A detection device and method for detecting an analyte in a liquid sample

Abstract

The present invention provides a detection device, which includes a base layer, a groove for accommodating a test element on the base layer, and a sample cavity for collecting a fluid sample on the base layer. The detection device can be used to quickly, efficiently and accurately detect an analyte in a liquid sample, and can allow an operator to use the detection device more conveniently and freely without causing incorrect detection results.

Description

Technical Field

[0001] The present invention relates to a device and a method for detecting an analyte in a fluid sample. Background Art

[0002] The following background art is used to help readers understand the present invention and is not to be regarded as prior art.

[0003] Illegal drug abuse has become a recognized and growing problem in our society. In 2003, the U.S. Department of Health and Human Services survey found that approximately 19.5 million Americans, or 8.2% of the population aged 12 and over, were currently using illegal drugs. "Recent use of an illegal drug" was defined as use of an illegal drug in the month prior to the HHS survey. Marijuana was found to be the most commonly used illegal drug, accounting for 6.2% (14.6 million). An estimated 2.3 million people (1.0%) currently use cocaine, 604,000 use crack, 1 million use hallucinogens, and an estimated 119,000 use heroin.

[0004] In order to combat drug abuse and monitor this social problem, drug testing has become a standard testing procedure in various industries such as employment, education, sports, and law enforcement. To promote this effort, a drug testing industry has been formed. This industry provides a variety of drug testing products. A classic testing product is a urine collection cup that allows the sample to be analyzed. These devices can be complicated, difficult, or dirty for the user, or may cause problems with sample adulteration in order to conceal the recent use of illegal drugs. In addition, urine samples cannot be collected in certain places, such as on the roadside or in public places.

[0005] Many other sample collection and testing devices are inefficient in extracting samples from the collection device, and there are always many problems, such as sample leakage and contamination of the environment, or too little or too much sample collected, which affects the test results, or there are multiple operation steps, which makes the test complicated. Many of these devices are also very complex in their design and manufacturing and require the use of relatively expensive materials. Therefore, better methods and devices are needed for collecting and testing samples. Summary of the invention

[0006] In order to solve the problems existing in the prior art, the present invention provides a detection device for detecting an analyte in a fluid sample and a method for detecting an analyte in a fluid sample using the detection device. The use of such a device and detection method can avoid many problems and provide an operating method with better performance and more reliable detection results.

[0007] In one aspect of the present invention, there is provided a detection device, which includes a substrate for supporting a test element, the substrate having a groove for accommodating the test element, and the substrate also including a sample cavity for collecting a fluid sample.

[0008] In some preferred embodiments, a test element is disposed in the groove, and a portion of the liquid sample application area of ​​the test element is located in the sample cavity.

[0009] In some preferred embodiments, the device further comprises a covering layer, the covering layer covering the groove on the base layer, thereby forming a partially sealed channel, the channel can be used to accommodate the test element. Optionally, the covering layer covers the groove to seal the groove. Optionally, the channel includes a test element.

[0010] In some preferred embodiments, the sealed portion of the channel forms the sample chamber to collect the fluid sample. In some preferred embodiments, the sample chamber has an opening located on the groove; optionally, part of the groove is not sealed to form the opening, which forms the opening of the sample chamber.

[0011] In some preferred embodiments, the base layer is a flat plate structure having a plurality of slots for accommodating the test elements.

[0012] In some preferred embodiments, the base layer is a rigid base layer, and the covering layer is a flexible covering layer. Optionally, the base layer has a certain thickness, and the thickness of the covering layer is less than the thickness of the base layer.

[0013] In some preferred embodiments, the base layer is transparent, the covering layer is opaque, and the opening is located on the transparent base layer; optionally, the base layer is opaque, and the covering layer is transparent, and the opening is located on the covering layer; or, in the above two embodiments, corresponding openings are provided on the base layer and the covering layer to serve as the opening of the sample cavity.

[0014] In some preferred embodiments, the test element comprises a test area and a sample application area, wherein the test area is downstream of the sample application area.

[0015] In some preferred embodiments, the base layer is covered with a flexible covering layer, and the covering layer allows the card slot to form a partially sealed channel. In some preferred embodiments, an opening is located on the base layer, and the opening is used to allow the fluid sample to flow into the sample cavity. In some preferred embodiments, the opening is located on the covering layer. The opening is used to allow the fluid sample to flow into the sample cavity, and the fluid sample entering the sample cavity contacts a portion of the sample application area on the test element, thereby allowing the fluid sample to flow from the sample application area to the test area, thereby completing the detection of the analyzed substance in the sample. In some preferred embodiments, a portion of the sample application area of ​​the test element is located in the sample cavity. In some preferred embodiments, the seal is a liquid seal or an air seal.

[0016] In some preferred embodiments, in the card slot for accommodating the test element, the remaining card slot portion except the opening for allowing the fluid sample to flow into the sample cavity is covered and sealed by a covering layer to form a channel.

[0017] In some preferred embodiments, the base rigid structure is formed in one go, in particular, is formed by one-time injection molding. The covering layer is made of a flexible or rigid material and can be covered on the base to seal the slot, thereby forming a channel with one end open and the other end sealed, wherein the part of the test strip is located in the channel, and preferably, the marking area and the detection area of ​​the test strip are located in the sealed channel. The opening is located on the rigid base. In some preferred embodiments, the opening is located on the base forming the slot and corresponds to the part of the sample application area.

[0018] In some preferred embodiments, the card slot includes a structure for reducing, limiting or eliminating capillary flow, and the structure is located on the card slot, in particular, on the surface forming the bottom of the card slot or on the side wall of the card slot, so that the liquid can flow on the test element to the maximum extent without flowing along the gap formed between the test strip and the card slot. The so-called gap is a capillary gap. The so-called reduction is to prevent part of the liquid from flowing through the capillary gap, the so-called restriction is to prevent the liquid from flowing through the capillary gap to the maximum extent, and the so-called elimination is to prevent all liquid from flowing through the capillary gap, such as 100% blocking, 95% blocking, 90% blocking, and 89% blocking.

[0019] In some preferred embodiments, the side wall of the card slot includes a protruding snap-in structure, which can prevent part of the liquid from flowing along the capillary gap formed between the test strip and the side wall. For example, the structure located at the bottom or side wall of the card slot for reducing, limiting or eliminating the capillary flow, such as snap-ins 1008 and 1018, is used to block the capillary flow. At the same time, these structures make the gap between the test strip and the side wall of the card slot larger than the size that can form the capillary flow, thereby eliminating the capillary flow of the liquid through the test strip and the side wall of the card slot into the sealed card slot channel, resulting in the so-called "flooding" phenomenon.

[0020] In some preferred embodiments, the structural groove for reducing capillary flow is located upstream of the test element marking area, or downstream of the test area, or upstream of the sample cavity; preferably, the structural groove for reducing capillary flow is located upstream of the test element marking area, or the structure for reducing capillary flow is arranged corresponding to the marking area of ​​the test element. In some preferred embodiments, the so-called capillary flow is the capillary gap formed between the test strip and the card slot, or the capillary gap formed between the test strip and the bottom area of ​​the card slot.

[0021] Of course, these structures such as snap-ons also have the effect of fixing the test strip at the same time.

[0022] In some preferred embodiments, the card slot includes a pressure release structure or an exhaust structure. When the liquid enters the sealed card slot channel through the capillary flow of the test strip, the pressure of the sealed card slot channel increases. If this pressure is not discharged and released through the structure in the channel, the capillary flow cannot continue, and the test strip cannot work normally, forming the so-called "non-running" phenomenon. In some preferred embodiments, the pressure release or exhaust structure is a groove structure. In a preferred embodiment, the groove forms a "piece" or arrow shape. Preferably, the top of the arrow is pointed in the same direction as the flow direction of the sample on the test element. In some preferred embodiments, the exhaust or pressure release groove structure is located upstream of the test element marking area, or downstream of the test area, or upstream of the sample cavity; preferably, the exhaust or pressure release groove structure is located upstream of the test element marking area, or the exhaust or pressure release groove structure is set corresponding to the marking area of ​​the test element. In some preferred embodiments, the pressure release or exhaust structure is located at the bottom of the card slot, wherein one end of the structure is connected to the inside of the card slot, and the other part is connected to the outside, so as to facilitate the removal of gas. In some embodiments, one end of the groove structure is connected to the interior of the slot, and the other part is connected to the outside (for example, through an opening), thereby facilitating the removal of gas. In some preferred embodiments, the pressure release or exhaust structure is located at the bottom of the slot, wherein one end of the structure is connected to the interior of the slot, and the other part is connected to the opening, thereby facilitating the removal of gas.

[0023] In some preferred embodiments, a support structure for supporting the sample application area of ​​the test element is included in the sample cavity, so that the various areas of the test strip are on the same plane. In some preferred embodiments, the support structure for supporting the sample application area is located in the sample cavity. In some preferred embodiments, the sample cavity is formed by or includes a bottom, a portion of the covering layer and a portion of the base layer. Optionally, the sample cavity is composed of a bottom, an opening, a portion of the covering layer, and a portion of the groove. In some preferred embodiments, a recessed side wall is included in the sample cavity.

[0024] The present invention provides a method for detecting an analyte in a liquid sample, the method comprising: providing a device as in any of the aforementioned embodiments, immersing one end with a sample cavity into the liquid sample, keeping it for a period of time, then taking it out, and reading the detection result on the test element.

[0025] Alternatively, the present invention provides a method for detecting an analyte in a liquid sample, the method comprising: providing a device as in any of the aforementioned embodiments, immersing the entire detection device in the liquid sample, keeping it for a period of time, then taking it out, and reading the detection result on the test element.

[0026] In some preferred embodiments, the holding time is 1 second to 1 hour. Preferably, the holding time is 1 second, 3 seconds, 5 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 1 minute, 2 minutes, 3 minutes, 5 minutes, 10 minutes, 20 minutes, 30 minutes, 45 minutes, or 1 hour.

[0027] In some preferred modes, the immersion method is partial immersion or full immersion. In some modes, the detection device is thrown into, inserted into, or immersed in the liquid sample at any time in a random or free manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] FIG1 is a schematic diagram of the principle structure of the detection device of the present invention, wherein Figure 1A Schematic diagram of the structure of the card slot on the base layer, wherein the left side is a schematic diagram of the structure of the assembled detection device, the middle is a schematic diagram of the structure of the base layer including the card slot, and the right side is a schematic diagram of the structure of the covering layer; Figure 1B is a schematic structural diagram of a test element in a specific implementation manner; Figure 1C It is a top view schematic diagram of the test component placed in the card slot.

[0029] Figure 2 It is a schematic diagram of the three-dimensional structure of a test element according to a specific embodiment of the present invention.

[0030] Figure 3 It is a schematic structural diagram of the base layer in a specific embodiment of the present invention (back side).

[0031] Figure 4 yes Figure 3 A schematic diagram of the enlarged three-dimensional structure of part of the base layer.

[0032] Figure 5 It is a schematic diagram of the partial structure enlargement of the card slot of the base structure in a specific implementation manner.

[0033] Figure 6 It is a schematic diagram of the partial structure enlargement of the card slot of the base structure (the sample cavity position) in a specific implementation manner (physical product).

[0034] Figure 7 It is a schematic diagram of the three-dimensional structure of the covering base layer after covering the back side of the covering base layer in a specific embodiment of the present invention (the covering layer is the back side).

[0035] Figure 8 It is a schematic diagram of the cross-sectional structure (sample cavity) after the covering layer covers the back side of the base layer in a specific embodiment of the present invention.

[0036] Fig. 9 This is a physical picture of the front structure of the base layer.

[0037] Fig.10It is a schematic diagram of the three-dimensional structure of placing the test element on the base layer.

[0038] FIG. 11 is a schematic diagram of the isolated structure of a cover in a specific embodiment of the present invention. Fig.11A It is a schematic diagram of the three-dimensional structure of the cover body; Fig. 11B This is a schematic diagram of the internal structure. Fig. 11C Schematic diagram of the cross-sectional structure of the cover body. DETAILED DESCRIPTION

[0039] The following further describes the structures involved in the present invention or the technical terms used in these descriptions. These descriptions are only used as examples to illustrate how the methods of the present invention are implemented, and cannot constitute any limitation to the present invention.

[0040] Detection

[0041] Detection means to test or examine a substance or material for the presence or absence of a substance or material, such as, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolite, a drug or a drug metabolite, an organic tissue or a metabolite of an organic tissue, a nucleic acid, a protein, or a polymer. In addition, detection means to test the amount of a substance or material. Furthermore, assay also means immunoassay, chemical assay, enzyme assay, etc.

[0042] Downstream and Upstream

[0043] Downstream or upstream is divided according to the direction of liquid flow. Generally, liquid flows from upstream to downstream area. The downstream area receives liquid from the upstream area, and liquid can also flow from the upstream area to the downstream area. Here, it is generally divided according to the direction of liquid flow. For example, on some materials that use capillary force to promote liquid flow, liquid can flow in the opposite direction of gravity due to gravity. At this time, upstream and downstream are still divided according to the flow direction of the liquid.

[0044] Gas flow or liquid flow

[0045] Gas flow or liquid flow refers to the ability of liquid or gas to flow from one place to another, and may be guided by some physical structure during the flow. The flow here can be the liquid or gas due to its own action (gravity or pressure), or it can be passive flow.

[0046] Test components

[0047] A variety of test elements can be combined and applied to the present invention. Test elements include test strips, and analytical test strips can have a variety of forms, such as immunological or chemical test forms, for detecting analytes in samples, such as drugs or related metabolites indicating physical conditions. In some forms, the test strip is a water-absorbing material with a liquid sample (application) sample area, a reagent area and a test result area. The sample is added to the sample area and flows into the reagent area using capillary action. In the reagent area, the sample dissolves the reagent and mixes with it to detect the analyte (if the analyte is present in the sample). Of course, the reagent area and the sample application area can also be the same area, and some reagents for processing liquid samples are processed in advance in the sample application area. At this time, the sample with the reagent continues to flow to the test result area. Other reagents are fixed in the test result area. These reagents fixed in the test area react and combine with the analyte (if present) or with the first reagent in the reagent area. In the non-competitive detection form, if there is an analyte in the sample, a signal will be generated, and if the analyte does not exist, no signal will be generated. In a competitive assay format, a signal is generated if the analyte is not present in the sample, and no signal is generated if the analyte is present. The present invention is applicable to test elements of various assay formats.

[0048] For example Figure 1C and Figure 2 As shown, when the test element is a test strip 20, it can be made of absorbent or non-absorbent materials, and a test strip can use multiple materials for liquid transfer. One material of the test strip can be superimposed on another test strip material, for example, filter paper is superimposed on nitrocellulose. Alternatively, a region of the test strip containing at least one material is located behind another region containing at least one different material. In this case, the liquid is circulated between the regions, and they may or may not be superimposed on each other. The materials on the test strip can be fixed on a support 27 such as a plastic liner or a hard surface to enhance the holding power of the test strip.

[0049] In some embodiments where the detected object is detected by a signal generating system (e.g., at least one enzyme reacts specifically with the detected object), at least one signal generating substance can be adsorbed on the analyte detection zone of the test strip, just as it is specifically adsorbed on the material of the test strip as described above. In addition, the signal generating substance present in the sample application zone, reagent zone, analyte detection zone, or throughout the entire test strip of the test strip can be pre-treated in advance on one or more materials of the test strip. This can be achieved by adding a solution of the signal generating substance to the surface of the application zone or soaking one or more materials of the test strip in a signal solution. After the test strip is added with the signal solution or soaked in the solution, the test strip is dried. In addition, the above method is present in the sample application zone, reagent zone, analyte detection zone, or throughout the entire test strip. The signal generating substance can be pre-treated in advance on one or more materials of the test strip. In addition, the signal substance present in the sample application zone, reagent zone, analyte detection zone, or throughout the entire test strip can be added to one or more surfaces of the test strip material as a labeling reagent.

[0050] The various regions of the test strip 20 can be arranged as follows: a complete and necessary test strip may include a sample application region 23 and a test region 22. Usually, the liquid first contacts the sample application region and then flows to the test region 22 based on capillary action. Of course, the test strip may also include the following regions as needed, a sample addition region or a sample application region 23, or at least one reagent region, at least a test region 22, a test result region 24 on the test region, or at least one control region 25, or may include at least one adulteration detection region and a liquid absorption region 21. If the test region includes a control region, it is preferred that the control region is located after the analyte detection region of the test result region. All of these regions or their combinations may be on a single test strip containing a material. In addition, these regions are made of different materials and connected together in the direction of liquid transfer. For example, different regions may transfer liquid directly or indirectly. In this example, different regions may be connected end to end along the direction of liquid transfer, or superimposed on each other along the direction of liquid transfer, or connected by other materials, such as a connecting medium material (preferably a water-absorbent material such as filter paper, glass fiber or nitrocellulose). When using connecting materials, the connecting materials can form liquid circulation by making the material including the ends of each region connected to each other, the material including the ends of each region connected to each other but the liquid does not flow, or the material including the regions overlapping each other (for example but not limited to overlapping from head to tail) but the liquid does not flow.

[0051] If the test strip contains an adulteration detection control zone, the zone can be placed before or after the result detection zone. When the result determination zone contains a control zone, the adulteration control zone is preferably placed before the control zone, but this may not be the case. In one embodiment of the present invention, the test strip is a control test strip for adulteration analysis judgment and / or control, and the adulteration control zone can be located before or after the control zone, preferably before the control zone.

[0052] In a specific embodiment of the present invention, any type of test element or test strip can be located in the slot or groove 100 of the base layer 104, 30, or in the channel formed by the slot on the base layer covered by the covering element. How the test strip is arranged in the detection device of the present invention will be explained in detail below.

[0053] sample

[0054] Samples that can be detected by the detection device of the present invention include biological fluids (such as case fluids or clinical samples). Liquid samples or fluid samples can be derived from solid or semi-solid samples, including excrement, biological tissues and food samples. Solid or semi-solid samples can be converted into liquid samples by any appropriate method, such as mixing, mashing, macerating, incubating, dissolving or digesting solid samples by enzymatic action in a suitable solution (such as water, phosphate solution or other buffer solution). "Biological samples" include samples derived from animals, plants and food, such as urine, saliva, blood and its components, cerebrospinal 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. Food samples include food processed substances, final products, meat, cheese, wine, milk and drinking water. Plant samples include any plant, plant tissue, plant cell culture and media derived from. An "environmental sample" is derived from the environment (eg, a liquid sample from a lake or other body of water, a sewage sample, a soil sample, groundwater, seawater, and a wastewater sample). An environmental sample may also include sewage or other wastewater.

[0055] The present invention and a suitable detection element can be used to detect any analyte, and preferably the present invention is used to detect small drug molecules in saliva and urine.

[0056] Analyte

[0057] Examples of analytes that can be used in the present invention include some haptens, including drugs (such as drugs of abuse). "Drugs of abuse" (DOA) refer to the use of drugs for non-medical purposes (usually to paralyze nerves). Abuse of these drugs can lead to physical and mental damage, dependence, addiction and / or death. Examples of drugs of abuse include cocaine; amphetamine AMP (e.g., Black Beauty, White Amphetamine Pills, Dextroamphetamine, Dextroamphetamine Pills, Beans); methamphetamine MET (crank, methamphetamine, crystal, speed); barbiturates BAR (such as Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleeping aids); lysergic acid diethylamide (LSD); depressants (downers, goofballs, barbs, blue devils, yellow jackets, methaqualone); tricyclic antidepressants (TCA, i.e. imipramine, amitriptyline and doxepin); MDMA; PCP; tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e. morphine MOP or opium, cocaine COC; heroin, hydroxydihydrocodeinone); antianxiety drugs and sedatives and hypnotics. Antianxiety drugs are a class of drugs mainly used to relieve anxiety, tension, fear, stabilize mood, and Drugs with hypnotic and sedative effects include benzodiazepines BZO (benzodiazepines), atypical BZs, fused diazepine NB23Cs, benzodiazepines, ligands of BZ receptors, open-ring BZs, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocyclics, imidazole-type sedatives / analgesics (such as oxycodone OXY, methadone MTD), propylene glycol derivatives-carbamates, aliphatic compounds, anthracene derivatives, etc. The detection device of the present invention can also be used to detect drugs that are for medical purposes but are prone to overdose, such as tricyclic antidepressants (imipramine or analogs) and acetaminophen, etc. These drugs will decompose into different small molecules after being absorbed by the human body. These small molecules exist in body fluids such as blood, urine, saliva, sweat, etc., or some body fluids contain the above-mentioned small molecules.

[0058] For example, the analytes detected by the present invention include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic stimulating hormone, progesterone hormone, follicle stimulating hormone, etc.), blood, white blood cells, sugars, heavy metals or toxins, bacterial substances (e.g., protein or sugar substances for specific bacteria, such as Escherichia coli 0157:H7, Staphylococcus, Salmonella, Clostridium, Campylobacter, L.monocytogenes, Vibrio, or Bacillus cereus) and substances related to physiological characteristics in urine samples, such as pH and specific gravity. Any other clinical urine chemistry analysis can be detected using the lateral flow detection format in conjunction with the device of the present invention.

[0059] Detection device

[0060] The detection device of the present invention is a device that can detect the presence or quantity of the analyte in the sample by any technical principle, i.e., qualitative or quantitative detection. The detection device includes a test element for detecting the presence or quantity of the analyte in the sample, and in addition to the test element, it can also include a device for accommodating the test element.

[0061] The detection device of the present invention includes a base layer, and the base layer includes a groove for accommodating a test element, and a covering element covering and sealing the groove. In this way, the covering element can cover or seal the test element in the groove, so that the sample can be tested. Preferably, the detection device also includes a sample cavity, wherein the sample application area of ​​a part of the test element is located in the sample cavity. Preferably, the sample cavity is composed of a part of the groove and a covering layer. In some preferred embodiments, the base layer has an opening, and the opening is used to allow a liquid sample to enter the sample cavity. In some preferred embodiments, the covering layer has an opening, and the opening is used to allow a liquid sample to enter the sample cavity.

[0062] The detection device of the present invention can also be combined with other equipment to complete the detection of the analyzed substance in the sample. Such equipment can be a detection result reading device, a scanning device, etc. to read the detection results, store the result data, or transmit data.

[0063] Base layer, covering components, test components

[0064] The detection device of the present invention comprises a base layer, and the base layer comprises one or more card slots. Figure 1AThe schematic diagram in the middle shows a detection device including a card slot. A card slot 100 is included on the base layer 104. The base layer 104 has a certain thickness. A groove of a certain depth (also called a card slot, an open channel) can be opened on the base layer. The width of the card slot 100 is equivalent to the width for accommodating the test element, and can also be greater than the width of the test strip, such as the test strip 20. The depth is equivalent to the thickness of the test strip, and can also be greater than the thickness of the test strip. Since the card slot is located on the base layer ( Figure 1A ), only a covering layer 101 is needed to be covered on the base layer to seal the entire card slot, so that the card slot forms a sealed channel, and the channel formed in this way can accommodate the test element ( Figure 1A For example, a sealed channel is used to accommodate the detection area and the marking area of ​​the test element. Of course, optionally, a sealed channel is used to accommodate the water absorption area, the marking area, the detection result area, and the detection result control area of ​​the test element ( Figure 1C ).

[0065] Generally, a base layer including a slot is first provided, and a slot corresponding to the length of the test strip is opened on one side of the base layer, and the slot is completely exposed to the outside. Then, the test strip 20 is placed in the slot, with the back of the test strip facing downward (the side with the support structure 27) and the top facing upward (the side where the detection area or filter paper can be seen). A covering element 101 is provided, and the covering element includes a first covering area 810 and a second covering area 102, and an opening 103 between the first area and the second area. Finally, the covering element is covered on the base layer, so that the first covering area 810 covers the test area of ​​the test element, the second covering area 102 covers a portion of the sample application area, and the opening 103 exposes a portion of the sample application area, so that, for example Figure 1AThe position 102 in the cover element 101 is actually a part of the covering element 101, and the partial covering element 810 covering the card slot also covers the card slot, thereby forming a sealed channel at one end for accommodating a part of the test strip element. The opening 103 opened on the covering element 101 is used to expose a part of the sample absorption area 23 of the test element. In this way, a sample cavity is formed at one end of the card slot by the partial card slot on the base layer and the second covering area 102 of the covering element. The sample cavity is used to collect samples. The height of the sample cavity is determined by the length of the partial covering element 102, and the volume depends on the depth of the card slot and the height of the covering element 102, so the volume of the sample can be arbitrarily adjusted and changed by the depth of the card slot and the height of the covering element 102. In addition, the first covering area 810 of the covering element forms a sealed channel with the partial card slot, so that the test result area and the marking area of ​​the test element are located in the sealed channel. It can be said that due to the covering element opening 103, the entire sealed card slot is divided into two sealed channels. The sealed channel (one end is sealed and the other end is not sealed) formed by the card slot partially covered by the covering element 810 is used to accommodate part of the test strip elements, such as the test result area and the marking area of ​​the test element; and the other sealed channel (the sealed channel formed by the card slot partially covered by the covering element 102) forms a sample cavity. The two sealed channels are connected to the outside world through the common opening 103.

[0066] like Figure 1B A specific form of the test element is a test strip 20, which includes a sample application area 23 and a test area 22. If possible, the test strip may also include a labeling area 26 and a sample absorption area 21. For example, the test area is a nitrocellulose membrane, and the sample application area may be glass fiber. The test area may include a test result area 24 and a test result control area 25.

[0067] When assembling the detection device of the present invention, firstly, a card slot 100 is formed on the base layer 104. This formation method can be a one-time injection molding. Then, the test strip 20 is placed in the card slot 100, so that one end of the liquid absorption area 21 of the test strip is located at the upper part of the card slot, and the sample application area 23 is located near the opening of the covering element and corresponds to the position of the opening 103. Finally, a covering element 101 is covered on the base layer. The covering element has an opening 103, so that part of the sample application area of ​​the test element is exposed to the outside. In addition, the end of the test element in the sample application area 23 is located in the sample cavity ( Figure 1A The left side of the figure shows the fully formed test device 10, the middle is the base layer including the card slot, and the right side is the covering element). The top view of the fully formed test device is shown in FIG. Figure 1C, only part of the sample application area on the test element is exposed to the outside, while the other part of the sample application area is located in the sample cavity. Here, the base layer can be transparent or non-transparent, and the cover layer can be partially transparent, for example, the test result area and / or the test result control area corresponding to the test element is transparent, so as to facilitate reading the result of the test area.

[0068] When testing is required, put the test device (such as Figure 1A The diagram on the left or Figure 1C The test device is inserted into a liquid sample, such as urine, through the opening 103 into the sample cavity in the card slot. The depth of the inserted liquid can be just enough to submerge the entire covering element 102 that constitutes the sample cavity, or the liquid level can be any height higher than part of the covering element 102, or even the entire test device can be submerged in the liquid sample. This allows the liquid to easily enter the sample cavity through the opening 103. When inserted into a liquid sample, it can be taken out immediately, or taken out after a while, and then placed horizontally, or the test device can be left in the liquid sample. As the liquid sample enters the sample cavity, the liquid contacts the sample application area, and the liquid flows along the test strip from the sample application area 23 to the marking area 26, and then flows to the downstream test area, and is finally absorbed by the absorption area 21 (such as Figure 1C Since the sample chamber still collects or retains the sample, it is enough for the test strip to absorb and complete the test, thus overcoming the defect of insufficient liquid in the conventional technology, because insufficient sample may cause the possibility of failure to complete the test, because insufficient liquid cannot complete the flow on the test element, for example, it only flows to the upstream of the test result area 24 and then stops, or when it flows to the test result area 24, the liquid is too little to wet the area.

[0069] The device of the present invention provides the tester or operator with more freedom of operation comfort and randomness. For example, the entire test device can also be submerged in the liquid sample. During this submersion process, the liquid will not enter the sealed channel including the marking area and the detection area. This is because one end of this channel is sealed and the other end is sealed by the entering liquid. Therefore, a section of gas is sealed in the channel. In this way, the liquid can almost only flow from upstream to downstream along the test strip based on the capillary action on the test strip, and no additional liquid will enter the channel. This test provides great freedom and convenience in operation, so that the operator (such as a doctor or laboratory tester) can directly throw the test device into the liquid sample, and only take out the test device to read the test result after the reaction is completed or the test result is available. In addition, conventional similar detection devices need to be inserted into the liquid sample for a sufficient time in the hope of obtaining sufficient sample, while the present invention provides a sample cavity at one end of the card slot, close to the sample absorption area of ​​the test strip, so that it can be quickly inserted into the liquid and quickly taken out because sufficient sample has entered the sample cavity, thereby improving the efficiency of detection. In particular, when multiple samples are detected in a limited time, the advantages of the present device are more prominent.

[0070] In other embodiments, since the partial covering element 810 covers part of the slot, when the test element is located in the slot, the part of the slot (the part covered by 810) is in a sealed state at one end; when the detection device is inserted into the liquid sample, the sample will not enter the channel formed by the slot covered by the partial covering element 810, and since one end of the channel is sealed, the liquid that enters seals a section of gas in the channel of the slot. Therefore, no matter how long the detection device is inserted into the liquid sample or how deep it is inserted into the liquid, the liquid will not submerge the test area and the marking area, thereby ensuring the accuracy of the detection. In a more preferred embodiment, the marking area and the test area on the test element are covered and sealed by the partial covering element 810. More preferably, the opening 103 is located below the marking area and retains part of the sample application area 23. More preferably, the part of the sample application area is located in the sample cavity ( Figure 1C ).

[0071] The above introduction only uses a single test strip as an example to illustrate how the device of the present invention can be implemented. Of course, the base layer can include multiple similar card slots, and the covering element can also seal and cover multiple card slot structures to form multiple openings, each opening corresponds to a sample cavity, and each sample cavity is relatively independent. In this way, multiple different analyzed substances can be detected for the same sample.

[0072] The base layer of the present invention can be a rigid base layer, such as plastic, aluminum alloy, etc., and the covering layer can be a flexible or rigid covering layer. Optionally, the base layer and the covering layer are both rigid, and the base layer and the covering layer are bonded together; or the base layer is a flexible layer, and the covering layer is rigid. In some preferred embodiments, the base layer generally has a certain thickness, and the groove formed thereon has a suitable depth and width, and is covered with only a thin film layer to cover the groove and seal the groove. In some preferred embodiments, the base layer has a certain thickness, and the covering layer also has a certain thickness. A card slot is provided on the base layer, and a card slot is also provided on the covering layer. When the base layer and the covering layer are bonded face to face, their respective slots correspond to each other, thereby forming a channel, and a test element is placed in the channel. An opening is provided on either the base layer or the covering layer, and the opening is located in the middle of the groove near one end, so that a sample cavity is formed, and the sample cavity can accommodate part of the sample. For example, the base layer does not include the opening 112, and an opening 112 is provided on the covering element (for example Figure 1C ), the opening is connected to the sample chamber fluid, or the base layer has an opening 112, but the covering element does not have an opening 112 ( Figure 8 ); Alternatively, openings 112 are provided at the same position on both the base layer and the covering element, and the two openings are connected to the sample chamber fluid.

[0073] In some preferred embodiments, the base layer or the cover layer is transparent, or partially transparent, and in particular, the area corresponding to the test area is transparent; in other preferred embodiments, the base layer is not transparent, but the cover layer is transparent; or, the base layer is transparent, but the cover layer is not transparent. When the front side of the test element faces the base layer, the base layer may be completely transparent or partially transparent, or the base layer may be transparent corresponding to the test area and / or the marking area on the test element ( Figure 3 Optionally, when the front side of the test element faces the covering layer, the covering layer may be completely transparent or partially transparent, or the covering layer may be transparent corresponding to the test area and / or marking area on the test element ( Figure 1C ), and the base layer can be transparent or opaque.

[0074] The method of forming the slots on the base layer can be completed in one step by injection molding, or the slot structure can be formed by laser etching. The rigid base layer can be composed of a material such as a "thermoplastic". "Thermoplastic" here refers to a hot-melt plastic polymer that becomes a fluid when heated and solidifies into a glass-like substance when cooled enough. This thermoplastic can be a polymer of a high molecular weight material, whose chains are connected by weak van der Waals forces, stronger dipole-dipole interactions and hydrogen bonding or aromatic ring stacking. Thermoplastic materials can include additional components, such as laser-sensitive substances. Some examples of thermoplastic materials can be acrylonitrile butadiene styrene polymer (ABS), acrylic polymer (PMMA), celluloid, cellulose acetate or cellulose acetate, cycloolefin copolymer (COC), ethylene vinyl acetate (EVA), ethylene vinyl alcohol (EVOH), fluoroplastics (PTFE, with FEP, PFA, CTFE, ECTFE, ETFE), ionomers or ionomers, acrylic / PVC, alloys, liquid crystal polymers (LCP), polyethylene (POM or acetal), polyethylene (acrylic acid), polyacrylonitrile (PAN or acrylonitrile), polyamide (PA), polyamide-imide (PAI), polyaryletherketone (PAEK or ketone), polybutadiene (PBD), polyethylene (PB), polyethylene terephthalate (PBT), polycaprolactone (PCL), polychlorotrifluoroethylene ( Polyethylene terephthalate (PCTFE), polyethylene terephthalate (PET), ethylene terephthalate (PCT), polycarbonate (PC), polyhydroxyalkanoates (PHAs), polyketones (PK), polyesters, polyethylene (PE), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyetherimide (PEI), polyethersulfone (PES), polyvinyl chloride (PEC), polyimide (PI), polylactic acid (PLA), polymethylpentene (PMP), polyphenylene oxide (PPO), polyphenylene sulfide (PPS), polyphthalamide (PPA), polypropylene (PP), polystyrene (PS), polysulfone (PSU), polytrimethylene terephthalate (PTT), polyurethane (PU), polyvinyl acetate (PVA), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC) and polystyrene-acrylonitrile (SAN).

[0075] The covering element may be formed of a polymer, such as a plastic film, a flexible covering element formed of double-sided adhesive, a polymer, etc., which can be covered on a rigid base layer to seal the slot in the rigid base layer, or a thin layer of material formed of the above base material, or a thin layer of flexible material. The so-called "rigidity" and "flexibility" here are relative concepts, not absolute concepts.

[0076] In some other specific embodiments, Figure 3As shown, the detection device of the present invention includes a base layer 30, which can be made of plastic and formed in one step by injection molding. One or more card slots 100 are arranged on the base layer 30, and the card slots have a certain depth and width. The width of the card slot is equivalent to the width of the test element accommodated, and can be equal to or slightly wider than the width of the test strip. The length of the card slot is equivalent to the length of the test strip, and can also be slightly longer than the length of the test strip ( Figure 3 As a preferred embodiment, a fixing structure is provided at one end of the slot, close to the end of the base 130, such as a pair of protruding snap structures 108, 1081, respectively provided on opposite side walls 1002, 1003 constituting the slot ( Figure 4 ), the protrusion keeps the test element in a relatively fixed position in the slot.

[0077] An opening 112 is provided at one end close to the base layer 132. Each card slot has an opening 112, but the opening is not opened to the bottom end 132 of the card slot, but a certain position 902 ( Figure 7 ), the portion 902 reserved on the front and the covering element subsequently covering the card slot together form a sample cavity ( Figure 8 ), when multiple card slots are formed on the base layer, a sample cavity is formed at one end 132 of each card slot, so that a test strip is placed in each sample cavity, and each test strip can detect different analytes. These sample cavities exist independently and cannot exchange liquids with each other. In this way, multiple sample cavities all have liquid samples of the same nature, but because the test elements are set for different analytes, multiple different analytes can be detected.

[0078] In addition, the card slot includes a structure that can reduce, prevent or limit capillary flow. In the card slot designed in this way, there are two main locations where capillary gaps are generated. One is that the distance between the side of the test strip and the side wall surface of the card slot may generate a capillary gap, thereby generating capillary flow. Such capillary flow is undesirable because the generation of such capillary flow will cause the liquid to reach the downstream area earlier than the liquid flowing based on the capillary action of the test strip itself, so that the early liquid will dissolve or wet the test strip, causing abnormal detection. This is mainly because the abnormal capillary flow is only the circulation of the liquid sample, while the normal liquid relying on the capillary action of the test strip can dissolve the reagents processed on the test strip, such as the labeling reagent, the reagent for processing the liquid sample, etc., thereby increasing the accuracy and sensitivity of the detection.

[0079] like Figure 4As shown, for example, a pair of snap structures 1008, 1018 are also provided at the position of the slot side wall near the opening 112, which can not only play the role of fixing the test, but also has a more meaningful structure. The structure can reduce, prevent or limit capillary flow. For example, the structure can protrude from the side wall. When the test element is equal to or close to the width of the slot, the test element is placed in the slot, and the protruding snap squeezes the test strip, so that the side of the test strip is a certain distance from the side wall of the slot, and the distance is greater than the size of forming capillaries, so that capillary flow cannot be formed. In this way, the snap plays the role of reducing or limiting capillaries. In addition, even if there is a capillary gap between the test strip and the slot side wall, the snap structure is in close compression contact with the test strip, and the liquid coming from the upstream of the snap is blocked at the snap, so that the liquid cannot continue to flow downstream along the capillary gap, thereby preventing the liquid passing through the capillary gap from reaching the downstream area, such as the marking area or the detection area, earlier than the liquid in the test strip. The position of such a protruding card structure is generally located upstream of the labeling area, or downstream of the sample application area, or upstream of the detection area, or arranged corresponding to the labeling area.

[0080] In some preferred embodiments, the structure for reducing capillary flow, such as the shoot structure, is located upstream of the test element marking area, or downstream of the test area, or upstream of the sample cavity; preferably, the structural groove for reducing capillary flow is located upstream of the test element marking area, or the structure for reducing capillary flow is arranged corresponding to the marking area of ​​the test element. In some preferred embodiments, the so-called capillary flow is the capillary gap formed between the test strip and the card slot, or the capillary gap formed between the test strip and the bottom area of ​​the card slot. In addition, the structure similar to the shoot can also be some other structures, as long as it has one or more structures with similar functions as described above, for example, the shoot structure actually protrudes upward from the surface of the side wall of the card slot, higher than the plane of the side wall, so that the card slot becomes narrow at the shoot, and the shoot can be symmetrically distributed on the surface of the two side walls, of course, it is not necessarily symmetrically distributed. In addition, the number of structures for reducing, preventing or limiting capillary flow can be multiple, and they can be distributed at any position of the card slot, and can be a single shoot structure, or multiple shoot structures can be distributed in a staggered manner, rather than necessarily symmetrically distributed.

[0081] In some preferred embodiments, Figure 4As shown, the card slot also includes another structure for reducing, preventing or blocking capillary flow, which can minimize the flow of the liquid sample along the capillary structure formed between the test strip and the bottom 1001 of the card slot (which is another position where capillary flow may occur), thereby maximizing the flow of the liquid sample only along the test strip. This is because, when the test strip is placed in the card slot, in general, the front side of the test strip (the side of the test area and the marking area that can be seen by the naked eye) is directly in contact with the bottom surface 1001 of the card slot, so that a gap structure, such as a capillary gap structure, is formed between the bottom surface 1001 of the card slot and the test strip. When the detection device is inserted (immersed) into the liquid sample according to the above method, part of the liquid sample is absorbed by part of the sample application area, part enters the sample cavity, and part may flow upward through the capillary gap formed between the bottom surface 1001 of the card slot and the front side of the test strip, thereby causing the liquid sample to wet the marking area or the test area in advance, and the liquid on the test strip will be delayed to reach the marking area and the test area, thereby causing inaccurate test results. In severe cases, the test strip may not work properly.

[0082] In order to avoid such problems, the present invention also includes a structure for reducing capillary flow in the card slot, which can reduce or avoid the capillary flow of liquid outside the test strip. In other words, the capillary structure can maximize the flow of liquid only on the test element through the capillary force of the test strip itself, while reducing the flow of capillary gaps formed between the test strip and the card slot. In some preferred embodiments, such as Figure 4 As shown, the structure for reducing the capillary flow outside the test strip is located on the bottom 1001 of the card slot. The structure is one or more grooves 1004, 1005, 1006. These grooves can absorb part of the liquid sample, thereby preventing the liquid sample from continuing to flow along the capillary gap formed between the test strip and the bottom of the card slot. The groove structure can be multiple or one. The multiple grooves can be as follows: Figure 4 As shown, the groove forms a "Y" shape, but it can also be any other form, such as a cross, letter shape, circle, rectangle, square, diamond, ellipse, etc. Of course, the groove is only one of the structures that reduce capillary flow, and it can also be holes, holes, carved marks, or channels, etc. These can generally absorb liquid samples through a large surface area or prevent the liquid sample from continuing to flow. For example, once the liquid encounters the structure that reduces capillary flow, the liquid is absorbed or blocked and cannot, or cannot actually flow forward and downstream.

[0083] These structures for reducing capillary flow can be distributed all over the bottom surface 1001 of the card slot, or can be limited to some positions. Preferably, these structures for reducing capillary flow are located at a certain position of the card slot. In some embodiments, these structures for reducing capillary flow are located upstream of the test strip marking area 26. When liquid flows upward through the capillary gap formed between the bottom surface of the card slot and the test strip, the liquid is blocked or reduced here due to the presence of the structures for reducing capillary flow, so that the liquid sample will not wet the marking area in advance. In some preferred embodiments, the structures for reducing capillary flow are located at the corresponding position of the marking area.

[0084] In some preferred embodiments, the structure for reducing capillary flow is located downstream of the opening 112 and upstream of the marking area. Alternatively, the structure for reducing capillary flow is located on the bottom 1001 of the slot near the opening.

[0085] In some preferred embodiments, the structural attachment for reducing capillary flow may further include another pair of structures 1018, 1008 for fixing the test strip, so that the fixing structures at different positions on the card slot can allow the test strip to be fixed in the card slot ( Figure 4 ).from Figure 4 and 3 It can also be seen that the card slot 100 has a bottom 1001 and two corresponding edges 1002, 1003, the edges define the depth of the card slot, and the bottom 1001 defines the width of the card slot. When the card slot is formed on the base layer, the base layer has a certain thickness, so that it is convenient and easy to form a groove of a certain depth on the base layer to place a test element with a certain thickness. In fact, the base layer used to form the card slot has two sides, one side is used to open the card slot (which can be called the back side of the base layer), and the other side is used as the bottom 1001 of the card slot (which can be called the front side of the base layer). The bottom surface 1001 is set on the side of the thickness of the card slot, for example, the thickness is the thickness indicated by the mark 1007, and the thickness can be 1 mm to 8 mm, such as 1 mm, 2 mm, 4 mm, 5 mm or 8 mm. The thickness of this base layer can be arbitrarily selected according to different needs. Here, the bottom 1001 of the card slot is not complete, but has a hollow structure for a certain distance, that is, the opening 112 is formed by the hollowing. However, the bottom 1001 of the card slot is not completely hollowed out, but is hollowed out in the middle, leaving the other two parts. One part is used to support the detection area of ​​the test strip or form a structure to reduce capillary flow, and the other part is a part of the structure that forms the sample cavity. The hollowed-out opening 112 can be an opening of any length, any area, and any shape, such as a rectangle, square, circle, or diamond. Generally, the opening is used to receive a liquid sample into the sample cavity. On the other hand, the opening is used to expose part of the test strip, such as exposing part of the sample application area.

[0086] In this way, the back side of the base layer Figure 3 As shown, the front Figure 8 When the test element 20 is placed in the card slot, the water absorption area 21 ( Figure 2 ) is close to the end 130 of the base layer, and the end with the sample application area 23 is close to the end 132 of the base layer, and the sample application area with the absorbent material faces the front side, and the absorbent material of the sample absorption area, such as glass fiber or other fiber material ( Figure 1C or Fig.10 ,or Figure 2 After the test strip is placed, a cover layer 900 of a flexible material is covered on the back of the base layer ( Figure 8 ). Thus, the entire card slot 100 is sealed. Thus, the entire card slot on the back of the base layer is sealed and covered by the cover layer ( Figure 7 ), at this time, a sample cavity is formed at one end of each card slot near the base layer 132, and a portion of the sample application area 23 ( Fig.10 ), located in the sample cavity, wherein part of the sample application area is exposed in the opening 112, and the remaining parts, such as the marking area, the test area and the absorption area are covered by the covering layer and sealed in the card slot at one end near the base layer 130 ( Fig. 9The front side shown). When the base layer is a transparent plastic, the test area and the marking area can be seen through the front side of the base layer. Of course, here, the test strip can also be opposite to the test strip in the above example, so that the back side of the test strip (the side with the support sheet 27) directly relies on the bottom 1001 of the contact slot, and the sample absorption area, the detection area or the absorption area or the marking area are arranged facing the covering element. In this way, the covering element 900 is covered on the back side of the base layer to seal the entire slot, but the covering element is transparent, and what can be seen through the opening 112 of the base layer is the back side of the support surface 27 where the sample application area of ​​the test element is located, rather than the front side with the absorption material. When testing, the test result of the detection area on the test element can be directly seen through the transparent covering element. At this time, the covering element does not have an opening 112, but only has an opening 112 on the base layer. Of course, the opening 112 can be formed on the covering element and the base layer at the same time, and the shape and size of the opening can be the same or different, so that two openings are formed to communicate with the sample cavity. When it is necessary to detect the substance to be analyzed in the liquid sample, the test device composed of the base layer, the test strip and the covering element is inserted into the liquid sample, and the end with the opening 112 is inserted into the liquid sample, and then taken out, so that the liquid sample flows along the reagent strip from the sample application area to the marking area, then flows to the test area, passes through the test result area and the test result control area, and finally reaches the absorption area to complete the detection. Since the sample cavity retains enough sample, sufficient liquid can be provided to flow on the test strip to avoid the defects of the existing traditional technology of insufficient liquid sample. In addition, the production and manufacture of such a test device is also extremely simple and low-cost, because the base layer can be completed in one time, the test strip is an existing test strip, and then covered with a layer of covering element, and the production steps are simple and fast. In addition, as mentioned above, such a detection device can be directly immersed in the liquid sample to be detected completely at will. No matter what way is used to put it in, no matter how long it is immersed in the liquid sample, the liquid can flow normally on the test strip, and the correct result can be obtained. This does not need to impose many restrictions on the operator like traditional similar detection devices.

[0087] In some preferred embodiments, the detection device further includes an exhaust, decompression or pressure reduction structure, one end of which is in gas flow communication with the sealed channel, and the other end is in fluid communication with the outside atmosphere. The structure is used to exclude part of the gas in the sealed channel, especially when liquid enters the sealed channel, because a section of gas is sealed in the channel by the liquid, the pressure increases, thereby preventing the liquid from entering. In fact, in order to make the test card compact and low-cost, the width and thickness of the card slot are slightly larger than the test strip, so that when the test strip is located in the card slot, the test strip is surrounded by the card slot, so that the test strip is in the channel wrapped by the card slot and the covering layer, and when the liquid enters the entrance of the channel (for example, the entrance of the sealed channel and the opening of the sample cavity are shared), the liquid can easily seal the entrance of the channel. Designing this structure allows the gas to be excluded, thereby allowing the liquid to enter the sealed channel to provide a sufficient liquid sample. In some preferred embodiments, such as Figure 4 As shown, the exhaust structure is located in the bottom 1001 of the card slot. The groove structure can be multiple or one, and the multiple grooves 1004, 1005, 1006 can be as follows Figure 4 As shown, the groove forms a "Y" shape, and can also be any other form, such as a cross, a letter shape, a circle, a rectangle, a square, a diamond, an ellipse, etc. Of course, the groove is just one of the structures for exhaust or decompression, for example, holes, holes, carved traces, or channels, etc. can also be made. When liquid enters the sealed channel, one end of these grooves circulates with the gas in the sealed channel, and the other end circulates with the external atmospheric gas, so that excess gas can be removed, so that more liquid enters the sealed channel. Once the groove structure is sealed by liquid, the inside of the sealed channel and the external atmosphere reach equilibrium, and the liquid no longer enters the channel. In some preferred embodiments, one end of the groove that circulates with the external atmospheric gas is connected to the opening 112, and the gas in the channel is removed through the opening.

[0088] These exhaust structures can be distributed all over the bottom surface 1001 of the card slot, or can be limited to certain positions. Preferably, these exhaust structures are located at a certain position of the card slot. In some embodiments, these exhaust structures are located upstream of the test strip marking area 26. In some preferred embodiments, the exhaust structure is located at a corresponding position of the marking area. The exhaust structure is one or more grooves 1004, 1005, 1006, which can allow other gases in the channel to be discharged into the external atmosphere. The groove structure can be multiple or one, and the multiple grooves can be as follows: Figure 4 As shown, the grooves form a "Y" shape, but may also be in any other form, such as a cross, letter shape, circle, rectangle, square, diamond, oval, etc.

[0089] The exhaust groove structure here and the groove for reducing capillary force mentioned above can be a structure together, which has a dual function, one is to reduce capillary force, and the other is to exhaust and reduce pressure. Of course, the two structures can also be different structures, each with its own form and function.

[0090] In some preferred embodiments, the sample cavity is located at one end of the base layer and near the sample application area of ​​the test strip. Figure 3 , Figure 5 and Figure 6As shown, the sample cavity is formed by a portion 902 of the card slot on the base layer and the covering element 900. Because the base layer has a certain thickness, the card slot on the base layer has a depth. The depth of the card slot near the end of the base layer 132 is determined by the height of the bottom 107 of the card slot. The structural area 107 constitutes the bottom area of ​​the sample cavity, and the other part of the area 110 of the bottom of the card slot isolated from the opening of the covering element and the two opposite partial edges 125, 127 forming the card slot form the side walls of the sample cavity, thereby forming the sample cavity of the present invention. The sample cavity accommodates a sample application area of ​​a part of the test element. In some preferred embodiments, at the bottom position 107 near the sample cavity, there is a protruding structure 111 from the bottom 802 of the card slot upward. The protruding structure allows the sample application area of ​​the test strip to be close to the covering element 102, which plays a role in fixing the test strip and frees up a certain space to accommodate more liquid samples. This is because the test strip also has a certain thickness, and the height of the protrusion structure 111 is slightly shorter than the depth of the card slot, and the height is equivalent to the thickness of the test strip. Since the sample application area of ​​the test strip is generally made of glass fiber and other materials, it has a certain elasticity, so the protrusion structure 111 can press the supporting sheet on the back of the sample application area of ​​the test strip close to the covering element. In addition, since the test strip has a certain thickness, and the depth of the card slot is slightly greater than the thickness of the test strip within a certain range, generally 2-5 mm, when one end of the test strip is located in the sample cavity, it occupies most of the volume of the sample cavity. In this way, it is difficult to allow the sample cavity to accommodate more liquid samples to meet the complete wetting of the test strip. Therefore, on the one hand, the protrusion structure 111 can be set to compress the material of the soft sample application area, and on the other hand, the thickness of the bottom of the card slot can be made thinner, for example, with a slope 115, the slope reduces the thickness of the bottom of the card slot, thereby increasing the volume of the sample cavity. In addition, if the position of the test strip in the sample cavity is too close to the bottom of the card slot (the position where the inclined surface is formed), a capillary gap will be formed, so that the liquid sample is not easy to enter the sample cavity, and due to the complexity of the capillary gap structure, the volume of the sample cavity entering each card slot is also different, thereby increasing the inaccuracy and uncertainty of the detection. Therefore, near the opening 112, the side wall of the sample cavity (such as the bottom area 1001 of the card slot) is thinned, the distance between the card slot and the test strip is increased, and the liquid sample is convenient to enter the sample cavity. At the same time, the volume of the sample cavity is also increased, and sufficient liquid sample can be provided to complete the wetting of the test strip. Of course, in order to increase the volume of the sample cavity, the side walls surrounding the sample cavity (the area 110 of the thickness of the base layer and the two opposite sides 125, 127 forming the card slot) can be made thinner, or recessed holes can be set on these side walls, but although these methods are feasible, they are not as easy as making the area of ​​the bottom 110 of the card slot thinner.

[0091] In some preferred embodiments, a cover element may be provided. After the detection device is inserted into the liquid sample, the detection device is taken out and one end of the opening 112 is inserted into the cavity 12 of the cover element 10, thereby protecting the area in contact with the sample and preventing contamination. In order to limit the depth of the cover, symmetrical limiting structures 30, 31 may be provided on the base layer to limit the depth of insertion of the cover ( Fig.11A -B). In order to increase the stability of the lid on the base layer, two protruding fastening strips 13, 14 are set inside the lid. When one end of the base layer is inserted into the cover body, the fastening strips 13, 14 increase the adhesion between the cover body and the base layer, so that the cover body is not easy to fall off, thereby preventing the liquid sample from leaking out of the opening 112 at one end of the base layer and causing pollution to the external environment. The bottom of the cover body also includes an extended part 11, which is used to guide one end of the opening 112 of the detection device into the cover body element 10 to prevent the operator from contacting the sample. The edge of the extended part 11 of the cover body also has a cover edge 15 that is higher than the bottom surface (higher than the plane where the extended surface is located). This design can prevent the liquid carried when the detection device is taken out of the liquid sample from leaking when the cover body is closed, causing pollution to the external environment. In some preferred embodiments, the position of the fastening strips 13, 14 is opposite to the extension part, so that the base layer can be inserted into the cover body in a single direction.

[0092] Assembling method of detection device

[0093] The present invention provides a method for manufacturing a detection device, which is simple and low in cost. In some embodiments, a one-time injection molded substrate is provided, which includes Figure 3 The card slot shown in the figure has a certain depth and width. The width of the card slot is equivalent to the width of the test element accommodated, and can be equal to or slightly wider than the width of the test strip. The length of the card slot is equivalent to the length of the test strip, and can also be slightly longer than the length of the test strip. Figure 3 The back view of the base layer. Figure 8 108 is a front view of the base layer). As a preferred method, a fixing structure is provided at one end of the card slot, close to the base layer 130, such as a pair of protrusions 108, 1081. An opening 112 is provided at the end close to the base layer 132. Each card slot has an opening 112, but the opening does not extend to the bottom end 132 of the card slot, but a certain position 102 is reserved ( Figure 5 ), such as the hollow opening 112 described above. Provide a test element, the test element includes a sample application area, a marking area, a test area and a water absorption area, wherein the sample application area is located upstream of the marking area, the test area is located downstream of the marking area, and the test area includes a test result area and a test result control area (such as Figure 1B and Figure 2). Place the test strip in the card slot so that one end of the sample application area corresponds to the opening 112 of the card slot, and one end of the water absorption area is close to one end of the base layer 130. At the same time, part of the sample application area is located in the sample cavity and relies on the protrusion structure 111 in the sample cavity. In addition, the label area of ​​the reagent strip is located upstream of the capillary structure, and the side of the test with the support sheet 27 is exposed through the card slot. Provide a flexible covering layer, which covers the back of the base layer, thereby sealing the entire card slot and also adheres to the surface of the test with the support sheet 27. At the same time, a covering element, such as a double-sided tape, an adhesive film, etc., forms a sample cavity on the front side of the card slot 902, so that part of the sample application area is exposed through the opening 112, and the label area and the test area are sealed in the card slot by the covering layer. Of course, the base layer may include multiple similar card slot structures, and the covering element is adapted to the size of the back of the base layer. Only one covering element is needed to seal multiple card slots. Thus, test elements for detecting different analytes are placed in each card slot, forming a sample cavity in each card slot, and multiple different analytes can be detected simultaneously for the same sample.

[0094] Detection Methods

[0095] On the other hand, the present invention provides a method for detecting an analyte in a liquid sample, the method comprising inserting a detection device in any of the aforementioned methods, immersing it at will, into a liquid sample, and then taking it out, and reading the test result on the test area through the transparent front side of the base layer or the covering element. The reading method can be visual interpretation, or it can be machine interpretation, such as quantitative reading using a machine designed based on photoelectric principles, or scanning and saving the test result through a scanner.

[0096] Insertion here means that the end with the sample cavity is first contacted with the liquid sample and then removed, or the end with the sample cavity is first contacted with the sample and then continued to be inserted, so that the entire detection device is immersed in the liquid sample.

[0097] Example 1

[0098] Combination Figure 2-8 A detection device of the present invention is provided, a plastic rigid base structure is provided, and the following Figure 28 identical structure drawers. Each reagent strip that provides reagent strip can detect analyzed substances such as amphetamine, cocaine, methamphetamine, opiate, THC and phencyclidine in urine respectively. Adopt gold particles as labeling material, utilize competitive method to carry out the detection of these analyzed substances. The front of reagent strip is installed in the drawer towards the direction of opening 112, and can see the absorbent material on the sample application area of ​​reagent strip, for example glass fiber through opening 112. Cover the transparent adhesive label of the same size and shape as the base layer on the back side of base layer then, so just formed detection device.

[0099] The 50 negative samples were spiked with a cocktail of drugs of abuse, including amphetamines, cocaine, methamphetamine, opiates, THC and phencyclidine, while 50 negative samples were also provided.

[0100] During the test, the test device (test card) is inserted into the urine samples and immersed in the urine for 30 seconds, 1 minute, 2 minutes, 3 minutes, 5 minutes, or the entire test device is randomly thrown into the liquid sample and immersed for more than 15 minutes, and the test device is allowed to perform the test. In the end, the flow of the liquid can be completed correctly and effective results can be obtained. This shows that the device is more casual and friendly to use, while ensuring the accuracy of the results.

[0101] The invention shown and described herein can be implemented in the absence of any element, limitation specifically disclosed herein. The terms and expressions used are used as illustrative terms rather than limiting, and it is not intended to exclude any equivalents of the features shown and described or parts thereof in the use of these terms and expressions, and it should be recognized that various modifications are feasible within the scope of the present invention. It should therefore be understood that, although the present invention is specifically disclosed through various embodiments and optional features, modifications and variations of the concepts described herein can be adopted by those of ordinary skill in the art, and it is believed that these modifications and variations fall within the scope of the present invention as defined in the appended claims.

[0102] The contents of the articles, patents, patent applications, and all other documents and electronically available information described or recorded herein are incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. Applicants reserve the right to incorporate into this application any and all materials and information from any such article, patent, patent application, or other document.

Claims

1. A detection device for detecting an analyte in a liquid sample, the device comprising: A base layer, having a groove for accommodating the test element on the base layer, and also comprising a sample cavity for collecting a liquid sample on the base layer; A covering layer, which covers the groove on the base layer to form a channel, and the channel is configured to accommodate the test element; wherein the sample cavity is configured to accommodate a portion of the liquid sample application area of ​​the test element, and the detection device also includes an opening, which is fluidly connected to the sample cavity, and when the end with the opening is inserted into the liquid sample and left, the liquid sample enters the sample cavity from the opening, and a portion of the liquid sample is retained in the sample cavity for absorption by the portion of the liquid sample application area, wherein the test element is arranged in the groove, and the portion of the liquid sample application area of ​​the test element is located in the sample cavity.

2. The detection device according to claim 1, wherein: Part of the channel is a sealed channel, and part of the test element is contained in the partially sealed channel.

3. The detection device according to claim 1, wherein: The base layer comprises a back side and a front side, the groove is located on the back side or the front side of the base layer, and the covering layer covers the front side or the back side of the base layer.

4. The detection device according to claim 3, wherein: The base layer is a rigid base layer, and the covering layer is a flexible or rigid covering layer.

5. The detection device according to claim 4, wherein: The base layer has a certain thickness, and the thickness of the covering layer is smaller than the thickness of the base layer.

6. The detection device according to claim 5, wherein: The opening is located on the base layer, and is used to allow the liquid sample to flow into the sample chamber.

7. The detection device according to claim 5, wherein: The opening is located on the cover layer, and is used to allow the liquid sample to flow into the sample chamber.

8. The detection device according to claim 5, wherein: The opening corresponds to the liquid sample application area on the test element, or the opening exposes a portion of the liquid sample application area.

9. The detection device according to claim 5, wherein: The opening is formed by hollowing out a part of the bottom area of ​​the groove.

10. The detection device according to any one of claims 1 to 9, wherein: The sample cavity is located at one end of the substrate, upstream of the marking area of ​​the test element.

11. The detection device according to claim 1, wherein: The detection device also includes a structure for reducing, limiting or eliminating capillary flow, which prevents the liquid from flowing through the capillary gap formed between the test element and the wall of the side of the groove.

12. The detection device according to claim 11, wherein: The structure for reducing capillary flow is located on the side wall of the groove.

13. The detection device according to claim 12, wherein: The structure for reducing, limiting, eliminating, and capillary flow is a protruding snap-in structure, which allows a certain distance to be maintained between the test element and the wall of the side of the slot, thereby reducing, limiting, and eliminating the capillary gap formed between the test element and the wall of the side of the slot.

14. The detection device according to claim 12, wherein: The structure for reducing capillary flow is located upstream of the marking area of ​​the test element, or downstream of the test area of ​​the test element, or upstream of the sample chamber.

15. The detection device according to claim 14, wherein: The structure for reducing capillary flow is located upstream of the marking area.

16. The detection device according to claim 1, wherein: A support structure is included in the sample chamber to support the sample application area of ​​the test element so that various areas of the test element are located in a plane.

17. The detection device according to claim 1, wherein: A sloped area is included in the sample chamber, which increases the volume of sample that can be collected.

18. The detection device according to claim 1, wherein: The sample cavity includes a region where a side wall forming the sample cavity is thinned, thereby increasing the volume of a sample that can be collected in the region.

19. The detection device according to claim 17, wherein: The sloped area is located near the opening.

20. The detection device according to claim 1, wherein: The tank also includes an exhaust structure. When the liquid sample enters the tank, part of the gas in the tank is exhausted to the outside of the tank through the structure.

21. The detection device according to claim 20, wherein: The exhaust structure is located at the bottom of the groove.

22. The detection device according to claim 20, wherein: The exhaust structure is a groove structure.

23. The detection device according to claim 20, wherein: One end of the exhaust structure is communicated with the groove, and the other end is communicated with the outside atmosphere.

24. The detection device according to claim 20, wherein: One end of the exhaust structure is communicated with the groove, and the other end is communicated with the opening.

25. A method for detecting an analyte in a liquid sample, characterized in that: Provide a detection device as described in any one of claims 1 to 24, allow the sample cavity of the detection device to enter the liquid sample, allow the liquid sample to enter the sample cavity through the opening, so that the liquid sample is retained in the sample cavity for absorption by the test element to complete the test, remove the detection device, and read the result of the detection area of ​​the test element.

26. The method according to claim 25, wherein: By reading the detection results in the detection area, the presence or amount of the analyzed substance in the sample can be determined.

27. A method for detecting an analyte in a liquid sample, the method comprising: Provide a detection device as described in any one of claims 1 to 24, immerse the entire detection device in a liquid sample, and keep it for a period of time, so that the liquid sample enters the sample cavity through the opening, so that the liquid sample is retained in the sample cavity for absorption by the test element to complete the test, and then take it out and read the test result on the test element.

28. The method according to claim 27, wherein the period of time is any of 1 second, 3 seconds, 5 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 1 minute, 2 minutes, 3 minutes, 5 minutes, 10 minutes, 20 minutes, 30 minutes, 45 minutes or 1 hour.

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