Device for detecting an analyte in a liquid sample

Abstract

Device for detecting an analyte in a liquid sample The present invention relates to a detection device which comprises: a chamber (201) for receiving a liquid sample, a cover body for sealing the chamber (201), wherein the cover body (101) further comprises a holder (30) with a groove for receiving and retaining a test strip, and the cover body (101) further comprises an orifice, the orifice being in communication with the groove, wherein the cover body (101) is provided with a mark, the connection between the mark and the orifice being the shortest distance, wherein the mark is provided to indicate the direction of inclination when a test is performed, thereby allowing the liquid sample to contact a test area of ​​the test strip disposed in the groove. Figure to be published with the abstract: FIG. 1

Description

Title of the invention: Device for detecting an analyte in a liquid sample Technical field

[0001] The present invention belongs to the field of in vitro diagnostics and is used for testing an analyte in a liquid sample, and more particularly relates to a device for detecting certain analytes in urine samples and properties of urine. TECHNICAL CONTEXT

[0002] In the field of testing, a test cup is a medical device commonly used for testing samples stored in liquids, typically urine, blood, wastewater, semi-solid substances (semi-solid substances are those that have been transformed into liquid samples by any suitable method), etc.The common testing tool for liquid samples is the test strip, and there are generally two ways for the test strip to obtain liquid samples: one is to place the test strip directly into the liquid sample, and the bottom of the test strip then contacts the liquid sample, so that the test strip can obtain liquid samples; the other is the drip type, which uses tools such as droppers to suck up liquid samples and then add them to the test strip, so that the test strip can obtain liquid samples. These two common methods of using test strips are localized and in contact with the liquid sample. Often, test strips are only used for one testing project, and to change the test items, different test strips need to be replaced.

[0003] Furthermore, when a test strip has more than one test element, especially in biochemical tests, it is hoped that each test area of ​​the test strip will be in contact with the liquid sample at the same time, so that each test area can carry out the reaction at the same time and judge the result at the same time, but if manual operation is used, it seems unsafe and unhygienic.

[0004] It is therefore necessary to further improve existing conventional devices in order to adopt a convenient, more hygienic and safer method for performing sexual tests, in particular the use of chemical methods for testing analytes in urine. DISCLOSURE OF THE INVENTION

[0005] In order to overcome the drawbacks of the prior art, the present invention aims to provide a device for detecting an analyte in a liquid sample, which comprises:

[0006] a chamber for receiving a liquid sample, said chamber comprising an opening and a transparent side wall surrounding the chamber;

[0007] a cover body, said cover body being intended to seal the opening of the chamber;

[0008] a holder with a groove, said holder being adapted to receive and retain a test strip, wherein said holder has a tubular structure which allows the test strip to be stably retained in the groove without leaving said groove when the holder is retained in the groove; and

[0009] a test strip, said test strip comprising one or more test areas which are used to test for the presence or content of an analyte in a liquid sample.

[0010] According to some embodiments, said chamber comprises an opening and a chamber body, said chamber being surrounded by a transparent wall. According to some embodiments, the chamber comprises an edge of the opening which is provided with threads, the threads engaging the threads of the lid body and allowing the lid body to seal the opening of said chamber. According to some embodiments, the bottom of said chamber is covered with an opaque labeling paper bearing a minimum liquid level mark and a maximum liquid mark. According to some embodiments, said labeling paper does not completely seal the side walls of the transparent chamber, but forms a window area where the sample can be observed.In some embodiments, said window area is conveniently provided with a color block with a standard color card for comparing the color of the test area with the color of the test area of ​​the test strip to determine a positive or negative test result for the test area. In some embodiments, said chamber has a protrusion near the upper opening of the chamber, which protrusion serves to prevent the lid body from rotating, thereby maintaining the lid body in a fixed position in the chamber. When the lid body contains a holder, the holder is inserted into the chamber, thereby limiting the holder to a specifically defined position in the chamber.

[0011] According to some embodiments, the lid body further comprises an orifice, one end of the orifice being in communication with the groove, the orifice is provided to allow a test element to pass through and into the groove of the holder. According to some embodiments, the lid body comprises a chamber tilt mark, the connection between the mark and the orifice is the shortest distance from other positions. In some embodiments, the lid body further comprises a sealing plug for sealing the orifice, the sealing plug being further provided with a mark which further serves to indicate the direction of inclination of the chamber. In some embodiments, said groove is surrounded by a bottom surface and two side surfaces, said groove has an opening, said opening faces a side wall of the collection chamber. In some embodiments, said groove comprises one or more orifices which are provided to allow liquid to pass through and into the groove to contact the test area on the test strip. Of course, once the liquid sample has contacted the test area, it may flow out of the groove through the orifices.In some embodiments, the chamber has a tubular structure at its end near the lid body, the tubular structure being provided to allow the test strip to remain in the chamber without detaching.

[0012] According to some embodiments, said test strip comprises one or more test areas that are used to test for the presence or content of an analyte in a liquid sample. According to some embodiments, said test strip comprises a non-hydrophilic backing sheet, one or more test areas are disposed on the backing sheet, and the test areas are composed of a water-absorbent material. According to some embodiments, said test area on said test strip comprises a chemical substance that is capable of reacting directly or indirectly with the analyte in the liquid sample and producing a colored substance.In some embodiments, the analyte may be one or more pH values ​​in urine, an analyte in urine, such as leukocytes or white blood cells, erythrocytes, urinary choline, urinary vitamin C, urinary crystals, urine specific gravity, urinary albumin, urinary ketones, urinary colony count, urinary pH, nitrites. In some embodiments, said test strip is provided with two identical test areas that contain the same chemical substance and detect the same analyte, wherein said two test areas are provided at two ends of the test strip. In some embodiments, the test strip comprises two groups of test areas that each comprise two or more test areas for testing different analytes, both groups comprising identical test areas for testing the same analyte.

[0013] In a second aspect, the present invention aims to provide a method for detecting an analyte in a liquid sample, comprising: providing a detection device comprising: a chamber for receiving a liquid sample, said chamber comprising an opening and a transparent side wall surrounding the chamber; a cover body, said cover body being for sealing the opening of the chamber; and a test strip which is used for testing an analyte in a liquid sample, wherein said test strip comprises a non-hydrophilic backing sheet, and said test area is provided on the backing sheet, and wherein said test area is composed of a water-absorbent material;

[0014] firstly arranging the test strip in the chamber, and keeping a part of the test strip in the tubular structure, the test area then not coming into contact with the liquid sample, then, letting the liquid sample come into contact with the test area for a certain time, finally, taking out the liquid sample from the test area.

[0015] In some embodiments, the manner of allowing the liquid to contact the test area includes tilting the chamber in the direction of the test strip or inverting the chamber.

[0016] According to some embodiments, the lid body further comprises a holder with a groove for receiving and retaining a test strip, and the lid body further comprises an orifice, one end of the orifice being in communication with the groove, the orifice is provided to allow a test element to pass through and into the groove of the holder, wherein the orifice is closed by a sealing plug; said test strip comprising one or more test areas which are used to test for the presence or content of an analyte in a liquid sample;wherein the cover body is provided with a mark, the connection between the mark and the hole is the shortest distance, wherein the mark is provided to indicate the direction of inclination when a test is performed, thereby allowing the liquid sample to contact a test area of ​​the test strip disposed in the groove; a liquid sample is collected with the chamber so that it is located at the bottom of the chamber, said liquid sample being a urine sample; the opening of said chamber is sealed with a cover body, thereby allowing insertion of the holder into the chamber; ;

[0017] Open the sealing cap and allow the test strip to be inserted into the groove through the hole in the cover body, then seal said hole with the sealing cap; allow the chamber to tilt in the direction indicated by the marks on the cover body, the tilting being for a period of 1 to 10 seconds; then allow the chamber to return to its original position.

[0018] According to some embodiments, when inserting the test strip into the groove of the holder, keeping the test area of ​​the test strip close to the orifice in the cover body, further, said liquid sample is urine, said test strip comprises a non-hydrophilic backing sheet, and said test area is disposed on the backing sheet, and wherein said test area is comprised of a water-absorbent material. DESCRIPTION OF FIGURES

[0019] [Fig.l] shows a three-dimensional diagram of the structure of the detection device (without test strip) according to the embodiment of the present invention.

[0020] [Fig.2] shows a three-dimensional diagram of the structure of a chamber according to the present invention, in which the chamber contains a support as well as a test element on the support, with positive and negative color blocks in the chamber for interpretation of the results.

[0021] [Fig.3] shows a diagram of the structure of the cover body combined with the support according to the embodiment of the present invention.

[0022] [Fig.4] shows a three-dimensional diagram of the structure of the cover body according to the present invention, with a mark intended to indicate the direction of inclination of the chamber (when the cover body is combined with the chamber, or when the cover body is combined with the chamber for testing).

[0023] [Fig.5] represents a three-dimensional diagram of the structure of the joint according to the present invention, the joint further bearing a symbol of the direction of inclination.

[0024] [Fig.6] shows a diagram of the structure of the test strip according to the embodiment of the present invention.

[0025] [Fig.7] shows a diagram of the structure of the test strip according to the embodiment of the present invention.

[0026] [Fig.8] shows a diagram of the structure of the test strip according to the embodiment of the present invention.

[0027] [Fig.9] shows a specific embodiment of the present invention in which the chamber contains a liquid, the holder is located in the chamber and the test strip is located on the holder when the test is performed.

[0028] [Fig. 10] shows a diagram of the inclined structure along the arrow mark on the cover body.

[0029] [Fig. 11 A] represents a diagram of the principle of the embodiment of the present invention.

[0030] [Fig. 1 IB] shows a diagram of the principle and structure of the inclination along the direction of the orifice and indicated by the arrow.

[0031] [Fig. 1 IC] shows a diagram of the principle and structure of the inclination along the direction of the orifice and the point. Detailed description Detection

[0032] Detection indicates the chemical examination or testing of a type of substance or material, whether, for example, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolic product, a drug or drug metabolite, an organic organization or a generation of organic organization, a thank object, a nucleic acid, a protein, or a polymer. Furthermore, detection indicates the analysis of a content of a substance or material. Furthermore, chemical detection further refers to an immunoassay, a chemical assay, an enzyme assay, etc. Sample

[0033] Samples that can be tested by the detection device according to the present invention include biological fluids (e.g., case fluids or clinical samples). The liquid samples can be from the sample in the solid or semi-solid state, including feces to the liquid sample, biological tissue and food samples. The solid or semi-solid samples can be converted into a fluid sample using any suitable method, such as mixing, crushing, macerating, incubating, dissolving or digesting the solid sample in a suitable solution (such as water, phosphate solution or other buffer solutions) using enzymolysis.“Biological samples” include samples from animals, plants, and foods, including human or animal samples such as urine, saliva, blood and its ingredients, cerebrospinal fluid, vaginal fluid, semen, feces, sweat, secretion, tissue, organ, tumor, tissue and organ culture, cell culture, and culture medium. Preferred biological samples are urine and, preferably, saliva, sputum, nasal secretions, etc. Food samples include substances from food processing, finished products, meat, cheese, wine, milk, and drinking water. Plant samples are derived from a plant, plant tissue, and the medium.“Environmental samples” are samples from the environment (e.g., a lake or other water body liquid sample, a wastewater sample, a soil sample, groundwater, seawater, and a waste liquid sample). Environmental samples may further include wastewater or other wastewater.

[0034] According to some embodiments, the samples of the present invention may be human or mammalian urine samples. Therefore, the present invention may be used to test for the presence of an infection in a medicinal solution, or specific analytes or their levels in urine. Downstream and upstream

[0035] Downstream or upstream divides the flow direction of the liquid, and generally the liquid flows from upstream to downstream. The downstream area is located to receive the liquid from the upstream area, and the liquid can further flow along the upstream area to the downstream area. Here, the liquid is generally divided according to the flow direction, for example, on some materials where capillary force is used to induce the flow of the liquid, the liquid can flow in the opposite direction to gravity by gravity, and at this time, the upstream and downstream are still divided according to the flow direction of the liquid.For example, in the collection device of the present invention, according to certain preferred embodiments, the first chamber serves as a collection chamber for a liquid sample, while the second chamber is in liquid communication with the first chamber, and liquid entering the first chamber flows into the second chamber, and the first chamber may be called upstream, while the second chamber may be called downstream. This flow is, of course, a natural flow of the liquid by gravity. Optionally, this natural flow is a flow of liquid from the first chamber to the second chamber. Communication of gases or liquids

[0036] Gas or liquid communication refers to the ability of a liquid or gas to flow from one location to another, where the flow may be guided by a physical structure. Passage through physical structures generally refers to the liquid passing through the surface of physical structures, or the interior space of structures, and flowing passively or actively to another location; passively, the flow is usually caused by an external force, such as capillary flow. Liquids or gases may further flow passively by their own action (gravity or pressure). Detachable suit

[0037] Detachable combination means the connection relationship between two parts is in several different states or positional relationships, for example when it comes to two parts in the physical sense, they can be separated initially, when they are connected or combined together in a first suitable case, and when in a second suitable case it is possible to separate the two parts, and such separation is a spatial separation in the physical sense, without contact. The two parts can further be combined initially and, when circumstances are suitable, they can be made to form a physically significant spatial separation. In short, the combination of the two parts or their separation can be easily achieved, and the combination of the two parts or the separation can be repeated in several cycles, or, of course, it can be a combination and of a single separation. In addition, there may be a detachable combination between two parts or a detachable combination between three or more parts. For example, with a first, second, and third component, the first component and the second component are detachably combined, and the second component and the third component may further be detachably combined. Test item

[0038] The test element may be selected from lateral flow test strips, which can detect a wide range of analytes. Of course, other suitable test elements may further be used within the scope of the present invention. Any element that detects the presence or absence of the analyte in one or more samples may be called a test element, regardless of the technical principle on which the detection is based, immunological, chemical, electrical, optical, physical, etc. Various test elements may be combined and used within the scope of the present invention. One of these is the test strip.

[0039] The test strips used in the present invention may be what are commonly referred to as lateral flow test strips, and the specific structure and detection principles of the test strips are well known in the prior art to those of ordinary skill in the art. A common test strip comprises a sample collection area, a labeling area, a detection area, and an absorbent area, wherein the sample collection area comprises a sample acceptor pad, the labeling area comprises a labeling pad, and the absorbent area may comprise an absorbent pad, the detection area comprising the chemicals necessary to detect the presence of the analyte, for example, immunological or enzymatic chemical reagents.In general, commonly used test strips are nitrocellulose membrane test strips, that is, the detection area includes a nitrocellulose membrane, a nitrocellulose membrane in which specific binding molecules are immobilized to show the test results; it may further be a cellulose acetate membrane or a nylon membrane and so on, of course, downstream of the detection area may further include the results of the control area detection, usually, the control area and the detection of the area in the form of a horizontal line appears as a line for the detection line or the control line. These test strips are conventional strips, but, of course, other types of test strips using capillary action for detection are further possible.In addition, the test strip typically contains a composition of dry chemical reagents, such as a fixed antibody or other reagent, which, upon encountering a liquid, flows along the test strip by capillary action and, . with the flow, allows the dry reagent composition to dissolve in the liquid in order to move to the next area to process the dry reagent in the area so that it reacts and thus performs the necessary detection. The flow of the liquid is mainly by capillarity.

[0040] The present invention and a suitable detection element make it possible to detect any analyte. Preferably, the present invention is used to detect small drug molecules in saliva and urine. Of course, the collection device of the present invention makes it possible to collect all of the aforementioned forms of samples, whether solid or liquid, provided that the liquids or liquid samples are tested by inserting test strips into the cover of the collection chamber after they have flowed into the collection chamber.

[0041] In some embodiments, the test strip of the present invention is made of a non-absorbent material serving as a support structure, with an absorbent test area on the non-absorbent material, which is made of an absorbent material, and which is pretreated with a chemical substance capable of reacting with the analyte to produce a color change, thereby determining the presence of the analyte or the shape of the sample. This reaction may be that the analyte reacts directly with the colored substrate to produce a new colored substance, or that the analyte reacts with certain chemicals to produce a new substance that reacts with the colored substrate to produce a new colored substance.This is the original production of colored substances using chemical reactions, which are precipitated and fixed to the absorbent material, causing the latter to exhibit a specific color, which is then compared to a standard color card to determine the test result.

[0042] Urine, for example, may be tested for urine pH, analytes in the urine, such as leukocytes or white blood cells, erythrocytes, urinary chologen, urinary vitamin C, urinary crystals, urine specific gravity, urinary albumin, urinary ketone bodies, urinary colony count, urine pH, and nitrites. In some embodiments, two or more indicators may be selected from those mentioned above, such that one or more absorbent materials are disposed on the non-absorbent material as a support structure, such as a filter paper pad, a thin sheet of filter paper, an absorbent sheet, etc.When two or more substances are to be detected, two or more absorbent sheets are adhered to the non-absorbent material as a support structure, which is treated with a chemical substance that reacts with the two or more analytes in the sample and produces a color, which then precipitates onto the corresponding absorbent block or sheet according to a standard color chart to compare the depth or brightness of the color to determine the color of the analyte. corresponding. These colored substances are then deposited on the corresponding absorbent pads or sheets and then compared to the darkness or lightness of the colors according to a standard colorimetric card to determine whether the corresponding analyte is positive or negative.

[0043] According to some embodiments, such as those illustrated in [Fig. 6] to 8, a test strip containing four test areas 51, 52, 53, 54, each testing a different analyte, is arranged on a non-hydrophilic sheet 55. The arrangement is carried out several times in the direction of the longitudinal axis, and the analyte corresponding to each test area can be printed or marked on the carrier sheet 55, or, of course, the analyte can be marked on the standard colorimetric card provided in the order corresponding to the test strips, as well as the color block corresponding to the negativity or positivity of the substance.Typically, the non-hydrophilic backing sheet may be a rigid sheet of paper, plastic, or metal, while the absorbent test area is typically made of filter paper, onto which a chemical substance is pretreated and then dried to form a testable filter paper pad, or, alternatively, the filter paper pads are first made of a long strip of filter paper treated with a dried chemical substance and then affixed to the non-hydrophilic backing sheet 55. .

[0044] According to some embodiments, as illustrated in [Fig. 7], the test strip comprises four test areas 61, 62, 63, 64, wherein test area 61 corresponds to the same analyte tested in test area 63, and similarly, test area 62 corresponds to the same analyte tested in test area 64. The order of arrangement on the test strip 60 is a spaced order, with test 61 and test area 62 arranged in order, and test areas 63 and 64 arranged in order. One advantage of the arrangement is that the test strip is to be inserted into a liquid sample, and when the drug sample is very low in the collection chamber, it can be allowed to wet the test areas 63 and 64 below to supplement the test results.Furthermore, when the urine sample is large enough to wet all four test areas, it is sufficient to select the result of one test area for the colorimetric card. Furthermore, in case of operator inattention, regardless of the direction of insertion into the holder and immersion of one end in the liquid sample, there are always two test areas that are dry before the test and not wet, so that the test can be successfully completed. There is also the feature that, for example, in some cases, it may be the case that one of the test areas out of the 4 test areas is pre-moistened due to careless handling, for example, if 64 is pre-moistened, for example, by water, then test area 62 can still be used to test the analyte in the urine, thus ensuring that . the test strip can complete the entire test around not being wasted. For example, if a test strip 60 is removed from a box in which the test strips are kept, usually by pressing the location 65 of the arrow in the hand, and sometimes falls, perhaps accidentally, from the hand onto a laboratory bench, which may contain a liquid, for example water, some test areas of the test strip 50 will be pre-moistened, for example the test area 61 is pre-moistened with water, and if the pre-moistened test area 61 is then used to contact urine, so that the test area 61 can be used to test for the analyte in the urine, so that the test strip is not wasted.The saturated water absorption on a test area is a customization, the saturated water absorption is the maximum value of the water volume absorbed by the test area from the dry state, and once the maximum value is reached, no more water can be absorbed. If the absorbent material of the test area has absorbed enough water to reach saturation or has absorbed water (without reaching the saturated water absorption volume), if it then comes into contact with a real liquid sample, such as a urine sample, at that time, the test area cannot absorb more urine on the test area or absorbs part of the urine on the test area, which is equivalent to the pre-moistened water in the test area having a dilution effect on the urine, thus on the saturated water absorption volume, and the saturated water absorption on the test area.Test area 61 reduces the concentration of the analyte in the actual urine, resulting in false negative results or even no reaction with the analyte in the urine. Generally, urine is used to contact the test area instantly and must be left immediately, without allowing the test area to be immersed in the tested fluid sample for an extended period of time. The so-called instantaneous or short contact time is about 1 to 2 seconds, 1 to 10 seconds, and then the urine is allowed to leave the test area so that the chemical substance on the test area reacts with the possible analyte in the urine resting on the test area to produce a colored substance and rest on the test area. At this time, if there is a backup test area 63 that remains dry, this still allows the dry test area 63 to come into contact with the urine, thereby obtaining a true test result. In particular, when a test strip contains 5 to 10 or more test areas, it is not possible to give up, because a test area is moistened in advance, so that two or more identical test areas can be set up as a backup. Specific instructions will be given later in connection with the operation. Such a configuration not only meets the needs of professionals, but also those of inexperienced people who wish to conduct tests themselves at home.

[0045] Such a configuration further has another advantage, for example, as illustrated in [Fig. 7], the test areas 61 and 63, 62 and 64 of the same test analyte are arranged in sequence, so that, for example, the test areas 61 and 62 each test the same analyte (e.g., leukocytes (test area 61) and nitrous acid (test area 62)) as the test areas 63 and 64 each test (e.g., leukocytes (test area 63) and nitrous acid (test area 64)). During testing, it is actually desirable that the sample be removed immediately after contact with the test area, rather than allowing the test area to be uniformly immersed in the liquid sample.In fact, by having the same two test areas located at each end of the test strip, or 2 test areas with 2 other test areas located at each end of the test strip, when testing with the device of the present invention, it is ensured that the test strip is inserted into the chamber by the insertion mechanism and remains in the chamber without disengaging from the chamber, which 201 is used to receive the liquid sample (illustrated in [Fig.l] or [Fig.9]).If the liquid sample in the chamber is too large and exceeds the maximum mark (MAX), for example, the height of the liquid exceeds the position of the test area 64 on the test strip 60, so that during the test, the test area 64 will be immersed in the liquid all the time, so that due to the immersion in the liquid, even if a colored substance appears, the colored substance will be dissolved or dispersed in the urine, this prevents the colored substance from being deposited exactly on the test area 64.However, in the present invention, there is further an identical test area 62 located on the test strip 50, the test area 62 may be above the height of the liquid sample level, so that the liquid can be discharged immediately after the urine is contacted with the test area 62 or the urine can be discharged immediately after contacting the test area 62, so as to perform the analyte test on the test area 62. Therefore, for the test strip shown in [Fig.7], as long as the height of the urine is lower than the position of the test area 62, the test areas 61, 62 can still perform the intended analyte test. Thus, the use of a test strip as illustrated in [Fig. 7] is a test that can be performed regardless of the direction of insertion into the holder and into the lumen, if it is inserted into the lumen in the direction of the single arrow in [Fig.7] or in the direction of the 3 arrows opposite the direction of insertion into the holder. As illustrated in [Fig.8] further, a test strip with two test areas 71,72 provided on a non-hydrophilic backing sheet 70, the absorbent materials are located at one end of the test strip and when inserted into the holder and into the chamber 201 using the three arrows in opposite directions, the test area at one end, although accessible. to the liquid sample, has further been immersed for a long period of time, which would result in a false negative test result.

[0046] Further, the test strip itself is used to test the liquid sample in contact with the liquid in the chamber 201, to test for the presence of the analyte in the liquid sample. According to some preferred embodiments, the test element may further be provided on a card having a number of grooves in which the test element is located, and the entire test card may be inserted into the chamber 201, and the liquid sample in the chamber is then allowed to contact the plurality of test areas on the test strip to test for the presence of the analyte.Of course, the test cards with test strip may be placed in the chamber 201, and the collected liquid sample may then contact the plurality of test areas on the test strips as it enters the chamber 201, thereby completing the test for the analyte in the liquid sample.

[0047] For example, according to some embodiments, the chamber 201 may first collect the liquid sample, then test it using a test strip alone or a card or holder with a test strip inserted into the first chamber. According to a preferred embodiment of the present invention, the chamber 201 is used to receive or collect a liquid sample, then a holder 30 is inserted into the chamber 201, such as the holder 30, then put a test strip on the holder, allowing the liquid in the chamber 201 to contact a test area, such as a plurality of test areas, on the test strip, and allowing the test area to be used to test for the analyte in the liquid sample, and, after the test is completed, allow the test strip to remain in the chamber 201 and in the holder 30.In some embodiments, the holder 30 includes a groove for arranging the test strips of the present invention, such as the test strips 50, 60, 70 (see [Fig. 6] to 8). If there are multiple grooves, each recess may be equipped with a test strip, each test strip having multiple test areas.The groove is an open groove to allow liquid to enter the groove to contact the test areas on the test strips, rather than as a laminar layer, because the backing sheet that supports the test areas is non-hydrophilic, while the material on the test areas is water absorbent, so something like allowing the liquid samples to diffuse through all of the test strips is actually employing an action or manner of allowing the liquid disposed in the chamber 201 to actively move into the groove, thereby allowing the liquid samples to enter the groove. The liquid sample actively moves into the groove and diffuses through the groove so as to wet each test area and. to leave it quickly without the test area being immersed in the liquid sample for a long period of time. Analyte

[0048] The analytes of interest according to the present invention may include a number of small molecules, including drugs (e.g., drugs of abuse). "Drug abuse" (DOA) refers to the non-medical use of pharmaceuticals (which often act to numb the nerves). Drug abuse can lead to physical and mental impairments, dependence, addiction, and / or death.Drug abuse includes: cocaine; AMP amphetamines (e.g., Black Beauty, white amphetamine pills, dextroamphetamine, dextrophenylisopropylamine pills, Beans); MET methamphetamines (crank, methamphetamine, crystal, speed); BAR barbiturates (e.g., Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleep aids); lysergic acid diethylamide (LSD); depressants (downers, goofballs, barbs, blue devils, yellow jackets, ambien); tricyclic antidepressants (TCAs, i.e., promethazine, amitriptyline, and doxepin); dimethyldioxymethamphetamine (MDMA); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); and opiates (morphine MOP or opium, cocaine COC, heroin, hydroxydipyridone); Anxiolytics and sedative-hypnotics, Anxiolytics are a class of drugs primarily used to reduce anxiety, tension and fear, stabilize mood and also have a hypnotic and sedative effect, including benzodiazepines BZO (benzodiazepines), atypical BZ, fused diazepines NB23C, benzodiazepines, BZ receptor ligands, ring-opening BZ and dibenzomethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocycles, imidazole-type sedatives / analgesics (e.g. hydroxydiphenyldiazocorticosterone OXY, methadone MTD), propylene glycol derivatives - aminocarbamate esters, aliphatic compounds, anthracene derivatives, etc.The detection device of the present invention can further be used to detect tests for medical use but susceptible to overdose, such as tricyclic antidepressants (promethazine or analogs) and acetaminophen. These drugs are absorbed by the body and metabolized into small molecules which are present in body fluids such as blood, urine, saliva, sweat, etc. or in a portion of body fluids where said small molecules are present.

[0049] For example, analytes tested with the present invention include, but are not limited to, creatinine, bilirubin, nitrites, proteins (nonspecific), hormones (e.g., human chorionicity-promoting hormone, luteinizing hormone, follicle-stimulating hormone, etc.), blood, white blood cells, sugars, heavy metals or toxins, bacterial substances (e.g., proteins or saccharides directed toward specific bacteria such as, for example, Escherichia coli 0157:H7, Staphylococcus sp. Salmonella, Clostridium, Campylobacter, L. monocytogenes, Vibrio or Cactobacillus) and substances in the urine sample related to physiological characteristics such as pH and specific gravity. Any other clinical urine chemistry can be detected using a lateral cross-flow assay format in conjunction with the device of the present invention. Any analyte can be detected using a suitable sensing element or test element of the present invention. Preferably, the present invention is used to detect small molecule drugs in saliva and urine.Preferably, it is possible to detect small molecules such as viruses and bacteria in saliva, throat or nasal fluids. In addition, it may include white blood cells, red blood cells, urinary cholagen, urinary vitamin C, urinary crystals, urine specific gravity, urinary albumin, urinary ketones, urinary colony count, urinary pH, nitrite in fluid samples. Examples include the levels of white blood cells, erythrocytes, urobilinogen, urinary vitamin C, urinary crystals, urine specific gravity, urinary albumin, urinary ketones, urinary colony count, urinary pH and nitrous acid in a urine sample.

[0050] The method for testing analytes in urine can be immunological or chemical. The chemical method involves treating the absorbent material with chemicals. When urine contains specific analytes, up to a certain content, a chemical reaction occurs in the absorbent material, with the production of colored substances, the colored substances give color to the absorbent material, by comparing it with the standard colorimetric card, you can know whether the analytes present in the urine sample or the approximate content of presence, generally the stronger the color, the stronger the color, the stronger the color, the stronger the color. The stronger the color, the higher the level of the analyte. For example, nitrite diazotizes with the aromatic amine sulfanilamide to form a diazonium compound.This diazonium compound in turn couples with l,2,3,4-tetrahydro-benzo(h)quinolin-3-phenol to produce a pink color at the test area.

[0051] Granulocyte leukocytes present in urine contain esterases that catalyze the hydrolysis of the privatized amino acid pyrrole ester to release 3-hydroxy-5-phenyl pyrrole. This pyrrole then reacts with a diazonium salt to form a purple color. Detection device

[0052] Detection device means a device used to detect the presence or absence of an analyte in a sample. Collection device: A device for collecting and storing liquid samples. The detection device may include a collection device, the collection device may include a detection device, or the collection device may be separate from the detection device, and the collection device and the detection device may be combined at the time of detection to complete the detection. The collection device and the detection device may further be made of a single piece, so that once the liquid sample is collected, testing can be performed immediately to obtain a result, and separation of the test sample from the collected sample is performed so that a secondary test can be performed (if desired).The terms "detection device" or "test chamber" are interchangeable herein, and the terms "collection device" and "collection chamber" are further interchangeable, only the functions are interchanged by playing different roles. For example, when the present invention speaks of a collection device, it may not include a test chamber or a first chamber, but the collection device may include a test element or a holder containing a test element, and a collection device containing a test element may further be referred to as a detection device, e.g., a first chamber containing a test element. Of course, the collection device may include a space for the test element, but it does not necessarily have to contain the test element, which may be combined with the collection device at any suitable time thereafter to form a detection device.For example, the collection device may include a space for the test element, such as containing a test chamber, or have a suitable location for the test element or the holder containing the test element in the liquid collection chamber of the collection device. Collection chamber of the detection device.

[0053] The present detection device comprises a liquid sample collection chamber, a cover body 101 and a holder for carrying a test strip. In some embodiments, the collection chamber refers to a liquid sample receiving chamber used to receive a sample, such as a urine sample, as illustrated in [Fig. 2]. Collection can be performed either by the person letting the liquid sample enter the chamber 201 directly, or by means of another tool, such as a pipette gun or other container, so that such a sample can be collected in the chamber 201. The chamber has a bottom 205 and a chamber 201 surrounded by a side wall 216 attached to the bottom, which is transparent. In some embodiments, the chamber has an opening 204 for receiving the liquid sample. In some embodiments embodiment, the opening of the chamber 201 has an outer edge 203 with threads 2015, and the chamber 201 is divided into two parts, a part of the outer edge 203 of the opening 204, and a body 217 of the chamber 201, in which the diameter of the outer edge 203 is larger than the diameter of the body 217, so that the reception of the liquid sample is facilitated by the large outer edge with the opening 204, and the small chamber 217 is intended to store the liquid, so that a connection part 202 between the small chamber 217 and the large outer edge 203, similar to a flared mouth. This has the advantage of allowing the subject to urinate directly into the chamber 201, through the large outer edge provided with an opening.In some embodiments, the outer edge of the chamber 201 has a wrap-around label 210 near the bottom, which primarily serves to record information about the tester, such as the time the sample was taken, the tester's name or number. In some embodiments, the label further has a line indicating the minimum liquid height and a line indicating the maximum liquid height; a minimum liquid height (MIN) mark 209 (arrow) and a maximum liquid height (MAX) mark (arrow) 208, respectively, indicate the maximum liquid height and the minimum liquid height required in the chamber 201, which actually appears to be the liquid volume.This is a marking indicating the maximum volume of the liquid sample relative to the minimum volume of liquid, but in some cases, if the value tester performs the test himself, by urinating directly into the chamber 201, the maximum liquid height mark is often exceeded, adjustments to the test area of ​​the test strip (for example, using the test strip design of [Fig. 7]), can avoid a number of potential problems, and the test strip can be placed. The explanation is again illustrated later in connection with specific examples. In some embodiments, the label does not surround the entire bottom of the chamber, but reserves a window 207, which is not covered by the label, and the height of the liquid sample or the state of the liquid sample can be observed through the transparent window 207, which will be explained in detail later.Typically, the labels are simply opaque, so that while the chamber body 217 is entirely transparent, the label 210 at the bottom actually makes part of the chamber opaque.

[0054] According to some embodiments, if a color change is made on the test area, it is necessary to compare the color with a standard colorimetric card to determine the test result, which seems unorthodox, and it is necessary to approach the entire chamber 201 to the colorimetric card, which does not seem very practical, thus, according to some embodiments, the standard color block is printed directly on the transparent averages of the chamber 201, which can be printed directly, and in another way. One of them is to print the standard color block on the surface of the sticker, and the color is affixed to the side wall of the chamber and near the holder 30, so that after the test area of ​​the holder 30 is tested, the color can be directly compared with the standard color card located next to it to determine whether the test result is negative or positive. If the standard color card is attached to the surface of the chamber 201, as shown in [Fig. 2], some means are used so that the different chambers, the holders are all located in the same or practically the same position in the chamber 201, so that it is more convenient to carry out the evaluation of the results.

[0055] Cover body and support containing the cover body

[0056] According to some specific embodiments of the present invention, the detection device further comprises a cover body 10, which is for sealing the opening 204 of the chamber 201, by providing a thread 103 on the cover body, the thread 103 being engaged with a thread 2015 on the outer edge of the opening 204 of the chamber, thereby sealing the chamber. According to some embodiments, a holder 30 for carrying a test strip is further included, the holder being provided with a groove 301, the groove 301 serving to carry a test strip (e.g., a test strip as illustrated in [Fig.6] to 8), where the conveyance includes allowing the test strip to rest on the groove and remain there, and another role is for the test strip to be inserted into the chamber from one end of the holder as a guide, and yet another role is to allow liquid to enter the chamber and contact the test area of ​​the test, and yet another role is to allow the test strip to remain in the chamber without slipping when the liquid leaves it.According to some embodiments, the holder and the cover are in one piece, the holder 30 has two ends, one end 305 and the other end 308 has a groove 301 in the middle, the groove has a bottom surface 309 and the two sides 310, 311 surrounded, and the other end 308 is directly connected to the cover, here the groove 301 is actually in the form of an open mouth, not a pipeline, to facilitate in the subsequent test, let the liquid sample quickly into the test area, and let the liquid sample quickly into the test area. An opening 105 is provided in the cap body, and the other end 308 of the chamber is directly connected to the opening 105 in the cap body, i.e., when the test strip is inserted through the opening 105 in the cap body, the test strip actually enters the chamber and extends to the front.In this way, the test strip can be inserted into the chamber 201 through the hole 105 of the cover body, and the groove can serve as a specific position for guiding the test strip to . insert into the chamber, that is, when the test strip is inserted into the chamber 201 through the port 105 to contact urine, it can only be inserted into the chamber in the direction of the groove and cannot be inserted in any other position, and the groove actually serves as a specific limiting position of the test strip in the chamber 201. According to some embodiments, a cover piece 303 is provided at one end of the chamber near the cover body, which cover piece 302 is above a section of the chamber above the opening of the chamber, forming a pipe structure 302, when the test strip is inserted into the chamber through the pipe structure, so that the test strip is not easy to detach from the chamber in a subsequent operation.According to some practical operations, in some cases, the test strip comprises a non-hydrophilic backing sheet, and one or more absorbent test areas are provided on the backing sheet, and when the test strip is inserted into the chamber 201 through the holes 105 in the cover body, at this time, the chamber 201 has a liquid sample, and at the time of insertion, it is not desirable for the test areas on the test strip to contact the liquid sample, so it is desirable for the test areas to remain in a dry state, when the test strip is inserted, the liquid sample is not absorbed.Once inserted, the liquid sample contained in the chamber 201 may be brought into contact with the test area by tilting, shaking the chamber 201, or otherwise shaking it, so that the test area absorbs the liquid sample and, once in contact, for example for 1 to 10 seconds, allowing the remainder of the liquid sample to leave the test area, and similarly, by immersing the test area in the liquid sample for a very short time, for example for 1 to 10 seconds, with the test area immersed in the liquid sample. The test area is then allowed to move away from the liquid sample and the chemical reagents on the test area are allowed to react with the analyte in the liquid sample and produce a colored substance which is deposited on the test area.When tilting, shaking or swinging the chamber, the liquid will have a certain impact on the groove 30, and it is desirable that the test strip remains in the groove without detaching therefrom, so the structure 304 of the tube serves to prevent the detachment from floating in the liquid or immersing the entire liquid sample by detaching from the groove 30 during operation, or it is undesirable that some test areas on the test strip remain immersed in the liquid sample, especially if the test strip remains immersed in the liquid sample, or if the test strip remains immersed in the liquid sample, especially if the test strip contains a relatively large number of test areas. In this case, the role of the limiting tube. 302 becomes more important. In some cases, especially when the length of some test strips is less than the total length of the groove or when the length of the test strip is the same as the length of the groove, the structure of the pipe 302 that limits the detachment of the groove is particularly useful for preventing the strip from falling off the groove and ensuring that some test areas are immersed in the liquid for a long time, especially when the liquid is actively in contact with the test area of ​​the test strip during a specific operation. Most of the test areas are immersed in the liquid sample.In some embodiments, most of the grooves are uncovered and are in the form of an open mouth, intended to expose the test area of ​​the test strip and to facilitate observation of color changes or color shades on the test area through the partially transparent avoidance of the chamber 201, in order to evaluate the results of the test.

[0057] According to some embodiments, the bottom 305 of the chamber may further be provided with numerous small orifices 306, the function of the small orifices being that, when the chamber 201 is shaken, rocked, or tilted, liquid may be allowed to quickly enter the chamber and contact the test area on the test strip in the chamber, and liquid samples may flow through the small orifices into the chamber, so that the liquid samples may contact the test area as much as possible and in a short period of time. Of course, when liquid is desired to leave the groove, the orifices allow the liquid in the groove to flow quickly, thereby maintaining the test area in a relatively independent position.The main function is that the test area is composed of an absorbent material on which the chemical reagents necessary to react with the analyte are treated. These chemical reagents come into contact with the analyte in the liquid sample and, if the analyte is present, react, directly or indirectly, to produce a substance with a color, which is retained by the test area.If the test area is immersed in the liquid sample for a long time, the colored substances will be dissolved or diffused in the liquid sample, which will cause the color of the test area to be reduced, and thus the concentration to be decreased, and the color will not be obvious, which may cause a false negative result, and the colored substances diffused in the urine may be adsorbed or absorbed by another test area, and then will have color in the other test area, which may cause a false positive result. In summary, it is important not to leave the test area immersed in the liquid sample for a long time and . to try to leave the liquid sample as soon as possible after brief contact with the test area.

[0058] According to some embodiments, allowing the liquid to shake or tilt the chamber 201 is to allow the liquid sample to actively contact the test area of ​​the test strip while the latter remains in a relatively fixed position, and how to know that the liquid has contacted the test area, one way to know is the observation and judgment by the naked eye of the operator, by shaking or tilting the chamber in the hand when used to be held in the hand, through a partially transparent shield 217 of the chamber 201 to prevent the liquid from contacting the test area. In the event of contact, the chamber is placed in an upright position by the action of the hand, which allows the liquid to leave the test area.According to some embodiments, in order to more easily observe the structure of the test area, for example, when the sample is located at the lowest height 209, if there are more sample test areas on the test area, and there are individual test areas (e.g., the dotted test area 55 in [Fig. 2], located between the lowest sample height and the largest sample height) that are covered by the labels on the chamber, at that time, it is desirable that each time the holder remains in a chamber, the position is fixed, e.g., the position of the chamber is the same as that of the test area. For example, when resting in the fixed position shown in [Fig. 2], the holder rests in the area defined by the window 207 so that the test results can be observed for all the test areas.If the carrier 30 is allowed to remain in a fixed area each time, a standard color card may further be provided near the area to facilitate interpretation of the test results, for example, as shown in [Fig.2], a standard color block 5.6 is provided near the area to facilitate interpretation of the test results.In order to find a solution that allows the holder 30 to be in a fixed position in the chamber during the testing of different detection devices (for different individual liquid samples), one of the options is a piston-shaped seal between the cover and the chamber opening, for example, by providing a protrusion on the inside 102 of the cover body, which is similar to a piston, inserted directly into the chamber opening or snapped onto the opening, so that it is possible to track the position, each time, to have the holder 30 to be located in a fixed position. Another option is to design the threads of the cover body according to the threads of the chamber 201.This can be achieved by designing the start of the threads of the cover body with the start of the threads of the chamber, in the present invention, the threads of the chamber body have a thread turn where the start point 2021 and the end point 2020 are located in . the same longitudinal position, and the cover body 10 is further substantially corresponding to the turn of the threads 103, where the starting point (not shown) and the ending point 1031 are in line with the openings of the chamber, so that regardless of the position of the cover body from which it is engaged with the chamber, the final place where the threads of the chamber are exhausted is the same, so that the cover body cannot rotate after the threads of the cover body and the chamber are exhausted, and the cover body and the chamber are in the same position, the final position where the threads of the chamber are exhausted is the same, so that the cover body cannot rotate after the threads of the cover body and the chamber are exhausted, and the cover body and the chamber are in an identical position,and here is a combination of several test devices where the positions where the lid body seals the chamber stays are in the same, or substantially the same, position on each detection device, i.e., the positions of the threads 2015 of the outer edge 203 of the chamber opening 207 in [Fig.2] the starting position 2021 with 2020, where the cap body stays because the threads are exhausted and cannot rotate. In this way, the holder remains in substantially the same position in the chamber 201 for the different test devices, for example, all stay on the transparent area where the window area 207 is located. In this way, the problem of being able to easily observe all the test areas of the test strip in their entirety, while avoiding that part of the test area is masked by the label and the fixed setting of a standard color card, is further solved. ,

[0059] In the conventional product, while the thread 103 of the cover body 10 cooperates with the thread 2015 of the chamber 201 to seal the opening 204 by rotating the thread of the cover body and the chamber, the rotation of the cover body 10 simultaneously drives the rotation of the support 30, and when the thread is exhausted, the support is immobilized when the cover body can no longer be rotated. In practice, the starting position of the threads of the cover body engaging the threads of the chamber 201 is arbitrary, so that the position of the cover body resting on the chamber is arbitrary, and the position of the support 30 relative to its position inside the chamber is further arbitrary.Thus, at one point, the test strip is inserted into the groove of the holder, a portion of the test strip is masked by the label 210 at the bottom of the chamber (when there are a relatively large number of test areas), and at one point, the holder is in the area of ​​the window 207 reserved for the label, so that most of the chamber, and of course, most of the test strip, can be observed through the entire window area, and in fact, one or more test areas on the test strip can be observed. One or more areas . test strip, so that when the chamber is tilted, it is possible to observe through the entire transparent part whether any liquid has touched each test area, then stand up again and wait for the reaction as well as observe the test results on the test strip. This is the randomness of the actual wires, as well as the traditional way of designing, and if it is covered by the labels, the color change of the test area cannot be observed effectively.

[0060] The third embodiment is to provide an integral protruding structure along the opening of the chamber, which protruding structure can prevent the movement of the cover body, and the adjustment method is as follows: when the cover body rotates for a few weeks, once the cover body encounters the protrusion that blocks the cover body, the cover body can no longer be rotated, and the cover body remains in the same position, and the support body 30 remains in the same position, and the adjustment method can be mentioned in Patent Publication No. US7300633B2, for example, in this document, the element marked 112 has a similar role, in this US patent is considered as the blocking that allows the cover body to seal the chamber, while the present invention adopts such a structure, which is the role of allowing the cover body to be specifically positioned.Therefore, the cover body 10 driving the holder 30 can further be rotated in the area of ​​the window 207 where the cover body is blocked by the protruding structure and can no longer be rotated. At the time of testing, by directly tilting the liquid, it is possible to observe through the transparent area 207 whether the liquid sample is in contact with the test areas 51-54, but also to determine whether each of them is in contact with the liquid sample, and by a brief contact, for example for 1 to 10 seconds, the chambers are immediately allowed to rise, when the height lines of the liquids are all located below the test area 54 which is closest to the liquid on the test. At this point, a reaction is expected in the area, and when the reaction is complete, the color of the tested area is compared with a standard color card, and the result is interpreted as a positive or negative result.

[0061] According to some embodiments, regardless of the position of the holder 30 in the chamber 201, it can be simply operated so that the liquid can lift each test area on the test strip, making the operation more convenient. In this case, it does not matter where the holder 30 rests, as long as the test strip is located in the recesses of the holder in the chamber 201. To achieve this, a marking should be established that indicates an inclination in the direction of the shortest distance from the line connecting the holes 105 of the cover body, which will allow the liquid to contact all the test areas of the test strip. According to one embodiment, a sealing plug is further provided, this sealing plug 43 sealing the port 105 in the cover body 10, sealing to the effect that when the chamber 201 is tilted, the liquid does not flow out through the port 105. Furthermore, if the test strip is long and a part of the test strip is in the port 105, the sealing plug 43 can hold the test strip in place while sealing the port 105. According to one embodiment, the sealing plug 43 is provided with a sealing cover 40 which has a sealing head 41, the cover sealing head having a direction indicating role which can be shortest in line with the markings 106 on the cover body (the position of the sealing head is essentially the position of the bore 105 of the cover body).According to another embodiment, the cover body 10 includes an indication mark 106 that indicates a direction that is in line with the direction of the opening of the groove of the holder 30, both toward the transparent avoidance of the chamber 201, as illustrated where the two arrows are in the dotted line of [Fig. 4]. The indication mark is located near the hole 105, and on the cover body, a position mark that is at the shortest possible distance from the hole, and the mark 106 corresponds to the holder below, and the indication mark 106 is present to indicate the direction of the opening of the groove of the holder. When the sealing plug 43 closes the hole 105, the sealing head 41 of the sealing plug is aligned with the marking 106 on the plug body, and the sealing head 41 further serves to indicate the direction in which the chamber is to be tilted.The "tilt direction" defined in the present invention is when the cover 10 is placed over the opening of the chamber 201, generally, the test area 71, 72 on the test strip is not in contact with the liquid sample 908 inside the chamber, the chamber 201 contains the liquid sample 908, and the chamber is in an upright position (as shown in [Fig. 1 1 A]). The chamber 201 is tilted so that the liquid flows from the bottom 205 of the chamber to the top of the cover body or to the opening of the chamber (as shown in [Fig.l IB]), so that the liquid sample 908 is dispensed laterally into the chamber 201, and it is hoped that the laterally dispensed liquid sample contacts the test strips on the laterally dispensed holder (after tilting, the holder 30 tilts, and the test strips on it tilt with it), in particular to contact the test strips on the test area. Immediately after a determined period of contact, leave the chamber upright again and return to the position shown in [Fig.l 1 A]. In this way, the sealing head 41 performs the indication in a direction which is in a substantial plane with the holder. Alternatively, there are further several marks 42 on the sealing head which are aligned with the marks 106 on the body of the cap. In a specific operation, the liquid sample is first allowed to accumulate in the chamber 201, and then the threads of the cover body 10 are allowed to seal against the threads of the opening of the chamber 201 with an engaging fit, at which time regardless of the position of the holder 30, at which time the test strip is inserted through the opening 105 into the chamber 201 at which time the liquid sample, if within the range of the maximum height, only the non-hydrophilic supporting part of the test strip can be in contact with the liquid, and the test strip is not in contact with the liquid, and the test strip is not in contact with the liquid. The opening 105 is then sealed with a plug 43, the sealing head 41 or the marking 42 then being aligned with the marking 106 on the body of the plug.When it is necessary to operate, the chamber is directly tilted so that the place 106 with the marking is tilted downward, for example, so that the place with the marking is tilted on the table 90, at this time, the liquid sample 908 which is located at the bottom of the chamber 201 will be gathered inside the corresponding chamber with the marking 106, at this time, the liquid will touch the test strip and the test area on the test hop, or, at this time the entire test strip is immersed in the liquid (as shown in [Fig. 10]). For example, tilt the chamber in this way for 1 to 10 seconds, and then let it stand (return to the position shown in [Fig. 9]). At this time, the test strip is still in the groove and the test results on the test area can be read through the transparent side walls of the chamber.By means of the marking, regardless of the position of the holder 30, that is, regardless of the vertical position of the test strip in the chamber 201, the test strip on the holder can be immersed in a liquid sample by tilting it toward the marking 106, the sealing head 41, the marking 42 on the plunger head, and the shortest line connecting the points of the plunger ports, making the operation more convenient, regardless of the position of the cap body, the position of the holder, the position of the plunger head, the position of the holder, or the specific position of the test strips and the like in the chamber, the test can be completed, after all, the holder 30 is fixedly attached to the cover body, and the test strips are inserted into the grooves of the holder through the ports 105 and are held in the grooves.

[0062] Conversely, without this mark, if in a direction opposite to the position of the support, or if the mark is not inclined in the direction of the shortest position from the hole 105, but rather in the direction of the other positions, the liquid sample, although all distributed laterally, may not come into contact with the support, and does not enter, for example, in the direction of the position 109 as contrasted in [Fig. 4], in the direction indicated by the direction indicated by the direction indicated by the direction indicated by the direction indicated by the direction indicated by the direction 1091, or 1092. The most extreme direction would be an inclination in the direction indicated by the distance 109 furthest from the orifice so that the liquid would not come into contact with the holder (as shown in [Fig. llC]), much less with the test strip on the holder, and, of course, would not come into contact with the test area on the test strip, and therefore could not complete the test.

[0063] According to some embodiments, as illustrated in [Fig. 9], two sets of test areas for testing the same analyte are provided on the test strip 60, with one set of areas 61, 62 located at one end of the test strip, and the other set of areas 63, 64 located at the other end, and the test can be performed regardless of the section of the test strip inserted into the opening 105 of the cover body and located in the groove of the holder, for example, as illustrated in [Fig. 9], 64 is located in the liquid, and the test areas 61, 62, 63 are located at a height 2081 from the liquid, without contacting the liquid sample. If a test strip such as that of [Fig.8], and if it is inserted in the opposite direction, so that the direction with the three arrows is inserted into the air, the test area 71 of the test areas 71,72 located near the arrows may remain in the liquid sample without completing the test. DETAILED PRESENTATION OF THE IMPLEMENTATION METHOD

[0064] As illustrated in [Fig.l] to 6, 8, the present invention provides a detection device comprising a chamber 201 for receiving a liquid sample, the bottom of the chamber having a label 210 covering a portion with an indicator line on the label for a maximum 208 and minimum 209 liquid height. There is further a cover body 10 with a holder 30 with a groove, which is provided to allow the test strip 70 to rest in the groove 301 of the holder, and which comprises an orifice 105 in the cover body, said test strip can be inserted into said groove of the holder through the orifice 105. Furthermore, the groove of the holder has a tubular structure 302 near the cover body, and a portion of the test strip is arranged in the tubular structure, thereby fixing the test strip in the chamber without it falling.In some embodiments, said groove includes one or more orifices 306 on the lower surface 305, which are provided to allow liquid to pass through the orifice and into the groove to contact the test strip, in particular the test area on the test strip. In some embodiments, this holder is located on the edge 110 of the lid body and a mark 106 is provided at the shortest distance from the orifices, with an arrow pointing in the direction in which the chamber can be tilted when in use (see [Fig. 4]). A test strip 70 is provided, as shown in [Fig. 8]. This is a . non-absorbent plastic 74 serving as a backing sheet with two test areas 71,72, a test area for testing urine samples for leukocytes 71, and an area for determining nitrite 72, located at one end of the test strip, and with three arrows 73 on the test strip indicating the direction in which it should be inserted into the holes 105 in the cover body.

[0065] In operation, the chamber 201 is first used to collect a liquid, for example to collect a urine sample, etc., the urine volume to be greater than the minimum height 209, which may be located below the maximum liquid height mark 208, then the chamber is left at rest, at which time the chamber is covered with a lid 10, which is allowed to seal the chamber after the lid has sealed the chamber by means of the threaded toothing, the sealing plug 40 is removed from the port 105, then the test strip 70 is inserted into the port 105 by relying on the direction indicated by the arrows 73, so as to allow the test strip 70 to pass through the tube 302 on the holder and be located in the groove 305. At this time, the test strip is arrowed near the port 105 in the body of the cap, and the test area 71,72 is located in the groove under the tube.A sealing plug is then placed in the port 105. The chamber is then tilted in the direction indicated by the marks 106 on the cover body, as shown in [Fig. 10], and placed on the test bench for 5 seconds, and then the wearer allows the chamber to stand. The change in color of the test areas 71 and 72 is observed, and a color comparison is made with the standard color card provided, and if there is a change in color, the test structure is judged on the basis of the color of the standard color card, and if there is no change in color in the test area, this indicates a negative result, and if there is a change in color, which is the same as that printed on the standard positive, the test result is a positive result. The results are judged valid if read within three minutes, and invalid if read for more than three minutes.

[0066] The following embodiments are further part of the present invention.

[0067] A device for detecting an analyte in a liquid sample, comprising:

[0068] a chamber for receiving a liquid sample, said chamber comprising an opening and a transparent side wall surrounding the chamber;

[0069] a cover body, said cover body being intended to seal the opening of the chamber;

[0070] a holder with a groove, said holder being adapted to receive and retain a test strip, wherein said holder has a tubular structure which allows the test strip to be stably retained in the groove without leaving said groove when the holder is retained in the groove:

[0071] a test strip, said test strip comprising one or more test areas which are used to test for the presence or content of an analyte in a liquid sample.

[0072] According to certain embodiments, said tubular structure comprises a cover piece which covers the partial groove.

[0073] According to some embodiments, said groove is surrounded by a bottom surface and two side surfaces, said groove has an opening, said opening faces a side wall of the collection chamber, said cover piece covers the opening of the partial groove.

[0074] According to some embodiments, the lid body includes an orifice that is in communication with the holder, such that a test strip can be inserted through the orifice into the groove of the holder, wherein, during insertion, the test strip passes through the tubular structure.

[0075] According to some embodiments, the lid body is provided with a mark, the connection between the mark and the hole is the shortest distance, wherein the mark is provided to indicate the direction of inclination when a test is performed, thereby allowing the liquid sample to contact a test area of ​​the test strip disposed in the groove.

[0076] In some embodiments, the orifice is provided to indicate the direction of tilt when a test is performed, thereby allowing the liquid sample to contact the test area of ​​the test strip disposed in the groove.

[0077] According to some embodiments, said groove comprises one or more orifices which are provided to allow liquid to pass through and into the groove to contact the test area on the test strip.

[0078] According to certain embodiments, said support is fixedly connected to the cover body.

[0079] According to certain embodiments, said tubular structure is close to the cover body.

[0080] In certain cases, said support is opaque.

[0081] According to some embodiments, the bottom of said chamber is covered with an opaque labeling paper bearing a minimum height mark for the lowest liquid sample volume and a maximum height mark for the highest liquid sample volume.

[0082] According to some embodiments, said test area on said test strip comprises a chemical substance that is capable of reacting directly or indirectly with the analyte in the liquid sample and producing a colored substance.

[0083] According to some embodiments, said test strip is provided with two identical test areas which contain the same chemical substance and detect the same analyte, wherein said two test areas are disposed at two ends of the test strip.

[0084] According to some embodiments, said liquid sample is urine, said test strip comprises a non-hydrophilic backing sheet, and said test area is disposed on the backing sheet, and wherein said test area is comprised of a water-absorbent material.

[0085] A method for detecting an analyte in a liquid sample, comprising: providing a detection device comprising: a chamber for receiving a liquid sample, said chamber comprising an opening and a transparent side wall surrounding the chamber; a cover body, said cover body being for sealing the opening of the chamber; a holder with a groove provided in the chamber, said holder being provided for receiving and retaining a test strip, wherein said holder has a tubular structure that allows the test strip to be stably retained in the groove without leaving said groove when the holder is retained in the groove;and a test strip which is used for testing an analyte in a liquid sample, wherein said test strip comprises a non-hydrophilic backing sheet, and said test area is provided on the backing sheet, and wherein said test area is composed of a water-absorbent material; ;

[0086] firstly arranging the test strip in the groove of the holder, and keeping a part of the test strip in the tubular structure, the test area then not coming into contact with the liquid sample, then, letting the liquid sample come into contact with the test area for a certain time, finally, taking out the liquid sample from the test area.

[0087] According to some embodiments, the method further comprises: inserting the test strip into the groove of the holder, and the test strip passing through the tubular structure during insertion.

[0088] According to some embodiments, the method further comprises: fixedly connecting the cover body to the holder, the cover body being provided with an orifice, and during testing, the test strip passing through the orifice and being in the groove of the holder.

[0089] In some embodiments, the manner of allowing the liquid sample to contact the test area on the test strip is to allow the chamber to be tilted in the direction indicated by the orifice in the lid body, thereby allowing the liquid sample to contact the test area for 1 to 20 seconds.

[0090] According to some embodiments, the method further comprises: after allowing the liquid sample to contact the test area, again leaving the chamber upright, thereby allowing the liquid sample to leave the test area.

[0091] According to some embodiments, the method further comprises: upon inserting the test strip into the groove of the holder, holding the test area of ​​the test strip close to the hole in the lid body.

[0092] All patents and publications mentioned in the description of the present invention indicate that they are prior art in the field and that the present invention can utilize. All patents and publications cited in the present invention are further listed in the references, as if each publication were specifically cited by reference. The present invention may be practiced in the absence of an element or combination of elements, a limitation or combination of limitations, and the limitations are not specifically stated. For example, in each embodiment, one of the terms "comprise", "consisting essentially of..." and "consisting of..." may be substituted for the other two. The terms and expressions used herein are descriptive and not limiting.Furthermore, nothing indicates that these terms and explanations described herein exclude any equivalent feature, however, it is known that all appropriate changes or modifications may be included within the scope of the present invention. It is understood that, the embodiments described in the present invention are those of preference and characteristics, and those skilled in the art may make modifications and variations without departing from the scope of the present invention.

Claims

Claims

1. A device for detecting an analyte in a liquid sample, comprising: a chamber (201) for receiving a liquid sample, said chamber (201) comprising an opening (204) and a transparent side wall (216) surrounding the chamber (201); a cover body (101), said cover body (101) being for sealing the opening (204) of the chamber (201); a holder (30) with a groove (301), said holder (30) being provided for receiving and retaining a test strip (60), wherein said holder (30) has a tubular structure (302) which allows the test strip (60) to be stably retained in the groove (301) without leaving said groove (301) when the holder (30) is retained in the groove (301);and a test strip (60), said test strip (60) comprising one or more test areas (61, 62, 63) which are used to test the presence or content of an analyte in a liquid sample.;

2. Device according to claim 1, wherein said tubular structure (302) comprises a cover piece (303), the cover piece (303) covers the partial groove (301).

3. Device according to claim 2, wherein said groove (301) is surrounded by a bottom surface (305) and two side surfaces (310, 311), said groove has an opening, said opening faces a side wall of the collection chamber, said cover piece (303) covers the opening of the partial groove.

4. A device according to claim 2, wherein the cover body (101) comprises an orifice (105), the orifice (105) is in communication with the holder (30), so that a test strip (50) can be inserted through the orifice (105) into the groove (301) of the holder (30), wherein, during insertion, the test strip passes through the tubular structure (302).

5. A device according to claim 4, wherein the cover body is provided with a mark (106), the connection between the mark (106) and the hole (105) is the shortest distance, wherein the mark (106) is provided to indicate the direction of inclination when a test is carried out, thereby allowing the liquid sample (908) to contact a test area (71, 72) of the test strip disposed in the groove (301).

6. A device according to claim 4, wherein the orifice (105) is provided to indicate the direction of inclination when a test is performed, thereby allowing the liquid sample (908) to contact the test area (71, 72) of the test strip (70) disposed in the groove (301).

7. The device of claim 1, wherein said groove (301) comprises one or more orifices (306) which are provided to allow liquid to pass through and into the groove to contact the test area on the test strip.

8. Device according to claim 6, wherein said support (30) is fixedly connected to the cover body (101).

9. A detection device according to claim 1, wherein said support (30) is opaque.

10. The device of claim 1, wherein the bottom of said chamber is covered with opaque labeling paper (210) bearing a minimum height mark (208) for the lowest liquid sample volume and a maximum height mark (209) for the highest liquid sample volume.

11. The device of claim 1, wherein said test area (61, 62, 63, 64) on said test strip (60) comprises a chemical substance which is capable of reacting directly or indirectly with the analyte in the liquid sample and producing a colored substance.

12. A device according to claim 1, wherein said test strip (60) is provided with two identical test areas (61, 63) which contain the same chemical substance and detect the same analyte, wherein said two test areas (61, 63) are arranged at two ends of the test strip.

13. The device of claim 1, wherein said liquid sample is urine, said test strip (73) comprises a non-hydrophilic backing sheet (70), and said test area (71, 72) is disposed on the backing sheet, and wherein said test area is composed of a water-absorbent material.

14. A method of detecting an analyte in a liquid sample, comprising: providing a detection device comprising: a chamber (201) for receiving a liquid sample, said chamber comprising an opening (204) and a transparent side wall (216) surrounding the chamber; a cover body (101), said cover body (101) being for sealing the opening (204) of the chamber; and a test strip (73) which is used for testing an analyte in a liquid sample, wherein said test strip comprises a non-hydrophilic backing sheet (70), and said test area (71, 72) is provided on the backing sheet, and wherein said test area is composed of a water-absorbent material;first placing the test strip (73) in the chamber (201), the test area then not coming into contact with the liquid sample, then, allowing the liquid sample (908) to come into contact with the test area (71, 72) for a certain time, finally, taking out the liquid sample from the test area.;

15. The method of claim 14, wherein the manner of allowing the liquid (908) to contact the test area (71, 72) comprises tilting the chamber (201) in the direction of the test strip or inverting the chamber.

16. The method of claim 15, wherein a holder (30) with a groove (301) is provided in the chamber, said holder being provided for receiving and retaining a test strip, wherein said holder (30) has a tubular structure (302), the tubular structure (302) allows the test strip to be stably retained in the groove without leaving said groove when the holder is retained in the groove (301).

17. The method of claim 16, further comprising: inserting the test strip (73) into the groove (301) of the holder (30), and the test strip passing through the tubular structure (302) during insertion.

18. The method of claim 17, further comprising: fixedly connecting the cover body (101) to the holder (30), the cover body (101) being provided with an orifice (105), and during testing, the test strip (73) passing through the orifice and being in the groove of the holder.

19. The method of claim 18, wherein the manner of allowing the liquid sample to contact the test area on the test strip is to allow the chamber (201)

20.

21. to be tilted in the direction indicated by the orifice (105) in the cover body, thereby allowing the liquid sample to contact the test area (71, 72) for 1 to 20 seconds. The method of claim 15, further comprising: after allowing the liquid sample to contact the test area, again leaving the chamber upright, thereby allowing the liquid sample to leave the test area. The method of claim 15, further comprising: when inserting the test strip (73) into the groove of the holder, holding the test area of ​​the test strip close to the hole in the lid body.

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