Device for detecting an analyte in a liquid sample

Abstract

The present invention relates to a device for detecting an analyte in a liquid sample, which comprises: a sample chamber for receiving a liquid sample, the sample chamber comprising an opening and a side wall surrounding a chamber body; a test chamber, the test chamber being in fluid communication with the sample chamber, wherein the test chamber has an opening, the opening is arranged to allow a test element to be inserted into the test chamber through the opening, the test element having a test area; a first cover body, the first cover body serving to seal the opening of the test chamber. Such a device allows testing the analyte in the liquid sample, which is particularly suitable for self-testing at home. Abstract Figure: 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 detection device used to test the content or presence of an analyte in a liquid sample, when a test is required, by allowing the test element to be inserted into the test chamber to test the assay.

[0006] In some embodiments, the test element of the present invention comprises a test area and a support of non-absorbent rows, said test area being placed on the support. In some embodiments, this test area comprises absorbent supports that are pretreated with reagents, for example, chemical substances, immunological reagents, etc. In some embodiments, the test area can only be wetted by direct contact with the liquid sample and cannot rely on the support to absorb the liquid. The support is not hygroscopic, so that even if the support is in contact with the liquid, the test area can remain dry if it is not in contact with the liquid.In some embodiments, when a test is required, the test is set up, placed, or inserted into the test chamber, where the liquid sample in the test chamber does not contact the liquid sample, or the carrier cannot be relied upon to indirectly absorb the liquid, or the test area is not permitted to contact the liquid sample by absorbing the liquid through the carrier. In some embodiments, the test element is provided with one or more test areas, each test area comprising a water-absorbent material, and these multiple test areas are spaced apart from each other on a non-absorbent carrier. In some embodiments, each test area detects an analyte, and if there are multiple test areas, for example, 2, 3, 5, 10, 12, 2 to 12 different analytes can be detected at the same time.In some embodiments, the test strip comprises an area for attaching the test area and an area that does not contain the test area, both provided on a non-absorbent support of the test strip, the area containing the test area being close to one end of the test strip and the area not containing the test area being close to the other end of the test strip. In some embodiments, when the strip is inserted into the test chamber to start the test, the area of ​​the strip containing the strip is close to the opening of the test chamber, and the area of ​​the strip not containing the test area is close to the bottom of the test chamber in contact with the liquid in the bottom of the test chamber, at which time the test area does not come into contact with the liquid in the bottom of the test chamber, and at which time the test area is in the first state of being dry.When the liquid is allowed to come into contact with the test area, it is in a second wet state, after being in contact for a certain time, for example 1 to 60 seconds, after 1 to 10 seconds the test area is . is in a second state, when the test area is in contact with the liquid, it is also necessary to allow the liquid to leave the test area, the test area is then in a third state, and the test area is wet, but is not in contact with the liquid. At this time, it is possible to allow the substance on the test area, such as a chemical substance, to react with the analyte in the liquid sample, and during the reaction process, a color appears in the test area, and the test result is judged by comparing the concentration or amount of the color in the test area with a standard colorimetric card.

[0007] According to some embodiments, the device comprises a sample chamber for receiving a liquid sample, the body of the sample chamber comprising an opening with transparent sidewalls surrounding the chamber, a test chamber, the test chamber allowing insertion of the test element, wherein the test chamber is in fluid communication with the sample chamber, and wherein, when the liquid sample is served into the sample chamber, a portion of the liquid sample flows into the test chamber. According to some embodiments, the test element can only be inserted into the test chamber after the liquid has entered the test chamber and, of course, according to some optional embodiments, the test element is first placed in the test chamber and then the sample chamber is allowed to receive the liquid sample.So, at first, the test chamber does not contain the test chamber, and when the test chamber contains liquid, the test strip is inserted into the test chamber.

[0008] According to some embodiments, the test chamber is in fluid communication with the sample chamber via a channel. According to some embodiments, the test chamber is located on an exterior wall of the sample chamber, and a channel is provided in a wall common to the test chamber and the sample chamber, such that when the liquid sample enters the sample chamber, a portion of the liquid sample also enters the test chamber. According to some embodiments, said channel is located at the bottom of the test chamber and the sample chamber, and when the sample chamber collects a liquid sample, a portion of the liquid sample enters the test chamber.

[0009] According to some embodiments, a first lid body is provided with a second lid body, the first lid body being an opening for sealing the test chamber and the second lid body being an opening for sealing the sample chamber. Thus, the test chamber includes an opening for inserting the test element into the test chamber, and the sample chamber includes an opening for receiving a liquid sample. When the sample chamber has finished collecting the sample, the second lid body is used to seal the opening in the sample chamber. In some embodiments, after the test element is inserted into the test chamber, a first lid body is used to seal the opening of the test chamber. In some embodiments, the sample chamber contains a liquid sample and air, and the test chamber contains a liquid sample and air.When, in an initial state, the strip is inserted into the test chamber, the test area is not in contact with the liquid but is in a space containing air, and when it is necessary to allow the liquid to contact the liquid sample, the test device may be inverted, tilted, or otherwise allowed to allow the liquid in the test chamber to be in the open portion, thereby contacting the test area. In some embodiments, the test chamber has a bottom with an open portion, and when the strip is inserted into the test chamber, the test area is close to the open portion, and the liquid sample is located in the bottom space of the test chamber. In a way, at this point, the liquid sample does not contact the test area.In some embodiments, when the liquid sample is desired to leave the test area after the liquid has contacted it, the device is allowed to return to its initial state, e.g., to an upright position, at which point the liquid in the test chamber returns to the bottom of the test chamber.

[0010] According to some embodiments, the holder comprises a housing, and the test element is disposed in the housing. Said holder may comprise an insertion chamber to allow the test element to be inserted into the housing.

[0011] According to some embodiments, the holder comprises an insertion area near the opening of the test chamber which guides the insertion of the test element into the chamber of the holder. According to some embodiments, this insertion area comprises an inlet, this inlet being in communication with the recess, and the test element is inserted through the inlet while the test element is simultaneously located in the recess. According to some embodiments, the dimensions of the inlet of the insertion area are adapted to the thickness expenditure of the test strip. According to some embodiments, the insertion area contains a beveled surface, the bottom of this beveled surface being the inlet, which allows the test strip to be inserted into the recess.In some embodiments, said recess faces a side wall of the test chamber, said recess forming a slot with the side wall of the test chamber. In some embodiments, the side wall is transparent and the results of the test on the test item can be read through the transparent wall. In some embodiments, . said recess has a depth that forms a slot with the side wall of the test chamber, and said test strip is placed in the recess such that when liquid is moved in the test chamber from the bottom to the open portion, the test strip remains held in the recess without moving. According to some embodiments, said holder has two ends, one close to the opening of the test chamber and the other close to the bottom of the test chamber, the other end being located at a distance from the bottom of the test chamber, this distance being analogous to an opening or orifice through which liquid can pass into the slot.

[0012] In the further aspect, the present invention provides a device for detecting an analyte in a liquid sample, which comprises: a sample chamber for receiving a liquid sample, the sample chamber comprising an opening and a side wall surrounding a chamber body; a test chamber, the test chamber being in fluid communication with the sample chamber, wherein the test chamber has an opening, the opening is arranged to allow a test element to be inserted into the test chamber through the opening, the test element having a test area; a first cover body, the first cover body serving to seal the opening of the test chamber.

[0013] collecting the liquid sample by the sample chamber 100, allowing a portion of the liquid sample to flow into the test chamber 200;

[0014] inserting the test element through the opening 201 of the test chamber 200, without allowing the liquid sample to contact the test area and allowing the test area to remain dry upon insertion of the test element.

[0015] According to some embodiments, after insertion of the strip into the test chamber, the liquid sample may come into direct contact with the test area of ​​the test element, and when contact is established for a period of time, the liquid may leave the test area.

[0016] According to some embodiments, the test area on the test strip has a first initial state, a second state in which the contact with the liquid is wet, and a third state after the liquid leaves the test area.

[0017] In some embodiments, the opening of the test chamber is sealed by a first cap body after the strip is inserted into the test chamber through the opening of the test chamber. When a liquid sample is introduced into the test chamber through the opening of the sample chamber, the opening of the sample chamber is sealed by a second cap. In some embodiments, when it is desired for the liquid sample to contact the test area, inverting or tilting the device allows the liquid in the test area to move and contact the test area. After contact with the test area, the detection device is then returned from the inverted or inclined position to the upright position.

[0018] According to some embodiments, a channel is provided between the test chamber and the bottom of the sample chamber, and the cover of the test chamber seals the opening of the test chamber when the sample chamber is used to receive the liquid sample. At this time, the volume of liquid entering the test chamber is fixed. Of course, the opening of the test chamber is not sealed when the sample chamber can be used to collect the liquid sample, and at this time, the height of the liquid in the test chamber is equal to the height of the liquid level in the sample chamber. According to some embodiments, it is good that after inserting the test element into the test chamber through the opening of the test chamber, the height of the liquid level of the test chamber is located below the test area without touching the test area.The liquid in the test chamber is then displaced from the bottom to the opening by inversion, allowing the test area to be immersed in the liquid sample. In some embodiments, the duration of time the test area is immersed in the liquid sample may be any length of time, for example, between 1 second and 1 minute, between 1 minute of cooperation and 1 minute and 5 minutes, generally between 1 and 10 or 1 and 30 seconds.According to some embodiments, after allowing the liquid to contact the test area, it is necessary to allow the liquid to leave the test area without allowing the test area to be immersed in the liquid sample for a long time, the main reason being that when the test area handles the chemical substance in contact with the analyte, the chemical substance undergoes a color change or produces a colored substance that may be dissolved or diluted by the liquid sample, leading to a false negative result.

[0019] According to some embodiments, the liquid sample is urine and the analyte is one or more of the following substances: pH, analyte in urine, for example, white blood cells, red blood cells, urinary cholagens, urinary vitamin C, urinary crystals, urinary specific gravity, urinary albumin, urinary ketone bodies, urinary colony count, urinary acidity or alkalinity, nitrous acid. In a way, the places where the color change occurs are substrates, these funds are capable of changing color, these funds are treated in advance on the test area, and since the test area contains absorbent material, these reagents in the form of liquid solutions are treated on the test area, dried and used as the area for the test.

[0020] Also provided is a method for detecting an analyte in a liquid sample, comprising:

[0021] providing a device which comprises: a sample chamber for receiving a liquid sample, said sample chamber comprising an opening and a side wall surrounding a chamber body; a test chamber, said test chamber being in fluid communication with the sample chamber, wherein said test chamber has an opening, the opening is arranged to allow a test element to be inserted into the test chamber through the opening, said test element having a test area; and a first cover body, said first cover body serving to seal the opening of the test chamber;

[0022] collecting the liquid sample by the sample chamber, allowing a portion of the liquid sample to flow into the test chamber;

[0023] inserting the test element through the opening of the test chamber, without allowing the liquid sample to contact the test area and allowing the test area to remain dry upon insertion of the test element.

[0024] According to other embodiments of the method:

[0025] - when the test element is inserted into the test chamber through the opening of the test chamber, sealing said opening of the test chamber using a first cover body, then, after allowing the liquid sample to contact the test area for a certain time, allowing the liquid sample to leave said test area;

[0026] - once the liquid sample has come into contact with the test area, leave the test area becomes moist;

[0027] - said test area comprises one or more test areas, said area(s) test areas being absorbent, said test areas being arranged on a non-absorbent support;

[0028] - the method allowing the liquid sample to come into contact with the area of test consists of allowing the detection device to be inverted or tilted;

[0029] - the method allowing the liquid sample to leave the test area after having letting the liquid sample come into contact with the test area is to let the detection device return to the upright position. DESCRIPTION OF FIGURES

[0030] [Fig.l] shows a three-dimensional diagram of the structure of the detection device (with test strip) according to the embodiment of the present invention.

[0031] [Fig.2] represents an exploded view of the structure of the device according to the present invention;

[0032] [Fig. 3] shows a diagram of the three-dimensional structure of a specific embodiment of the present invention combined with a product (at this stage, it is the test element that is inserted into the test chamber).

[0033] [Fig.4] represents a structural sectional view of the device according to an embodiment of the present invention.

[0034] [Fig.5] shows a three-dimensional diagram of the structure of the detection device (with test strip) according to the embodiment of the present invention.

[0035] [Fig.6] shows a structural sectional view of a sample chamber and a test chamber in a specific embodiment of the invention, in which the test chamber does not contain a test element.

[0036] [Fig.7] shows a three-dimensional diagram of the structure of the detection device (with test strip) according to the embodiment of the present invention.

[0037] [Fig.8] shows a three-dimensional diagram of the structure of the detection device (with test strip) according to the embodiment of the present invention.

[0038] [Fig.9] shows a three-dimensional diagram of the structure of the test strip according to the embodiment of the present invention.

[0039] [Fig. 10] shows a structural sectional view of the first step among the testing steps according to an embodiment of the present invention.

[0040] [Fig. 11] shows a structural sectional view of the second step among the testing steps according to an embodiment of the present invention.

[0041] [Fig. 12] shows a structural sectional view of the third step among the testing steps according to an embodiment of the present invention.

[0042] [Fig. 13] shows a structural sectional view of the fourth step among the testing steps according to an embodiment of the present invention.

[0043] [Fig. 14] shows a schematic of an inclined test chamber according to one embodiment of the present invention. Detailed description Detection

[0044] 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 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. In addition, chemical detection further refers to an immunological test, a chemical test, an enzymatic test, etc. Sample

[0045] 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.

[0046] 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

[0047] 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 may 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 may flow in the opposite direction to gravity by gravity, and at this time, upstream and downstream are always divided according to the direction of liquid flow. For example, in the collection device of the present invention, according to some 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 the liquid entering the first chamber flows into the second chamber, and the first chamber can be called upstream, while the second chamber can be called downstream. This flow is, of course, a natural flow of 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

[0048] 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 passively or actively flowing 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

[0049] 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 single combination and separation.Further, 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.

[0050] 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.

[0051] 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 usually contains a dry chemical reagent composition, 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 treat the dry reagent in the area so that it reacts and thus performs the necessary detection. The flow of the liquid is mainly by capillary action.

[0052] The present invention and a suitable detection element allow the detection of 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 can collect all of the above-mentioned 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.

[0053] The test strips listed above rely on capillary force to allow liquid to flow from one end to the other and pass through the test area to complete the analyte test. There are also test strips that do not rely on capillary action, but allow liquid to come into direct contact with the test area to perform an analyte test. The commonly described biochemical urine test strip is one example. Thus, 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 can 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, allowing the latter to exhibit a specific color, which is then compared to a standard color card to determine the test result.Therefore, the absorbent material serves as the test area and is placed on a non-absorbent backing sheet, and the liquid cannot flow from one end to the other, but rather the backing sheet serves to hold the test area in place, and if there are multiple test areas, multiple test areas are held in place at regular intervals on the backing sheet, and the testing need is such that it is necessary to bring the test area into contact with the liquid samples directly to carry out the test test.

[0054] 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, a sheet absorbent, 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 is then precipitated 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 corresponding analyte. These colored substances are then dropped onto the corresponding absorbent blocks or sheets and then compared to the darkness or lightness of the colors according to a standard color chart to determine whether the corresponding analyte is positive or negative.

[0055] 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. .

[0056] According to some embodiments, as illustrated in [Fig.7], the test strip comprises four test areas 61, 62, 6, 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 completed successfully. There is also the feature that, for example, in some cases, it may be 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 the 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 arrow location 65 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. Saturated water absorption on a test area is a customization, saturated water absorption is the maximum value of water volume absorbed by the test area from dry state, and once the maximum value is reached, water can no longer 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 an actual 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 water moistened in advance in the test area having a diluting effect on the urine, thus on the saturated water absorption volume, and the absorption of saturated water on the test area. The 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 liquid sample for a prolonged period. 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 contact 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 abandon, because a . The test area is pre-moistened, 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. This setup meets the needs not only of professionals, but also of inexperienced people who wish to carry out tests themselves at home.

[0057] 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. 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.

[0058] 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.

[0059] 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 has a groove that allows for the disposition of 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 in the form of 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 that something like . allowing the liquid samples to diffuse through all the test strips actually employs 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 quickly leave it without the test area being immersed in the liquid sample for a long period of time. Analyte

[0060] 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 bodily fluids such as blood, urine, saliva, sweat, etc. or in a part of the bodily fluids where the said small molecules are present.

[0061] 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 analysis can be detected using a lateral cross-flow test format in conjunction with the device of the present invention.Any analyte can be detected using a suitable detection element or test element of the present invention. Preferably, the present invention is used to detect small drug molecules 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 be white blood cells, red blood cells, urinary cholagen, urinary vitamin C, urinary crystals, urine specific gravity, urinary albumin, urinary ketone bodies, urinary colony count, urinary pH, nitrite in fluid samples.Examples include levels of white blood cells, erythrocytes, urobilinogen, urinary vitamin C, urinary crystals, urine specific gravity, urine albumin, urinary ketone bodies, urine colony count, urine pH, and nitrous acid in a urine sample.

[0062] 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 find out 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 the l,2,3,4-tetrahydro-benzo(h)quinolin-3-phenol to produce a pink color at the test area.

[0063] 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

[0064] 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, the test can be performed immediately to obtain a result, and the 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.

[0065] The present detection device comprises a liquid sample collection chamber, a cover body and a holder for carrying a test strip. In some embodiments, the collection chamber refers to a A liquid sample receiving chamber used to receive a sample, such as a urine sample, as illustrated in [Fig. 2]. Collection may be performed either by the person allowing the liquid sample to enter the chamber 201 directly, or by means of another tool, such as a pipette gun or other container, so that such a sample may be collected in the chamber 201. The chamber has a bottom 205 and a chamber 201 surrounded by a sidewall 216 attached to the bottom, which is transparent. In some embodiments, the chamber has an opening 204 for receiving the liquid sample.According to some embodiments, 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 connecting 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 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, 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.

[0066] 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 means 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 support 30, so that after the test area of ​​the support 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 supports 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.

[0067] Cover body and support containing the cover body

[0068] 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 later 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, that is, 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 be inserted into the chamber, that is, when the test strip is inserted into the chamber 201 through the hole 105 to contact urine, it can only be introduced 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 position for limiting 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 during 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 rocking the chamber, the liquid will have some impact on the groove 30, and it is desirable that the strip . test strip remains in the groove without detaching therefrom, so that 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 for some test areas on the test strip to 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.

[0069] 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 result in a false negative result, and the colored substances diffused in the urine may be adsorbed or absorbed by another test area, and will then have a color in the other test area, which may result in 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 try to leave the liquid sample as soon as possible after brief contact with the test area.

[0070] 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 holder 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 testing of different detection devices (for different individual liquid samples), one option is a piston-shaped seal between the lid and the chamber opening, for example, by providing a protrusion on the inside 102 of the lid 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 support 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 turn of threads 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 start point (not shown) and the end 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 location 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 cover 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 body of the cap remains 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 remain 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.

[0071] 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 a time given, the test strip is inserted into the groove of the holder, a part 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 a given time, 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 test areas on the test strip, so that when the chamber is tilted, it is possible to observe through the entire transparent part whether a liquid has touched each test area, and 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.

[0072] 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.

[0073] 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 orifice 105 in the cover body 10, sealing so that when the chamber 201 is tilted, the liquid does not flow through the orifice 105.Furthermore, if the test strip is long and a portion of the test strip is in the hole 105, the sealing cap 43 can hold the test strip in place while sealing the hole 105. According to one embodiment, the sealing cap 43 is provided with a sealing cover 40 which has a sealing head 41, the cover sealing head having a direction indicating role which may 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 which indicates a direction which is in line with the direction of the opening of the groove of the support 30, both towards 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 which 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 inclined.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. 11A). 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. 11B), so that the liquid sample 908 is dispensed laterally into the chamber 201, and it is hoped that the liquid sample dispensed laterally. contacts the test strips on the laterally dispensed holder (after tilting, the holder 30 tilts, and the test strips on it tilt with it), particularly to contact the test strips on the test area. Immediately after a determined contact period, leave the chamber upright again and return to the position shown in FIG. 11 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 cap body. 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 holes 105 and are held in the grooves.

[0074] Conversely, without this mark, if in a direction opposite to the position of the holder, 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 holder, and does not enter, for example, in the direction of the position 109 as contrasted in [Fig. 4], in the direction indicated by ...1 IC), let alone 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.

[0075] 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

[0076] As shown in FIGS. 1-13, the present invention provides a test device comprising a sample chamber 100 having an opening 101, a bottom 105, which is cylindrical, and a cover 400 with a sealed opening, and a test chamber 200 external to the sample chamber, which also has a bottom 208, and an opening 201, and a cover 600 also with a sealed opening. Inside the test chamber, a holder 300 is provided, with a recess 305 that faces the front wall 202 of the test chamber, and on the holder, near the opening 201 of the test chamber 200, there is an introduction chamber 301 that has an inlet 313 at the bottom of the chamber, the introduction chamber and the inlet 313 being the area where the test strip is allowed to be inserted, and which is the same as the recess 305, so that when the test strip is inserted into the test chamber, it is directly allowed to be arranged in the recess, and that the length of the test strip is generally longer than the length of the recess. In addition, the end of the holder is close to the bottom of the test chamber, but does not touch the bottom, and there is a height between the end and the bottom of the test chamber which forms the hole 210, and there is a channel 800 between the bottom of the test chamber and the bottom of the sample chamber.

[0077] A test strip 700 has four test areas 702, 703, 704, 705 at one end 709 of the test strip, which are arranged in order from one end 709, while a blank area is reserved without a test area on the area at the other end 708, all of which are arranged on an absorbent plastic sheet. The plurality of test strips are kept sealed in a bottle, and the test chamber with the sample chamber does not contain the test strips.

[0078] When a test is required, the sample chamber cover 400 is first removed to allow the sample chamber to collect a liquid sample, such as urine, so that the urine sample is in the sample chamber, then the test chamber cover 600 can be removed, allowing the liquid from the sample chamber to also enter the test chamber, and the height of the liquid in both chambers remains the same, with the liquid then being between the maximum liquid level height line and the minimum liquid level height line.At this time, the cover body 400 of the sample chamber can be covered, and then a test strip is removed from the bottle, so that one end 708 of the test strip first enters the introduction area 301, and then is inserted into the groove 305 of the test chamber through the opening 313 at the bottom and remains in the test chamber 200. At this time, as shown in [Fig. 10], the blank area at the second end of the test strip is located in the liquid but the test area, but the lowest test area 705 is located in the liquid level, and then the cover body of the test chamber 200 is covered and the opening 201 of the test chamber is sealed.Invert the test chamber (invert the sample chamber), let the liquid located in the test chamber flow to the position of the opening 201 of the test chamber and form a liquid level height at the opening position, at this time, the four test areas on the test strip 700 are located in the liquid, and the test area absorbs the liquid, and after inverting for 10 seconds (as in [Fig. 11]), invert the test chamber again, let the test chamber return to the state of [Fig. 10], where the liquid located in the test chamber has flowed downward, and formed a liquid level height at the bottom. At this time, wait for the color of the test area to change and, within three minutes, provide a standard colorimetric card with color blocks on which the result of . The test is marked as positive or negative depending on the intensity of the color. If the color of the tested area does not change, the test result is considered negative, and if the color of the tested area is the same as the color block corresponding to the positive test on the test card, the test result is indicated as positive.

[0079] In a way, it is also possible to tilt the test chamber, or tilt the sample chamber so that the liquid in the test chamber contacts the test area. A preferred way to tilt the chamber is to tilt it in the direction where the test chamber is located. For example, as shown in [Fig. 14], the test chamber is located on one side of the sample chamber, and the tilting direction is to tilt towards where the test chamber 200 is located, then the liquid can fill the test chamber or at least submerge the test area on the test strip, and when tilted from one end to the other, after letting the test chamber return to the orthostatic position, as shown in [Fig. 12], and at this time, the liquid has returned to the bottom of the test chamber and left the test area.The test area is no longer in contact with the liquid, allowing the analyte in the sample on the test area (if present or above a certain concentration level) to react with the substance on the test area to produce a color. Comparison with the color block on the provided standard color card determines whether the test result is negative or positive. The term "toward the test chamber" refers to allowing the test to fill with liquid or allowing the liquid at the bottom of the test chamber to flow backward into the test chamber opening so that the liquid contacts the test area on the test strip as the liquid fills the test chamber or flows backward. As shown in FIGS.10, 14, the tilting direction is such that the test chamber is tilted, and the test strip, which is in a relatively fixed position in the test chamber, is also tilted with the test chamber so that in the tilting process, the liquid gradually fills the test chamber so that it can contact the liquid sample. Again, for example, in [Fig. 13], if the test chamber is tilted in the opposite direction ([Fig.13]) to the orthogonal direction of [Fig.10], the liquid in the test chamber will flow into the sample chamber, and the test item will remain dry on the test item without being able to contact the liquid sample, and then the test will not be completed. [Fig.13] is used here to illustrate the question of the direction of tilt, although in a way, after the test sample has contacted the test area, the way to follow [Fig. 13] is to allow the liquid inside the test chamber to leave the test chamber as far as . possible without resting on the test area, and in particular to allow the liquid resting in the slot 290 to flow out.

[0080] The following embodiments are further part of the present invention.

[0081] A device for detecting an analyte in a liquid sample, which comprises: a sample chamber for receiving a liquid sample, the sample chamber comprising an opening and a sidewall surrounding a chamber body; a test chamber, the test chamber being in fluid communication with the sample chamber, wherein the test chamber has an opening, the opening is arranged to allow a test element to be inserted into the test chamber through the opening, the test element having a test area; a first cover body, the first cover body serving to seal the opening of the test chamber.

[0082] According to some embodiments, said test element comprising one or more test zones having a water absorption capacity, said one or more test zones being arranged at intervals on a non-absorbent support. According to some embodiments, a liquid flow is incapable between said test zones or a liquid flow is incapable between the test zones due to the presence of a non-absorbent support. According to some embodiments, the test element has a first state and a second state in the test chamber, when the test element is inserted into the test chamber, said test zones do not come into contact with the liquid sample or the liquid does not come into contact with the test zones, and in the second state, the test zones come into contact with the liquid sample or the liquid sample is in direct contact with the test zones.In some embodiments, said test area further comprising a third state, wherein when the second state is performed, the test area is in a third state in which the test area leaves the liquid sample or the liquid sample leaves the test area. In some embodiments, the test area is dry when the test area is in the first state, and wherein the test area contains a portion of the liquid sample on the test area in the second state and in the third state. In some embodiments, the test chamber contains the test element before the test is initially performed, and it is when the test is to be performed that the test strip is inserted into the test chamber.In some embodiments, when the strip is inserted into the test chamber, the test area is also not immediately tested, and the test area then does not contain a liquid sample. In some embodiments, the test device does not contain a test element in the test chamber at the time the test device begins collecting liquid with the sample chamber. In some embodiments, the passage between the test chamber and the sample chamber. has a height which, when the test item is inserted into the test chamber, is less than the test area of ​​the test item closest to the bottom of the test chamber.

[0083] According to some embodiments, said test chamber having a support on which the test element rests, said test element resting on the support when the test element is inserted into the test chamber. According to some embodiments, said support comprising a housing in which the test element is disposed. According to some embodiments, said support comprises an insertion chamber through which the chamber is guided to allow the test strip to be inserted into the recess. According to some embodiments, said insertion chamber comprises an opening at the bottom through which the test strip is guided into the recess. According to some embodiments, said recess faces a transparent front wall of the test chamber and, according to some embodiments, when the strip is inserted into the recess, the test area faces the front wall of the transparent test chamber.In some embodiments, when the strip is inserted into the holder, a portion of one end of the strip is disposed in the insertion chamber, thereby holding the strip stable in the recess without detaching it.

[0084] In some embodiments, the test chamber is located outside the sample chamber and wherein there is an opening at the bottom of the test chamber and at the bottom of the sample chamber, when the sample chamber is used to collect a liquid sample, the liquid sample contained in the sample chamber flows through the opening at the bottom into the test chamber. In some embodiments, when the sample chamber contains the liquid sample, a portion of the liquid sample is in the test chamber, and the test element is inserted into the test chamber, the test area of ​​the test element does not contact the liquid sample.In some embodiments, when the sample chamber contains the liquid sample, a portion of the liquid sample is in the test chamber, the test element is inserted into the test chamber, and the detection device is placed in an inverted position, the liquid sample in the test chamber contacts the test element, leaving the test area in the second state. In some embodiments, the test area contains a chemical substance that is capable of reacting directly or indirectly with the analyte in the liquid sample to produce a colored substance that precipitates on the test area. In some embodiments, the device further comprises a second cover body for sealing the opening of the sample chamber.

[0085] The liquid sample with the sample chamber, by allowing the liquid to enter the test chamber, and then inserting a test element into the test chamber, wherein the liquid does not flow past the test element, or the test area does not contain the liquid sample, or the test area is unable to contact the liquid sample. In some embodiments, the opening of the test chamber is sealed by a first plug, or the opening of the sample chamber is sealed by a second plug, or the opening of the test chamber is sealed by the first plug and the opening of the sample chamber is sealed by the second plug, or the openings of the test chamber and the sample chamber are sealed by a single plug at the same time.The liquid in the test chamber is then brought into contact with the test area of ​​the strip for an appropriate period of time, such as 1 to 30 seconds, 1 to 60 seconds, 5 seconds, 10 seconds, to allow the test area to absorb sufficient liquid, or some of the liquid. The liquid is then immediately allowed to leave the test area or separate from the test area, allowing the test area to absorb the liquid sample.In some embodiments, the liquid may contact the test area or leave the test area after contact in various ways, such as after collecting the liquid sample, by allowing the test chamber to be inverted, tilted, or inverted and then tilted, or tilted and then inverted, and so on, all of which are essentially those that allow the liquid to flow into the test chamber, and the flow may contact the test area or leave the test area. In some preferred embodiments, the test chamber is inverted so that the liquid at the bottom of the test chamber flows into the opening of the test chamber, allowing the test area to be submerged in the liquid sample for a period of time.

[0086] According to some embodiments, when the test element is inserted into the test chamber through the opening of the test chamber, sealing said opening of the test chamber using a first cover body, then, after allowing the liquid sample to contact the test area for a period of time, allowing the liquid sample to leave said test area. According to some embodiments, once the liquid sample has contacted the test area, allowing the test area to become wet. According to some embodiments, said test area comprises one or more test areas, said one or more test areas being absorbent, said test areas being disposed on a non-absorbent support. According to some embodiments, the method of allowing the liquid sample to contact the test area comprises allowing the detection device to be inverted or tilted.According to some embodiments, the method allowing the sample . liquid to leave the test area after allowing the liquid sample to contact the test area is to allow the detection device to return to the upright position.

[0087] 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, the terms "comprising," "essentially comprising..." and "consisting of..." may be replaced by either of the remaining two terms. The terms and expressions used herein are descriptive and not limiting.Furthermore, nothing is intended to indicate that these terms and explanations described herein exclude any equivalent feature, however, it is understood that all appropriate changes or modifications may be included within the scope of the present invention and claims.

Claims

Claims

1. A device for detecting an analyte in a liquid sample, comprising: a sample chamber (100) for receiving a liquid sample, said sample chamber comprising an opening (101) and a side wall (106) surrounding a chamber body; a test chamber (200), said test chamber being in fluid communication with the sample chamber, wherein said test chamber (200) has an opening (201), the opening being arranged to allow a test element (700) to be inserted into the test chamber through the opening (201), said test element having a test area (706); a first cover body (600), said first cover body serving to seal the opening (201) of the test chamber.

2. A device according to claim 1, wherein said test element comprises one or more test areas (702, 703, 704, 705) having a water absorption capacity, said one or more test areas being arranged on a non-absorbent support (701).

3. The device of claim 2, wherein liquid flow is incapable between said test areas (702, 703, 704, 705) or liquid flow is incapable between the test areas due to the presence of a non-absorbent support 300.

4. The device of claim 1, wherein the test area (706) of the test element (700) has a first state and a second state in the test chamber, when the test element (700) is inserted into the test chamber (200), said test areas (706) do not contact the liquid sample or the liquid does not contact the test areas, and when the test area (706) is in the second state, the test areas (706) contact the liquid sample or the liquid sample is in direct contact with the test areas.

5. The device of claim 4, wherein said test area (706) further comprises a third state, wherein, when the second state is achieved, the test area (706) is in a third state in which the test area leaves the liquid sample or the liquid sample leaves the test area.

6. The device of claim 5, wherein the test area (706) is dry when the test area is in the first state, and wherein the test area contains a portion of the liquid sample on the test area in the second state and in the third state.

7. The device of claim 1, wherein said test chamber (200) has a support (300) on which the test element rests, said test element (700) resting on the support (300) when the test element (700) is inserted into the test chamber (200).

8. Device according to claim 7, wherein said holder (300) comprises a housing (305), the test element (700) is disposed in the housing (305).

9. A device according to claim 8, wherein said holder (300) comprises an insertion chamber (301) for allowing the test element to be inserted into the housing.

10. The device of claim 9, wherein the test chamber (200) is located outside the sample chamber (100) and wherein there is a channel (800) at the bottom of the test chamber and at the bottom of the sample chamber, when the sample chamber is used to collect a liquid sample, the liquid sample contained in the sample chamber flows through the opening (800) at the bottom into the test chamber.

11. The device of claim 10, wherein when the sample chamber contains the liquid sample, a portion of the liquid sample is in the test chamber, and the test element is inserted into the test chamber, the test area of ​​the test element does not contact the liquid sample.

12. The device of claim 11, wherein when the sample chamber contains the liquid sample, a portion of the liquid sample is in the test chamber, the test element is inserted into the test chamber, and the detection device is placed in an inverted position, the liquid sample in the test chamber contacts the test element, leaving the test area in the second state.

13. The device of claim 1, wherein said test area contains a chemical substance which is capable of reacting directly or indirectly with the analyte in the liquid sample, to produce a colored substance which precipitates on the test area.

14. The device of claim 1, wherein said device further comprises a second cover body (400) for sealing the opening (101) of the sample chamber (100).

15. A method of detecting an analyte in a liquid sample, comprising: providing a device which comprises: a sample chamber (100) for receiving a liquid sample, said sample chamber comprising an opening (101) and a side wall (106) surrounding a chamber body; a test chamber (200), said test chamber being in fluid communication with the sample chamber, wherein said test chamber has an opening (201), the opening being arranged to allow a test element (700) to be inserted into the test chamber through the opening, said test element having a test area (706); and a first cover body (600), said first cover body serving to seal the opening of the test chamber; collecting the liquid sample by the sample chamber, allowing a portion of the liquid sample to flow into the test chamber;inserting the test element (700) through the opening (201) of the test chamber, without allowing the liquid sample to contact the test area (706) and allowing the test area to remain dry upon insertion of the test element.;

16. The method of claim 15, wherein, when the test element is inserted into the test chamber through the test chamber opening, sealing said test chamber opening (201) with a first cover body (600), and then, after allowing the liquid sample to contact the test area for a period of time, allowing the liquid sample to leave said test area.

17. The method of claim 15, wherein, after the liquid sample has contacted the test area, allowing the test area to become wet.

18. The method of claim 15, wherein said test area comprises one or more test areas (702, 703, 704, 705), said one or more test areas being absorbent, said test areas being arranged on a non-absorbent support (701).

19. The method of claim 16, wherein the method allows to the liquid sample from coming into contact with the test area is to allow the detection device to be inverted or tilted.

20. The method of claim 19, wherein the method allows to the liquid sample to leave the test area after allowing the liquid sample to contact the test area is to allow the detection device to return to the upright position.

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