CN119198273A

CN119198273A - Device for detecting analyte in liquid sample

Info

Publication number: CN119198273A
Application number: CN202310754174.6A
Authority: CN
Inventors: 雷似愚; 方剑秋
Original assignee: Zhejiang Orient Gene Biotech Co Ltd
Current assignee: Zhejiang Orient Gene Biotech Co Ltd
Priority date: 2023-06-25
Filing date: 2023-06-25
Publication date: 2024-12-27

Abstract

The invention provides a device for detecting an analyte in a liquid sample and a testing method, wherein the device comprises a cover body, a sample cavity for accommodating a sample collector and a liquid cavity containing sample treatment liquid are arranged on the cover body, so that when the sample volume collected by the collector is insufficient, liquid in the liquid cavity is released to increase the volume of the liquid sample or even the dried liquid sample is dissolved again in the secondary test, and the secondary test can be facilitated.

Description

Device for detecting analyte in liquid sample

Technical Field

The present invention relates to a device and a detection device for collecting liquid samples, in particular to a device for detecting analyte in liquid samples in the field of rapid diagnosis, such as urine and saliva collection.

Background

The following background description is only an illustration of some of the general background knowledge and is not intended to limit the invention in any way.

In the field of in vitro diagnosis (In vitro Diagnosis, IVD), chromatographic techniques are often used to diagnose and detect diseases and other projects, for example, immune colloidal gold test paper, dry chemical test paper, immune fluorescent test paper and the like are all used to pretreat samples by using the principle of chromatography and react with reagents, and finally, the diagnosis result reflecting whether the diseases exist or not is obtained. The fluorescent immunochromatography test paper has the functions that after a sample (whole blood, plasma and the like) is dripped into a sample pad, liquid flows to the end of water-absorbing filter paper, sample treatment is carried out in the sample pad, red blood cells are filtered, interference substances and the like are removed, the sample flows through a binding pad, antigen and antibody are combined in an immune mode, and a fluorescent group is carried on the sample, and when the sample flows through a nitrocellulose membrane, the sample is combined with the antigen and antibody which is bound on the sample pad in advance, the fluorescent group gathered on a test line and a control line can reflect a test result, and other interference substances which are not combined are absorbed by the water-absorbing filter paper. Because the fluorescent immunochromatography technology has the characteristics of simple operation, strong specificity, high sensitivity, quantification and the like, the fluorescent immunochromatography technology is widely applied to the POCT detection field in recent years. However, in recent decades, most immunochromatographic test cards have been able to perform single-item testing with a single test strip. However, with the development of medical technology, diagnosis of diseases requires simultaneous detection of multiple targets to make more accurate decisions, such as joint detection of myocardium 3, joint detection of myocardium 5, and the like. In some cases, it is desirable to detect the status of multiple organs simultaneously to determine disease, such as heart lung 5 joint inspection.

Currently, detection devices for detecting whether a sample contains an analyte are used in a large number of hospitals or homes, and these detection devices for rapid diagnosis contain one or more detection reagent strips, such as early pregnancy detection, drug abuse detection, and the like. The rapid diagnostic test device is very convenient and can obtain test results on the test reagent strips in one minute or at most ten minutes. Drugs are detected in various types and frequently. Some require collection of a sample and then require a specialized testing facility or laboratory to perform the test. Some require on-site detection and then timely obtain the detection result.

In some cases, when the amount of collected sample is insufficient, it is desirable to dilute the sample and perform the test, and usually, the sample is diluted separately, but it is always desirable to perform the test while simultaneously diluting the sample, for example, as described in WO2021/019415a 2, and still another solution needs to be provided for achieving the purpose of operation more conveniently.

Disclosure of Invention

To overcome the deficiencies of the prior art, an apparatus for detecting an analyte in a liquid sample includes a cap including a sample chamber for receiving a sample collector thereon, and a liquid chamber containing a sample processing liquid.

In some modes, the liquid cavity is movably connected with the cover body, or the liquid cavity can move on the cover body, and the liquid in the liquid cavity can be released in the moving process. In some embodiments, the liquid chamber has a locked condition on the cover in which the liquid chamber is secured in a fixed position on the cover and an unlocked condition in which the liquid chamber is movable relative to the cover.

In some embodiments, the liquid chamber may be locked to the cover by a locking element that, when moved (e.g., away from the cover), allows the liquid chamber to be in a locked or unlocked state. The movement of the locking element may be a change in the position of the locking element on the cover, or may be a removal from the cover, or the like. In some embodiments, the locking element comprises a snap ring, the fluid chamber has a groove for receiving the snap ring, and the groove is configured to lock the fluid chamber when the groove is coupled to the snap ring, and unlock the fluid chamber when the groove is decoupled from the snap ring. In some embodiments, the liquid chamber has a slot at one end with a recess, the locking element has a snap ring, and the locking element moves laterally to engage the snap ring with the slot. In some embodiments, the fluid chamber is positioned at an opposite elevation when the fluid chamber is locked by the locking element, and is movable from the elevation to a lower elevation when the locking element is moved to unlock the fluid chamber. The high and low positions are referred to herein as being longitudinal with respect to the cover or as being relative to a lancing structure fixed within the test chamber when the lancing element is positioned within the test chamber, the high and low positions are referred to herein as being principle lancing elements and the low position is adjacent to the lancing element.

In some forms, the cover has a docking area provided with an aperture that allows the fluid chamber to pass through and expose a portion of the fluid chamber. In some embodiments, the docking area has a plane surface with a hole for a liquid chamber to pass through, one end of the liquid chamber being exposed and located a distance above the plane surface, the hole being located in the plane surface. In some embodiments, the locking element is engaged with the exposed portion of the cavity, the locking element includes a snap ring, and the exposed fluid cavity includes a snap groove, the snap ring engaging the snap groove to secure the fluid cavity to the cover via the locking element while in the raised position. In some embodiments, the locking element comprises a card having a notch to form a snap ring that mates with a portion of the cavity of the exposed cover to hold the liquid chamber in a fixed position on the cover. In some modes, the clamping groove is formed by the pressing part at the top of the liquid cavity and the main body of the liquid cavity, the clamping groove is similar to the neck part of the liquid cavity, the clamping groove comprises a skirt edge and a groove which press the circumference of the top, the clamping ring of the locking element is clamped on the groove or the neck part, and therefore one end (the pressing end of the liquid cavity) of the cavity is located at a position which is higher than the plane of the area by a certain distance and is located at a fixed position with the cover body. In some embodiments, the liquid chamber is in a fixed position with the cover by the locking element, while the locking element allows the liquid chamber to be a distance above the plane and in a fixed position with the cover.

In some embodiments, the locking element occupies a substantial docking area, the locking element is positioned or moored to the docking area, and the fluid chamber is shielded or hidden by the locking element, such that the fluid chamber is exposed only if the locking element is moved away or out of the docking area. In some ways, the locking element is moved away or out of the docking area, the liquid chamber being in an unlocked state, at which time the liquid chamber may be moved, for example by pushing the liquid chamber from a raised position to a position, or by pushing the liquid chamber into the test chamber. In some embodiments, the snap ring on the locking element further comprises a cover surface, the snap ring is located under the cover surface, under the projection of the cover surface, the snap ring is located in the projection area, that is, when the cover surface is parallel to the snap ring on the card, the card cannot be seen when the cover surface is overlooked, or the cover surface covers the top of the liquid cavity, and is combined with the docking area, so that the locking element covers or wraps the liquid cavity on the whole plane, and the liquid cavity is hidden.

In some embodiments, the cover has two faces, one of which faces the interior of the detection chamber, also referred to as the back face, and the other of which faces the other face of the detection chamber, also referred to as the front face. In some embodiments, the inlet of the sample chamber is located on the front face of the cover, and in some embodiments the inlet of the sample chamber is located on a plane above the plane of the docking area. The docking area thus resembles a stepped structure, e.g. an "L" line structure, with the locking elements on the one hand bringing the liquid chamber into a locked position in combination with the cover and on the other hand covering the entire exposed liquid chamber part, hiding the liquid chamber, and in addition the locking position, the position on the docking area being in a certain fixed position, since the locking elements are to be unlocked or locked. In some embodiments, the locking element is integral with the cover when the locking element is in the docking area, leaving only the sample chamber entrance. By "hidden" is meant that by the cooperation of the structure of the locking element with the structure of the docking area on the cover, the outer part of the fluid chamber (at least the part above the plane of the docking area) is enclosed so that the fluid chamber can be seen from the outside, and if the device comprises a test chamber, the part of the fluid chamber located below the plane is located in the test chamber and is not easily seen, so that the whole appears to be free from the outside, the main purpose of the hiding being to prevent deliberate manipulation so that detection is done in advance, e.g. by the subject collecting the sample himself, and not by a professional, so that it may be falsified against the sample and not be found.

In some ways, the liquid chamber may be moved in the direction of the back of the cover when the locking element is unlocked or moved away from the docking area. In some of these ways, the liquid chamber may leave the docking area in the direction of the back of the cover, or the liquid chamber may move from a higher position to a lower position on the docking area. In some embodiments, the liquid chamber is movable into the detection chamber when the cover is engaged in the detection chamber. In some embodiments, the test chamber has a test element therein for testing the analyte of the liquid sample, and a lancing element. The fluid chamber is not pierced when the fluid chamber is locked on the cover by the locking element, and the piercing element pierces the fluid chamber when the fluid chamber is unlocked and moves from the high position to the low position or away from the docking area, or thereafter, releasing the treatment fluid into the detection chamber. In some embodiments, the fluid chamber is remote from the lancing element when in the locked position. When unlocked, the liquid chamber is moved from the high position to the low position either near the lancing element or is lanced by the lancing element. In some embodiments, the liquid chamber includes a reagent solution for processing the sample. In some embodiments, the fluid chamber includes an easily penetrable sealing membrane thereon that is easily penetrable by sharp puncturing structures.

In some aspects, the liquid chamber has a locked first position and an unlocked second position relative to the cover. In some embodiments, the liquid in the liquid chamber is not released when the liquid chamber is in the locked first position and the liquid in the chamber is released when the liquid chamber is in the unlocked second position. In some embodiments, the liquid chamber is in a locked position and is locked to the cover by a locking element. In some embodiments, the locking element includes a structure capable of restricting movement of the fluid chamber from a locked state to an unlocked state when the restricting structure is disengaged from the fluid chamber. In some embodiments, the liquid chamber is movable relative to the cover when the liquid chamber is in the unlocked state. In some aspects, the movement includes downward movement relative to the cover.

In some embodiments, the sample chamber includes a channel therein, and the absorbent member on the collector is compressed when the collector is inserted into the sample chamber, thereby releasing the liquid sample into the sample chamber, and the liquid flows out of the sample chamber along the channel. In some embodiments, the sample chamber has a platform at the bottom that forms the bottom, and the absorbent member of the collector contacts the bottom and is compressed to release the liquid sample from the absorbent member. In some embodiments, the bottom of the sample chamber extends downward through a channel through which the squeezed or released liquid sample flows. In some embodiments, when the cover is used to cover a test chamber with a test element, the liquid sample from the sample chamber enters the test chamber when the cover is closed. Or the root sample cavity and the liquid cavity extend outwards from the cover body in the same direction. In some embodiments, the fluid chamber is movable relative to the cover, and the sample chamber and cover are integrated into a fixed, unitary structure that is not movable relative to each other, such that when the fluid chamber is positioned in the test chamber, the position in the test chamber is fixed and the fluid chamber in the test chamber is movable, such movement being controlled by the locking element.

In some embodiments, the device further comprises a test chamber with a test element, the cover covers the opening of the test chamber, and the sample chamber and the liquid chamber are located in the test chamber. In some embodiments, the test chamber includes a puncturing element operable to puncture the fluid chamber, the puncturing element puncturing the fluid chamber and into the fluid chamber as the fluid chamber moves relative to the cap into the test chamber, thereby forcing fluid in the fluid chamber into the test chamber. In some embodiments, the lancing element has a sharpened lancet and a base connected to the needle, the base having a diameter comparable to the diameter of the fluid chamber. In some embodiments, the test chamber includes a carrier carrying the test elements, the carrier having slots for holding the test elements.

In some embodiments, the cover includes an aperture in communication with the atmosphere, the aperture having a channel extending in the same direction as the sample chamber, or the channel extending in the same direction as the liquid chamber and the sample chamber, or both extending from the cover to the back of the cover, or both extending into the detection chamber. The purpose of the hole communicating with the outside atmosphere is to keep the test chamber communicating with the outside, so that when the treatment liquid in the liquid chamber is pierced, the treatment liquid easily flows into the detection chamber, and in addition, the liquid sample collected by the sample chamber also easily flows into the detection chamber.

In some aspects, the invention provides a method of assaying a substance in a liquid sample, the method comprising providing a device comprising a cap comprising a sample chamber for receiving a sample collector and a liquid chamber containing a sample processing fluid, the liquid chamber having a locked state and an unlocked state, and a test chamber with a test element capable of assaying the substance in the sample, collecting the liquid sample with the collector and inserting the liquid sample into the sample chamber and releasing the liquid sample into the sample chamber, flowing the liquid sample in the sample chamber into the test chamber and into contact with the test element, unlocking the liquid chamber, and then pushing the liquid sample chamber into the test chamber to release the processing fluid into the test chamber. In some embodiments, a puncturing element is disposed in the detection chamber such that the fluid chamber is in contact with the puncturing element, whereby the puncturing element punctures the fluid chamber and releases the fluid. In some embodiments, the lancing element is allowed to enter the fluid chamber, thereby forcing the fluid chamber to release the treatment fluid into the detection chamber.

In some ways, the timing of unlocking is also a unique place of the present invention. The main reason is that, when the first detection is performed, some detection results are found in an undetermined section, for example, in a negative or positive section, but the final result cannot be determined, which is a problem inherent to the immunological detection, and at this time, the detected sample needs to be sent to a higher-level and more precise experimental equipment for confirmation detection. At this time, if the sample is relatively small, the water in the original sample evaporates and even dries during transportation, and at this time, when the detection is confirmed, the locking element is activated, and after unlocking, the treatment liquid in the liquid chamber is punctured and flows into the detection chamber, the dry analyte is dissolved, and then sampling is performed for a second test. Thus, the defect that the sample can not be confirmed and detected secondarily after being reduced or dried in the transportation process is overcome.

In some embodiments, in all of the foregoing embodiments, the liquid sample may be blood, urine, saliva, sweat, and the like.

A method of detecting an analyte in a liquid sample, the method comprising:

The cover device comprises a cover body, wherein the cover body comprises a sample cavity for accommodating a sample collector and a liquid cavity containing sample treatment liquid, the liquid cavity is provided with a locking state and an unlocking state, and a detection cavity is provided with a test element capable of testing an analyzed substance in a sample;

Collecting a liquid sample with a collector and inserting into the sample chamber and releasing the liquid sample into the sample chamber;

the liquid sample in the sample cavity flows into the detection cavity and contacts the test element;

The liquid cavity is unlocked, then the liquid sample cavity is pushed into the detection cavity, and the treatment liquid is released into the detection cavity.

Advantageous effects

The invention combines the treatment liquid with the liquid sample, and when the liquid sample is few, the treatment liquid can be mixed with the liquid sample. If the liquid sample is sufficient, no treatment liquid may be used, so that there may be multiple choices. In addition, the treatment liquid of the present invention is not used to be in direct contact with the collector, but is provided separately. When the primary test is completed, if the test result is suspected and questioned, secondary confirmation is required, and the test result is often transported to a professional laboratory through a long distance, and at the time, the sample in the test chamber may evaporate and become less or even not (the water is evaporated), and at the time, the liquid can enter the test chamber to dissolve the residual sample or the analyzed substance to form a new liquid sample, so that the sample is easy to sample for secondary confirmation detection.

Drawings

FIG. 1 is a schematic diagram of a test element in one embodiment of the invention.

FIG. 2 is a schematic perspective view of a test element according to one embodiment of the present invention.

Fig. 3 is a schematic perspective view (assembled in full) of the detection device of the present invention.

FIG. 4 is a schematic exploded view of the detection device of the present invention.

Fig. 5 shows a schematic perspective view of the cover (without locking elements).

Fig. 6 is a schematic cross-sectional structure of the cover (with locking elements).

Fig. 7A is a schematic cross-sectional structure of the cover along A-A of fig. 7B (the locking element is separated from the cover).

Fig. 7B is a top view of the cover.

Fig. 8 is a schematic perspective view of the cap (without the liquid chamber).

Fig. 9A is a schematic perspective view of a locking element.

Fig. 9B is a schematic perspective view of section A-A' of the top view of the locking element and a top view.

Fig. 10A is a schematic perspective view of a test chamber.

Fig. 10B is a top view of the test chamber.

FIG. 11 is a schematic cross-sectional view of a test chamber.

FIG. 12 is a schematic cross-sectional view of the cap in combination with the test chamber, with the collector in the sample chamber, and the liquid chamber in an elevated position and in an unlocked state.

Fig. 13A-13B are schematic cross-sectional views of the cap in combination with the test chamber, the collector in the sample chamber, and the liquid chamber in a lowered and unlocked state.

Detailed Description

The structures and terms of art to which the present invention pertains are further described below, as understood and interpreted in accordance with the general terms of art unless otherwise specified.

Detection of

Detection indicates the assay or testing for the presence of a substance or material, such as, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolic product, a drug or drug metabolite, an organic tissue or a metabolite of an organic tissue, a nucleic acid, a protein or a polymer. In addition, the detection indicates the amount of the test substance or material. Further, assays also refer to immunoassays, chemical assays, enzymatic assays, and the like.

Sample of

The sample of the detection device of the present invention includes biological fluids (e.g., case fluids or clinical samples). The liquid sample or liquid specimen may be derived from solid or semi-solid samples, including fecal matter, biological tissue, and food samples. The solid or semi-solid sample may be converted to a liquid sample using any suitable method, such as mixing, mashing, macerating, incubating, dissolving, or digesting the solid sample with enzymatic digestion in a suitable solution (e.g., water, phosphate solution, or other buffer solution). "biological samples" include animal, plant and food samples, including, for example, urine, saliva, blood and components thereof, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures and media derived from humans or animals. Preferably the biological sample is urine, preferably the biological sample is saliva. Food samples include food processed materials, end products, meat, cheese, wine, milk and drinking water. Plant samples include plants, plant tissues, plant cell cultures and media derived from any plant. An "environmental sample" is derived from the environment (e.g., a liquid sample from a lake or other body of water, a sewage sample, an earth sample, groundwater, seawater, and a waste liquid sample). The environmental sample may also include sewage or other wastewater.

Any analyte may be detected using a suitable detection device of the present invention. Preferably, the invention is used for detecting drug small molecules in saliva and urine. Of course, the sample to be detected using the detection device of the present invention may be any of the above forms of sample, whether initially solid or liquid, so long as such liquid or liquid sample is capable of being absorbed by the sample application area of the test element. The sample application area is generally made of a water absorbent material, and the liquid sample or liquid sample can be absorbed by the capillary or other characteristics of the material of the absorbent element, so that the liquid sample can flow in the sample application area. The material of the liquid sample application region may be any material capable of absorbing liquid, such as sponge, filter paper, polyester fiber, gel, nonwoven, cotton, polyester film, yarn, etc. Of course the liquid sample application area need not be of a material having water absorbing properties, but may be of a non-water absorbing material, but may have holes, threads, cavities in the absorbing element, on which structures samples may be collected, typically solid or semi-solid samples, which are filled in between the threads, holes, or holes, to collect the samples. Of course, alternatively, the liquid sample application area may be comprised of non-absorbent fibers, hair, and these materials may be used to scrape a solid, semi-solid or liquid sample that is held on the liquid sample application area. When detection is desired, a buffer solution is applied to the sample application area to dissolve the sample, thereby allowing the dissolved sample to flow over the test element or the detection element.

Downstream and upstream

Downstream or upstream is divided with respect to the direction of liquid flow, typically liquid or fluid flows from upstream to downstream regions. The downstream region receives liquid from the upstream region and liquid may also flow along the upstream region to the downstream region. Here, the flow direction of the liquid is generally divided, for example, by capillary force, so that the liquid can flow against gravity in a direction opposite to the gravity, and the flow direction of the liquid is divided into upstream and downstream. For example, in the test device of the present invention, after the fluid-directing element receives the liquid sample, the fluid may flow from the fluid-directing element to the sample application region or sample application pad of both test elements, then the liquid flowing to the sample application pad flows to the downstream label pad, then mixes with the labeled labeling substance, flows through the transition pad to the downstream test pad, where the test region is located upstream of the test result control region, and finally flows to the absorbent pad on the downstream absorbent region. The test area may be a polyester film and the flow directing element may be a glass fiber, a polyester sheet, a polyester film. At this point, the flow directing element is upstream of the test element marking area. The structure of a particular test element is shown as 20 in figures 1-2. When part of the sample is applied to the pad, the liquid on the sample pad flows mainly by capillary force.

Gas or liquid communication

Gas or liquid communication refers to the ability of a liquid or gas to flow from one location to another, where the flow may be directed through some physical structure. By physical structures is generally meant that liquid passes over the surfaces of the physical structures, or spaces within the structures, and flows, either passively or actively, to another location, the passive being generally induced by external forces, such as capillary flow, air pressure, etc. The flow may be liquid or gas, or may be passive flow due to its own action (gravity or pressure), or may be positive flow, or may be reverse flow, or may be air pressure to cause fluid to flow from one location to another. Communication herein does not necessarily require the presence of a liquid or gas, but merely in some cases indicates a connection or state between two objects, and if a liquid is present, may flow from one object to another. Here, it refers to a state where two objects are connected, but conversely, if there is no liquid communication or gas communication between the two objects, if there is liquid in or on one object, the liquid cannot flow into or on the other object, and such a state is a non-communication, non-liquid or gas communication state.

Test element

By "test element" is meant herein that an element that can detect whether a liquid sample or fluid sample (liquid sample or liquid sample) contains an analyte of interest can be referred to as a test element, and such detection can be based on any of the principles of technology, immunology, chemistry, electricity, optics, molecular, nucleic acid, physics, and the like. The test element may be a lateral flow (Latteral flow) test strip that detects multiple analytes. Of course, other suitable test elements may be employed in the present invention. In the present invention, test element and "lateral flow test element, or test strip" are used interchangeably to refer to the same meaning.

Various test elements may be combined together for use in the present invention. One form is test paper. Test strips for analyzing analytes in a sample, such as drugs or metabolites indicative of a physical condition, may be in various forms, such as immunoassay or chemical analysis. The test strip can adopt an analysis mode of a non-competition method or a competition method. The test strip generally comprises a bibulous material having a sample application area, a reagent area and a test area. The fluid or liquid sample is applied to the sample application region and flows by capillary action to the reagent region. In the reagent zone, the sample binds to the reagent if the analyte is present. The sample then continues to flow to the detection zone. Other reagents, such as molecules that specifically bind to the analyte, are immobilized in the detection zone. These reagents react with and bind the analyte (if present) in the sample to the region, or to a reagent in the reagent region. The label for displaying the detection signal is present in a separate label zone from the reagent zone.

A typical non-competitive assay format is one in which a signal is generated if the sample contains an analyte and no signal is generated if the sample does not contain an analyte. In competition methods, a signal is generated if the analyte is not present in the sample, and no signal is generated if the analyte is present.

The test element can be a test paper, and can be made of a material which absorbs or does not absorb water. The test strip may comprise a variety of materials for liquid sample transfer. One of the test strips may be coated with another material, such as a filter paper, on a nitrocellulose membrane. One region of the test strip may be of one or more materials and another region of the test strip of a different material or materials. The test strip may be adhered to a support or hard surface for improving the strength of the pinch test strip.

The analyte is detected by the signal generating system, e.g., using one or more enzymes that specifically react with the analyte, and the composition of the one or more signal generating systems is immobilized on the analyte detection zone of the test strip using the method of immobilizing a specific binding material on the test strip as described previously. The signal generating substance may be on the sample application zone, reagent zone, or test zone, or the entire test strip, and the substance may be impregnated with one or more materials of the test strip. The solution containing the signal is applied to the surface of the test strip or one or more materials of the test strip are immersed in the solution containing the signal. The test paper added with the signal-containing substance solution is dried.

The various zones of the test strip or lateral flow test strip of the present invention may be arranged in a sample application zone 905, a label zone 904, a detection zone 902, which includes a test result zone 906 and a test result control zone 907. The control zone is located after or downstream of the detection zone. All zones may be arranged on a strip of paper of only one material. Different materials may be used for the different regions. Each zone may be in direct contact with the liquid sample or the different zones may be arranged in accordance with the direction of flow of the liquid sample, with the ends of each zone being connected to and overlapping the front end of the other zone. The material used may be a material with good water absorption such as filter paper, glass fiber or nitrocellulose membrane. The test strip may take other forms.

The reagent strip is usually a nitrocellulose membrane reagent strip, namely the detection area comprises a nitrocellulose membrane (NC), and specific binding molecules are immobilized on the nitrocellulose membrane to display the detection result, and the reagent strip can also be a cellulose acetate membrane or a nylon membrane. Such as the reagent strips or devices ：US 4857453;US 5073484;US 5119831;US 5185127;US 5275785;US 5416000;US 5504013;US 5602040;US 5622871;US 5654162;US 5656503;US 5686315;US 5766961;US 5770460;US 5916815;US 5976895;US 6248598;US 6140136;US 6187269;US 6187598;US 6228660;US 6235241;US 6306642;US 6352862;US 6372515;US 6379620; containing the reagent strips and US 6403383 described in some of the following patents. The test strips disclosed in the above patent documents and similar devices with test strips can be used in the test element or test device of the present invention for the detection of an analyte, for example in a sample.

The test strips used in the present invention may be so-called Lateral flow strips (latex flow TEST STRIP) whose specific structure and detection principles are well known to those of ordinary skill in the art. A typical test reagent strip (fig. 1-2) includes a sample application or application region 905, a label region 904, a detection region 902, a sample collection region including a sample receiving or application pad, and a label region including a label pad. A water absorbent region 901 may also be included to absorb liquid samples from the nitrocellulose membrane, and may include a water absorbent pad. In some embodiments, the labeling zone includes color particles coupled to the antibody, which may be latex particles, gold particles, or dyes. The detection zone 902 includes necessary chemicals, such as immunological or enzymatic chemicals, to detect the presence of the analyte. A commonly used test reagent strip is a nitrocellulose membrane strip, i.e. the test area 902 comprises a nitrocellulose membrane on which specific binding molecules are immobilized to reveal the result area 906 (T-line) of the test, and may also be a cellulose acetate membrane or nylon membrane, etc., and of course, a test result control area 907 (C-line) may also be included downstream of the test area, typically in the form of a transverse line on the control area and the test area, as a test line or control line. Such test strips are conventional, although other types of strips that utilize capillary action for testing are possible. In addition, the test strip typically carries a dry reagent component, such as an immobilized antibody or other reagent, which, upon encountering the liquid, flows along the strip with capillary action, and with the flow, dissolves the dry reagent component in the liquid, thereby allowing the dry reagent in the zone to react to the next zone for the necessary test. The liquid flow is mainly by capillary action. May be used in the detection device of the present invention, or may be disposed in the detection chamber in contact with the liquid sample, or may be used to detect the presence or amount of analyte in the liquid sample entering the detection chamber.

In addition to the above-described test strips or the lateral flow test strips themselves are used to contact a liquid sample to test the liquid sample for the presence of an analyte. The test element according to the invention can itself be used as a detection device for detecting an analyte in a sample, so that the detection device itself is here equivalent to the test element. For example, after the liquid sample is mixed with the treatment liquid, the liquid sample is directly detected by the test element. As will be described in greater detail below, the test element may be used alone for testing when the receiving means is described as processing a liquid sample. .

Analyte substance

Examples of analytes that can be used in the present invention include small molecule substances, including drugs (e.g., drugs of abuse). "drug of abuse" (DOA) refers to the use of drugs (typically acting to paralyze nerves) in non-medical destinations. Abuse of these drugs can lead to physical and mental impairment, dependence, addiction and/or death. Examples of drug abuse include cocaine; amphetamine AMP (e.g., black americans, white amphetamine tablets, dextroamphetamine tablets, beans); methamphetamine MET (crank, methamphetamine, crystal, speed), barbiturates BAR (such as Valium, roche Pharmaceuticals, nutley, new Jersey), sedatives (i.e. sleep aids), lysergic diethylamide (LSD), inhibitors (downers, goofballs, barbs, blue devils, yellow jackets, hypnotic), tricyclic antidepressants (TCA, imipramine, amitriptyline and doxepin), dimethoxymethylaniline MDMA, phencyclidine (PCP), tetrahydrocannabinol (THC, pot, rope, hash, weed, etc.), opiates (i.e. morphine MOP or opium, cocaine COC, heroin, hydroxydihydrocodeinone), anxiolytics and sedatives, the anxiolytics being a class of drugs which are mainly used to relieve anxiety, stress, fear, stabilize mood, and have hypnotic effects, including benzodiazepines BZO (benzodiazepines), atypical BZ, diazepines, benzodiazepines 23, BZ, benzodiazepine, oxazine derivatives, oxamic derivatives, heterocyclic derivatives, such as the derivatives of the class of the heterocyclic classes, such as the oxamic acid, the heterocyclic derivatives of the oxamic acid derivatives, the heterocyclic derivatives, such as the oxamic derivatives, the derivatives, such as the oxydol, the derivatives, etc. The detection device can also be used for detecting medical application and is easy to take excessive medicines, such as tricyclic antidepressants (promethazine or analogues), acetaminophen and the like. These drugs are metabolized into small molecular substances after being absorbed by the human body, and these small molecular substances exist in body fluids such as blood, urine, saliva, sweat, etc. or some body fluids exist in these small molecular substances.

For example, analytes to be detected with the present invention include, but are not limited to, creatinine, bilirubin, nitrite, proteins (non-specific), hormones (e.g., human chorionic gonadotropin, progestin, follicular stimulating hormone, etc.), blood, leukocytes, sugars, heavy metals or toxins, bacterial substances (e.g., proteins or carbohydrate substances directed against specific bacteria, such as e.g., E.coli 0157: H7, staphylococci, salmonella, clostridium, campylobacter, L. Unicytogenes, vibrio, or Cactus) and substances associated with physiological characteristics in urine samples, such as pH and specific gravity. Any other clinical chemistry assay can be tested using lateral flow assay formats in combination with the device of the present invention. It is also possible to detect the presence of viral antigens such as neocoronal antigens, influenza antigens.

Carrier containing test elements

In some embodiments, the test element may also be disposed on some carrier element such that the carrier element contains the test element to perform detection and assaying of the analyte in the liquid sample. Thus, in some embodiments, the detection device comprises a carrier on which the test element is disposed. In some embodiments, the carrier of the present invention is a carrier or housing for carrying or housing test elements, the carrier elements themselves not participating in a direct test function, but acting as carriers or housings for carrying or housing test elements. For example, as shown in fig. 4, two carriers 311,301 are provided, each of which is provided with a slot configured to receive a test element 20, and a plurality of slots 307,308,309,310 may be provided on one carrier, each of which is provided with a test element, typically with a sample application area of the test element at one end of the slot opening. After the test element is placed in the well, a transparent film is coated on the surface of the carrier 301, and then the carrier 301 is inserted into the test cavity. The test chamber has two opposite planar faces 312,313, and the carrier is inserted into the test chamber and rests on the planar faces while the face with the test element rests on the planar faces so that the test results on the test element can be read through the transparent face of the chamber when tested.

In some embodiments, each of the grooves in the carrier 301 has a raised structure at one end that allows the test element to be secured in the groove, the raised structure generally being a location of a suction pad that snaps over the suction area of the test element. In some embodiments, the test chamber is an opening 306, including a bottom and a sidewall 312. The opening 306 can be sealed by a cover to form a sealed space within the test chamber, which space contains a carrier on which one or more test elements are disposed that are capable of detecting the analyte in the sample. In the middle of the bottom of the test chamber there is a raised structure, the bottom of which forms a slit or slot with the bottom of the side walls 312,313 of the test chamber, which have a plane, on the bottom of which the carrier 301,311 is arranged, the end of the sample application area of the test element being close to the bottom of the slot. When the liquid sample enters the test chamber, the liquid sample may flow into the slit with the liquid sample in the slit to contact the bottom of the test strip, particularly the end of the sample application area of the test strip, and the liquid flows by capillary action over the test strip to detect the substance being analyzed in the liquid sample. Further details and descriptions will be provided below in connection with the detailed description.

Test chamber containing test elements

The present invention provides a test chamber 300, which may be referred to as a test chamber, that contains test elements, which may be one or more test elements. In some embodiments, the test element is disposed on a carrier having a plurality of channels, each channel having a test strip disposed therein, the carrier being disposed in the test cavity. As shown in fig. 3,10-11, the illustrated test chamber includes an opening 306, including the bottom of the test chamber and surrounding sidewalls defining the chamber, with a raised structure 382 at the bottom of the chamber, and a channel or channel 381,3811 formed between the raised structure 382 and two opposing planar sidewalls 312,313, the two channels being formed at the bottom of the respective planar walls. A channel or passage 387 is also provided in the raised structure and communicates with the passage 381,3881 below the side wall, thus allowing fluid communication between each passage and allowing fluid flow between the passages. A circular mesa is provided on the raised surface between which the channel 387 is provided, the channel 387 dividing the mesa into two parts 385,386, the raised surface being the bottom 255 for receiving the sample chamber. The bottom 255 of the sample chamber is brought into contact with the raised surface 385,386 and a perimeter wall is formed around the raised mesa surface around the bottom of the sample chamber so that the sample chamber is in a stationary position within the test chamber (fig. 12). Meanwhile, the channel 224 at the bottom of the sample cavity is located in the channel 387 between the two surfaces 385,386, when the liquid sample in the sample cavity flows out through the channel 224 at the bottom 255 of the sample cavity, the liquid sample directly flows into the channel 387, so that the liquid sample can flow into the grooves or the channels 381,3811 at the bottom of the sample cavity respectively, the sample application parts of the test elements are arranged at the bottoms of the two grooves, or the carriers are arranged on the two grooves, the end parts of the sample application areas of the test elements on the carriers are located at the bottom surfaces of the grooves, and the liquid sample in the grooves can contact the test elements, so that the detection of the analyzed substances in the liquid sample is completed.

On one side of the bottom of the test chamber, e.g., near side wall 391, a lancing element 900 is positioned internally, with a sharpened lance 901 and a needle-positioning base 909 on the side of the interior of the test chamber, with 4 cross-webs 903,904,905,906 dividing the base into 4 sections, one of the cross-webs functioning as a conduit for the flow of process fluid to the bottom of the test chamber when the lance pierces the membrane at the bottom of the fluid chamber, and the cross-web intersecting at a point at the top of base 909 that forms the lance. In some embodiments, the bottom of the base is located on a ramp 387 that extends on both sides of the base 909, on a ramp 387 of the base adjacent the planar side wall 312, and on a ramp 388 adjacent the planar side wall 313 that extends above the channel. As shown in fig. 10, to allow the test carrier to be held within the channel 381,3811, a holding clip 392,393 is provided at each end of the communication, and where the holding clip and lancing element base support are also inclined surfaces 387, corresponding pairs of inclined surfaces 388 also extend between the holding clip 393 and the lancing element base. Thus, when the lancing element lances the fluid chamber or the entire lancing base enters the fluid chamber, fluid flows down the lancing base and, at this time, the process fluid flows along the sloped surfaces into grooves or channels 381,3811, respectively, and if there is not necessarily as much fluid on both sides, the fluid is allowed to equilibrate on both sides by grooves 387, maintaining the fluid evenly distributed in both channels 381,3811. In some embodiments, a hole 391 is provided in the side wall 305 of the test chamber, a piston or sealing plug 304 is provided in the hole, and after the test is completed, a secondary sample confirmation can be performed through the hole 391.

Cover body containing sample cavity and liquid cavity

In some aspects, the invention provides a cap configured to seal or cover a test cavity with an immunoassay test element. In some embodiments, the cover includes a sample chamber for receiving the collector and a fluid chamber including a treatment fluid, where the fluid chamber is movably connected to the cover or the fluid chamber and the cover are capable of moving relative to the fluid chamber, or the fluid chamber and the cover are in a locked and fixed state and an unlocked state, and are capable of moving relative to the cover. As shown in fig. 5-6, the cover has two sides, a front side 222 and a back side 223, and a cover rim 221, the overall shape and size of the cover corresponds to the shape and size of the opening 306 of the test chamber to be covered, and when the cover is covered on the opening 306 of the test chamber, part of the liquid chamber and the sample chamber are located in the test chamber. In the specific embodiment of the invention, the opening of the test cavity is similar to a U shape, and the overall shape of the cover body is also a U shape matched with the test cavity, so that when the cover body covers the test cavity, the direction is unique, errors in assembly are avoided, that is, when the cover body is overlapped with the opening of the test cavity, the cover body can be correctly covered, the direction is wrong, and the cover body cannot cover the test cavity.

In some embodiments, the cover includes a sample cavity having an opening 211 and a tube 225 extending along the opening, the tube having a cavity 266, the cavity being for receiving the sample collector 400. The sample chamber is integral with the cover, the opening is provided in the front 222 of the cover and the tube extends toward the back 223 of the cover, the sample chamber is positioned within the test chamber when the cover is closed over the test chamber, and in particular, the bottom of the sample chamber is positioned on the raised mesa 385,386 of the test chamber and the bottom extending channel is positioned in the channel 387 between the raised surfaces 385,386. In some embodiments, the sample chamber has a bottom 255 that primarily allows the absorbent member 403 of the collector 400 to contact, which is capable of absorbing the liquid sample, and which is also compressible, such that when the bottom 255 of the sample chamber contacts the absorbent member, the absorbent member is compressed by virtue of the force of the bottom moving with the collector at a position within the chamber, thereby releasing the sample from the absorbent member into the sample chamber. In some embodiments, the bottom of the sample chamber has a channel 224 for the purpose of allowing the liquid sample to flow out along the channel 224 or directly into the test chamber (if present) after the absorbent member 403 has been squeezed to release the liquid sample. The collector is inserted from an opening 211 of the sample chamber, which is provided in the cover, with a rotating arrow sign near the opening of the sample chamber, indicating the direction of rotation, e.g. clockwise or counter-clockwise, after insertion of the collector into the sample chamber. The collector 400 has a hand-held portion 408 with a similar protruding strip around it, which increases roughness and increases friction. The lower end of the hand-holding portion of the collector has an external thread, which is engaged with the thread inside the sample chamber of the opening 211, so that the collector is inserted into the liquid chamber and fixed to the liquid chamber by the thread engagement, and at the same time, the collector is gradually introduced into the sample chamber while the collector and the chamber are rotatably fixed to each other, and at this time, the absorbing member 403 is compressed to release the liquid sample. In some embodiments, the collector has an annular recess 405 in the upper end of the absorbent member in which is disposed an elastomeric seal 406. The annular seal 406 sealingly engages the inner wall 229 of the chamber when the collector is inserted into the sample chamber 266, thus allowing liquid sample to flow out through the passage 224 of the base 255 as much as possible when the absorbent member 403 is squeezed or compressed, while avoiding liquid sample flow into the sample chamber defined by the seal 406 and the threads.

Of course, if the cover is assembled with the test chamber, the cover is typically sealed from the opening of the test chamber, which creates a sealed space within the test chamber, and if the collector is also sealed from the sample chamber, this increases the pressure in the test chamber, which is detrimental to the flow of liquid sample into the test chamber, so that in some embodiments the test chamber is vented to the outside atmosphere through other structural designs, so that the liquid can flow naturally with the natural direction of gravity in the absence of gas pressure. Therefore, the cover further comprises a through hole 212, which has a downward extending channel 213, which extends into the test chamber, and which mainly keeps the test chamber open to the outside atmosphere, so that the inside of the test chamber is equal to the outside atmosphere, and in this case, liquid easily flows from the sample chamber to the test chamber.

In some embodiments, a liquid chamber is also included on the cover, the liquid chamber including a treatment liquid therein. The effluent liquid here generally does not contain the analyte, but may include functional components such as reagents that improve the detection of the liquid sample on the test element, such as PH adjusting reagents, deproteinizing reagents, carbohydrates, etc., or some eluting, stabilizing reagents for the analyte, etc., when the treatment liquid is mixed with the liquid sample from the absorbent element. Yet another effect of the treatment fluid is to mix with the fluid sample in time, increasing the total volume of fluid, which is primarily when the amount of sample absorbed by the absorbent member 403 is relatively small, and it is desirable to detect multiple indicators or multiple analytes at one time, thus increasing the total volume of fluid when there is insufficient fluid collection by the actual collector. For example, the present invention includes two carrier elements, each comprising 8 test strips, for a total of 16 test strips, that can substantially detect 16 analytes, each of which requires sufficient fluid to complete the flow to achieve effective test results. The flow from the sample application zone to the absorbent zone, such as 20 microliters of liquid per test strip, while a minimum of 320 microliters is required for 16 test strips, but if the amount of liquid compressed from the absorbent element is only 300 microliters, plus the loss of flow, the amount up to 300 microliters on the test strip is insufficient to complete the entire process of liquid flow per test strip, and may result in undetectable, at this time the treatment liquid in the liquid chamber is released, mixed with the liquid sample, increasing the volume of liquid, ensuring that the entire test can be completed, at least ensuring that the amount of liquid is sufficient. The third effect of the treatment fluid is to dissolve the analyte, such as when performing an immunoassay of the test element, the squeezed fluid chamber on the absorbent member 403 is sufficient to perform the assay, but when a secondary assay is required, the entire test device is transported to a higher laboratory where it is subjected to confirmation of the assay by more sophisticated equipment, such as liquid phase, weather or mass spectrometry equipment, but most commonly, the temperature of the environment during transport is elevated, causing the water in the fluid sample in the test chamber to volatilize or evaporate, sometimes completely without the presence of fluid, and the analyte is deposited at the bottom of the test chamber and in the dry state, at which time no sub-sampling is performed and confirmation of the assay is possible. If a secondary test is required at this time, the liquid sample in the test chamber is sucked for testing, and at this time, the treatment liquid is released into the test chamber, the dried sample is dissolved by the treatment liquid, and the analyte in the dried sample is dissolved again, so that the liquid can be sucked from the test chamber for performing a secondary confirmation test. The primary tests are performed on the immunoassay strips, but are not very accurate, and particularly for some ambiguous results, further confirmation is required, at which time more accurate tests are required to be sent to a specialized laboratory for further confirmation of the test, such as mass spectrometry, liquid phase or liquid phase mass spectrometry connectivity.

Therefore, the treatment liquid in the liquid chamber of the present invention can be released at different timings. Thus, the liquid sample cannot be automatically released, and the conventional operation is performed, but the first release and the liquid sample are mixed according to the amount of the sample, or the solution analyzed substance is required to be released again when the second confirmation is required after the first immunoassay. This requires the operator to release the treatment fluid under different conditions, which requires a controlled action on the fluid chamber of the treatment fluid. Moreover, the liquid in the liquid treatment chamber of the present invention is not directly in contact with the absorbent member, but is used as a replenishing liquid for eluting the adsorbed substances on the absorbent member, and if the amount of liquid is insufficient, the replenishing liquid is used as a replenishing liquid, and if the evaporation of the liquid sample is secondarily confirmed, the replenishing liquid is used as a replenishing liquid for dissolving the dry analyte in the test chamber. Therefore, in some embodiments, the cover also includes a fluid chamber that is maintained in two different states with respect to the cover, a stationary locked state in which the fluid chamber remains stationary and cannot be operated (e.g., pushed or not exposed), and a non-stationary locked state in which the fluid sample is stored in the fluid chamber and cannot be released, and in which the fluid chamber is movable to allow the treatment fluid to be released from the fluid chamber. In some embodiments, the cover includes a docking area, similar to a ship docking area, that includes a liquid sample chamber therein. At the same time, a locking element is also in the docking area, by means of which locking element the liquid chamber is fixed in the docking area, which liquid chamber can be moved or moved away or in the docking area when unlocked. For example, as shown in fig. 5-6, on the carrier, a docking area is located beside the sample chamber opening 211, which docking area resembles a stepped pattern or a notch, which notch is masked when the locking element enters the docking area, and which appears to be a complete lid from the outside without a notch. The docking area enables the locking element to fix the liquid cavity at a fixed position, plays a role of covering the liquid cavity, prevents misoperation, removes the locking element when the release of the treatment liquid is needed, exposes the liquid sample cavity, and can operate the liquid cavity, such as releasing the liquid to the test cavity, mixing with the liquid sample of the test cavity and the like.

In some embodiments, the docking area includes a platform area 217 adjacent to which is disposed a docking area including two sides disposed limit areas 290,219,226,218. In a specific embodiment, the locking element can be fastened to the docking area in both the platform area and the docking area, or can leave the docking area. The locking element is fixed in the area by either or both of the platform area and the docking area, and the liquid cavity is also fixed in the area by the locking element, and optionally, the locking element is also hidden in the area. Specifically, an orifice 216 is provided in the land area 217, which allows the liquid chamber to extend from the orifice, and when the orifice 216 is provided, the land area is divided into an area containing the orifice and a planar area 217 surrounding the orifice. The platform region includes an extension region 209 in which the planar region 217 is stepped, which is also a part of the cover, and is entirely curved, and the region 209 is a region that mates with the portion of the test chamber opening, and the test chamber opening is a region 3911 that is curved, so that the extension region is also curved. A detent 220 is formed between the land area 217 and the extension area 209. As can be seen in fig. 5, the land area 217 extends partially towards the extension area 209, and a detent structure is formed at the distance between the two areas 217,209, which detent structure cooperates with a detent of the locking element projecting rib 282,2991,233 to secure the locking element to the docking area. Specifically, the card slot 220 is located at an arc position, and part of the card slot is distributed on two sides 293,2931 of the cover, and the card operations on the two sides are matched with the protruding ribs 299,233 on the locking element, one is to make the locking element enter the docking area through the card slot, the entering mode is similar to the mode of a sliding rail and a sliding chute, and the card slot 220 is matched with the protruding ribs 2991, so that the locking element is fixed on the docking area 294 on the cover. In one embodiment, such as the locking element of fig. 9, the locking element comprises a three-dimensional semicircular structure including a main structure including a top surface region 231 and a bottom surface region 299, and a cross section 201 connecting the top surface and the bottom surface, the top surface region 231 forming a semicircular notch 281, a semicircular card 282 being disposed between the top surface and the bottom surface, the card having a notch 286 formed in a snap ring-like structure, the notch being sized to match the size of the neck 208 formed between the top of the liquid chamber and the chamber body 205 of the pressing portion 202 of the liquid chamber, such that the notch of the card can be brought into the neck 208 of the liquid chamber to a position where the neck is secured on the locking element without being naturally released from the cover or the liquid chamber being brought into a high position. The neck is in fact the pressing part 202 and the liquid chamber body 205 have an annular groove 208, and the notch 286 of the card can be clamped together around the groove 208, and the card has a certain width, so that the pressing part is located on the card, and the liquid chamber is in a fixed high position. While the annular card or clasp has two ends 285,232, as can be seen in fig. 8 in combination with fig. 6, the docking area's connection area and planar upstanding surfaces 291,292 contact the clasp's two ends 285,232, thereby limiting the distance of lateral movement of the locking element, for example, into the docking area as indicated by the arrow in fig. 7. In some embodiments, the card 282 is positioned within the space defined between the top surface region 231 and the bottom surface 299 of the locking member, such as where the ends 285 and 232 of the card are both retracted within the edge defined by the cutout in the top surface 231, i.e., where the projected region of the card onto the top surface 231 is positioned within the top surface region 3231, although the top surface region is also notched, such that the top surface region 231 covers the entire liquid chamber pressing portion 202, thereby concealing the liquid chamber within the docking region, and in addition, the top surface region has a notch 281, resembling an arcuate notch, which cooperates with the region defined by the face 266,290 of the spacing region of the docking region and the liquid chamber entrance 211, thereby covering the upper portion of the entire liquid chamber, while the locking member also covers the left and right regions of the docking region, thereby concealing the entire liquid chamber envelope exposed within the docking region. In the bottom surface 299 of the locking element, which is in fact defective or missing, one or more ribs or inwardly extending catches 233,282,2991 are provided inwardly at the bottom edge of the cross section 201, which inwardly extending ribs enter into engagement with the catch recess 220,293,2931 formed between the platform region 217 and the extension region 209, thereby limiting the longitudinal position of the locking element in the docking area. The ribs or cards 233,282,2991 are equidistant from the notched card 282 from the liquid chamber neck 208 and platform region 217 so that the liquid chamber is in the initial first position (fig. 5) when the locking element is entered into the docking area. When the locking element leaves the docking area leaving the liquid chamber in a free state, the liquid chamber can be pressurized so as to move from top to bottom in the longitudinal direction, either with the neck 208 moving onto the plane 217 or with the neck with the pressing part 202 moving through the hole 216 out of the cover. For a better fixation of the locking element to the docking station, two facing surfaces 2882,283 are formed on the cross section 201, which contact the surface 219,218 of the docking area, thereby fixing the locking element to the docking area, defining the position of the locking element from side to side. Likewise, the notch 281 of the top surface 231 mates with the face 290,226 of the stopper region to match the area formed along the edge of the opening of the sample chamber, thereby allowing the top surface of the notch 281 to be in surface contact with the face 219,226 of the stopper region. In the case of a solid cross section 201 without any hollowing out, the locking element can be arranged to cover the entire docking area, the liquid chamber can be hidden in the docking area, and the position of the liquid chamber cannot be known from the outside, so that incorrect operation is prevented (as shown in fig. 3), and the position of the liquid chamber is only exposed (as shown in fig. 5,12,15) when the locking structure leaves the docking area. Some arrow indications are provided on the top surface of the locking structure to indicate how to disengage the locking structure from the docking area and leave the liquid chamber in an unlocked state when it is desired to activate the liquid chamber. I.e. the initial state of the locking element into the docking area, the liquid chamber is in a stationary, immovable state, while the liquid chamber is in a raised state (fig. 12), and when the locking element leaves the docking area, the liquid sample is in a free or movable state, so that the liquid chamber can move, possibly releasing the liquid. in some embodiments, protruding ribs are provided on the outer wall of the liquid chamber near the lower part of the pressing part 202, the rib surface is in contact with the hole 206 on the platform 217, leaving a gap between the liquid chamber and the hole, the ribs mainly increasing friction between the liquid chamber and the inner surface of the hole, and when the locking element is removed, the liquid chamber is kept in an initial high position and cannot fall out of the planar area freely. In another aspect, the gap maintains the test cavity in atmospheric communication with the outside, and although the locking structure covers the docking area, the top surface 231 of the locking structure may be provided with holes to allow the interior of the test cavity to communicate with the outside through the gap, and of course, may also contact the mechanical gap between the locking structure and the docking area to maintain communication. Thus, when the liquid chamber enters the test chamber from a high position, more gas than the volume occupied by the liquid chamber can be removed from the gap, and of course, can be removed from the gas channel 213. Of course, it is also possible to lack a slit, and as shown in fig. 6, the liquid chamber 205 is in sealing engagement with the inner wall of the extending pipe 2161 of the hole 216 in the docking area on the cover, the outer wall of the liquid chamber is provided with a sealing ring 2031 sealing against the inner wall of the pipe, while the balance between the air vent 210 and the pipe 213 extending towards the test chamber is maintained in the test chamber.

Fig. 3 is a schematic perspective view of the whole detecting device of the present invention, fig. 12 is a schematic sectional view of the locking member removed, and it can be seen from this view that both the sample chamber and the liquid chamber are located in the test chamber, and fig. 12 shows that the collector is inserted into the sample chamber and releases the liquid sample into the test chamber, and it is desired to release the processing liquid in the liquid chamber, so that the locking member is moved away from the docking area to expose the liquid chamber, which is in a high position, and the liquid chamber can be moved. The liquid chamber contains a treatment liquid, the bottom of which is sealed by a sealing film, and the liquid chamber is arranged above the puncture element in the test chamber. When the fluid chamber is pushed downward from the high position to the low position (fig. 12), the fluid chamber is pierced by the piercing element located in the test chamber, and then the treatment fluid in the fluid chamber is released into the test chamber to mix with the liquid sample released by the absorbent element on the collector, so that a normal test can be completed.

In operation, therefore, a perspective assembly schematic is provided as shown in fig. 3, wherein the collector is not positioned in the sample chamber, but rather is packaged separately, the absorbent member of the collector 400 is inserted into the inlet to absorb saliva sample when testing is desired, the collector is inserted into the sample chamber 225 after the absorbent member 403 has absorbed the liquid sample, the absorbent member of the collector is brought into contact with the bottom 255 of the sample chamber by the threads on the collector rotationally engaging the threads in the opening 211 of the sample chamber, and the entire collector is moved downwardly in the sample chamber as the collector is rotated integrally within the sample chamber, thus squeezing the absorbent member 403 to release the liquid sample from the squeezed absorbent member 403. The absorbent member herein is made of any material that can absorb water, such as filter paper, fiber, sponge, defatted resin, polyester material, etc. Wherein part of the material is hard when dry and softens after absorbing water. Upon softening, the liquid sample may be compressed and released. The liquid sample released from the compression flows through channel 224 at the bottom of Yang Benqiang into channel 387 and then flows in channel 387 to the two side channels 381.3881, respectively, where it contacts the test element. At this point, when the amount of liquid on the collector is found to be relatively small, and the required amount of liquid for all test strips may not be achieved, at this point, the locking element is moved away from the cap, exposing the liquid chamber (see fig. 12), and then the liquid chamber is pressed to move the liquid chamber downward in the test chamber, so that the puncturing element 900 at the bottom of the test chamber punctures the sealing membrane at the bottom of the liquid chamber, thereby allowing the process liquid in the liquid chamber to flow into the test chamber. Because the test chamber is generally transparent, it is possible to observe whether the liquid sample is sufficient through the side walls of the test chamber, and if insufficient, activate the locking element, allowing the locking element to be removed from the cover, exposing the liquid chamber, and performing the subsequent operations.

When a sufficient amount of liquid sample is perceived to be able to complete the flow test of the immunoassay test strip, the liquid chamber is not activated, concealment of the liquid chamber is continued, and the locking member is not moved away from the docking area on the cover. When a problem is suspected in the detection result after the primary detection or the result displayed by the T line on the test strip cannot be judged correctly, such as when the positive or negative result is unknown, the sample is expected to be sent to a more specialized laboratory for secondary confirmation, after the laboratory for secondary detection receives the sample, the sample is absorbed by extending into the aspirator through the hole 391 on the side wall, if the sample amount is insufficient or no liquid sample is found, the liquid chamber is started at this time, the locking element is separated from the cover body, then the liquid chamber is exposed, the pressing part 202 of the liquid chamber is pushed by force, the liquid chamber is moved from the high position to the low position, the puncturing structure in the test chamber punctures the liquid chamber, and the processing liquid is released into the test chamber to dissolve the dried sample or the volume of the sample is increased. Typically, the volume of the treatment fluid in the fluid chamber is fixed, such as 1 ml, 2 ml, 3 ml, 4 ml, 5 ml. Thus, the volume of the treatment liquid is known in advance, and when the liquid sample is insufficient, the volume of the released treatment liquid is known, so that the speed of diluting the liquid sample can be simply converted. In some embodiments, more than 2 fluid chambers are included in the docking area, the arrangement of which is the same as the arrangement of the embodiments described above, for example two holes are provided in the plane 217 of the docking area, one in each hole and two side-by-side lancing elements are provided in the detection chamber, each of which is locked together by a locking element, both fluid chambers being pushed to be lanced by the lancing elements in the test chamber when unlocked. The provision of two fluid chambers allows the operator more options, for example, one fluid chamber in which the treatment fluid is to adjust the PH of the fluid sample and the other fluid chamber in which the sample is diluted to remove large particulate matter from the fluid sample. A targeted selection is made when based on the characteristics of the sample. Of course, after the operation of the liquid chamber has been completed, the liquid chamber is now in a lowered position, but the locking element may again be moved into the docking area, thereby covering the entire docking area, again leaving the liquid chamber in a concealed position, thus preserving the integrity of the test device or other mishandling.

All patents and publications mentioned in the specification are indicative of those of ordinary skill in the art to which this invention pertains and which may be applied. All patents and publications cited herein are hereby incorporated by reference to the same extent as if each individual publication were specifically and individually indicated to be incorporated by reference. The invention described herein may be practiced in the absence of any element or elements, limitation or limitations, not specifically disclosed herein. For example, the terms "comprising," "consisting essentially of," and "consisting of," in each example herein, may be replaced with the remaining 2 terms of one of the two. The term "a" or "an" as used herein means "one" only, and does not exclude that only one is included, and may also mean that more than 2 are included. The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described, but it is recognized that various modifications are possible within the scope of the invention and of the claims. It is to be understood that the embodiments described herein are illustrative of the preferred embodiments and features and that modifications and variations may be made by those skilled in the art in light of the teachings of this invention and are to be considered as falling within the scope of the invention and the appended claims.

Claims

1. An apparatus for detecting an analyte in a liquid sample includes a cap having a sample chamber for receiving a sample collector and a liquid chamber containing a sample processing liquid.

2. The apparatus of claim 1, wherein the liquid chamber containing the treatment liquid is positionally movable relative to the cover.

3. The device of claim 2, wherein the liquid chamber has a locked first position and an unlocked second position relative to the cover.

4. A device according to claim 3, wherein the liquid in the liquid chamber is not released when the liquid chamber is in the locked first position and the liquid in the chamber is released when the liquid chamber is in the unlocked second position.

5. A device according to claim 3, wherein the liquid chamber is in a locked position, locked to the cover by a locking element.

6. The device of claim 5, wherein the locking element comprises a limit structure capable of limiting movement of the fluid chamber, the fluid chamber changing from a locked state to an unlocked state when the limit structure is disengaged from the fluid chamber.

7. The device of claim 6, wherein the liquid chamber is movable relative to the cover when the liquid chamber is in the unlocked state.

8. The device of claim 7, wherein the movement comprises a longitudinal movement from a high position to a low position relative to the cover.

9. The device of claim 8, wherein the fluid chamber includes an easily penetrable sealing membrane that is penetrable by the puncturing element when the fluid chamber is moved downward relative to the cap body to release the fluid from the fluid chamber.

10. The device of claim 5, wherein the cover includes a docking area, the fluid chamber being located within the docking area, the locking element having a fixed locking position of the fluid chamber on the docking area.

11. The device of claim 10, wherein the locking element conceals the fluid chamber within the docking area when the locking element leaves the docking area, exposing the fluid chamber.

12. The apparatus of claim 10, wherein the docking station includes a platform including an aperture therein, the liquid chamber passing through the aperture and being in a raised position away from the platform, wherein the raised position away from the platform is locked by the locking element.

13. The device of claim 12, wherein the liquid chamber is movable from a high position away from the platform to a low position adjacent the platform when the locking element is moved away from or out of the docking area.

14. The device of claim 1, wherein the sample chamber includes a channel therein, and wherein the absorbent member on the collector is compressed after the collector is inserted into the channel of the sample chamber, thereby releasing the liquid sample into the sample chamber, and the liquid flows out of the sample chamber along the channel.

15. The device of claim 7, further comprising a test chamber with a test element, wherein the cover is positioned over the opening of the test chamber, and wherein the sample chamber and the fluid chamber are positioned in the test chamber.

16. The device of claim 1, wherein the sample chamber and the liquid chamber extend outwardly from the cover in the same direction.

17. The device of claim 15, wherein the test chamber includes a puncturing element operable to puncture the fluid chamber, the puncturing element puncturing the fluid chamber and into the fluid chamber as the fluid chamber moves relative to the cap into the test chamber, thereby forcing fluid in the fluid chamber into the test chamber.

18. The device of claim 17 wherein the lancing element has a sharpened lancet and a base connected to the needle, the base having a diameter comparable to the diameter of the fluid chamber.

19. The device of claim 15, wherein the detection chamber comprises a carrier carrying the test elements, the carrier having slots for holding the test elements.

20. The device of claim 19, wherein the cover includes an aperture in communication with the atmosphere, the aperture having a passageway extending toward the test chamber.