be tested and the staff of a service provider who uses the test device for the person to be tested, unless something special is carried out.
  • the display window is generally an opening in the housing cover or the top of the test device, above the reaction and indication unit, which can also be drawn as a test strip.
  • a carrier element is provided for applying at least part of a scan code, which is designed as a foil or a plate made of a transparent or translucent material.
  • the term display window is to be understood very broadly and also means a digital display window in the case of a (micro)electronic evaluation unit of the reaction, which is usually located inside and includes, for example, an ADC (analog-to-digital converter), so that a digital display signal can be applied to or can be displayed in a display window and is visible from the outside.
  • the subsequent reaction can directly generate a digital signal that can be displayed in the display window.
  • the display window or the carrier element is formed from a label over the opening in the housing cover or the top of the test device. This is applied with at least one scan code before or after the application of the scan code, in particular as printing.
  • the label is designed to be transparent and/or translucent at least in partial areas, in particular completely, and can be designed, for example, as a self-adhesive label, as a sleeve label or as another suitable label.
  • the use of labels as display windows has the great advantage that even simple, existing test devices can be retrofitted very easily and the labels provided with a scan code can be produced independently of the production of the labels.
  • test devices can also be equipped in this way that have no carrier element over an opening in the housing cover that acts as a display window.
  • a first scan code and the display window are arranged on the first side, the first scan code being arranged relative to or on the display window such that the marking changes the first scan code to a secondary scan code.
  • the first side (top side) can have a larger disc on which at least one scan code is applied, in particular printed.
  • the scan code can also only be partially arranged on the display window and/or on a border or frame area of the display window.
  • the great advantage is that the design of existing test devices for known quick tests does not have to be changed.
  • the scan codes can be applied using known imaging methods such as screen printing, pad printing or direct printing methods. Disposal and economy are also not adversely affected by other components, in particular by additional (metallic) electronic components.
  • the first and secondary scan codes are automatically readable with a scanner.
  • the first scan code can have a multiplicity of complementary fields, with complementary meaning that different colors and/or contrasts are provided. In particular, this can be light and dark fields, in particular black and white fields.
  • Such scan codes are in particular QR codes or bar/bar codes.
  • scanner means in particular the respective data processing program and/or the app, which, using the associated reading device, such as a smartphone, a tablet computer, etc., is connected to the detection device, for example an (integrated) camera and the necessary electronic components , capture a scan code and evaluate it locally on the reader or server and/or cloud-based.
  • the detection device for example an (integrated) camera and the necessary electronic components , capture a scan code and evaluate it locally on the reader or server and/or cloud-based.
  • the identification that appears as a result of the test or the test reaction transforms the first scan code into the secondary scan code by marking at least one field or field area, in the case of a QR code in usually converts several fields of the first scan code into at least one complementary field.
  • a complementary field is to be understood here as meaning the associated second type of color or contrast, generally a dark, colored or black (complementary) field.
  • At least one of the scan codes is an active (hyper)link that can be connected to an (active) internet link, a cloud (application) and/or leads to it.
  • a further improvement can consist in the active (hyper) link activating a further scanner, which is designed proprietary for the secondary scan code in order to be able to capture and evaluate it.
  • the test device has a further, third scan code, which is arranged completely outside the display window and/or an identification resulting from the test method. In a first step, this third scan code could include the same function (active link) as the first scan code and, for example, be designed identically. Alternatively, neutral usage instructions could be made available via this third scan code.
  • the first scan code is connectable to or initiates a first active link and the secondary scan code leads to or is connectable to a second active link.
  • An active link is understood to be any connection that activates or causes an HTML protocol, a website, a browser function or any other remote software function.
  • the second active link of the secondary scan code is different from the first active link of the first scan code or comprises different information or receives or sends different information.
  • this second scanner can be a proprietary scanner that is specifically designed to be compatible with the secondary scan code.
  • a further control scan code is arranged on the first page in the area of the display window and/or one of the markings.
  • security is further increased in that the first scan code and the further control scan code are each provided for an identification (T, C) and interact with them in the same way when they appear, as described above.
  • control scan code is changed by the first identification to a secondary control scan code
  • the first scan code is changed to a secondary scan code by the identification different from the first identification, in particular the C mark.
  • an inventive test method is included, whereby to determine a concentration and/or a threshold value of a substance, in particular of inorganic pollutants, antibodies, viruses and/or bacteria, the following steps being carried out one after the other are included: ?
  • At least one reaction and indication unit and subsequent recording of the test result usually in the form of a flat color change, a small line or a display bar or the like.
  • processor or server-side identification and verification steps can also be carried out directly in an associated software application, hereinafter referred to as an app, and in particular on the associated reading device.
  • a control scan code and a secondary control scan code are also detected and transmitted in an analogous manner, or activation is carried out with this.
  • test device is advantageously designed according to one of the embodiments described above.
  • the scanning takes place with a reading device, such as a mobile device, such as a smartphone, a tablet, or a standard barcode scanner.
  • a reading device such as a mobile device, such as a smartphone, a tablet, or a standard barcode scanner.
  • a pre-identifier is stored in a database, especially in an online database, cloud or server, for the first scan code by the manufacturer or when used for the first time by a user, and at least one more of the at least one is stored for the secondary scan code Identification of dependent additional postal identifiers saved. This can also be stored by the manufacturer as an expected value in a database, which can be addressed directly or indirectly via the active link. It is advantageous here if the pre-identifier and the at least one post-identifier together result in a predefined target identifier when they are combined. The combination can be done using an algorithm and, in the simplest case, is the sum or combination of two numerical values.
  • pre- and post-identifiers are combined to form at least one actual identifier, depending on conditions and/or parameters, and compared with a target identifier. Incorrect actual identifiers lead to negative authentication or verification or trigger additional direct or indirect security requirements.
  • conditions and/or parameters can be in particular:
  • An improvement is that, depending on the target identifier, information is sent to a mobile device, especially the device that performed the scan, and/or another database and/or at least one other display device.
  • a pre-identifier could be provided by a provider, such as a company or an authority, and employees or employees could be routinely prompted to carry out a quick test before entry. This can be initiated on a regular basis, for example once a week.
  • the pre-identifier could be a central, site-wide or personalized QR code or the mobile device itself. The provider could thus comprehensively ensure, essentially without any manual effort, that only users who tested negative have access to a defined area and/or contact with other people in the area.
  • a control organization such as a health authority, an accounting organization, a border guard, etc.
  • results obtained in this way could be used directly for access systems and/or capacity planning.
  • the data could be made anonymous for a provider, but access to electronic entry and access systems could be prevented.
  • a provider who is an event organizer could request the implementation of the method according to the invention, possibly in addition to other regulations, such as the vaccination obligation/proof.
  • a provider could provide a pre-identifier with which an event participant must register before carrying out the test method according to one of the aforementioned method variants.
  • the provider could make specifications as to how long and/or how often such a quick test must be carried out before the event.
  • a proof of entitlement is sent to the event participant, in particular online.
  • the authorization is in particular a digital authorization code that is transmitted to the registered mobile device. When entering the event, the provider can check the authorization, in particular using a digital reading device.
  • a further improvement can be that the at least one target identifier can be combined as information for contact tracing systems, such as the Corona app, Luca app or comparable systems.
  • this test device and also the method can be expanded with known identification and authentication methods.
  • at least one registration, entry of a password, entry of a telephone number, etc. can represent a useful addition in order to ensure the clear, personalized use of a test device.
  • the test method does not have to be completed if the test is positive, ie if the positive marking (T marking) appears.
  • T marking positive marking
  • the associated feedback, login or registration is not possible, so that a provider of a pre-identifier cannot distinguish whether the test execution was simply aborted because, for example, the connection was interrupted, the user was disturbed or whether due to an positive test result, the feedback, registration or registration was no longer intended by the user or was revoked.
  • additional visual checks are carried out in order to rule out manipulation as far as possible after the start of the procedure and in particular of the actual test.
  • an additional central optical control step takes place, in that at least one imaging recording is made of the display window, the application window and/or the at least one reaction and indication unit.
  • several images, recordings or even video sequences are generated so that, for example, a typical discoloration or discoloration progression can also be identified.
  • This image data is ideally sent to the cloud, the database application and/or a local app located on the mobile device itself, in which the at least one received recording is evaluated.
  • recording should not be understood as limiting, but as already explained, as any type of imaging, colored, gray or black-and-white recording.
  • This central optical control step is carried out after the first scan code has been scanned, the first active link has been activated and the test substance has been applied to the application window.
  • at least one picture is taken before the complete (final) appearance of a label in the display window, ie after about 2/3 of the waiting time between task and reading of the test result (8 to 12 minutes after application).
  • a peripheral optical control step can be carried out by generating a first imaging recording of the top side comprising the display window, in particular one that includes at least the first scan code and at least a second imaging recording is generated, with the identity of the both imaging recordings is checked. This is particularly advantageous if mandatory handwritten markings or other special markings that cannot be easily copied or reproduced are applied.
  • this peripheral control step can be improved such that at least part of the viewing area of the display window is evaluated as an excluded verification area in the evaluation, which is not checked for identity in the peripheral optical control step.
  • the reason for this is that test-related changes are expected and wanted in defined areas of the display window.
  • an application can provide optical, haptic and/or acoustic information, for example.
  • the marking for a positive test is very bright, weakly developed and/or has little contrast due to the corresponding marking. So it can be advantageous if, as an alternative or in addition to the secondary scan code, at least one imaging recording is made when the label appears completely (finally) in the display window, i.e. immediately at the end of the waiting time or close to the end of the waiting time, such as in a period of +/ - 0.5 to 5% of the specified waiting time.
  • the imaging recording can be made as a gray value or color recording without using the scanner, so that an additional, technically independent control image is generated. can be additionally or alternatively transmitted to the authentication and verification process described and/or stored for documentation purposes. This control image can be compared with at least one stored TARGET control image and/or transmitted to an evaluating entity, for example to the provider, together with the detection result of the secondary scan code.
  • a further improvement can be that a primary packaging is provided in which a scan code or control scan code can be detected through a transparent window with a reading device and/or a scanner.
  • the test device which is still protected and closed, can be recorded by a provider
  • the test device includes an application window and a first side or a side part with a display window, with an identification area or area being provided in the display window. This marking part is defined by the subsequent position of one or more markings that appear in the display window when used as intended. It is also included that at least one first scan code is applied to the first side of the test device.
  • at least the first scan code is applied as a film or label, for example a self-adhesive film or a self-adhesive label. These can be translucent or ideally transparent.
  • the labels or the foils are applied with a scan code using a printing method, in particular digital direct printing.
  • This printing step ideally occurs prior to the application of the label or film to the test device or part of the test device.
  • the tag is on one further improved method, a sleeve or sleeve label, which encloses the test device at least over a partial length in the direction of the longitudinal axis.
  • a primary display window is provided in the housing cover or in the top side of the housing, which consists of an opening or recess, the final display window being created by a label that is transparent at least in partial areas covering this primary display window in whole or in part which was provided with at least one scan code in a previous manufacturing step and is fixed there on the housing cover or the test device in a position.
  • a label forming the display window can be additionally printed in a further printing step, for example with a further scan code, and can be embodied, for example, as a self-adhesive label or sleeve label.
  • the display window is a digital display window or covers a digital display device, which, as described above, is at least partially covered in an analogous manner with at least one first scan code.
  • At least the first scan code is advantageously applied in a room that is conditioned with regard to temperature, humidity and/or purity, so that the secure hold and complete application of a color, in particular printing ink, is ensured.
  • This is also advantageous when a label or foil serves as a carrier for a scan code, so that appearance-changing inclusions are avoided.
  • the test device or at least part of the test device is sanitized after the at least one scan code has been applied.
  • This hygienization can be carried out in particular by means of a radiation device, such as a pulsed UV emitter.
  • the degree of sanitation depends on the sensitivity of the reaction and indication unit to foreign substances and environmental influences and can even go as far as sterilization.
  • sanitization is carried out with radiation, by means of which the drying and/or curing of the (printed) ink of at least the first scan code is also carried out.
  • Atmospheric separation means that, by means of a forced flow direction of, for example, clean room air, no air flows from the first side and/or the part of the test device on which the scan code is applied in the direction of the reaction and indication unit.
  • further scan codes are applied spatially or atmospherically separately in an analogous manner.
  • the production process can be further improved by introducing the test device into a primary packaging, in particular into a gas-tight and/or watertight primary packaging, in at least one packaging step after completion.
  • a primary packaging in particular into a gas-tight and/or watertight primary packaging, in at least one packaging step after completion.
  • This can consist of a plastic and have the shape of a bag, a pouch, etc., for example.
  • a further improvement can be that the primary packaging has at least one viewing window, with the test device being introduced into the primary packaging and possibly fixed therein in such a way that the primary scan code in particular is recorded and/or scanned through the at least one viewing window without opening the primary packaging the can.
  • the test device it is possible for the test device to be recognizable as a whole, it being advantageous if the reaction and indication unit is not exposed to any UV radiation and is therefore at least partially covered in a protective manner.
  • test devices can be made available by a provider to people such as employees, visitors or guests and at least the first scan code can be recorded and saved without opening the primary packaging.
  • it can thus be checked and ensured that only defined test devices and/or defined test devices are used in a specified time.
  • the primary scan code and/or a scan code that can be functionally correlated or correlated with the primary scan code can be placed on the primary packaging.
  • the primary packaging can be connected to the test device in an analogous manner.
  • “correlating” or “correlatable” means that there is or can be a logical link between the first scan code and the scan code applied to the primary packaging in order to be able to check a defined use of the test device.
  • a further improvement consists in the primary packaging being placed in a light- and/or UV-impermeable secondary packaging in a further packaging step and/or being wrapped therewith, in particular with other associated materials and/or information means. In this way negative influences on the reaction and indication unit can be avoided.
  • the first scan code is inspected and/or verified by means of an optical detection device after it has been applied to the first side of the test device, in particular at least two scan codes on the test device are inspected by means of at least one optical detection device and/or verified.
  • the detection device should not be understood in a restrictive manner here and can be, for example, a laser scanner or a CCE camera. This means that after a scan code has been applied, the optical quality and readability can be checked and it also enables independent definition or verification of the digital content.
  • the scan codes on the primary packaging and/or on the respective associated test device can be recorded and stored during or immediately before the packaging step, ideally stored in a cloud.
  • the primary scan code and/or additional scan codes are stored on a server and/or a cloud, in particular after the inspection and/or verification using the at least one optical detection device are stored or the storage is dependent on the inspection and /or verifying continues.
  • the generation step of scan codes in particular a unitary generation step, can be decoupled from the packaging step and the removal of test devices from the manufacturing process or the prefabrication of primary and/or secondary packaging can be carried out without disadvantages for the later correlation with the test device.
  • a scan code such as in particular the first scan code
  • direct printing or that of a label is not restricted. It is thus possible for only the dark or black fields of a code to be printed and for example the light or white surfaces of the test device to supply the complementary contrasting color of the other fields of the code. However, light or white fields can also be printed.
  • the area in which the respective identification of a test result must be recognizable, in particular in order to convert the primary scan code into a secondary scan code always remains an exception.
  • Scan code and/or control scan code can each be a code that is identical for many test devices, for example for a batch of test devices.
  • scan codes and/or control scan codes can be unitary from test device to test device, ie occur only once.
  • the test device can also take place via the third scan code, which must be recorded and transmitted in a defined sub-step or partial step in order to complete the process.
  • the first scan code covers a base area which is identical to the identification area in the display window, at least in some areas. The two surfaces thus overlap at least partially.
  • the test device is designed according to one of the aforementioned forms of embodiment.
  • the first scan code is ideally applied using a printing method, in particular using a direct printing method, and/or applied as a label. This enables fast, flexible adaptation and change.
  • production data for the first scan code and also for future, expected secondary scan codes can be generated, stored and made available for a subsequent authentication and verification process.
  • test device all the advantages, possible combinations and aspects described for the test device apply in an analogous manner to the test method and/or the production method, although this should also be understood the other way around.
  • Fig. 5a, b an alternative embodiment of the test device with a first scan code to Fig. 3a, b and additionally a control scan code
  • FIG. 6 shows an embodiment comparable to FIG. 5 with a different alignment of the first scan code
  • FIGS. 3, 4 shows an alternative embodiment to FIGS. 3, 4 with a different display window and another position of the scan code
  • FIG. 9 shows an alternative embodiment to FIG. 8 as a top view, with a control scan code and a first scan code
  • FIG. 5 an alternative embodiment to FIG. 5 as a plan view and sectional views with an optical separating strip
  • FIG. 12 shows a packaging step of the manufacturing process in a schematic representation.
  • the reference symbols are always used identically in all figures, so that in order to avoid repetition, not all of the reference symbols shown in the figures are repeated in the text.
  • the test device 1 shown in FIG. 1 is state of the art, for example common for a rapid corona test. It consists of a plastic housing with at least six sides.
  • the first page 2, the top or user page, has the essential elements.
  • an application window 4 is arranged in the lower part and a display window 5 is arranged in the center.
  • first markings 6 are laid out as letters C and T and next to them, for example, as small arrows or triangles, second markings 7 that indicate the possible display areas for the present case a dash or bar as a marking 11 as a result of the tests carried out.
  • the display window 5 often represents a simple opening to the test strip arranged underneath and not shown, or is covered with a transparent material, usually a plastic disc or film.
  • the first line or bar is the reference to the correct test procedure and appears only in the viewing window in the case of a negative test.
  • another marking not shown here, appears at the level of the letter T, so that if the test was carried out correctly and positively, both markings (C, T) would appear.
  • marking 11 is used collectively.
  • a user-readable inscription is also attached at the top of the upper side 2 .
  • the test device shows a single marking 11 at the height of the first marking with the letter C (Control), as an indication that the test was carried out correctly but had a negative result. This test is not personalized in any way and could be photographed multiple times and the result shared or the entire test device passed on to another user, i.e. another person.
  • FIG. 2a shows a first embodiment of a test device 1 according to the invention, which is constructed analogously to the test device according to FIG.
  • a first scan code 9 is now arranged on the first side 2 and at the height of the display window 5, which partially protrudes laterally into the display window 5 or is applied to it.
  • the display window is presently a transparent plastic film or sheet, but could also be a glass sheet or any other suitable transparent or translucent material.
  • the scan code 9 shown is in the form of a bar code.
  • the detailed view in FIG. 2b shows this scan code 9 after the test has been carried out and two markings 11.1, 11.2 have appeared in the display window 5. These protrude from the right into gaps or free areas of the barcode or barcode, so that the scan code 9 is divided into an unchanged primary area 9.1 and a secondary area 9.2 that can be changed or changed by the identifiers 11.1, 11.2.
  • This secondary area 9.2 represents a new one secondary scan code 10, which provides independent, new information and can be evaluated and processed independently.
  • the identification area 17 is outlined as a dashed frame and describes the area within which the respective identification 11.1 or 11.2 appears depending on the test result.
  • FIGS. 3a), b An embodiment comparable to FIGS. 2a), b) is shown in FIGS. 3a), b), the first scan code 9 being a QR code. This likewise protrudes into the display window 5 or is partially depicted thereon. Due to the required full-area detection of a QR code, the secondary area 9.1 shown in dashed lines is an integral, clear sub-area of the entire scan code 9, so that the two identifiers 11.1, 11.2 generate a clear secondary scan code 10.
  • Figure 3a also shows the first scanning or recording process with a reading device 12, here a smartphone as the mobile terminal device, with the first scan code 9 being recorded using the software-provided recording window 13 of a QR reader app and via a wireless Connection 14 followed an active link and a data transfer 50.1 is initiated.
  • a reading device 12 here a smartphone as the mobile terminal device
  • the first scan code 9 being recorded using the software-provided recording window 13 of a QR reader app and via a wireless Connection 14 followed an active link and a data transfer 50.1 is initiated.
  • the first scan code 9 together with the device data of the reader 12 and/or an ID code provided by an app on and via the reader 12 can be a first, unique (unitary quick) test ID code result.
  • This test ID code can be stored in the cloud 100 or a server in a suitable manner and identifies the user for the subsequent steps of the test procedure.
  • a test ID code could also be generated by a third scan code 20, as described in FIG.
  • a test ID code can also be formed from a general access code leading to an event, as is known as a publicly available QR code for events, in combination with the device data of the reading device 12 and/or an ID -Code provided by an app on and via the reader 12 and/or the first scan code 9.
  • the activation of the second active link and further data transfer 50.2 via the secondary scan code 10 is expected from an associated software application.
  • the other process steps and processors are not shown. They can take place within an app on the scanning reading device 12 or another processor unit, in particular in a cloud 100 or on a server.
  • Such authentication and verification processes are known in principle from e-commerce applications, for example, and can be used here in an analogous manner.
  • the results of the test execution can be directly stored and kept in appropriate databases in order to further process them as required to issue authorization papers for the user, a provider and/or a control organization.
  • the identification area 17 is outlined as a dashed frame and describes the area within which the identification 11.1 or 11.2 appears depending on the test result, as also in Figure 5a) and 5b).
  • the cloud 100 or a comparable server or cloud application leads to the respective websites 100.1, 100.2, associated applications, data areas or the like.
  • the first scan code 9 is applied to a separate, at least partially transparent or translucent carrier disk.
  • the underlying reaction and indication unit 27 (not shown in detail) (FIGS. 10, 11) also extends under this carrier disc 18 of the first scan code 9.
  • This web section 19 to improve the display and detection by a reading device 12 can be designed as a covering web of material of the test device 1, especially the upper side of the test device 1.
  • this web section 19 can also consist of printing that is printed continuously or in certain areas on the upper - Was applied or underside of the carrier disc 18, in particular printed. Such an example is described in detail in FIG.
  • two scan codes are arranged on a partial area of the display window 5, and a separate scan code 9 is provided for each of the possible identifiers 11.1 and 11.2.
  • the additional control scan code 25 correlates with the identification 11.1 (C identification) and is changed in an analogous manner into a secondary control scan code 26 by the optical appearance of the identification 11.1 (C identification).
  • the first scan code 9 is assigned to the second identification 11.2 (T identification) and is changed into a secondary scan code 10. This results in an analogous manner to two identification fields 17.1 and 17.2. in which the respective markings 11.1, 11.2 appear.
  • independent scan codes as a control scan code 25, which only indicates that the test procedure has been carried out correctly and can be read in and transmitted separately, reduces incorrect presentation and interpretation of the test results and is technically easier to produce.
  • a secure identification method it increases the security level because double initial detection and transmission is performed and double result detection and result transmission can be performed, which can be correlated with each other. It can be required, for example, that only a certain amount of time may elapse between the individual recordings and transmissions and/or in addition to the transmission of the respective scan code or control scan code, another identifier must also be transmitted, such as an access password/number , which, for example, a provider of an event has made available in a personalized way.
  • FIG. 6 a structure and arrangement of the first scan code 9 and the control scan code 25 that is analogous to FIG. 5 is shown, with the first scan code 9 being applied rotated by 90°.
  • the type and structure of scan codes, especially QR codes, are not to be understood as limiting.
  • an identifier 11 is generally shown transversely and only partially protrudes into a scan code 10, in particular a QR code, but this is not to be understood as limiting.
  • An identifier 11 could protrude along at least one complete line of a QR code and/or at least part of the length of the lines protrude below several lines, so that, for example, due to the width of the identifier 11, several lines appear when an individual identifier 11 appears in terms of its digital value or In stop being changed.
  • FIG. 7 shows an embodiment in which a further scan code 20 is fitted completely outside of the display window 5.
  • this further scan code 20 is identical to the first scan code 9. This can be useful if, for example, there is very little space available for existing tests that are to be retrofitted according to the invention.
  • An improvement consists in placing an additional scan code 20 activating the test process on the back 3, so that a user starts the entire test process without contact before removing and touching the test device.
  • This additional scan code 20 can include additional functions, such as monitoring expiry dates, batch information or identifying and localizing the place of use/application and the reader 12 used, in particular a private smartphone or tablet, and the following To prepare or enable verification and security steps.
  • FIG. 8 an alternative embodiment to FIG. 4 is shown, in which a common, large carrier disk 21 is provided, on which the first scan code 9 is applied, which includes the identification area 17 and which also includes the display window.
  • a dividing line 22 between the scan code 9 and the display area of the former display window on the large carrier disc 21 made of a transparent or applied translucent material, in particular printed.
  • the first and/or the second marking (C, T) is also applied to the large carrier disk 21, in particular printed on it.
  • the exemplary embodiment according to FIG. 9 shows the arrangement of a control scan code 25, which is at least partially arranged on a common (larger) carrier disk 21, and which, analogously to the explanations in FIGS. 5 and 6, is characterized by the appearance of a first characteristic curve 11.1 (not shown), can be converted into a secondary control scan code 26.
  • an optical interruption is applied in the display window 5 as a separating strip 28, which is ideally printed on. Due to the separating strip 28 directly adjoining the respective code, the boundaries of the respective code are always sharply delimited even when an identification 11 underneath appears.
  • the sectional drawing of FIG. 10b) shows the variant that the display window 5 is arranged in the housing cover 23 of the test device 1, above the test strip 27. Reference number 24 designates the housing bottom.
  • the dash-dot horizontal line in FIG. 10a) indicates the vertical section of FIGS. 10b, c).
  • the separating strip 28 is applied to the underside of the display window 5 as a white adhesive strip, coating or printing, for example.
  • the identification 11.1 on the test strip 27 bridges this separating strip 28 in the transverse direction, so that the extension arranged on the left in the figure protrudes into the optical area of the secondary scan code 10.
  • the dash-dotted vertical line in FIGS. 10b), a) indicates the optical transition between the scan code 9, 10 and the separating strip 28.
  • FIG. 10 c) shows an example analogous to FIG. 10 b), the separating strip 28 being applied to the display window directly next to the scan code 9, 10.
  • the scan code 9 and the separating strip 28 or at least one analogous (smaller) separating area which is applied, for example, only at the level of a scan code 9, 25 or in the area of an identification area 17, is applied in a common printing process and/or printing step.
  • a separating surface 28 could be provided next to one of the scan codes.
  • the display window 5 is completely printed or covered, the display window 5 is transparent only in the area of the identification surface 17 or an expected or possible identification 11, so that an identification 11 that occurs changes the respective code at least partially .
  • test strips and two application windows with a corresponding display window are provided in parallel (test) lines in an embodiment that is not shown.
  • first line there is no scan code in the display window provided according to the previous statements and in the second (test) line in the display window, as in the prior art, only the C or T mark is provided.
  • test method according to the invention should also be carried out or whether an anonymous quick test should be carried out.
  • first scan code 9 and the control scan code 25 is primarily used for linguistic differentiation and should not be read in a restrictive manner.
  • the C mark/curve could also interact with the first scan code and the control scan code with the T mark/curve.
  • FIG. 11 shows an embodiment with a label 33 designed as a self-adhesive label, which can also alternatively be fixed with an adhesive or bonding agent applied to the housing cover or the label.
  • Figure 11 b) shows an embodiment with a label 33 designed as a sleeve label
  • the sleeve label 33 can also be printed on in a suitable manner before it is applied to the rapid test 1 .
  • FIG. 12 schematically shows the packaging step of the manufacturing process.
  • the first scan code 9 which is shown on the left-hand side in the manner described, is captured by the camera 30, which is a CCE camera, for example.
  • the same camera 30 also captures a packaging scan code 32 which is applied to the primary packaging 29 and which is ideally unitary.
  • a unitary correlation between test device 1 and primary packaging 29 can thus be established.
  • This data is stored individually or in combination on a server 31 and/or a cloud 100. In an embodiment that is not shown, several cameras are provided, each of which captures different scan codes.
  • the cloud 100 can be identical to that in FIG. 3, so that the data transfer 50.1, 50.2 can take place via a mobile reading device 12, for example analogously to the method described there.
  • the primary packaging 29 has a transparent window, under which at least one scan code 9, 25 is positioned at least temporarily and in particular after the final closure of the primary packaging 29, so that the at least one scan code 9, 25 can be seen by the camera 30 is detectable.
  • This transparent window can be covered in a subsequent manufacturing step. This can be beneficial to to protect the test device 1 against UV radiation, diffusing moisture, other negative influences or damage.
  • the transparent window is covered with a detachable, only adhesive element, so that a provider or an inspection organization can grasp the unopened primary packaging 29 and the test device 1 lying there.

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Abstract

L'invention concerne un dispositif d'essai destiné à l'affichage optique d'une valeur seuil, notamment de germes de maladie et/ou de messagers mesurables de ces derniers, comprenant un premier côté (côté supérieur) et d'autres côtés, ‑ au moins une fenêtre d'application pour un matériel d'essai à analyser, notamment un liquide, au moins une unité de réaction et d'indication qui permet le déclenchement d'une réaction consécutive en fonction du matériel d'essai appliqué et au moins une caractéristique est provoquée en fonction d'une valeur de seuil (par l'utilisation); au moins une fenêtre d'affichage dans laquelle peut être représentée l'au moins une caractéristique après la réaction consécutive, le premier code de balayage et la fenêtre d'affichage étant disposés sur le premier côté, le premier code de balayage étant disposé par rapport à ou sur la fenêtre d'affichage de manière à ce que l'identification modifie le premier code de balayage pour former un code de balayage secondaire. L'invention concerne en outre un procédé de test et un procédé de fabrication associés.
PCT/DE2022/000041 2021-04-14 2022-04-14 Dispositif d'essai et procédé d'essai pour essais rapides et automatiques Ceased WO2022218457A1 (fr)

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DE102021001941.5 2021-04-14
DE102021001941.5A DE102021001941A1 (de) 2021-04-14 2021-04-14 Testvorrichtung und Testverfahren für Schnell- und Selbsttests
DE102021005632 2021-11-13
DE102021005632.9 2021-11-13
DE102021005819 2021-11-23
DE102021005819.4 2021-11-23
DE102021006267.1 2021-12-20
DE102021006267 2021-12-20
DE102022000121 2022-01-13
DE102022000121.7 2022-01-13

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