Device and method for detecting an analyte in a fluid sample

Abstract

The present invention provides a device for collecting and detecting analyte in a fluid sample, the device comprising: a fluid sample collecting element; a test element carrier; and a retaining element, wherein the test element carrier is located in the retaining element. In a preferred embodiment, the fluid sample collecting element comprises an absorbing element and a grasping portion, wherein the grasping portion comprises a retaining structure that cooperates with the retaining element to allow the fluid sample collecting element to be separated from the retaining element.

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] Various sample collection and testing devices for clinical or home use are available and described in the literature. For example, U.S. Pat. No. 5,376,337 discloses a saliva sampling device in which a filter paper is used to collect saliva from the mouth of a subject and transfer the saliva to an indicator reagent. U.S. Pat. Nos. 5,576,009 and 5,352,410 each disclose a syringe-type fluid sampling device. In these devices, after obtaining the initial results, the collected fluid sample cannot be stored for subsequent use in a confirmatory test.

[0006] Many other sample collection and testing devices are inefficient in extracting samples from the collection device. Many of these devices are very complex in their design and manufacture and require the use of relatively expensive materials. Therefore, better methods and devices are needed to collect and test samples. Summary of the invention

[0007] In order to solve the problems existing in the prior art, the present invention provides a device for collecting and detecting substances to be analyzed in a fluid sample, the device comprising: a fluid sample collecting element; a test element carrier; and a retaining element, wherein the test element carrier is located in the retaining element.

[0008] In some preferred embodiments, the fluid sample collection element includes an absorption element and a gripping portion. In a preferred embodiment, the gripping portion has a structure that cooperates with the opening of the holding element, so that when the fluid sample collection element is inserted into the holding element, the gripping portion cooperates with the opening of the holding element, so that the fluid sample collection element is "held" in the holding element. In some preferred embodiments, the gripping portion and the opening of the holding element both have a triangular structure. In a preferred embodiment, the gripping portion has a structure that cooperates with the holding element, so that the fluid sample collection element is held in a relatively fixed position in the holding element. In some preferred embodiments, the gripping portion has a protruding gripping edge that cooperates with the opening edge of the holding element, so that the fluid sample collection element is in a relatively fixed position in the holding element. Preferably, the gripping portion and the holding element have a matching lock, dark buckle, plug-in, or bayonet method, so that when the fluid sample collection element is inserted into the holding element, the fluid sample collection element is held in the holding element, or the fluid sample collection element is held in a relatively fixed position in the near and far position. The so-called "retention" means that after collecting the sample, the collecting element is inserted into the retaining element. In one state, it is located in a relatively fixed position in the retaining element and cannot be further inserted into the retaining element, nor can it be pulled out and detached from the retaining element.

[0009] In some preferred embodiments, the absorbing element and the gripping portion are connected by a rod. Preferably, the collecting element, the gripping portion, and the connecting rod are an integrated structure. In some preferred embodiments, the fluid sample collecting element includes a sealing element, and when the fluid sample collecting element is inserted into the retaining element, the absorbing element is sealed in a cavity by the sealing element, so that the fluid in the absorbing element is sealed in a cavity and does not leak into the external environment.

[0010] In some preferred embodiments, the test element carrier includes a body for accommodating the test element and a cavity for accommodating the absorption element. Preferably, the test body includes one or more grooves for accommodating, placing and setting the test element. The cavity for accommodating the absorption element includes a receiving cavity, which is surrounded by an opening, a side wall and a bottom. In particular, the opening of the receiving cavity allows the absorption element to be inserted, the side wall and the fluid sample collection element include a sealing element that cooperates to allow the absorption element to be sealed in the receiving cavity, and the bottom contacts the absorption element, thereby squeezing out the fluid sample in the absorption element. In a preferred embodiment, the bottom of the receiving cavity includes a through hole, and the squeezed fluid sample flows out of the receiving cavity through the through hole.

[0011] In some preferred embodiments, the body for accommodating the test element and the cavity for accommodating the absorption element are an integrated structure. The integrated structure can be formed by integral injection molding, or the body for accommodating the test element and the cavity for accommodating the absorption element can be bonded by laser or bonding agent.

[0012] In some preferred embodiments, the bottom of the cavity that contains the absorbing element extends outward to form a bottom plate structure, a portion of which is the bottom of the cavity, and the other portion cooperates with the retaining element, so that the test element carrier is in a relatively fixed position in the retaining element. Preferably, the bottom plate of the receiving cavity and the cavity of the retaining element are substantially the same cross-section, and preferably, the gripping portion of the fluid sample collection element, the bottom plate of the receiving cavity, and the cavity of the retaining element are substantially the same cross-section, such as square, oval, rectangular, rhombus, pentagon, triangle, hexagon, heptagon, etc.

[0013] In some preferred embodiments, the holding element is a structure with a generally triangular cross section, and the holding element includes a first cavity and a second cavity, wherein the first cavity is used to accommodate or hold the test element carrier, and the second cavity is used to collect or collect the fluid sample on the absorption element. In some preferred embodiments, the bottom plate of the test element carrier divides the cavity of the holding element into two cavities, the upper cavity is the first cavity, which is close to the opening of the holding element and holds the test element carrier. The holding element is surrounded by an opening, a side wall and a bottom, and the opening of the holding element is used to insert the fluid sample collection element and cooperate with the gripping portion of the fluid sample collection element, so that the fluid sample collection element is in a relatively fixed position. The side wall includes multiple faces or one face, wherein the face facing the body of the nano-test element is transparent, so that the test result on the test element on the body can be directly read through the transparent face. The other faces of the holding element can be transparent or not.

[0014] There are some structural designs on the side wall at the bottom of the first cavity of the holding element, which provide a fulcrum for the bottom plate of the receiving cavity on the test element carrier, so that the test element carrier is in a fixed position in the holding element. At the same time, the bottom plate divides the cavity of the holding element into two upper and lower cavities. The structure providing the fulcrum can be a protruding platform on the side wall, which can be multiple or at least two, or a fulcrum structure attached to other structures in the cavity of the holding element. For example, the lower cavity of the holding element includes a structure for collecting fluid samples, which is located below the cavity for accommodating the absorption element and also below the bottom plate of the receiving cavity. Some fulcrum structures are arranged on the collecting structure to provide fulcrums for the bottom plate of the receiving cavity. In some preferred embodiments, the fulcrums of the fulcrum structure are in the same plane, so that the bottom plate of the receiving cavity on the carrier is in the same horizontal plane.

[0015] In some other specific embodiments, the device further includes a standing structure that allows the device to stand vertically and tilted, wherein the standing structure is located on the holding element. Preferably, the vertical standing structure and the tilted standing structure are formed at the bottom edge of the side wall of the holding element, and the vertical standing structure and the tilted standing structure are interchangeable standing states. Preferably, the vertical standing structure and the tilted standing structure are triangular contact surfaces, which are used to contact the support surface; wherein the vertical standing structure includes a second contact surface, and the tilted standing structure includes a first contact surface, and the first contact surface and the second contact surface are not on the same plane.

[0016] In another aspect, the present invention provides a device for collecting and detecting an analyte in a fluid sample, the device comprising:

[0017] A fluid sample collecting element, wherein the fluid sample collecting element comprises an absorbing element for absorbing the liquid sample and a gripping portion, and a connecting rod connecting the absorbing element and the gripping portion;

[0018] A test element carrier, wherein the test element carrier comprises a body for carrying the test element and a receiving cavity for receiving the absorbing element, wherein the body and the receiving cavity are an integral injection-molded structure;

[0019] A holding element having a cavity, wherein the cavity of the holding element is surrounded by an opening, an edge of the opening, and a side wall;

[0020] The holding element includes a structure that allows it to stand vertically and tilted.

[0021] In some specific embodiments, the vertical standing structure and the inclined standing structure are triangular contact surfaces, which are used to contact the supporting surface; wherein the vertical standing structure includes a second contact surface, and the inclined standing structure includes a first contact surface, and the first contact surface and the second contact surface are not on the same plane, wherein the second contact surface allows the maintaining element to stand vertically, and the first contact surface allows the maintaining element to stand inclined.

[0022] In some specific embodiments, the vertical standing structure and the inclined standing structure are located on the edge of the side wall of the retaining element.

[0023] In some specific embodiments, the first contact surface is composed of a surface formed by two edges of the side wall and a fulcrum formed by the intersection of one end of the surface formed by the two edges, wherein the surface of the two edges and the fulcrum form a triangular first contact surface.

[0024] In some specific embodiments, the test element carrier is located in the cavity of the retaining element; wherein the gripping portion and the opening of the retaining element have the same cross-sectional shape, and the cross-section is one of square, oval, rectangular, diamond, pentagon, triangle, hexagon, and heptagon.

[0025] On the other hand, a device for collecting and detecting an analyte in a fluid sample is characterized in that the device comprises:

[0026] A fluid sample collecting element, wherein the fluid sample collecting element comprises an absorbing element for absorbing the liquid sample and a gripping portion, and a connecting rod connecting the absorbing element and the gripping portion;

[0027] A test element carrier, wherein the test element carrier comprises a body for carrying the test element and a receiving cavity for receiving the absorbing element, wherein the body and the receiving cavity are an integral injection-molded structure;

[0028] A holding element having a cavity, wherein the cavity of the holding element is surrounded by an opening, an edge of the opening, and a side wall;

[0029] Therein, the retaining element includes a structure that allows it to stand.

[0030] In a specific embodiment, the standing structure includes a vertical standing structure and / or an inclined standing structure.

[0031] In a specific embodiment, the vertical standing structure and / or the inclined standing structure includes a contact surface that contacts the supporting surface; wherein the vertical standing structure includes a second contact surface that allows the maintaining element to stand vertically, and the inclined standing structure includes a first contact surface that allows the maintaining element to stand inclinedly, and the first contact surface and the second contact surface are not on the same plane.

[0032] In a specific embodiment, the first contact surface and / or the second contact surface are located on the edge of the side wall of the retaining element.

[0033] In a specific embodiment, the first contact surface and the second contact surface are formed by edges of side walls of the retaining element.

[0034] In a specific embodiment, the first contact surface includes a surface formed by two edges of the side wall and a fulcrum formed by the intersection of one end of the surface formed by the two edges, wherein the surface of the two edges and the fulcrum form the first contact surface.

[0035] In a specific embodiment, the width of the surface formed by the two edges of the side wall is defined by the thickness of the side wall.

[0036] In a specific embodiment, the first contact surface is in the shape of a triangle, and the second contact surface is in the shape of a triangle.

[0037] In a specific embodiment, the test element carrier is located in the cavity of the retaining element; wherein the gripping portion and the opening of the retaining element have the same cross-sectional shape, and the cross-section is one of square, elliptical, rectangular, rhombus, pentagon, triangle, hexagon, and heptagon.

[0038] In another aspect, the present invention provides a device for collecting and detecting an analyte in a fluid sample, characterized in that the device comprises:

[0039] A fluid sample collecting element, wherein the fluid sample collecting element comprises an absorbing element for absorbing the liquid sample and a gripping portion, and a connecting rod connecting the absorbing element and the gripping portion;

[0040] A test element carrier, wherein the test element carrier comprises a body for carrying the test element and a receiving cavity for receiving the absorbing element, wherein the body and the receiving cavity are an integral injection-molded structure;

[0041] A holding element having a cavity, wherein the cavity of the holding element is surrounded by an opening, an edge of the opening, and a side wall;

[0042] Wherein, the retaining element includes a structure for allowing it to stand; the standing structure includes a vertical standing structure and an inclined standing structure; the vertical standing structure and the inclined standing structure include contact surfaces that contact the supporting surface; wherein, the vertical standing structure includes a second contact surface for allowing the retaining element to stand vertically, and the inclined standing structure includes a first contact surface for allowing the retaining element to stand inclined, and the first contact surface and the second contact surface are not on the same plane; wherein, the first contact surface forms an acute angle with the second contact surface.

[0043] Beneficial Effects

[0044] The device of the present invention can not only be manufactured at low cost, but also make the detection and reading of results more convenient and faster, and the manufacturing cost is low. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 It is a schematic diagram of the structure of a sample collection element in a specific embodiment of the present invention.

[0046] Figure 2 It is a schematic diagram of the structural decomposition of a detection and collection device according to an embodiment of the present invention.

[0047] Figure 3 yes Figure 2 Schematic diagram of the structure of the test element carrier.

[0048] Figure 4 It is a schematic diagram of the three-dimensional structure of the retaining element.

[0049] Figure 5 It is a longitudinal cross-sectional view of a liquid sample collecting element, a testing element carrier and a retaining element during the matching process according to an embodiment of the present invention.

[0050] Figure 6 yes Figure 5 A schematic diagram of the partially enlarged structure of the device shown.

[0051] Figure 7 It is a schematic diagram of reading the test result on the test element after the test.

[0052] Figure 8 It is a schematic diagram of the “standing” structure of the retaining element in one embodiment of the present invention.

[0053] Fig. 9 It is a schematic diagram of the “standing” structure of the retaining element in one embodiment of the present invention.

[0054] Fig.10 This is a diagram showing the actual use effect of reading the result after the holding element in one embodiment of the present invention is "standing". DETAILED DESCRIPTION

[0055] 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.

[0056] Detection

[0057] 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.

[0058] Test components

[0059] A variety of test elements can be combined and applied to the present invention. The test element includes a test strip, and the analytical test strip 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 sample addition area, a reagent area and a test result area. The sample is added to the sample addition 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). 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, a signal will be generated if the analyte is present in the sample, and no signal will be generated if the analyte is not present. In the competitive detection form, 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 various analysis forms.

[0060] When the test element is a test strip, 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 in circulation between the regions, and they may or may not be superimposed on each other. The materials on the test strip can be fixed to a support such as a plastic liner or a hard surface to enhance the test strip's holding power.

[0061] 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.

[0062] The test strip regions may be arranged as follows: a sample application region, at least one reagent region, at least one test result region, at least one control region, at least one adulteration detection region and a liquid absorption region. 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 be directly or indirectly liquid transferred. In this example, different regions may be connected end to end along the direction of liquid transfer, or may be superimposed on each other along the direction of liquid transfer, or may be connected by other materials, such as a connecting medium material (preferably a water-absorbent material such as filter paper, glass fiber or nitrocellulose). When a connecting material is used, the connecting material can form liquid circulation by allowing a material containing regions where the ends are connected to the ends, containing regions where the ends are connected to the ends but liquid does not circulate, or containing regions that overlap each other (for example, but not limited to overlap from beginning to end) but liquid does not circulate.

[0063] 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.

[0064] In a specific embodiment of the present invention, the test element or the test strip may be located in a test element carrier, preferably, in a groove of a body of the test element carrier.

[0065] sample

[0066] The 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, tissue and organ cultures, 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. 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.

[0067] By using the present invention and a suitable detection element, any analyte can be detected. The present invention is preferably used to detect drugs in saliva.

[0068] 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.

[0069] Analyte

[0070] 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.

[0071] Sample collection element 100

[0072] The present invention also provides a fluid sample collection element 100. In one embodiment, the fluid or liquid sample collection element has an absorption element 103 and a gripping portion 101. The absorption element 103 is usually made of a medical-grade sponge or foam plastic material commonly used in the art. However, many other materials can also be made into the absorption element, such as cotton or paper, or any other material with water absorption properties. The gripping portion is usually rigid, which is convenient for handling the absorption element. The gripping portion 101 can be made of materials commonly used in the art, such as plastic, wood, metal or cardboard. In one embodiment, the gripping portion is connected to the absorption element 103 via a rod-like structure 102, one end of the rod-like structure is connected to the gripping portion 101, and the other end includes a wheel edge 110 (see attached Figure 1 ), the absorbing element 103 is attached thereto. In some specific embodiments, the wheel edge 110 includes a sealing element 108, such as a silicone elastic sealing ring, for sealing the absorbing element 103 to the receiving cavity 3041 of the carrier 300. In some embodiments, the gripping portion 101 includes a structure with a triangular cross section (see the attached Figure 1 ). The triangular gripping portion 101 includes a surface 111 surrounding a triangular structure, and a protruding edge 105 is provided or included on the surface 111. The protruding edge 105 can be formed around the surface 111 continuously or discontinuously. The protruding edge 105 divides the surface 111 into two upper and lower surfaces, a first surface 104 and a second surface 106. The protruding edge 103 cooperates with the opening edge of the retaining element 200 to keep the gripping portion 101 in a fixed position on the retaining element and cannot continue to enter the cavity of the retaining element 200. The gripping portion can be a hollow structure, which does not appear bulky and is convenient to operate. At the same time, the protruding edge 105 provided on the gripping portion can not only play a role in limiting the position, but also make it easier for hands or fingers to grasp, because the protruding edge gives the surface 111 a greater friction. In some specific embodiments, the length of each side of the triangular gripping portion 101 is 2.5, 3, 4, or 5 centimeters.

[0073] In some preferred embodiments, the surface 106 of the grip 101 includes protrusions 107, 130. Preferably, when the grip is triangular, protrusions are provided on three faces, and the protrusions cooperate with the grooves on the retaining element to keep the grip on the retaining element 200, thereby providing a fixed position.

[0074] Test element carrier 300

[0075] The carrier of the test element of the present invention is mainly used for carrying the carrier 300 of the test element, which includes a body 308 for accommodating the test element. The body 308 includes two front and rear surfaces 310 and 311, and includes a plurality of slot structures 301 on the front 310 of the body, in which the test element can be set or placed. In order to allow the test element to be fixed and not easily fall off in the slot structure 301, two pairs of protrusions 312 and 313 are set in the slot structure 301, which can keep the test element from falling off from the slot structure 301. In some embodiments, the sample absorption area of ​​the test element is exposed to the body, extending from a section of the opening 3130 of the slot 301, directly contacting the fluid sample, and the detection area is located between the protrusion pairs 312 and 313. In some ways, when the test element is set in the slot 301, a transparent thin sheet, such as plastic, aluminum foil, adhesive, etc., is covered on the surface 310 to keep the test strip in a dry environment or not affected by the external environment, for example, the assembly process can avoid accidental damage to the test strip. Of course, the sample absorption area of ​​the test strip may not be exposed from the opening of the card slot.

[0076] In some specific embodiments, the carrier of the test element of the present invention further comprises a cavity 307 for accommodating the absorption element 103, the cavity comprising a cavity opening 304, a side wall 317 and a bottom 318, the opening 304, the side wall 317 and the bottom 318 enclose a receiving cavity 3041. A through hole 306 is included on the bottom 318. The diameter of the through hole 306 can be smaller than the diameter of the absorption element 103, when the absorption element contacts the bottom, it can be squeezed by the force, so that the liquid sample absorbed on the absorption element 103 is squeezed out, and then flows out through the through hole 306. Preferably, the diameter of the through hole 306 is substantially equal to the diameter of the absorption element 103, and a "cross" hollow structure is provided at the through hole, so that when the absorption element contacts the "hollow" structure at the bottom through hole, it can be squeezed by the force, so that the liquid sample absorbed on the absorption element 103 is squeezed out, and then flows out through the through hole 306 or flows out of the receiving cavity 3041 through the gap of the hollow structure.

[0077] In some preferred embodiments, the shape of the cavity 307 or the shape of the receiving cavity 3041 is comparable to the absorption element, but slightly smaller than the diameter of the absorption element, but comparable to the wheel edge 110 of the fluid sample collection element 100, and the protruding elastic sealing ring on the wheel edge 110 cooperates with the inner surface of the side wall 317 of the receiving cavity 3041 of the cavity 307, so that the elastic sealing ring can contact the inner surface of the side wall 317 to form a seal, so that when the absorption element is inserted into the receiving cavity 307, as the absorption element enters the receiving cavity 3041, the sealing ring 108 forms a seal with the inner surface of the side wall 317, so that the absorption element is sealed in the cavity 307, and the fluid sample will not flow out of the cavity 307, so that the fluid can only flow out of the cavity 307 through the through hole 318. The sealing property is at least liquid-tight, so that the fluid squeezed out of the absorption element will not flow out of the cavity 307 through the opening 304 of the receiving cavity 3041, and the fluid can only flow out of the cavity 307 through the through hole 318.

[0078] In some preferred embodiments, the cavity 307 and the body 308 of the nano-test element are an integral structure. Preferably, the cavity 307 and the body 308 are injection molded at one time. In some preferred embodiments, the bottom 318 of the cavity extends in all directions to form a bottom plate 305, a portion of which is the bottom 308 of the cavity, and the remaining portion cooperates with the support structure in the retaining element 200, so that the test element carrier 300 is located at a fixed position in the retaining element 200. Preferably, the bottom plate 305 includes two contact surfaces 302, 303, and the two surfaces 302, 303 are respectively located on both sides of the body 308 of the rectangular nano-test element, roughly close to the position of the test slot opening of the body 308, and roughly located at a position of one-third of the length direction of the body ( Figure 2 Preferably, the bottom plate 305 is a triangular structure, and the two contact surfaces 302, 303 are respectively located at the two vertices of the triangle (see Figure 2 , Figure 3 ), and the other corner is the third contact surface 385.

[0079] Since a slot 301 is provided on the main body 308, the main body has a certain thickness and includes two surfaces 326, 325 on both sides of the main body near the two contact surfaces 302, 303. These two surfaces are restricted by the columns 1204, 1291 on both sides of the groove of the retaining element, so that the main body is fixed in the cavity of the retaining element. Preferably, the front face 310 of the main body and the surface 1220 of the retaining element 200 are kept in a relatively fixed position.

[0080] Retaining elements

[0081] In a specific embodiment, the retaining element 200 of the present invention is as follows: Figure 2 ,4, shape, of course, in addition to such a structure, it can also have other suitable structures. The retaining element 200 has an opening 212 and a side wall 220, and is surrounded by a bottom. The opening 212 has a retaining element opening edge 208, and the opening edge 208 is naturally formed by the thickness of the side wall. The edge 208 cooperates with the protruding edge 105 of the gripping portion 101 on the fluid collection element 100, so that the fluid collection element 100 can be inserted into a suitable position in the retaining element 200, or a suitable fixed position (detailed introduction will be given below). Preferably, near the opening 212 of the retaining element 200, the inner surface of the side wall 220 has slightly concave structures 209, 210, and the concave structures cooperate with the corresponding protruding structures 107, 130 on the surface 106 of the gripping portion 101. When the gripping portion 101 is inserted into the opening of the retaining element, the corresponding protruding structures 107, 130 on the surface 106 of the gripping portion 101 "click" into the slightly concave structures 209, 210 on the inner surface of the side wall 220, thereby indicating that the preset position has been reached. In this way, the fluid sample collection element is inserted into the retaining element 200, and there are two structures to limit the position of the fluid sample collection element to be inserted into the retaining element, which has a double insurance effect. Of course, if the gripping portion 101 is a triangular structure ( Figure 1 ), and the edge 208 of the opening of the holding element 200 is also a triangular structure, and protrusions and recessed structures can be respectively provided on the three sides of the triangular structure for cooperation, so that the gripping portion 101 is fixed in the holding element. Preferably, the gripping portion 101 can also play a role in sealing the opening 212 of the holding element 200 to prevent the reagent in the holding element from contaminating the external environment.

[0082] In some specific embodiments, the retaining element 200 includes a fluid collection structure near the bottom ( Figure 5 , Figure 6), the collecting structure is generally located at the bottom 305 of the receiving cavity 3041 that receives the absorption element 103. Specifically, the collecting structure is generally composed of an inclined plate 205, one end 280 of the inclined plate 205 upwardly contacts the inner surface of the side wall 2220 and the side wall 3220 of the holding original 200, and is terminated at the intersection of the two side walls, the side wall 2220 and the side wall 3220; the other end 281 downwardly contacts the inner surface of the side wall 1220 of the holding original 200. The other end 281 of the inclined plate 205 is bent and folded near the side wall 1220 to form a groove 206, and the fluid sample flowing down from the plate 205 is collected in the groove 206, so that the fluid sample contacts the absorption area of ​​the test element located in the groove in the groove 206, so that the fluid flows upward along the test element to complete the detection of the analyzed substance in the fluid sample. After reading the description of the present invention, a person skilled in the art has reason to believe that the inclined plate 205 can also be freely changed with the different cross-sectional shapes of the cavity of the holding element. For example, when the cross-sectional shape of the cavity of the holding element is a triangle, the inclined plate 205 structure can also be a triangle, but the plate 205 is inclined, which plays the role of draining the fluid sample from the receiving cavity 3041 to the groove for collection.

[0083] In some preferred embodiments, the retaining element 200 includes a cavity, which is divided into an upper cavity 201 and a lower cavity 202 by a bottom plate 305 of a receiving cavity 307 ( Figure 5 ,6). Preferably, the collecting structure is located in the lower cavity 202, the cavity 307 for accommodating the absorption element is located in the upper cavity, and the body 308 for accommodating the test element occupies the upper cavity 201 and the lower cavity 202, wherein one end of the absorption area with the test element is located in the lower cavity 202 and close to the groove 206, so as to facilitate contact with the fluid sample, and the other end of the body 308 for accommodating the test element is located in the upper cavity 201, and the front 310 directly faces the side wall 1220, so that when there is a test result, the test result on the test element can be directly read through the transparent side wall 1220 (for example, the first surface 1220), and the reading can be read by naked eyes, or directly read by a reading device, for example, it can also be read by taking a picture with a mobile phone, a camera, or scanning with a scanner.

[0084] In order to allow the test element carrier to have a fixed position in the cavity of the holding element, one or more support structures can be provided in the holding element to support the test element carrier. Specifically, there is a protruding surface 203 on the side wall of the holding element, and two surface columns 1204, 1291 are also provided at both ends of the bottom 2061 of the groove 206, one end of the column is connected to the bottom of the groove, the other end extends upward, and the other top forms a support surface 204, 291 (omitted), and the three support surfaces 203, 204, 291 are respectively in contact with the contact surfaces 302, 303, 385 of the bottom plate 205 of the cavity accommodating the absorption element, so that the carrier test element 300 is located in a fixed position in the holding element. In this way, the distance between the columns 1204, 1291 is equivalent to the width of the main body 308 of the test element carrier. In this way, when the test element carrier 300 is inserted into the cavity of the retaining element 200, the specific position of the test element carrier 300 in the cavity of the retaining element is specifically and accurately limited. The distance between the columns 1204, 1291 limits the left and right positions of the main body 309 of the test element carrier, and the three supporting surfaces 203, 204, 291 limit the upper and lower positions of the test element carrier.

[0085] More specifically, in some preferred embodiments, when the side wall of the holding element is a triangle formed by three faces, the holding element 200 has three faces 1220, 2220, and 3220. The front face 310 of the body 308 for accommodating the test element and carrying the test element 300 faces the first face 1220 of the holding element 200. Meanwhile, a groove 206 is provided at the lower part of the inside of the first face, and two columns 1204 and 1291 are provided at both ends of the groove, respectively. There is a certain distance between the two columns, and the distance is equivalent to the width of the body 308 for accommodating the test element. The two columns 1204 and 1291 extend upward from the bottom 3061 of the groove, and the tops of the two columns have two faces 204 and 291 (omitted). When the shape of the bottom plate of the cavity 307 for accommodating the absorption element on the load-bearing test element 300 is also triangular, the three contact surfaces 302, 303, 385 of the bottom plate 305 correspond to the three support surfaces 203, 204, 291 in the retaining element 200. When the load-bearing test element 300 is inserted into the retaining element 200, the three contact surfaces 302, 303, 385 of the bottom plate 305 contact the three support surfaces 203, 204, 291 in the retaining element 200 respectively. At the same time, the lower part of the body 308 for accommodating the test element is inserted into the distance between the two columns. In this way, not only the load-bearing test element 300 is fixed in the retaining element 200, but also the retaining element 200 is separated into an upper cavity 201 and a lower cavity 202 by the bottom plate of the accommodating cavity 307 for accommodating the absorption element 103. Assembled as Figure 5 and 6 As shown (without the fluid sample collection element 100).

[0086] For the sake of simple production and assembly, the holding element 200 and the three supporting surfaces 203, 204, 291 and the collecting structure, such as the inclined plate 205, the groove 206 and the two pillars 1204, 1291 respectively arranged at the two ends of the groove can be formed at one time. The body 308 for accommodating the test element, the receiving cavity 307 for accommodating the absorption element 103 and the bottom plate constituting the receiving cavity 307 are connected as an integral structure, and they are also injection molded at one time. More specifically, the front 310 of the body 308 for accommodating the test element is provided with a groove 301 for accommodating the test element, and the cavity 307 for accommodating the absorption element is arranged on the back 311, one side of the bottom plate 305 is in contact with the back 311, or part of the side wall of the receiving cavity 307 is formed by part of the back 311, or the side wall 317 of the receiving cavity 307 is surrounded separately without contacting the back 311 of the body 308. Thus, during assembly, the test element is first inserted into the card slot 307 on the front 310 of the body 308, and then the test element carrier 300 is directly inserted into the holding element through the opening 212 of the holding element, thereby forming a detection device very easily. The detection device includes the holding element 200 and the test element carrier 300 with the test element located therein, forming a detection device as shown in FIG. Figure 5 and 6 The structure shown (without the fluid sample collection element 100).

[0087] After reading the description of the present invention, the person skilled in the art has reason to believe that the structure of the bottom plate can also be freely changed with the different shapes of the cross-section of the cavity of the holding element. For example, when the shape of the cross-section of the cavity of the holding element is a triangle, the structure of the bottom plate can also be a triangle. After reading the description of the present invention, the person skilled in the art has reason to believe that the structure of the gripping portion 111 of the fluid collecting element can also be freely changed with the different shapes of the cross-section of the cavity of the holding element. For example, when the shape of the cross-section of the cavity of the holding element is a triangle, the structure of the gripping portion 111 of the fluid collecting element can also be a triangle. In addition to the gripping portion 111 of the fluid collecting element, the bottom plate 305 of the receiving cavity and the cross-section of the cavity 201 of the retaining element 200 being the same shape, such as a triangle, other shapes that fit each other can also be suitable. For example, in some preferred embodiments, the bottom plate of the receiving cavity and the cavity of the retaining element are substantially the same cross-section. Preferably, the gripping portion of the fluid sample collecting element, the bottom plate of the receiving cavity, the cavity of the retaining element, and the inclined plate of the collecting structure are all substantially the same cross-section or shape, such as a square, an ellipse, a rectangle, a rhombus, a pentagon, a triangle, a hexagon, a heptagon, etc.

[0088] Standing structure

[0089] In some preferred embodiments, the device includes a standing structure that allows the detection device to maintain a standing posture, so that the detection result on the test element on the body 308 can be conveniently read through a transparent surface, such as 1220. Preferably, the standing structure includes a structure that allows the holding element to stand tilted. The standing structure includes two surfaces 401 and 402, which are non-parallel surfaces ( Figure 8 ), the contact surface 408 (also called the intersection point) is formed at the intersection of the two surfaces 401 and 402. In this way, the two surfaces 401 and 402 and the cross contact surface 408 form a contact surface similar to a triangle. The various surfaces of the triangular contact surface are in the same plane. The plane formed by the triangle is not parallel to the plane on which the holding element stands vertically, but has a certain angle, such as 30°; 25°; 45°, etc. When it is necessary to make the holding element 200 stand at an angle, the two surfaces 401 and 402 and the contact surface formed by their cross contact surface 408 are allowed to contact the support surface 500 (such as the surface of a test bench, a detection bench, or an operating table). They stand steadily and tilted on these support surfaces, thereby facilitating the inspection to read the test results on the test element detection area, or directly use a reading device (mobile phone, camera) to take pictures and read, thereby saving the test results ( Fig.10 ).

[0090] In order to better complete the test, the standing structure can also include a structure that allows the holding element to stand vertically. In a preferred embodiment, standing planes 403, 404 and a standing point 407 are formed at both ends of the two surfaces 401 and 402, respectively. The planes 403, 404 and the standing point 407 form a triangle-like structure, and the planes 403, 404 and the standing point 407 are in the same plane, so that the holding element 200 stands vertically on the table. Allowing the holding element to stand vertically is conducive to the reaction and testing of the test element. The structure that allows the holding element to stand at an angle can facilitate the reading of the test results.

[0091] The so-called vertical standing and inclined standing are relative concepts, generally relative to the contact support surface 500. When the element is kept perpendicular to the support surface 500, it is generally vertical standing, and when the element is kept at a certain angle to the support surface 500, it is called inclined standing (for example, Fig.10 Therefore, the first contact surface and the second contact surface themselves have a certain angle, such as an acute angle.

[0092] The upright and inclined positions can be easily interchanged, e.g. Fig. 9In the structure shown, the triangular first contact surface formed by 408, 402 and 401 forms an angle with the vertically standing plane of the retaining element, so that when the first triangle contacts the support surface 500, the retaining element stands at an angle, and the standing points 404, 406 and 407 form another second contact surface similar to a triangle, and the second contact surface is not in the same plane as the first contact surface, but the second contact surface allows the retaining element to stand vertically. In a preferred embodiment, each point or surface forming the first contact surface and each surface or point forming the second contact surface are formed at the bottom of the side wall of the retaining element, and are directly formed by cutting the bottom of each surface 1220, 2220, 3220 of the side wall of the retaining element, without the need for additional structures, which facilitates low-cost production, such as one-time injection molding. The thickness of the side wall 220 can determine the width of each edge constituting the contact surface. For example, the thicker the side wall is, the thicker the edges 401, 402, 408, 406, 406, and 407 defined by the side wall are, and the more conducive it is to form a larger physical contact surface. In fact, due to the stability of the triangle, it can be known that as long as there are three points of the contact surface in contact with the support surface 500, the holding element can stand stably, such as standing vertically or standing at an angle. For example, the contact surface does not necessarily have to be a solid plane structure. As long as several edges forming the contact surface, such as 401, 402, 408, 406, 406, and 407, are distributed on the edges of the side wall, they can arbitrarily form various shapes of surfaces due to their position, such as triangles, squares, ellipses, diamonds, etc. The surfaces surrounded by these edges can allow the holding element to stand, such as standing vertically or standing at an angle.

[0093] During the test, in order to make the holding element stand upright, the second contact surface is in contact with the support surface 500. When the test is completed, when the holding element needs to be tilted, it only needs to be gently moved (a force is applied to tilt the holding element 200), so that the holding element 200 is slowly tilted backward, so that the first contact surface is in contact with the support surface 500, and the tilt is maintained. Thus, it can be easily interchanged.

[0094] It is easy for a person skilled in the art to understand that, in addition to the standing posture structure listed in the present invention, there are other similar structures that can keep the holding element in a vertical standing and inclined standing posture. Alternatively, a similar design can be adopted to allow the holding element to be transformed from a vertical standing state to an inclined standing state, or from an inclined standing state to a vertical standing state under different demand conditions. Because the vertical standing state is conducive to the reaction of the test element, and the inclined standing state is conducive to reading the test results on the test element, for example, it is very easy to read the test results on the test element by taking a picture, and it is convenient to save the read results.

[0095] Detection Methods

[0096] The following describes how to detect the substance to be analyzed in the fluid sample with reference to the accompanying drawings.

[0097] Prepare a fluid collection element 100 and an assembled detection device, which includes a holding element 200 and a test element carrier 300 (such as Figure 5 , 6). The absorption element 103 of the fluid collection element is placed into the mouth of a person to collect saliva. When the entire absorption head is full of saliva sample, the absorption head becomes soft. At this time, the collecting element 100 absorbing the saliva sample is inserted into the upper cavity 201 of the retaining element through the opening 212 of the retaining element 200. As the collecting element 100 enters or is inserted, the absorbing head enters the receiving cavity 3041 of the receiving cavity 307. Since the collecting element 100 is provided with a sealing element 108, the sealing element 108 contacts the inner surface of the side wall 317 of the receiving cavity 3041, thereby forming a sealed state, thereby sealing the absorbing element 103 in the receiving cavity 304. With further squeezing, the saliva retained in the absorbing element 103 is squeezed out and flows through the through hole 306 to the inclined plate 205 located below in the lower cavity. The inclined plate collects the saliva sample into the groove 206 and contacts the absorption area of ​​the test element located in the groove. Therefore, the saliva sample rises along the test element due to capillary action and flows to the detection area, thereby detecting the analyzed substance.

[0098] When the collecting element 100 is inserted into the holding element 200, the protruding edge 105 of the gripping portion 101 abuts against the edge formed by the opening 208 of the holding element, so that the collecting element can no longer move downward, thereby completing the extrusion of the fluid sample. At the same time, the protruding structure 107 on the surface 106 of the gripping portion 101 of the collecting element 100 cooperates with the recessed structure 209 on the inner surface of the side wall of the holding element, thereby allowing the collecting element to be retained in the holding element. In addition, since the sealing element on the collecting element 100 is in close contact with the inner surface of the side wall 317 of the receiving cavity 304, the collecting element 100 is more firmly retained in the upper cavity 201 of the holding element, so that it is not easy to fall off from the holding element.

[0099] At this time, the holding element is in a vertical standing state by relying on the standing structure at the bottom, such as the second contact surface, such as the standing point 407, the planes 403, 404 and the standing point 407 form a triangular structure, so that the holding element 200 stands vertically on the table. When it is necessary to shoot the test results of the test element on the front 310 of the body 308, the holding element is placed at an inclined angle ( Fig.10), so that the two surfaces 401 and 402 cross the contact surface 408, forming a first contact surface similar to a triangle to contact the table surface, and standing on the table surface at an angle, it is convenient to take pictures.

[0100] After taking the photos, the entire test device can be directly discarded because the holding element 200, the test element carrier 300 and the collecting element 100 are connected as an integrated structure, thereby preventing leakage of the sample and causing no secondary pollution to the environment.

[0101] Example 1

[0102] By placing the absorbing element 103 of the sample collection element in the examinee's mouth until it is full of saliva, 150 saliva samples were collected from 150 examinees using the sample collection element as herein described.After being loaded with sample, the sample collector is placed in the absorbing element receiving chamber 304 in the upper cavity 201 of the retaining element 200 of the device to compress the absorbing element and extrude the sample, directly test.The mixture of drugs of abuse is mixed with 50 negative samples, including amphetamine, cocaine, methamphetamine, opiate, THC and phencyclidine., adopt the same method to absorb liquid with suction element 103, perform the same operation.After 10 minutes, the record result is positive or negative.Three test strips are constructed on each body 308, and each test strip tests three kinds of drugs of abuse. Between the three test strips, the following six drugs of abuse were tested: amphetamine (AMP), cocaine (COC), methamphetamine (MET), opiate (OPI), tetra-hydrocannabinol (THC), and phencyclidine (PCP).

[0103] All 100 samples that had not been adulterated with drugs of abuse tested negative. All 50 samples that had been adulterated with a drug cocktail provided positive results for each of the six drugs, except that only 19 of the 20 samples tested positive for THC.

[0104] Confirmatory testing using widely accepted procedures was then performed on these samples. In the confirmatory testing, all 50 samples tested positive for all six drugs.

[0105] Example 2 - Detection sensitivity experiment

[0106] This example is to illustrate the detection sensitivity of the device and method of use of the present invention. Each sample solution was tested with ten devices, for a total of 300 tests. These devices tested saliva samples and used test strips with antigens of the drug being tested. The test strips used a competitive method with colloidal gold labeled antibodies in the labeling area and antigens on the test line.

[0107] The device was also tested with PBS solutions containing 0, 0.5, 1.5 and 3 times the detection limit of cocaine (COC), methamphetamine (MAMP), phencyclidine (PCP), tetrahydrocannabinol (THC), morphine (MOP) or amphetamine (AMP). For example, the detection limit of THC in saliva is 4ng / ml. Therefore, PBS solutions containing 0ng / ml, 2ng / ml, 6ng / ml and 8ng / ml of THC were tested. The following table shows the dosage of the drugs tested.

[0108] During the test, the negative saliva, PBS, or spiked PBS is absorbed by the absorbent sponge of the sample collector, and then squeezed into the absorbent head receiving cavity for testing, allowing the liquid to enter the groove 206 and contact the test strip, and the liquid passes through the test strip by capillary action. After 10 minutes, the test results are recorded and displayed in the following table.

[0109]

[0110] 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.

[0111] 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 device for collecting and detecting an analyte in a fluid sample, characterized in that: The device comprises: a fluid sample collecting element; a test element carrier; and a holding element containing a cavity, wherein the test element carrier is located in the cavity of the holding element; the fluid sample collecting element comprises an absorbing element and a grasping portion, wherein the grasping portion comprises a holding structure that cooperates with the holding element and allows the fluid sample collecting element to be fixedly held in the holding element; the absorbing element and the grasping portion are connected to form an integral structure through a connecting rod, and the fluid sample collecting element further comprises an elastic sealing element; The test element carrier comprises a body for accommodating the test element and a receiving cavity for accommodating the absorption element, wherein the body for accommodating the test element comprises at least one groove for accommodating, placing or setting the test element; the receiving cavity for accommodating the absorption element comprises an opening, a side wall and a bottom, wherein the bottom comprises a through hole, wherein the inner surface of the side wall of the receiving cavity can cooperate with the sealing element of the fluid sample collection element to seal the absorption element in the receiving cavity; the bottom extends outwardly to form a bottom plate structure, wherein the bottom plate divides the cavity of the holding element into a first upper cavity and a second lower cavity; The device further comprises a standing structure for allowing the device to stand vertically or tilted, wherein the standing structure is located on the holding element; the vertical standing structure or the tilted standing structure is formed by the bottom edge of the side wall of the holding element, and the vertical standing structure and the tilted standing structure are interchangeable standing states; The retaining element includes a fluid collection structure near the bottom, which is located at the lower side of the bottom of the accommodating cavity; the fluid collection structure is composed of an inclined plate, one end of which contacts upward with the inner surfaces of the first side wall and the second side wall of the retaining element, and stops at the intersection of the first side wall and the second side wall; the other end contacts downward with the inner surface of the third side wall of the retaining element, and is bent and folded into a groove near the other end of the inclined plate and the third side wall; the fluid sample flowing down from the inclined plate is collected in the groove, so that the fluid sample contacts the absorption area of ​​the test element located in the groove in the groove.

2. The device according to claim 1, wherein the holding structure comprises a gripping edge protruding from the gripping portion, the edge being in contact with an edge of the opening of the holding element.

3. The device according to claim 2, wherein the retaining structure comprises a protrusion structure located on the gripping portion and a recessed structure located on the side wall of the retaining element.

4. The device according to claim 3, wherein: The body for accommodating the test element and the receiving cavity for accommodating the absorption element are an integrated structure.

5. The device according to claim 4, wherein the bottom plate structure comprises one or more fulcrum structures, and the cavity of the retaining element comprises a supporting surface structure corresponding to the fulcrum structure.

6. The device according to any one of claims 1 to 5, wherein the bottom plate structure of the receiving cavity and the cavity of the retaining element are cross-sections of the same shape.

7. The device according to claim 6, wherein the gripping portion of the fluid sample collecting element, the bottom plate structure of the receiving cavity, and the cavity of the retaining element have substantially the same cross-sectional structure, which is one of square, oval, rectangle, diamond, pentagon, triangle, hexagon, and heptagon.

8. The device according to claim 7, wherein: The vertical standing structure and the inclined standing structure are triangular contact surfaces, which are used to contact the supporting surface; wherein the vertical standing structure includes a second contact surface, and the inclined standing structure includes a first contact surface, and the first contact surface and the second contact surface are not on the same plane.

9. A device for collecting and detecting an analyte in a fluid sample, the device comprising: A fluid sample collecting element, wherein the fluid sample collecting element comprises an absorbing element for absorbing the liquid sample and a gripping portion, and a connecting rod connecting the absorbing element and the gripping portion; A test element carrier, wherein the test element carrier comprises a body for carrying the test element and a receiving cavity for receiving the absorption element, wherein the body and the receiving cavity are an integral injection molding structure; the body for carrying the test element comprises at least one groove for receiving, placing, or setting the test element; the receiving cavity for receiving the absorption element comprises an opening, a side wall, and a bottom, wherein the bottom comprises a through hole, wherein the inner surface of the side wall of the receiving cavity can cooperate with the sealing element of the fluid sample collection element to seal the absorption element in the receiving cavity; the bottom extends outwardly to form a bottom plate structure, and the bottom plate divides the cavity of the holding element into a first upper cavity and a second lower cavity; A holding element with a cavity, wherein the cavity of the holding element is surrounded by an opening, an edge of the opening, and a side wall; the gripping portion of the fluid sample collecting element includes a holding structure that cooperates with the holding element to allow the fluid sample collecting element to be fixedly held in the holding element; Wherein, the holding element includes a structure for allowing it to stand vertically or tilted; the standing structure is located on the holding element; the vertical standing structure or the tilted standing structure is formed by the bottom edge of the side wall of the holding element, and the vertical standing structure and the tilted standing structure are interchangeable standing states; The retaining element includes a fluid collection structure near the bottom, which is located at the lower side of the bottom of the accommodating cavity; the fluid collection structure is composed of an inclined plate, one end of which contacts upward with the inner surfaces of the first side wall and the second side wall of the retaining element, and stops at the intersection of the first side wall and the second side wall; the other end contacts downward with the inner surface of the third side wall of the retaining element, and is bent and folded into a groove near the other end of the inclined plate and the third side wall; the fluid sample flowing down from the inclined plate is collected in the groove, so that the fluid sample contacts the absorption area of ​​the test element located in the groove in the groove.

10. The device according to claim 9, wherein: The vertical standing structure or the inclined standing structure is a triangular contact surface, which is used to contact the supporting surface; wherein the vertical standing structure includes a second contact surface, and the inclined standing structure includes a first contact surface, and the first contact surface and the second contact surface are not on the same plane, wherein the second contact surface allows the maintaining element to stand vertically, and the first contact surface allows the maintaining element to stand inclined.

11. The device according to claim 10, wherein: The vertical standing structure and the inclined standing structure are located on the edge of the side wall of the retaining element.

12. The device according to claim 11, wherein The first contact surface is composed of a surface formed by two edges of the side wall and a fulcrum formed by the intersection of one end of the surface formed by the two edges, wherein the surface formed by the two edges and the fulcrum form a triangular first contact surface.

13. The device according to any one of claims 9 to 12, wherein: The test element carrier is located in the cavity of the holding element; wherein the gripping portion and the opening of the holding element have the same cross-sectional shape, and the cross section is one of square, ellipse, rectangle, rhombus, pentagon, triangle, hexagon and heptagon.

Images