Dry chemical device for testing analyzed substances in urine at home

Abstract

The invention relates to a dry chemical device for testing an analyzed substance in urine at home, which comprises a test strip, the test strip comprises a non-water-absorbing support sheet, the support sheet is provided with at least two or more test areas, the test areas cannot be in liquid communication with each other, and the test strip is arranged on the support sheet. The test area comprises a water absorption material, the water absorption material comprises a reaction reagent, and the reaction reagent can detect an analyzed substance in a urine sample or test the property of a liquid sample; and the water-absorbing material is positioned below the supporting sheet, and when a liquid sample is added to each area passing through the two or more test areas, the water-absorbing material absorbs the redundant liquid sample, so that the interference of other test areas in which the liquid sample is not gradually added is avoided.

Description

Technical Field

[0001] This invention relates to the field of in vitro detection, and in particular to a detection device for testing analytes in urine samples and the properties of urine samples using dry chemistry methods. Background Technology

[0002] The following background information is merely a general overview and does not constitute any limitation on the present invention.

[0003] The composition and physical properties of liquids are often used to understand the condition of their source. For example, testing biological fluids for oxidants, pH, specific gravity, creatine anhydride, bilirubin, glucose, and similar indicators can reveal health conditions or contamination levels. Food and beverage testing includes pH, specific gravity, and detection of bacterial or toxic contamination. pH, specific gravity, bacteria, lead or mercury contamination are also indicators used in soil and water samples.

[0004] Generally, these rapid chemical tests can be performed using test strips with a series of chemical detection pads that allow for direct sample application and result reading without utilizing capillary action. The detection pads react chemically with the sample or sample components, causing a color change. Typically, the operator simply immerses the test strip in the liquid, observes the color change of the detection pads, and compares the color of the detection pads with the result card to confirm the test result.

[0005] However, these "sample-read" test strips have many drawbacks, especially their incompatibility with modern rapid immunoassay devices. Nevertheless, these chemical assays remain essential. New rapid immunoassay devices are designed to reduce operator contact with the sample, while this "sample-read" method requires the operator to open the device, potentially leading to sample contamination from the operator or other reagents on the test strip.

[0006] These "sample-result reading" test strips are typically operated by professionals. The general procedure involves inserting a test strip with multiple strips, such as 10 or 13, into the urine, then removing it. Each test area is then compared to a standard color chart, and the test result, such as positive or negative, is determined based on the color change compared to the standard color chart. Sometimes, the strip is directly inserted into a machine for automatic result reading.

[0007] However, the biggest challenge in transitioning from professional to home testing or OTC products for non-professionals is that the multiple test pads require significantly more time for non-professionals to compare the color changes of each test area with the standard color chart. Furthermore, these color readings must be done within a very short time (2 minutes to 30 seconds; exceeding this time renders the test results invalid). For example, with 10 test strips, all results must be read within one minute, which is virtually impossible for non-professionals. Therefore, improvements are needed in the design of these test strips and the testing methods to meet the needs of non-professionals conducting home testing. This would ensure accurate operation and reliable results, while also providing convenient access to results without causing contamination or interference between different test areas.

[0008] Therefore, it is essential to improve the methods and equipment for testing multiple indicators in urine samples. Summary of the Invention

[0009] To address the drawbacks of the aforementioned traditional technologies, this invention provides a dry chemical test strip containing multiple test areas sequentially arranged on a non-absorbent support sheet. These test areas are spaced apart.

[0010] In some methods, the spacing between test areas is achieved using non-absorbent support sheets. For example, the test area spacing is set on the surface of a non-absorbent liner. In other methods, an absorbent pad containing chemical reagents is placed on each test area to detect different analytes in the urine or to test urine performance indicators.

[0011] To make home testing easier, this invention allows the user to use a pipette to collect urine, add it to one test area, and read the result for that area. After reading the result, the user then adds urine to the next test area and reads the result for that area. In other words, urine is first added to one or two test areas individually, and the results are read from those areas. The reading is typically done by comparing the colors of the two test areas to a standard color chart to determine whether the result is negative or positive. After reading the results, another one or two test pads are applied, and the results are read from those pads, thus enabling home self-testing. This method is "intermittent or spaced out," meaning that liquid is not applied to all test pads at once and then compared sequentially. Instead, liquid is added to a portion of the test pads, the test is completed, and the results are read before adding liquid to the remaining pads on the same test strip and reading the results. This testing method is intermittent or spaced out.

[0012] In some methods, an absorbent material is provided beneath the test strip. If too much urine is added, the excess will flow to the absorbent material below and be absorbed, thus preventing contamination of other unfilled test pads. In other methods, the test pad is dry before testing and becomes wet upon contact with liquid, thus losing its absorbency.

[0013] In some embodiments, the test strip of this invention consists of a non-absorbent support sheet with multiple test areas. Each test area has an absorbent test pad, and each test pad is treated with different types of chemical substances. The chemical reaction is used to test the content of different analytes in urine or various urine properties (pH value, gravity). The spacing between each test pad is approximately 3-5 mm, and the total length of the test strip is approximately 15-20 cm. If a handheld component is included, the total length of all test areas is approximately 8-10 cm. In this case, if the test strip is directly exposed, and the operator sequentially adds urine to each test pad, pausing after each 1-2 pads to interpret the results—typically by holding the test strip close to a standard color chart for color comparison, then interpreting the structure and recording the results—while feasible, it is still not very convenient to operate. In the operator's area, there is a container for urine, a dropper, absorbent paper laid out on the table, and a standard color chart. All these items are in one place, and the test pads are concentrated on a long, thin strip, arranged relatively close together. There's a possibility of incorrect order in adding the liquid; for example, if the liquid is meant to be added to the first test pad, it might be added to the second or third, or vice versa. This can easily cause confusion and lead to incorrect comparisons when interpreting the test results with the standard color chart. Although using a single test strip and changing the way the liquid is applied allows for home self-testing, some operational inconveniences still exist.

[0014] In some methods, to ensure that the added urine is limited to only one or two test areas, the test areas are spaced apart. This prevents urine from being added to areas that are not intended for immediate testing. Furthermore, urine is only added to the areas to be tested immediately, while areas requiring subsequent testing are excluded. For example, if a test strip has 10, 13, and 15 test areas spaced apart, how can the addition of urine be clearly guided for non-professional users at home, avoiding randomness? This is because most operators tend to start from one end and end to the other, following a specific, sequential procedure to avoid errors and cross-contamination. Therefore, in some methods, the test areas are spaced apart, for example, with spacers separating each area. This ensures that the urine is not prematurely applied to adjacent test areas. There are various methods that allow the test area or multiple test pads to remain relatively independent when the sample is added and the test is completed. Each area receives the liquid independently, completes the test independently, and reads the test results independently within the effective time, without interfering with each other.

[0015] There are several ways to ensure that test pads operate independently and avoid mutual interference. For example, in some methods, a thin film is placed over the test area of ​​the test strip, such as covering the test pad itself. This film protects the test pad and also facilitates operation during testing. In other methods, a waterproof film is placed over each test pad. If the film is flexible, it is removed before each test pad is added to expose it, then urine is added, and the results are interpreted. When the next test is needed, the film is removed from the next test pad. This method can be called a "sequentially spaced" method. In some methods, a separate film can be placed over each test pad, or a single film can be used to cover multiple test pads. The film is then heat-pressed onto the test pad surface, allowing it to adhere to the spacers between the test pads. In this way, the film is peeled off sequentially from one end, exposing the test pads one by one. Urine is then added to the exposed test pads sequentially to complete the test or analysis. The "interval" between test pads can be controlled. The process and result interpretation for the next test pad are only performed after the previous test pad has completed its test and result has been read. This allows for individual control over the addition of liquid to the test pads based on the user's familiarity with the procedure. Simply follow the provided instructions. For example, when testing for white blood cells, the result should be read within 120 seconds of adding the liquid, and then the next test pad can be added for testing.

[0016] In some methods, an alternative to the film covering involves a sliding, transparent cover that completely covers the test pad before testing. When testing is required, the cover slides, exposing the test pad sequentially at intervals, allowing for sequential testing. In some methods, the sliding cover has a base plate on which the test strips are mounted. In other methods, the base plate has absorbent paper on which the test strips are mounted, and the base plate has grooves in which the sliding cover interacts to sequentially expose the test pads.

[0017] In other formulations, the test strip is housed in a device with windows for adding liquid, each window exposing one or two test pads. A spacer structure is positioned between the test pads to separate them. This spacer structure is located between the test pads and on a non-absorbent support sheet on the test strip. In some embodiments, the spacer structure includes a baffle positioned between the test pads, dividing multiple test pads into multiple independent units. For example, each test pad can be an independent unit, or two test pads can be separated into one unit. Thus, during testing, the test is performed sequentially from one end to the other. For example, urine is added to the first test pad in the first window, and the result is determined by comparing the color with a standard color chart. After this, urine is added to the test pad in the adjacent second window, and the result is again determined by comparing the color with a standard color chart. The comparison of the color on the test pad with the standard color chart to obtain the test result needs to be completed within a certain time, typically between 120 and 30 seconds. For example, some tests require a valid result to be read within 120 seconds; results exceeding this time are invalid. Others require 60, 45, 40, or 30 seconds. In some methods, this sequential interval approach arranges the test pads' reading times from longest to shortest. For instance, the effective reading time for the test pad with urine added first is longer than that for the test pad with urine added last. This allows the tester sufficient time to read the results. Furthermore, for first-time users, a longer initial time followed by shorter times aligns with their operational habits, increasing compliance and allowing them to gradually become familiar with the procedure and the sequential interval method.

[0018] In some methods, the window is located on an upper plate, which also has a spacer structure extending from it. A lower plate is also provided for holding the test strips. When the upper and lower plates are combined via holes and pins, each or every two test pads are separated by the window, and each pair of spacers is positioned between the test pads. Thus, the spacer structure and the window divide multiple test pads into multiple independent test units, with one or two test pads placed within each test unit (each window). When testing is required, urine is directly dripped onto the test pad through the window, and the color is compared with a standard color chart to determine the test result. In some methods, a standard color chart, corresponding to the color of the test item, is printed on the surface of the window, near the test pad. Generally, when the test pad shows a color change, the result, such as positive or negative, can be determined by directly comparing it with the color chart on the window surface. The convenience lies in the fact that the window serves as both the inlet for adding urine and the area for reading the results. Furthermore, the fact that the test pad in a single window receives the liquid does not affect the test pads in other windows, nor does the liquid spill onto other test pads. This allows the operator to perform tests sequentially and at intervals. For example, after the test pad in one window has completed the test and read the result, the operator can proceed to the next window. In this method, the "next window" is not necessarily adjacent; any window can be selected. Since each window exists independently, this provides greater convenience and flexibility for the operator.

[0019] In some methods, a thin film is placed over the top plate, specifically over the windows. This protects the test pads beneath the windows from moisture and also provides additional protection. For example, when liquid is added to the first window, the film is removed, but adjacent windows are covered by the film, preventing liquid from dripping into neighboring windows. Although the windows separate the test pads, they are still relatively close together. Using a waterproof film prevents liquid from being added to the wrong location and also avoids cross-contamination between test windows. This film can be a single strip covering multiple windows, or one layer covering each window, with the film removed for each test pad in that window, or removed sequentially.

[0020] In some methods, to maintain a constant volume of liquid added to the test pad and prevent overfilling, a layer of filter paper is placed under the support sheet. This filter paper absorbs excess liquid without contacting the test pad. In other methods, the partition structure of the upper plate longitudinally divides the test pad into independent units. When two or more test pads are located in a window, excess liquid may flow onto other test pads in the same window when the first test pad is added. Therefore, the width of the window is made larger than the width of the non-absorbent support sheet, creating a gap between the window and the support sheet. If excess liquid is present, it flows through the gap to the absorbent paper below, thus reducing excess liquid flowing onto the test pads in the same window. Therefore, in some preferred methods, only one test pad is placed in each window. By adding liquid to each window and completing the test results for that window's test pad individually, liquid is added to other windows, completing the testing of multiple test pads in an "intermittent" manner.

[0021] Another aspect of the present invention is to provide a method for analyzing liquid samples. The method includes: providing the aforementioned apparatus; sequentially and at intervals adding liquid to a test pad, allowing the test pad to react with the sample for a sufficient time to generate a measurable signal; and comparing the signal with a standard signal. In some specific embodiments, the measurable signal may be a change in color on the test pad. The "standard" can be any suitable, objective method for expressing a detection result. For example, the standard may be a standard comparison table or card provided on the apparatus, or with the apparatus, or in other possible ways. The comparison of the signal with the standard includes comparing the color of the test pad after testing with the color of the standard table or card, thereby determining the detection result through this comparison. The measurable signal can be an indication of any objective analytical result (e.g., fluorescence, enzyme-based assays, or spectrophotometric assays). The standard can be based on any of these or other detection methods. These methods include: allowing the reaction time to be sufficient for the sample to react with the reagent on the test pad, and comparing the color of the test pad with a standard result comparison table or card at the end of the reaction.

[0022] In some methods, the so-called sequential interval refers to adding samples according to the order in which the test pads are arranged. For example, liquid is added to the test pads one by one, and then the test results are awaited. This interval includes two aspects: firstly, the test pads being added are a subset of multiple test pads, such as one or two out of 13 or 12 test pads, but at least fewer than 10 or 13. Secondly, after adding liquid, it is necessary to wait for the test to complete before adding the remaining test pads or a portion of the remaining test pads. For example, if there are 10 test pads on a test strip, liquid can be added to one test pad first, and after that test pad has reacted and the test result is read, liquid can be added to another test pad, and so on, until the third or fourth test pad is completed. Here, "test finished" or "test completed" essentially means that the test pad has received the liquid, the test pad has reacted, and the reading has been obtained.

[0023] This invention also provides a kit for detecting liquid samples. The kit includes the device of this invention and an instruction manual. In various specific embodiments, the kit may also include an analytical result comparison table or other standards. The kit can be packaged in any suitable form, such as a vacuum-sealed box, plastic bag, or aluminum foil bag.

[0024] This invention provides a method for detecting urine samples. The method includes: providing an apparatus comprising: a test strip, the test strip including a non-absorbent support sheet, at least two or more absorbent test pads disposed on the support sheet, each test area being separated by the non-absorbent support sheet, and a reaction reagent comprising a material of the absorbent test pads, the reaction reagent being capable of detecting the analyte in the urine sample or the properties of the test liquid sample; intermittently applying the urine sample to the multiple test pads, and after each test area is applied, observing the color of the test area and comparing it with the color of a color chart to determine the content of the analyte in that test area, thereby completing the test.

[0025] In some methods, the test pad that takes the longest to obtain a test result is used for the first test, and then the test pad that takes the shortest time to obtain a test result is used for the next test.

[0026] In some methods, the test pads on the test strip are arranged in descending order of the time required to obtain test results, thereby testing the test pads in a sequential, intermittent manner.

[0027] In some methods, a urine sample is first applied to the first test pad with the longest effective reading time, and then the test result is read within the effective time. After the reading is completed, a urine sample is then applied to the second test pad with a shorter effective reading time than the first test pad.

[0028] In some embodiments, the test strip comprises 10 test pads, arranged in the order of receiving urine as follows: a first test pad for testing leukocytes, a second test pad for testing nitrite, a third test pad for testing urobilinogen, a fourth test pad for testing protein, a fifth test pad for measuring pH, a sixth test pad for measuring blood, a seventh test pad for measuring specific gravity, an eighth test pad for measuring ketones, a ninth test pad for measuring bilirubin, and a tenth test pad for measuring glucose. After urine is added to the first test pad, the test result is read within the valid time. After the first test pad's result is completed, urine sample is applied to the second test pad, and the result is read within the valid time for reading the second test pad's result. This process is repeated sequentially until the tenth test pad is tested.

[0029] In some methods, where the test results are read in the order of 10 test pads, the effective reading time is 2 minutes, 60 seconds, 60 seconds, 60 seconds, 60 seconds, 60 seconds, 40 seconds, 35 seconds, and 35 seconds.

[0030] In some methods, when urine is applied to the test pad for testing glucose, the dropper needs to be brought into contact with the test point and gently rotated to allow the urine to spread over the test area.

[0031] In some embodiments, the test strip also has a cover plate that covers the test area and is movable along the longitudinal direction of the test strip, which exposes the test pad sequentially as urine samples are dropped onto the test pad at intervals.

[0032] In some embodiments, the testing apparatus further includes a flexible film covering the test pad, which is sequentially peeled back to expose the test pad to which urine is to be applied as urine samples are sequentially applied to the test pad at intervals.

[0033] In some embodiments, the testing apparatus further includes an upper card with a window and a lower card as a base plate, the test strip is located between the upper and lower cards, the test pad is located inside the window, and the associated absorbent material is located on the lower card and below the support sheet.

[0034] In some embodiments, each window exposes one or two test pads, through which urine samples are applied sequentially at intervals.

[0035] In some embodiments, the upper card further includes a spacer structure located on a non-absorbent spacer area between test pads, thereby independently placing one or two test pads within the window.

[0036] In some embodiments, each window exposes one test pad, with a spacer extending between each window on a non-absorbent spacer area between every two test pads, thereby independently placing one test pad within the window; a urine sample is applied to each test pad through the window, and the color change of each test pad is observed to determine whether the test result is negative or positive.

[0037] In some embodiments, the width of the window is greater than the width of the test strip support, thereby creating a gap between the window and the support, allowing excess urine to flow through the gap into the absorbent material below for absorption.

[0038] In some embodiments, the testing apparatus further includes a color chart printed with color blocks of different color depths. By comparing the color on the test pad with the color on the color chart, the quantity of the analyte in the urine sample or the properties of the liquid sample can be obtained.

[0039] In some configurations, the color blocks are placed on the upper panel and near the window.

[0040] In some embodiments, the device includes test sequence markings on each test pad to guide the tester in performing sequentially spaced tests according to the markings.

[0041] In some embodiments, the device includes a time marker on each test pad indicating the time for reading valid test results, prompting the tester to obtain the test results within the valid time frame.

[0042] This invention also includes several other useful aspects described in detail herein. These will be fully understood through the use of these products. To obtain a complete evaluation of the invention, it is necessary to examine it further in conjunction with various specific embodiments. Furthermore, other aspects and specific embodiments of the invention will also be described in detail.

[0043] The overview of the invention is not limited to the above description, and other features and benefits of the invention will become apparent from the following detailed description and claims. Attached Figure Description

[0044] Figure 1 This is a structural schematic diagram of a specific embodiment of the present invention (containing 13 test indicators).

[0045] Figure 2 This is a structural schematic diagram of a specific embodiment of the present invention (containing 10 test indicators).

[0046] Figure 3A This is a schematic diagram of the operation process in a specific embodiment of the present invention.

[0047] Figure 3B This is a schematic diagram illustrating the operation process of comparing the test strip with the color card in a specific embodiment of the present invention.

[0048] Figure 4 This is a top view of the testing device in a specific embodiment of the present invention.

[0049] Figure 5 This is a schematic diagram of the testing device in a specific embodiment of the present invention.

[0050] Figure 6 This is an exploded structural diagram of the testing device in a specific embodiment of the present invention.

[0051] Figure 7 This is a cross-sectional structural diagram of the testing device in a specific embodiment of the present invention.

[0052] Figure 8 This is a longitudinal cross-sectional structural diagram of the testing device in a specific embodiment of the present invention.

[0053] Figure 9 This is an exploded structural diagram of the testing device in a specific embodiment of the present invention.

[0054] Figure 10 This is a schematic diagram of the testing device in a specific embodiment of the present invention.

[0055] Figure 11 This is a cross-sectional structural diagram of the testing device in a specific embodiment of the present invention.

[0056] Figure 12 This is an exploded three-dimensional structural view of the testing device in a specific embodiment of the present invention.

[0057] Figure 13 This is a three-dimensional structural diagram of the testing device in a specific embodiment of the present invention.

[0058] Figure 14 A schematic diagram of the assembly structure of the testing device in one specific embodiment of the present invention.

[0059] Figure 15 A schematic diagram of the assembly structure of the testing device in one specific embodiment of the present invention.

[0060] Figure 16 This is a cross-sectional structural diagram of another embodiment of the present invention.

[0061] Figure 17 An exploded three-dimensional structural diagram of the testing device in a specific embodiment of the present invention. Detailed description

[0062] In the following detailed description, the accompanying drawings and corresponding textual descriptions are merely illustrative of specific embodiments that may be implemented according to the present invention. We do not preclude the possibility that the present invention may be implemented in other specific ways or that its structure may be modified without departing from the scope of the invention.

[0063] Detection

[0064] "Detection" refers to the assay or testing for the presence of a substance or material, such as, but not limited to, chemical substances, organic compounds, inorganic compounds, metabolites, drugs or drug metabolites, organic tissues or their metabolites, nucleic acids, proteins, or polymers. Furthermore, "detection" indicates the quantity of the substance or material being tested. More specifically, "assay" also refers to immunoassay, chemical assay, enzyme assay, etc. In specific embodiments of the present invention, reaction pads or test pads are used to test the properties of a sample or the presence of the analyte through a chemical reaction. The analyte can also be tested using immunoassay methods.

[0065] sample

[0066] The samples in the detection device of this invention include biological liquids (e.g., case fluids or clinical samples). Liquid or fluid samples can be derived from solid or semi-solid samples, including excrement, biological tissues, and food samples. Solid or semi-solid samples can be converted into liquid samples using any suitable method, such as mixing, crushing, softening, incubating, dissolving, or digesting solid samples enzymatically in a suitable solution (e.g., water, phosphate solution, or other buffer solution). "Biological samples" include samples derived from animals, plants, and food, such as urine, saliva, blood and its components, cerebrospinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures, and media derived from humans or animals. Preferably, the biological sample is urine, and more preferably, the biological sample is saliva. Food samples include food processing substances, final products, meat, cheese, wine, milk, and drinking water. Plant samples include those derived from any plant, plant tissues, plant cell cultures, and media. "Environmental samples" originate from the environment (e.g., liquid samples from lakes or other water bodies, sewage samples, soil samples, groundwater, seawater, and wastewater samples). Environmental samples may also include sewage or other wastewater.

[0067] In some embodiments, the test element of the present invention requires manual application of the fluid sample, for example, by using a dropper to apply the liquid sample to a test pad, and testing the analyte and the properties of the liquid. In some embodiments, the sample of the present invention is a urine sample.

[0068] Downstream and upstream

[0069] Downstream or upstream is a division based on the direction of liquid flow; generally, liquids or fluids flow from upstream to downstream. A downstream region receives liquid from an upstream region, and the liquid can also flow from upstream to downstream. This division is generally based on the direction of liquid flow. For example, on some materials where capillary force promotes liquid flow, the liquid can overcome gravity and flow in the opposite direction of gravity; in this case, upstream and downstream are still defined according to the direction of liquid flow. For example, in the detection device of this invention, when a fluid sample is received at the bottom of the test chamber, such as a liquid sample flowing into the sample chamber, such as a urine or saliva sample from the test subject, the fluid can flow from one end of the test strip to the other, flowing from bottom to top.

[0070] Liquid Connectivity

[0071] Liquid connectivity refers to the ability of a liquid or gas to flow from one place to another, possibly guided by physical structures. These physical structures generally refer to the liquid flowing passively or actively through their surfaces or internal spaces. Passive flow is typically caused by external forces, such as capillary action or pressure. The flow can be due to the liquid's own forces (gravity or pressure) or passive flow. Pressure-driven fluids can flow in the direction of gravity or in the opposite direction, or be propelled by pressure from one location to another. Connectivity does not necessarily require the presence of a liquid or gas; it merely indicates a connection or state between two objects where liquid can flow from one object to another. Conversely, if there is no liquid or gas connectivity between two objects, and liquid cannot flow from one object to the other, this state is called non-connectivity, a state without liquid or gas connectivity.

[0072] Analyzed material

[0073] Examples of analytes applicable to this invention include small molecules, including narcotics (such as drugs of abuse). “Drug of abuse” (DOA) refers to the use of a drug for non-medical purposes (typically for numbing or paralyzing effects). Abuse of these drugs can lead to physical and psychological harm, dependence, addiction, and / or death. Examples of drug abuse include cocaine; amphetamines (AMPs) (e.g., Black Beauty, White Amphetamine Tablets, Dextroamphetamine, Dextroamphetamine Tablets, Beans); methamphetamine (METs) (crank, crystal, speed); barbiturates (BARs) (e.g., Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleep aids); lysergic acid diethylamide (LSD); and depressants (downers, goofballs, barbs, blue devils, yellow). Jackets (methaqualone); tricyclic antidepressants (TCAs, i.e., imipramine, amitratriptyline, and doxepin); dimethyldioxymethylaniline (MDMA); phencyclohexylpiperidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opioid preparations (i.e., morphine (MOP), opium, cocaine (COC), heroin, hydroxydihydrocodeine); anti-anxiety drugs and sedative-hypnotics. Anti-anxiety drugs are a class of drugs mainly used to reduce anxiety, tension, and fear, stabilize mood, and also have other effects. Drugs with hypnotic and sedative effects include benzodiazepines (BZO), atypical BZ classes, fused diazonium nitrates (NB23C), benzodiazepines, ligands of BZ receptors, open-ring BZ classes, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazides and thiazole derivatives, other heterocyclic compounds, imidazole-type sedatives / analgesics (such as hydroxydihydrocodeine ketone (OXY), methadone (MTD)), propylene glycol derivatives—carbamates, aliphatic compounds, anthracene derivatives, etc. The detection device of this invention can also be used to detect drugs intended for medical use but prone to overdose, such as tricyclic antidepressants (imipramine or analogues) and acetaminophen. After being absorbed by the body, these drugs are metabolized into small molecules, which are present in bodily fluids such as blood, urine, saliva, and sweat, or in some bodily fluids.For example, the analytes detected using this invention include, but are not limited to, creatine anhydride, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone, follicle-stimulating hormone, etc.), blood, white blood cells, sugars, heavy metals or toxins, bacterial substances (such as proteins or sugars specific to certain bacteria, such as Escherichia coli O157:H7, Staphylococcus, Salmonella, Clostridium, Campylobacter, L. monocytogenes, Vibrio, or Cactobacillus), and physiologically relevant substances in urine samples, such as pH and specific gravity. Any other clinical chemical analysis can be performed using a lateral flow detection method in conjunction with the device of this invention. The sample of this invention can be urine, and the analytes can be substances such as HCG and LH, used for ovulation testing or early pregnancy detection.

[0074] For example, the test strips or test apparatus of the present invention can be used to test the properties of liquid samples, such as urine, containing analytes. For example, the following analytes and their properties can be tested.

[0075] Glucose (GLU) is tested using an enzymatic method, employing two enzymes: glucose oxidase and catalase. Almost all test strips now use enzymatic methods due to their advantages such as high specificity, high sensitivity, and short reaction time. Different test strip models use different indicators. However, there are two methods for preparing the test pad for glucose testing. Because it's an enzymatic test, it's crucial to maintain enzyme activity and avoid using too much sample, as this will result in a very dark color and make testing impossible. Therefore, a small amount of liquid is generally required. To maintain enzyme activity, hydrophobic substances are added. These hydrophobic polymers, such as carboxymethyl cellulose, can maintain enzyme activity. However, these hydrophobic substances form a hydrophobic film on the test pad during treatment. When liquid is dropped onto the test pad surface, it doesn't spread naturally. Therefore, when adding liquid to the test pad, the bottom of the dropper must contact the test surface to allow the liquid to spread. Furthermore, when using this indicator for testing, it's undesirable to have too much sample on the test pad. For example, substances in urine, such as acidic pH and nitrogen, can affect enzyme function. Therefore, this indicator is often tested last, not first. Additionally, this indicator has the fastest effective reading time, generally within 30 seconds. By the time the operator has completed testing the 10th or 13th indicator, they are already familiar with the process. Therefore, placing the indicator with the shortest reading time last is a preferred embodiment of this invention.

[0076] The significance of testing blood samples includes the following aspects: First, physiological glycosuria is transient glycosuria, which is temporary and returns to normal after ruling out physiological factors. There are three main types: ① Dietary glycosuria, caused by consuming a large amount of sugar in a short period, leading to excessively high blood glucose levels; ② Stress-induced glycosuria, which occurs in cases of brain injury, cerebrovascular accident, emotional excitement, or periodic limb paralysis due to strenuous exercise, stimulating the medullary glucose center and causing abnormal secretion of adrenal hormones or insulin, resulting in temporary glycosuria; ③ Glycosuria is commonly seen in the mid-to-late stages of pregnancy. Pathological glycosuria can be divided into three types: ① True glycosuria, which is caused by a relative or absolute deficiency of insulin secretion, resulting in blood glucose concentration exceeding the renal threshold for glucose. Urine glucose testing can not only diagnose diabetes but also guide clinicians in determining insulin dosage and assessing treatment efficacy; ② Renal glycosuria, which is caused by impaired renal tubular reabsorption of glucose. In newborns, the proximal convoluted tubules are not fully developed, which can also lead to glycosuria; ③ Other types of glycosuria, such as excessive growth hormone (acromegaly), excessive thyroid hormone (hyperthyroidism), excessive adrenal hormone (pheochromocytoma), cortisol (Cushing's syndrome), and glucagon, can all cause blood glucose concentration to exceed the renal threshold for glucose, resulting in glycosuria. Additionally, obesity and hypertension can also cause glycosuria. Because the subsequent reaction in urine glucose analysis strips is a redox reaction, when the urine contains substances with a stronger reducing power than the pigment, the test results may be lower than expected or even false negatives. For example, the presence of vitamin C in the urine can cause lower test results or even false negatives. Therefore, the dripping method avoids some of the above-mentioned defects. Setting this indicator last also takes into account the interference of other substances. Therefore, it is not desirable for too much urine to be absorbed by the test pad. The more it is absorbed, the greater the interference. In addition, keeping the reading time within 30 seconds is also to minimize the interference of these interfering substances. After all, these interfering substances need time to react with enzymes and substrates. Therefore, the shorter the reading time, the more conducive it is to the accuracy of the test results.

[0077] Bilirubin (BIL) and urobilinogen (URO). Under acidic conditions, diazonium salts act on the center of bilirubin, causing it to break and couple with the diazonium salt to form two molecules of azobilirubin, resulting in a color change. There are generally two reaction principles for urobilinogen analysis strips: one is the aldehyde reaction of urobilinogen with p-dimethylaminobenzaldehyde under acidic conditions (i.e., urobilinogen condenses with aldehyde to form a red acetal compound, commonly known as Euler's reagent). The other is the diazonium salt method, where urobilinogen couples with diazonium salts under acidic conditions to form a purple-red azo compound. Clinical significance: 1. Bilirubin detection is of great value in the diagnosis of hepatobiliary diseases, as urobilinogen more sensitively reflects liver function. 2. Bilirubin detection helps in the diagnosis of jaundice. In cases of sepsis, favism, and incompatible blood transfusions, massive destruction of red blood cells leads to hemolytic jaundice. Although bilirubin levels are significantly increased in these cases, most are indirect bilirubin; therefore, bilirubin in urine remains negative. 3. The detection of prochobilins can sensitively reflect hepatocyte function. Clinical experience shows that prochobilins in urine are already significantly increased in the early stages of viral hepatitis, before jaundice appears. Their binding with bilirubin can provide a basis for diagnosing the type of jaundice. Jaundice can be broadly classified into three categories: ① Prehepatic jaundice, or hemolytic jaundice; ② Hepatogenic jaundice, or hepatocellular jaundice, caused by extensive lesions in hepatocytes or intrahepatic capillary bile ducts due to infection (such as viral hepatitis), poisoning, and cirrhosis, resulting in impaired uptake, binding, transport, and excretion of bilirubin by hepatocytes; ③ Posthepatic jaundice, or obstructive jaundice, caused by obstruction of the common bile duct due to stones, tumors, or congenital biliary atresia. Precautions: 1. The specimen must be fresh to prevent bilirubin from being oxidized to biliverdin. Strong sunlight will accelerate this reaction. Prolonged storage can cause urobilinogen to oxidize into urobilin. 2. High concentrations of vitamin C or nitrite in urine can inhibit the diazo coupling reaction, potentially leading to false negative results. False negatives may also occur when patients receive high-dose chlorpromazine treatment or when the urine contains metabolites of benzodiazepine hydrochloride. 3. Because analytical strips lack a negative gradient for urobilinogen, they cannot be used to detect a decrease or disappearance of urobilinogen. 4. Some endogenous substances in urine, such as bilirubin, indole, and bilirubin, can cause false positives; some medications, such as phenothiazines, can produce color interference. Furthermore, high levels of vitamin C or nitrite in urine can inhibit the diazo coupling reaction, resulting in lower test results or even false negatives.

[0078] Ketone bodies (KET). Urinary ketone bodies include acetoacetic acid, acetone, and β-hydroxybutyrate. While the latter is not a ketone, it often occurs alongside the former two, hence the collective term "ketone bodies." The reaction principle is that under alkaline conditions, acetoacetic acid and acetone in urine react with sodium nitroferricyanide to form a purple-red complex. This test method has a sensitivity of 5–10 mg / dL for acetoacetic acid and 40–70 mg / dL for acetone, and does not react with β-hydroxybutyrate. Clinical significance: 1. Diabetic ketoacidosis. Reduced glucose utilization and excessive ketone body production from fat breakdown make urinary ketone body testing valuable in diagnosing acidosis or coma in uncontrolled or improperly treated diabetes, differentiating it from hypoglycemia, cardiovascular and cerebrovascular acidosis, or hyperglycemic osmotic diabetic coma. 2. Infectious diseases (such as pneumonia, typhoid fever, sepsis, tuberculosis, etc. during the febrile phase), severe vomiting, diarrhea, prolonged starvation, fasting, and general anesthesia can all lead to ketonuria. In addition, ketonuria can also occur in pregnant women due to increased vomiting and reduced food intake caused by pregnancy reactions, leading to significantly increased body fat metabolism. 3. Ketonuria can also occur after chloroform or ether anesthesia, or in cases of phosphorus poisoning. 4. Ketonuria may also occur after taking biguanide hypoglycemic drugs such as phenformin, as the drugs inhibit cellular respiration. Precautions: Because acetone and acetoacetic acid in urinary ketone bodies are volatile substances; acetoacetic acid is easily decomposed into acetone upon heating; and ketone bodies disappear when urine is contaminated with bacteria, urine samples must be fresh, and testing should be timely to avoid low test results or false negatives. The sensitivity of dry chemistry methods for determining ketone bodies to acetoacetic acid is approximately 7-10 times that to acetone, therefore, it differs somewhat from other detection methods.

[0079] Specific Gravity (SG). Reaction Principle: The reaction principle of urine specific gravity test strips is ion exchange. The copolymer of the high molecular weight electrolyte—methyl vinyl ether and maleic acid—is a weakly acidic (-COOH group) ion exchanger. The electrolytes (M+X-) existing in urine in the form of salts dissociate in urine, releasing M+ cations (mainly Na+), which exchange with hydrogen ions in the ion exchanger to release H+ ions. The H+ ions cause a color change in the pH indicator bromothymol blue (color change from green to yellow). Clinical Significance: The measurement of urine specific gravity can estimate renal concentrating function. Since urine specific gravity is also affected by factors such as age, water intake, and sweating, multiple measurements are more effective in reflecting renal concentrating function than a single measurement. Precautions: 1. Urine samples must be fresh and free of strong alkalis, strong acids, or other substances (such as quinine, pyrimidines, etc.), as the presence of these substances will affect the measurement of urine specific gravity. When the urine pH is greater than 7, a correction of 0.005 should be added to the measurement result for strongly alkaline urine. 2. Urine analysis test strips actually measure the concentration of ions in urine. Non-ionic compounds in urine (such as glucose, contrast agents, etc.) will inevitably have some influence on the test results.

[0080] Occult blood (BLD). Reaction principle: The reaction principle of urine occult blood analysis strips utilizes the pseudoperoxidase activity of heme in hemoglobin to catalyze the decomposition of peroxides, producing nascent oxygen. This oxygenates an indicator, causing the indicator to show color. The intensity of the color indicates the concentration of blood in the urine. Clinical significance: 1. When urine contains more than 0.1% blood, it presents as gross hematuria. Blood levels below this can only be confirmed by occult blood testing or microscopic examination of urine sediment. Hematuria is commonly seen in urinary tract inflammation (acute nephritis, renal tuberculosis, urethritis, etc.), tuberculosis, and tumors. The presence of white blood cells indicates inflammation. A positive protein test, the presence of renal epithelial cells and casts in the urine sediment, should raise suspicion of nephritis. The presence of red blood cell casts, in particular, is evidence of renal parenchymal bleeding. 2. Hemoglobinuria is seen in paroxysmal hemoglobinuria, as well as in various poisonings, infections, streptococcal sepsis, malaria (blackwater fever), burns, and hemolytic transfusion reactions. Precautions: 1. Menstrual blood from adult women can often cause false positives in the test results; therefore, necessary urine collection measures should be taken to reduce contamination. 2. The analytical test strip can test not only red blood cells but also hemoglobin. Therefore, when hemoglobin breaks down, it can cause inconsistencies between the test strip results and the microscopic examination results, which should be differentiated. 3. The presence of heat-labile enzymes, myoglobin, or bacteriuria in urine can cause false positives. High levels of vitamin C in urine can inhibit subsequent reactions, leading to lower test results or even false negatives. Therefore, analytical test strips with vitamin C interference resistance should be used.

[0081] pH detection principle: acid-base indicator method; reagent composition: methyl red, bromothymol blue. Reaction process: when the two acid-base indicators, methyl red and bromothymol blue, come into contact with the urine sample, a color reaction occurs. The color range is: pH 5-9, changing from orange, green, and blue from acidic to alkaline.

[0082] Protein (PRO): Detection principle: Acid-base indicator protein error method; Reagent composition: Bromophenol blue acid-base indicator, citric acid buffer system, surfactant. Reaction process: When the bromophenol blue acid-base indicator in the reagent comes into contact with protein (mainly albumin) in the urine sample, a reaction occurs and a color reaction is produced. The intensity of the color is directly proportional to the protein (mainly albumin) content.

[0083] Nitrite (NIT): Detection principle: Nitrite reduction method; Reagent composition: p-aminophenylarsinic acid, 1,2,3,4-tetrahydrobenzoquinol. Reaction process: When p-aminophenylarsinic acid in the reagent comes into contact with nitrite in the urine sample, it reacts to form a diazonium salt. The diazonium salt then reacts with 1,2,3,4-tetrahydrobenzoquinol to produce a red compound. The intensity of the color is directly proportional to the nitrite concentration.

[0084] Other chemical testing methods for the analytes not described in this specification are all existing technologies and are conventional methods.

[0085] Test element

[0086] Figure 1 A specific embodiment of the present invention is illustrated, a test strip 100. The test strip includes a non-absorbent support sheet 90 on which test pads, made of absorbent material, are sequentially spaced from one end to the other. Each test corresponds to a test index, for example... Figure 1 As shown, the test pad contains 13 pads, each corresponding to a specific test indicator. For example, from left to right: pad 101 for leukocytes, pad 102 for nitrite, pad 103 for urobilinogen, pad 104 for microalbumin, pad 105 for protein, pad 106 for sample pH, pad 107 for blood cells, pad 108 for urine specific gravity, pad 109 for ascorbic acid, pad 110 for creatinine, pad 111 for ketones, pad 112 for bilirubin, and pad 113 for glucose. These pads are spaced apart by non-absorbent support sheets (e.g.,...). Figure 2 Parts 114 and 115 are non-absorbent support areas used to separate the test pads; then a blank area 90 is left on the left as a handhold, which can be held when testing individual test strips independently (see Figure 3). The absorbent test pads have 13 sections, each containing a chemical reagent for testing a substance in a liquid sample, and each test pad is spaced apart, for example... Figure 2 The white support area 114 is the interval area. The distance between each test pad is generally between 3-8 mm. There is no liquid flow between each test pad. Instead, the non-absorbent support pads are separated. In this way, when testing is required, the liquid is directly dripped onto the test pads in sequence to complete the test. When there are multiple test pads, there is a blank area between each two test pads, which is also the interval area between the test pads.

[0087] Traditionally, such test strips are typically operated by collecting liquid, such as urine, in a test tube with a depth similar to that of the test strip. The entire test strip is then inserted into the test tube, ensuring that each test pad comes into contact with the urine almost simultaneously. The strip is then removed from the test tube and placed into a machine for reading (using optical principles, such as taking a picture and analyzing the color patches of the test pads to automatically generate positive or negative results). Alternatively, multiple test pads can be visually compared with a colorimetric chart to determine the color on each test pad and obtain the test result. However, if such test strips are directly used by inexperienced testers, especially for home urine testing without automated results reading, and if the procedure involves inserting one end of the test strip (shown as 100, with the white blood cell count) into a test tube and then removing it to read the results, it presents a significant challenge. Firstly, the test strip contains 13 indicators. The operator needs to compare the color changes of the 13 test strips with a standard color chart. Furthermore, the color blocks on the standard chart have multiple meanings for each indicator, such as specific values ​​for positive results, white blood cell counts, pH levels, etc., and must complete the readings within a specified time. For someone without practical experience conducting home testing, this is a challenging task, almost impossible. One aspect is the difficulty in accurately reading the results. The test pads are numerous, with various color charts representing different meanings. Furthermore, each test pad must be read within a specified or required time; otherwise, the result is considered invalid. For example, when reading the first indicator, white blood cells, it is generally required to be completed within 2 minutes. The last indicator, glucose, needs to be read within 30 seconds. Reading from the first indicator to the third typically takes 2-3 minutes. Exceeding the reading time for the last indicator often results in the test pad finishing its reaction before the reading time is sufficient, rendering the result invalid. This method of contacting multiple test indicators with liquid and then reading the results sequentially is unsuitable for home testing, especially for those without experience or professional expertise in operation and result interpretation.

[0088] Therefore, this invention changes the traditional operating method, allowing the tester or operator to operate intermittently or at intervals. One or two test pads are selected, one pad receives the liquid first, and after that pad completes the test and the result is read, the next test pad is added and the result is read. There is an interval or waiting time in between. Although this is not very efficient, it is particularly suitable for people without operating experience, such as those doing home testing. For example, by adding liquid to a test pad and waiting for the reaction, the result can generally be read within a specified time. For example, for testing white blood cell counts, the result can be read within 2 minutes after adding liquid, while for testing nitrite, the result can generally be read within one minute. This allows the operator to complete the test smoothly, record the results, and have enough time to compare the results with each color patch on the standard color chart, select the closest color patch, and record the result value. There is no need to worry about the reading time of other test pads, since the others have not yet been applied to and therefore have no testing structure. After completing the first or second test pad, or after the first or second test pad is finished, two more test pads are used for testing, such as urobilinogen and microalbumin, also in an intermittent or interval-based manner. Urine is added to these two test pads, and after these two tests are completed, a third set of tests, such as protein and pH value, is performed. Although this intermittent or interval-based approach takes longer than traditional methods, it ensures that each test result is valid and accurate. Therefore, the "intermittent or interval-based" method described in this invention, when multiple indicators are available, selects a portion of the test pads for testing and reads the results. After the selected portion of the test pads is completed, the other portion of the test pads is then tested, instead of the traditional method where all test pads are exposed to liquid at once. For example, one test pad can be selected for testing, and after the test is completed, the next test pad is used.

[0089] The "test ended" or "test completed" mentioned in this invention refers to a testing process. This process may include, for example, introducing liquid into the test pad, observing the pad's reaction and color change (this usually occurs very quickly), comparing the test pad's color with a standard color chart, and then obtaining the test result based on the color comparison. The entire process constitutes the end of the test. Of course, it may also include the time required to read and record the test result. In other words, the test continues until one test pad has finished testing or completed, before starting the next test pad. In practice, the two test pads do not simultaneously contact the sample; there is a time interval between them. This allows even those without practical experience to operate the test at home.

[0090] In other embodiments, for example, Figure 2 The test strips shown have 10 selected test pads set on a non-absorbent support sheet 200. Each test pad corresponds to the following test indicators: test pad 101 for leukocytes, test pad 102 for nitrite, test pad 103 for urobilinogen, test pad 105 for protein, test pad 106 for pH, test pad 107 for blood, test pad 108 for specific gravity, test pad 111 for ketones, test pad 112 for bilirubin, and test pad 113 for glucose. The testing method is the same as described above, allowing for self-testing at home, suitable for both experienced and inexperienced users.

[0091] In some methods, to rationally arrange the testing order, the effective testing time for each test indicator is sequentially shortened, or the time for obtaining a valid test result is gradually reduced. In other words, when the test pads are arranged on the support sheet, they are arranged in descending order of the effective test result reading time. For example, the first test indicator (the first test pad) has the longest effective test result reading time, while the last test indicator (the last or latest test pad) has the shortest effective test result reading time. For instance, the test result reading time for test pad 101 for testing leukocytes is 2 minutes, meaning that the effective time from adding liquid to reading the test result is 2 minutes, or the test result read within 2 minutes is valid, while the result read beyond this time is invalid. This has the longest time among all 10 or 13 test pads and is ranked first for the first or first drop test. After the first test is completed, the subsequent test pads are used for intermittent testing. For example, the effective test times for the following indicators are: nitrite (60 seconds), urobilinogen (60 seconds), protein (60 seconds), pH (60 seconds), blood (60 seconds), specific gravity (45 seconds), ketone (40 seconds), bilirubin (30 seconds), and glucose (30 seconds). This sequential shortening does not mean that the effective time for each test pad is strictly reduced, but rather that the overall time is shortened. Several indicators may have the same effective time, but the overall trend is towards a shorter effective time.

[0092] It's understandable that the effective test time here is merely a specific example. This effective test time is pre-designed and may vary depending on the reaction principle, substrate, etc. However, in any case, the preferred approach is to test the longest effective test time first (the initial test) and the shortest effective test time last. For example, the glucose 115 test is placed last, with an effective test time of 35 seconds. The more test parameters there are, the different effective test times will be for each test pad; there will always be a specific duration.

[0093] The "effective test time" of this invention refers to the time from the application of the sample to the end of the test and the reading of the test results (including recording the test results). Test results obtained within this time range are valid. If this time is exceeded, the test results are invalid. This is because the reference is a chemical test, and the color change of the test pad may continue. Only test results read and completed within the specified time are valid. If the time is exceeded, the test is considered invalid.

[0094] The biggest advantage of arranging tests sequentially by valid test time is that at home, there's always a learning curve. The longest valid test time is placed first for the initial test, and the shortest last for the final test. This has several advantages: For first-time users, adding liquid, waiting for the test pad's color to change, and then comparing the test pad with the standard color chart is a relatively complex process. Especially when comparing the test pad's color with the standard color chart, choosing the closest match is crucial, which takes considerable time. Although the waiting time is the longest, as long as it falls within the fixed valid timeframe, the test result is valid, reducing the difficulty and increasing accuracy. Generally, a timer is present to provide reminders, allowing the user to understand the total time required for each test (test pad) from liquid addition to completion, or the total time needed to finish the test. This provides a reference for determining the completion time of subsequent test pads. For example, if the time from adding liquid to the end of the first test is 60 seconds, then when selecting the next test, you can choose only the nitrite test, which has a 60-second validity period. However, if the time from adding liquid to the end of the first test is 25 or 30 seconds, then for the next test, you can choose to test both nitrite and urobilinogen. This is because, with an even distribution, liquid can be added sequentially to the two test pads testing nitrite and urobilinogen, allowing for accurate readings within the 60-second validity period. Since these test pads react relatively independently, the order of operation can be chosen independently. Conversely, if the first test pad takes a relatively long time, say 110 seconds, then before proceeding to the next test pad, you should have time to consider or plan, choosing an appropriate time for the next test pad, such as 80-60 seconds, rather than choosing pads with very short effective test times, like 30-35 seconds. Therefore, the time taken to operate the first test indicator can roughly estimate which one or two indicators to test next. After all, different people have different time requirements; some people are more cautious and may take longer, while others, such as those with medical knowledge or good eyesight, may take less time. This allows for a more reasonable arrangement of the subsequent test procedures. After all, the people who conduct home testing are diverse, with varying personalities, levels of caution, different eyesight, and different educational backgrounds.Therefore, in some methods, the last few indicators tested have the shortest effective testing time, while the first indicator has the longest effective testing time. This ensures that operators can gradually become proficient from unfamiliarity to mastery. In addition, the range from the longest to the shortest effective time makes the test more adaptable and compliant, conforming to operational habits and making it more user-friendly.

[0095] The above refers to multiple test indicators being set on a non-absorbent support sheet. It's understandable that the non-absorbent support sheet of the test strip can have 10 test indicators, 13 test indicators, or sometimes only one test indicator, such as any one of 1-15, or any 2, 3, 4, 5, 7, 10, 12, or 15 of 15. The test pads corresponding to these test indicators are fixed sequentially or at intervals on the non-absorbent support sheet, and the arrangement can also be based on the effective test time from longest to shortest.

[0096] If only test strips are available, when adding liquid to the test pad, as shown in Figure 3, it is generally necessary to use a pipette to draw the liquid and then add 1 or 1-2 drops to the test pad. Although this is the requirement, often more liquid may be added. To solve this problem, an absorbent material 40 is placed under the test strip. This absorbent material absorbs excess sample, preventing it from flowing onto nearby test pads. For example, as... Figure 2 As shown, when adding liquid to test pad 101 for testing leukocytes, it is undesirable for the liquid to come into contact with the nitrite-containing test pad 102. Excess liquid should be allowed to flow onto the absorbent material 40. Additionally, sometimes, when only one drop of liquid is needed for the test pad, due to operator inexperience, a few extra drops may be added, and this excess liquid will be absorbed by the absorbent material 40 below. Because each test pad has a saturation absorption capacity, too much liquid can interfere with the test results. Therefore, it is desirable for excess liquid to be absorbed without affecting the test results. Some test pads have a saturation absorption capacity of only one drop, for example, 40-50 microliters. Figure 3A and 3BThe basic operating procedure is as follows: First, urine is collected using a urine cup 10. Second, a test strip 200 is removed from the packaging bag 20. Each test pad on the strip is then compared to the leftmost color band (calibration band, all negative and without color change) 32 on the standard color chart 30 (third step). If the color of each test pad matches the color band 32 on the standard color chart, the test strip is valid. If the color of any test point does not match the color of the color patch on the color chart, the test strip is invalid and cannot be tested. Therefore, the color on the leftmost color band 32 on the color chart should be the same as the color of the test pad that has not yet reacted. If the color of the test pad on the test strip changes, the test strip is invalid, for example, due to moisture or contamination, and cannot be tested; it should be discarded. When test strip 200 is deemed valid, place it on the surface of absorbent paper 40, then use pipette 50 to absorb liquid from the urine cup. Add one drop of liquid to the first test pad 101 and compare it with the corresponding color block on the color chart 30. Read the test result within the valid time. After the first test pad 101 is tested, proceed to the next test pad 102, repeating this process from the first to the ninth test pad 112. After the first test pad 101 is tested, add urine to the second test pad 102 and read the result within the valid time (e.g., within 60 seconds). When glucose is detected, add one drop of liquid, rotate the dropper to spread the droplet on the test pad surface, wetting the pad, and then read the result. This is because the test pad for this indicator contains hydrophobic material, making it difficult for the liquid to spread. The result must be read within 35 seconds.

[0097] Although a single test strip is used ( Figure 1-2The test can also be completed using the method shown in Figure 3, but it still has some drawbacks. For example, the distance between the test pads is relatively small. Sometimes, when adding liquid, it may drip onto a test pad that is not intended for testing, or when too much liquid is added to a test pad, this liquid will flow onto adjacent test pads. Although the space between the test pads is provided by partially non-absorbent support sheets, liquid will still flow onto adjacent test pads, causing mutual interference and affecting the final test results. For example, when adding liquid to the first test pad 101, it may also be added to the second test pad 102 at the same time. In this case, for inexperienced home users, this may cause concern and misjudgment, ultimately leading to abandoning the test, making the test unfriendly and inconvenient to operate. These disadvantages are mainly due to the large number of test pads, the many test items, and the fact that the user lacks professional experience. In addition, after each test, it is necessary to compare the color of the test pad with the individual color chart, which is actually a rather tedious task. The color chart has 10-13 test indicators, and the color depth of each test indicator is different, which can easily cause confusion. Often, when comparing with the color chart, confusion occurs, ultimately leading to incorrect results.

[0098] To improve the testing experience, especially the home testing experience, this invention provides alternative designs, such as... Figure 4-8 One embodiment shown provides a lower plate 323 and an upper plate 321. The lower plate has insertion holes 338 and 336, while the upper plate has insertion pins, allowing the upper and lower plates to be joined to form a device. The upper plate has multiple windows, such as windows 324, 325, 326, 327, and 328, each containing two test pads. The test strip is still a non-absorbent support sheet 200, on which multiple absorbent test pads 101, 102, 103, 105, 106, 107, 108, 109, 110, and 113 are arranged. Each test pad is separated by a gap 114 or 115 on the test strip.

[0099] 116, 117, 118, 119, 120, 121, 122, totaling 9 interval regions (e.g. Figure 2 The distance between each interval area is the same. Additionally, an absorbent filter paper 322 is placed below the support sheet 202. In some embodiments, partition structures 340, 341 are provided on the upper plate 321. These partition structures extend downward from the areas 339, 390 between the windows and contact the interval areas 117, 118 on the non-absorbent support sheet, exerting a compressive effect on these interval areas, thus placing the test pads in relatively independent spaces relative to the windows and partition structures. The test pads are grouped and spaced within the windows, for example... Figure 8As shown. The partition structures engage with the interval areas on the test strip. For example, window 331 contains two test pads 106 and 107, and partition structures 340 and 341 engage with the interval areas 117 and 119 from both ends of the test pads. This allows the two test pads to be located within the same window. In this way, every two test pads are divided into different windows. If there are 10 test pads, they are divided into 5 windows, separated by partition structures, making the test pads more independent and spatially separated. Figure 4-8 In the specific configuration shown, two test pads are placed within each window, which are separated by a partition structure. Specifically, barrier strips 340 and 341 are placed on the interval areas 117 and 119, with the width of the barrier strips being substantially equal to the width of the interval areas 117 and 119. The partition structure is positioned between the windows, with its ends covering the interval areas 117 and 119 on the test strips. This results in five independent windows, each with two independent test pads, each containing a first test pad 301 and 302. In other words, the partitions between the windows virtually prevent liquid flow between them. Thus, the operator only needs to drip liquid onto the test pads within the window; the window has sufficient depth to prevent liquid from dripping into adjacent windows. Furthermore, even if there is excess liquid in the first window, it will not flow into adjacent windows because the partitions prevent liquid flow.

[0100] Of course, in some methods, filter paper 322 is placed under the support sheet to absorb excess liquid sample. To better allow excess liquid to flow onto the filter paper below, the window width is slightly larger than the width of the test strip or the non-absorbent support sheet, with a gap 331 between the window and the test strip. When there is excess liquid, it first flows through the gap to the filter paper below for absorption. In some methods, colored blocks can be placed on both sides of the window, for example... Figure 4As shown, negative result color blocks 311, 312, 313, 314, 315, 316, 317, 318, 319, and 320 are set on the left side of the corresponding test pad in the window, and positive result color blocks (not shown) 201 and 202 (with the test item name) are set on the right side. When a droplet is added to the first test pad 301, the test result is read within the specified valid test result time. It is directly compared with the color blocks on the left and right to first determine whether it is a positive or negative result. In fact, it is enough to wait for the positive or negative result to pass. If it is a positive result, further testing is required to confirm. If the color is close to the color block on the left, it means that the color has not changed, and the test result is negative. If the color is the same as the color on the left or the color is darker, the test result is positive. Of course, if no test has started, it is necessary to observe whether the test pad in each window is consistent with the color block on the left. If they are consistent, it means that the test pad is valid. In this embodiment, the test indicators on the test strip are consistent with the color blocks on the left and right. Figure 2 The test strips shown have the same specifications, but the color patches are printed directly on the window. When judging the results, it's unnecessary to compare the test strips with a color chart containing many different color patches, thus avoiding confusion. In some methods, the arrangement of the test pads is also the same, and the testing order remains essentially unchanged, using sequential, intermittent testing, for example... Figure 5As shown, the first test is conducted on test pads with an effective reading time of 2 minutes, followed by tests on test pads with shorter effective reading times. The test using this example has several advantages: First, the window divides multiple test pad areas into several independent units, and the tests within each unit are independent of each other. This avoids errors in liquid addition. Each window is added separately, thus avoiding errors in the order of liquid addition, such as mistakenly adding liquid to the second test point instead of the first test pad. Second, if too much liquid is added to the first test point 101 or the second test pad 102, it will not flow onto the third test pad 103, ensuring the independence of the test pad 103 and preventing interference from excess liquid on the second test pad 102 (the function of the partition structure). It is understandable that when individual test strips exist, the operator may sometimes add liquid to both the second and third test pads when adding liquid to the second test pad 102. On the partition 114 between the test pads 103, although the liquid added to 114 is not absorbed by the support sheet, it can easily come into contact with the dry test pad. In this way, the two test pads are kept in fluid communication through the liquid on the partition 114, which causes cross-contamination between adjacent test pads. Then, a partition or blocking structure is set on the partition 114 to cut off the liquid flow between the second and third test pads, thereby avoiding cross-contamination. Third, negative color blocks 311-320 are tested near the window. These negative color blocks 311 are directly printed near the test pad. Before and after the test, the test results can be judged directly by referring to the color blocks, without having to compare the test strip with the standard color blocks. Because of the test device, the assembly of the upper and lower cards is larger than a single test strip, and it is more difficult to compare with the color card.

[0101] Adopting such Figure 4-8 The test kit may not be encapsulated in an aluminum foil bag, or multiple kits may be placed together, for example, in a large bag. Additionally, when multiple test kits are placed together, a test strip (e.g., ...) should be included in the kit. Figure 1 Or 2) Then a colorimetric card. To easily verify whether multiple testing devices are effective, directly compare a single test strip with the verification color chart of the colorimetric card. If the single test strip is effective, it means that multiple testing devices are also effective. This is especially suitable for families with multiple users or people who use it frequently.

[0102] Additionally, such as Figure 3B The test card is also for easy recording of test results. When comparing the color of the test pad with the color block on the color card, simply select the color block that is closest to the color of the test pad and circle it on the color card to indicate the test result.

[0103] In other ways, such as Figure 9As shown, each test pad 101 of the test strip is positioned within a window. If there are 10 test indicators, there are 10 test pads, providing 10 separate windows, with each window containing one test pad. Additionally, 9 partition structures are provided (the specific method is the same as...). Figure 4-8 The method shown is the same. Each partition is located in the interval area between the test pads, allowing each test pad to exist independently, and the added liquid will not flow between them and interfere with the test results. During operation, liquid is added directly into the window, and the result is read directly within the effective time. This is equivalent to each test pad being tested independently, and the added liquid is added through the window, ensuring that it does not drip into other windows. Similarly, color blocks, such as negative or positive color blocks, can be printed near each window. This makes it easy to compare the color of the test pad with the color blocks on the window to determine the test result, such as whether it is a negative or positive result. For example, a positive result is printed on the left side of the window, and a negative result color block is printed on the right side. When the color of the test pad is close to the negative color card, a mark is made directly on the negative color block, indicating that the result of the corresponding test pad is negative; conversely, a mark is made on the positive color block, indicating that the test result of the test pad is positive.

[0104] like Figure 4-8 The order of the test pads on the test strip shown in Figure 9 indicates that the first test pad has the longest effective test time, while the last test pad has the shortest. In some methods, to make home testing more convenient, the test sequence can be indicated next to the window, such as... Figure 13 As shown, such a testing device can have markings printed next to the window, such as numbers from 1 to 10, with 1 indicating the first pad to be tested. It can also display the effective reading time for the test results, such as 2 minutes, 60 seconds, 35 seconds, etc., indicating the effective reading time after liquid is added to the test pad, such as 1-2 minutes, 2-60 seconds, 3-60 seconds, 10-35 seconds, etc., reminding the operator which test pad it is and the effective reading time. This provides clear information and requires minimal instruction. Furthermore, each test pad can be operated independently; even if interrupted, testing can continue, as each pad can be operated and its results interpreted independently. This greatly facilitates home testing and provides greater convenience.

[0105] In other methods, three test strips are provided, each with two or more test items, such as... Figure 12As shown, three test strips 533, 534, and 535 are provided. The first test strip has two test pads, the second has four test pads, and the third has four test pads. Each test pad corresponds to a test item or indicator, and the indicator corresponding to each test pad is different. Correspondingly, a lower plate 522 and an upper plate 521 are provided. The upper plate has multiple windows, each containing one test pad, and a partition structure is set between each window. This partition structure is placed between the interval areas of the test sheet, so that each window contains one test pad. For example, as... Figure 11 As shown, test strip 525 has four test pads, each with a spacer area between it. There are three spacer areas, and three partition structures are provided on the window to separate the four test pads, allowing them to be independently located within the window. The test strip also has four absorbent test pads on a non-absorbent support sheet 530. Preferably, color blocks are provided near the window; multiple color blocks can be provided, including positive and negative color blocks. Different color depths can be used for the positive color blocks, which not only indicates whether the specific test indicator on the test pad is positive, but also provides the approximate content. Of course, in... Figure 4-12 The device shown can be labeled near each window with the name of the indicator being tested by each test pad, such as the abbreviation for white blood cell count (Leu), so that the operator knows the name of the analyte or indicator being tested by the test pad.

[0106] In some ways, in Figure 10 The test apparatus shown has a non-absorbent film covering one or more windows 525, 526, 527, 528. This transparent, non-absorbent film serves two purposes: firstly, it protects the test pad inside the window from moisture, and secondly, it prevents accidental liquid addition. During testing, the non-absorbent film can be peeled off from one end to expose one window's test pad. Liquid is then added to the exposed window. Because adjacent windows are covered by the transparent film, liquid is prevented from being accidentally added to nearby windows. Figure 10For example, a transparent film covers the surface of all three rows of windows. When testing the four test indicators of the third row 591, the transparent film is peeled off from the surface of the third row of windows to expose the first test pad (leftmost) of the third test strip 526. Urine is then added to the first window, and the test results are read within 2 minutes. At this time, the other windows in the third row are covered by the film, as are the windows in the second row 590 and the first row 589. This ensures that during operation, the liquid droplets can only be added to the test pad of the first window (for Leu). Preferably, these films can be black and opaque to prevent oxidation of the test pads by light. Peeling off the black film exposes the test pad, while the others remain covered by the black film, making it clearer to indicate the window where liquid is added and preventing liquid from dripping onto other windows, which are still covered by the film. When testing two test pads, such as for Nit, the film on the window is peeled off to expose the test pad inside, allowing for testing of that test pad. These films can be a single strip covering the entire window, or a single film covering a single window, such as film 532 covering the window for testing pH. Alternatively, films 529 and 530 can respectively cover the windows containing the two test pads on test strip 535. During testing, the films are removed one by one.

[0107] In other implementation examples, such as Figure 15-17 A test strip 200 is provided, on which a sliding cover 600 is attached. This sliding cover covers the test pad. When testing is required, the cover 600 is slid sequentially at intervals, gradually exposing the test pad for testing. For example... Figure 14 As shown, the cover is slidable to expose the test pad 101, and the test parameters of the test pad 101 are tested. After the test is completed, the cover is slid again to expose the test pad 102, and the test of the test pad 102 is completed. For easier operation, a base plate 700 is provided on the test strip. The base plate has grooves 701 and 702, while the cover has two rails 601 and 602. The cover has two edges 601 and 602 as rails, and the grooves are provided on the base plate. The rails can slide in the grooves. A water-absorbing material is provided on the base plate, which is located below the support plate of the reagent strip 200. The cover 600 slides longitudinally, while the base plate, the water-absorbing paper, and the test strip do not move. In this way, the test pads are exposed one by one for testing, avoiding liquid dripping onto nearby test pads and causing cross-contamination.

[0108] All patents and publications mentioned in this specification represent publicly available technology that can be used by this invention. All patents and publications cited herein are also listed in the references as individually referenced. The invention described herein can be implemented in the absence of any one or more elements, or one or more limitations, which are not specifically stated herein. For example, the terms “comprising,” “substantially consisting of,” and “consisting of” in each instance herein can be replaced by the other two terms. The term “an” herein simply means “one” and does not exclude the inclusion of only one, but may also indicate the inclusion of two or more. The terminology and expressions used herein are descriptive and not limiting, and there is no intention to suggest that the terms and interpretations described herein exclude any equivalent features; however, it is understood that any suitable changes or modifications can be made within the scope of this invention and the claims. It is understood that the embodiments described herein are preferred embodiments and features, and any modifications and variations can be made by those skilled in the art based on the spirit of the description, and such modifications and variations are also considered to fall within the scope of this invention and the limitations of the independent and appended claims.

Claims

1. A detection device comprising: The test strip includes a non-absorbent support sheet on which at least two or more absorbent test pads are disposed, with each test pad separated by a portion of the non-absorbent support sheet. The absorbent test pad includes a reaction reagent capable of detecting the analyte in the urine sample or the properties of the test urine sample. An absorbent material is disposed under the support sheet. When a urine sample is applied to one of the two or more test pads, the absorbent material can absorb excess urine sample, thereby preventing the excess urine sample from flowing onto other test pads where no urine sample has been applied.

2. The detection device according to claim 1, wherein, The absorbent test pad is dry before a urine sample is applied, and becomes moist after application, thus producing a color change that indicates whether the substance being analyzed in the urine sample is negative or positive.

3. The detection device according to claim 2, wherein, The urine sample was dropped onto the test pad in sequence at intervals.

4. The detection device according to claim 3, wherein, The sequential application of urine samples begins with the longest effective reading of the test results.

5. The detection device according to claim 4, wherein, The test strip also has a cover plate that covers the test area and can move along the longitudinal direction of the test strip. When urine samples are dropped onto the test pad in sequence at intervals, the cover plate exposes the test pad in sequence at intervals.

6. The detection device according to claim 4, wherein, The device also includes a flexible film covering the test pad, which is sequentially peeled off to expose the test pad to which urine is to be applied when urine samples are applied to the test pad at intervals.

7. The detection device according to claim 4, wherein, The testing device also includes an upper card with a window and a lower card as a base plate. The test strip is located between the upper and lower cards, the test pad is located inside the window, and the absorbent material is located on the lower card and below the non-absorbent support sheet.

8. The detection device according to claim 7, wherein, Each window exposes one or two test pads, through which urine samples are applied sequentially at intervals.

9. The detection device according to claim 8, wherein, The upper card also includes a spacer structure located on the non-absorbent spacer area between the test pads, thereby independently placing one or two test pads within the window.

10. The detection device according to claim 9, wherein, Each window exposes one test pad, and each window extends a spacer structure located on a non-absorbent spacer area between every two test pads, thereby independently placing one test pad within the window; a urine sample is applied to each test pad through the window, and the color change of each test pad is observed to determine whether the test result is negative or positive.

11. The detection device according to claim 9, wherein, The width of the window is greater than the width of the test strip support plate, thus creating a gap between the window and the support plate, allowing excess urine to flow through the gap into the absorbent material below for absorption.

12. The detection device according to claim 7, wherein, The device also includes a color card printed with color blocks of different color depths. By comparing the color on the test pad with the color on the color card, the quantity of the analyte in the urine sample or the properties of the liquid sample can be obtained.

13. The detection device according to claim 12, wherein, The color blocks are placed on the upper panel and near the window.

14. The detection device according to claim 10, wherein, The test pad has 10 test pads, each containing a chemical reagent capable of testing a substance or property in a urine sample. The 10 test pads are arranged in descending order of the time required to interpret the test results: leukocytes, nitrite, urobilinogen, protein, pH value, blood, specific gravity, ketone, bilirubin, and glucose.

15. The detection device according to claim 10, wherein, The testing area has 13 test pads, each containing a chemical reagent that can test for a substance or property in a urine sample. The 13 test points, in descending order of the time required to interpret the test results, are: leukocytes, nitrite, urobilinogen, protein, pH value, blood, specific gravity, ascorbic acid, creatinine, ketone, bilirubin, and glucose.

16. The detection device according to claim 1, wherein, The test pad contains a chemical substance for testing urine glucose, and the test pad comprises a hydrophobic polymer.

17. A detection device comprising: The test strip includes a non-absorbent support sheet on which at least two or more absorbent test pads are disposed, each test pad being separated by a portion of the non-absorbent support sheet. Each absorbent test pad includes a reaction reagent capable of detecting the analyte in a urine sample or the properties of the test urine sample. The test pads are arranged in such an order that the test pad with the longest effective test result is placed first and used for the first application of urine sample; the test pad with the shortest effective test result reading time (less than the first urine sample received) is placed next and used for the second urine sample reception, wherein the second urine sample reception time is after the first test pad's result has been read.

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