Device for testing substance to be analyzed in sample

Abstract

The present invention provides a device for testing sample properties or analytes, the device comprising: a liquid sample collection container, the collection container comprising a collection chamber having an opening for receiving a liquid sample, the collection chamber being enclosed by a side wall and a bottom, the side wall comprises a folding side wall which can be partially folded, so that the volume of the collecting cavity is reduced through folding; and a test device for being inserted into the cavity of the container to contact the liquid sample, the test device being configured to test the analyte in the liquid sample.

Description

Technical Field

[0001] This invention relates to the field of testing, specifically to an apparatus for testing the properties of a sample or the substances being analyzed in the sample, and particularly to a container for collecting urine. Background Technology

[0002] The following background information is provided to help readers understand the present invention and should not be considered as prior art.

[0003] In the medical and healthcare fields, obtaining urine samples from individuals is often necessary. Traditionally, urine collection devices have been containers with small openings, and providing samples in such containers has frequently been problematic for women. Various types of devices have been patented in an attempt to address this issue. However, none have achieved commercial success in modern medical facilities.

[0004] As early as the 1930s, efforts were underway to design funnel-shaped devices that could be attached to specimen containers for ease of use by women. Dwalker, U.S. Patent No. 1,928,170; Hill, 3,131,403; Gibson, 3,171,136 all show early efforts in this type of device. U.S. Patent Nos. 3,811,136 and Burnett, 4,559,649, suggest that one problem with these early funnels was their bulky shape, which prevented women from using them properly. Whitney et al.'s solution was to provide a foldable funnel that was "soft enough to conform to the perineum." Burnett's less costly solution was to "compensate for the women's difficulties by following the natural contours of the perineum, allowing the funnel to be placed close to the subject's body." While Burnett suggested a better fit by configuring the funnel with parallel sides that curve upwards, her design did not gain widespread acceptance.

[0005] Even recently, there have been proposals to abandon efforts to help women provide urine samples using the same small containers typically used by men, and instead provide a larger container that is easier for women to use. Jones discloses such a device in U.S. Patent No. 5,422,076. However, doctors may be reluctant to store two different types of specimen containers or require their male patients to use larger, more expensive containers.

[0006] To address the challenges of convenient urine collection for women, facilitating both testing and storage, it is necessary to improve existing traditional urine collectors. This improvement should allow for easy collection and analysis of analytes in the urine. The design should enable women to collect urine anytime, anywhere, whether traveling or on business trips, and to perform analyte testing at any time. Summary of the Invention

[0007] The purpose of this invention is to overcome some shortcomings of traditional testing devices, particularly the inherent defects of urine collection containers, and to provide a female urine collection device. This device not only facilitates urine collection for women but also allows for immediate testing of analytes in the urine, followed by convenient reading of the test results. Furthermore, the collector is reusable and can be folded for storage when not collecting urine; when needed, the folded portion can be extended and opened.

[0008] This device is particularly convenient for collecting urine and testing substances while traveling, on business trips, or in the wild, allowing for easy monitoring of one's health. Especially for women hoping to conceive, continuous ovulation testing is necessary. Traditional urine collection methods are inconvenient when traveling or on business trips. This invention's urine collection container is easy to operate, portable, and allows for convenient testing and recording of results.

[0009] On one hand, the present invention provides a device for collecting urine by a woman. The device includes a cavity, which is surrounded by a side wall and a bottom. The side wall includes a foldable or extendable side wall. By folding the side wall, the volume of the cavity is reduced, which facilitates storage, especially for travel or field storage. When the folded side wall is extended, the cavity formed facilitates the collection of sufficient urine for testing of substances to be analyzed in the urine.

[0010] In some embodiments, the foldable sidewall comprises multiple foldable regions, each separated by fold lines. The areas between these fold lines are made of a rigid material, such as a rigid plastic sheet. This folding of the sidewall via the fold lines reduces the volume of the cavity, facilitating transportation and storage and minimizing transport and storage volume. When the folded regions are extended, the cavity volume increases, facilitating urine collection and testing.

[0011] In some embodiments, the folded area is entirely or partially made of a flexible material, which is itself capable of contraction and expansion. In other embodiments, the sidewall includes multiple foldable frames with flexible material on them. Folding the frames causes the flexible material to contract, and opening the frames causes the contracted flexible material to unfold, thereby achieving the contraction and opening of the cavity.

[0012] In some embodiments, the sidewalls include rigid or non-folding regions, with the rigid region situated above the folding region. This rigid region serves as the opening of the cavity, providing a rigid opening that facilitates urine collection under the urethra by the woman. In some embodiments, the cavity also includes a base, also made of a rigid material. This base comprises part of the sidewalls and a bottom, and its purpose is to allow the cavity to stand upright on a platform after urine collection, facilitating testing. The rigid material is typically a plastic material that is not easily folded.

[0013] In some embodiments, the cavity includes a first rigid region forming an opening and a second rigid region forming a cavity base, with a foldable region between the first and second rigid regions. During folding, pressure is applied relative to the first rigid sidewall and the second rigid base, causing the cavity to fold. When opening is required, stretching is applied through the first rigid region and the second rigid base, causing the folded sidewall to open, thereby increasing the volume of the cavity. In some embodiments, the rigid sidewall, the foldable region, and the rigid base are injection molded in a single step. In some embodiments, the height of the cavity when open is three times or 1-8 times the height of the cavity when folded.

[0014] In some embodiments, an opening or through-hole is formed in the side wall, which serves as a control line for the maximum volume of urine collected. This allows excess urine to flow out during urine collection, increasing the convenience of urine collection. In other embodiments, these drainage-like through-holes are located on the side wall of a rigid base, controlling the height of the urine. This allows the test element to be inserted into the cavity by resting against the recess, facilitating operation during testing. For example, the height of the urine in the cavity can be controlled to be 1-2 cm or 1 cm. Of course, in other embodiments, when the cavity is full of urine, some urine can be poured out after collection, leaving a height of 1-2 cm of urine in the cavity. This is also a method of the present invention. However, providing a drainage hole is a preferred method. When receiving urine, excess urine is discharged through the drainage hole, for example, into the toilet, while only the required height of urine is retained in the cavity. This prevents contamination of the cavity opening and allows the test element to be placed flat on the dry opening.

[0015] In some embodiments, the cavity includes a bottom that is flexible and deformable. This flexibility allows the bottom to be fixed to a flat surface by adsorption. Thus, when the cavity is collecting urine, negative pressure can be used to fix the cavity to the flat surface, increasing the stability of the cavity.

[0016] In some embodiments, the opening of the cavity is elliptical in shape, corresponding to the female urethral opening. In some embodiments, a rotatable handle is attached to a first rigid sidewall, allowing the woman to hold the handle and insert it near the urethra to collect urine. In some embodiments, the handle is mounted on the rigid sidewall. In some embodiments, a control structure is provided on the rigid sidewall, limiting the handle's rotation position so that it can only rotate towards the opening, restricting its opening position. In some embodiments, the control structure includes a transverse shaft, with a shaft hole on the handle through which rotation is achieved. In some embodiments, a control console is located behind the shaft, limiting the handle's rotation position. This console restricts rotation towards the opening; if rotation moves away from the opening, the console limits the handle to a certain angle before stopping, fixing its position and facilitating urine collection. In some embodiments, the cavity opening is generally elliptical in shape, or has a longitudinal axis greater than its transverse axis, and a longitudinal width greater than its transverse width. The handle is mounted on a rigid sidewall in the longitudinal direction. In some embodiments, the control structure has two shaft holes, allowing the shaft to pass through when the handle's hole is aligned with the shaft holes, thereby achieving a rotatable connection between the handle and the cavity.

[0017] In some methods, a recess is provided on the first rigid sidewall. This recess allows the test element to rest against the liquid, facilitating its insertion into the cavity. In other methods, a pair of recesses are provided. After the test element contacts the liquid, the test strip is placed in the two recesses, allowing the test element to lie flat, thus facilitating the reading of the test results. For example, this can be done by visual inspection or taking a photograph with a mobile phone.

[0018] On the other hand, the present invention provides a method for a woman to collect urine and perform analysis on the substance to be analyzed. The method includes providing a collector including a cavity and a handle rotatably connected to the cavity. The cavity includes an opening and sidewalls and a bottom. The sidewalls include foldable sidewalls, such that when urine collection is not required, the cavity is folded, and when urine collection is required, the folded portion is stretched or unfolded to collect urine.

[0019] In some methods, after urine is collected, the chamber is placed on a flat surface, and then a test element is inserted into the chamber to absorb the liquid. In other methods, after the test element absorbs the liquid, it is placed horizontally over the chamber opening for analysis of the analyte and result reading.

[0020] In some methods, the handle is initially placed over the opening, then rotated until it cannot be rotated further. The person then holds the handle and inserts it under the female urethra to collect a urine sample. In other methods, a drainage hole is provided on the side wall of the cavity. The height of the drainage hole limits the height of the urine inside the cavity, and excess urine is discharged through the drainage hole.

[0021] In some methods, after testing, the collector is washed and dried with water, then the sidewalls are folded and retracted. The handle is then rotated and placed over the opening for storage. In some methods, when testing is required again, the collector is removed, and the folded sidewalls are extended. In some methods, the collector's sidewalls include a first rigid sidewall forming the opening, and a second rigid sidewall forming the base, with the foldable sidewall located between the first and second rigid sidewalls. In some methods, a force is applied to the relative movement of the first and second rigid sidewalls, causing the foldable sidewalls to fold and retract. When the cavity needs to be opened, the distance between the first and second rigid sidewalls is stretched, thus unfolding the sidewalls for collecting urine again to test for the analytes in the urine. Attached Figure Description

[0022] Figure 1A This is a three-dimensional structural diagram of a urine collector according to a specific embodiment of the present invention (handle extended or handle opened).

[0023] Figure 1B This is a cross-sectional structural diagram of a urine collector according to a specific embodiment of the present invention.

[0024] Figure 2 This is a front view of a urine collector according to a specific embodiment of the present invention.

[0025] Figure 3 This is a schematic diagram of the handle of a urine collector in a folded state according to a specific embodiment of the present invention.

[0026] Figure 4 This is a three-dimensional structural diagram of a specific embodiment of the present invention, in which a test element is inserted into the cavity to contact the urine and begin testing after the collector collects urine.

[0027] Figure 5 This is a three-dimensional structural diagram of a test element placed flat on a cavity after absorbing liquid, according to a specific embodiment of the present invention.

[0028] Figure 6 This is a three-dimensional structural diagram of a test element placed flat on a cavity after absorbing liquid, according to a specific embodiment of the present invention.

[0029] Figure 7This is a three-dimensional structural diagram of a test element placed flat on a cavity after absorbing liquid, according to a specific embodiment of the present invention.

[0030] Figure 8 A three-dimensional structural diagram of a urine collector after folding according to a specific embodiment of the present invention.

[0031] Figure 9A This is a three-dimensional structural diagram of a urine collector after folding (default handle) according to a specific embodiment of the present invention.

[0032] Figure 9B This is a schematic diagram of the longitudinal section structure of a urine collector after folding, according to a specific embodiment of the present invention.

[0033] Figure 10 This is a three-dimensional structural diagram of the collector after it has been folded in another specific embodiment of the present invention.

[0034] The structures involved in this invention or the technical terms used therein will be further described below. Unless otherwise specified, they shall be understood and interpreted in accordance with general terms commonly used in the art.

[0035] "Detection" means to examine or test 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. Additionally, "detection" indicates the quantity of the substance or material being tested. Furthermore, "examination" also refers to immunoassay, chemical assay, enzyme assay, etc. The terms "detection," "testing," "examination," and "inspection" are used interchangeably in this invention.

[0036] The detection device of this invention can test biological fluid (e.g., case fluid or clinical sample) samples or liquid samples. The terms "liquid sample" and "fluid sample" are used interchangeably. Liquid samples can be derived from solid or semi-solid samples, including excrement, biological tissue, 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 sample" includes 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. Urine is preferred as a biological sample; saliva is also preferred. Food samples include processed food materials, final products, meat, cheese, wine, milk, and drinking water. Plant samples include those derived from any plant, plant tissue, plant cell cultures, and media. "Environmental samples" are derived 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.

[0037] Using suitable detection or testing elements of this invention, the properties of analytes or liquid samples in any sample can be detected. Preferably, this invention is used to detect analytes, such as drugs, viruses, bacteria, and other antigens, in blood, saliva, nasal mucus, throat secretions, respiratory secretions, or urine, or the properties of liquid samples. Preferably, it can detect small molecules such as viruses and bacteria in urine, saliva, throat, or nasal fluid. The collector of this invention can collect samples of any form, whether initially solid or liquid, as long as these liquids or liquid samples can flow into the cavity of the collector.

[0038] In other ways, the collector of the present invention is used to collect female urine. For example, a woman can use the urine collector of the present invention to collect her urine herself, and then after collecting the urine, she can directly insert the test element into the urine collector to detect the substances to be analyzed in the urine.

[0039] Downstream or upstream is a division based on the direction of liquid flow. Generally, liquids or fluids flow from upstream to downstream. The downstream region receives liquid from the upstream region, and liquid can also flow from the upstream region to the downstream region. This division is generally based on the direction of liquid flow. For example, in 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 divided according to the direction of liquid flow. For example, as shown in Figure 5, the test element mentioned in this invention is a transverse flow test element 20, having a sample application area 201, a downstream marking area 202, and a test area 203 downstream of the marking area. These three areas are arranged sequentially from upstream to downstream. When the sample application area 201 comes into contact with the liquid, the liquid flows from the upstream application area 201 to the downstream marking area 202, and then the liquid in the marking area flows to the downstream test area 203. The test area typically has a test result area 2021 and a test result control area 2022. Both areas contain antibodies or antigens that specifically bind to the analyte. The test result area is usually represented by lines (T-line 2021), and the test result control area is also represented by lines (C-line 2022).

[0040] Gas or 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 also be due to the liquid or gas's own forces (gravity or pressure) or be passive. Pressure-driven fluids can flow in the direction of gravity, 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 to another. Conversely, if there is no gas or liquid connectivity between two objects, and liquid cannot flow from one object to the other, this state is called non-connectivity, a state where there is no gas or liquid connectivity.

[0041] Detachable assembly refers to the connection between two components existing in several different states or positions. For example, when there are two physically distinct components, they can initially be separate, connected or combined under suitable first conditions, and then separated under suitable second conditions—this separation is a physical spatial separation without contact. Alternatively, the two components can initially be combined, and then physically separated under suitable conditions. Or, two objects can initially be separate, combined to perform a certain function when needed, then separated again, or later combined again for a certain purpose. In short, the combination or separation of two entities can be easily performed and can be repeated multiple times; of course, it can also be a one-time combination and separation. Furthermore, it can be a detachable combination between two components, or a detachable combination of three or more components in pairs. For example, with first, second, and third components, the first and second components can be detachably combined, the second and third components can also be detachably combined, and the first and third components can also be detachably combined or separated. Additionally, the combination method can be that the two objects themselves are detachable, or that they can be indirectly combined through other objects. In this invention, the cover and the first test unit or the second test unit are detachable. When testing is required, the cover is removed, and after the test is completed, the cover is closed.

[0042] Examples of analytes that can be used in this invention include haptens, such as drugs (e.g., abused drugs). "Drug abuse" (DOA) refers to the use of drugs 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, 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); 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, fear, and stabilize mood, and also have hypnotic and sedative effects. They include benzodiazepines (BZO), atypical BZ, fused diazonium NB23C, benzodiazepines, ligands of BZ receptors, open-ring BZ, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazides and thiazole derivatives, other heterocyclic compounds, imidazole sedative / analgesics (such as hydroxydihydrocodeine 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 that are intended for medical use but are prone to overdose, such as tricyclic antidepressants (imipramine or similar drugs) and acetaminophen. These drugs, after being absorbed by the body, break down into different small molecules, which are present in bodily fluids such as blood, urine, saliva, and sweat, or in some bodily fluids.

[0043] For example, the analytes detected using this invention include, but are not limited to, creatine anhydride, bilirubin, nitrite, proteins (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 substances in urine samples related to physiological characteristics, such as pH and specific gravity. It can also include respiratory infection-related bacteria and viruses, such as influenza virus, coronavirus, respiratory syncytial virus (RSV), adenovirus, human metapneumovirus (HMPV), coronaviruses such as SARS and MERS, rhinovirus, coronaviruses such as SARS-CoV, MERS-CoV, and SARS-CoV-2, Coxsackie virus, echovirus, measles virus, herpes simplex virus (HSV), Hantavirus, and EB virus. These viruses can be tested in multiple ways simultaneously using the testing device or test strip of this invention. Any other analytes of clinical interest can also be detected using the lateral flow detection method in conjunction with the device of this invention. The analysis and testing of the above-mentioned analytes can be performed using the first testing element, i.e., using a lateral flow test strip, or, of course, using a non-lateral flow method.

[0044] The test strips or test apparatus of this invention can be used to test the properties of analytes or liquids in liquid samples, such as urine. The following analytes and components can be tested. For example, the test element can be used to test the properties of the following analytes or samples in a urine sample. Of course, a transverse flow test strip can be used to test the properties of the following analytes and liquids.

[0045] 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 manufacturing 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 processing. 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. Additionally, when using this indicator for testing, it's undesirable to have too much sample on the test pad, as substances in urine, such as acidic pH and nitrogen, can affect enzyme function. Therefore, this indicator is often tested last, not first.

[0046] The significance of testing blood samples lies in the following aspects: First, physiological glycosuria is transient glycosuria, which returns to normal after ruling out physiological factors. There are three main types: ① Dietary glycosuria, caused by consuming large amounts 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 Pancreatic glycosuria, where there is a relative or absolute deficiency in insulin secretion, causing blood glucose concentration to exceed 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, where the renal tubules have reduced glucose reabsorption capacity. 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 final step in urine glucose analysis is a redox reaction, when 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 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.

[0047] 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 bilirubinogen, indole, and bilirubin, can cause false positives; some medications, such as phenothiazines, can cause color interference. Additionally, high levels of vitamin C or nitrite in urine can inhibit the diazo coupling reaction, leading to lower test results or even false negatives.

[0048] 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.

[0049] 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. The urine sample must be fresh and must not contain 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.

[0050] 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. Positive protein, renal epithelial cells, and casts in 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 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] Other chemical testing methods for analytes not described in this specification are all existing technologies and are conventional methods. In some methods, a first testing element is used to test small drug molecules, and a second testing element is used to test the properties of the sample. In some methods, the sample is a urine sample. In some methods, the properties of the analytes and the liquid sample can be tested using a lateral flow method, or the properties of the analytes or the liquid sample can be tested using a non-lateral flow method.

[0055] The term "test element" here refers to any element that can detect whether a sample contains an analyte of interest. This detection can be based on any technical principle, including immunology, chemistry, electricity, optics, molecular biology, nucleic acid science, physics, etc. A test element can be a laterally flowing test strip capable of detecting multiple analytes. Of course, other suitable test elements can also be used in this invention; for example, non-flowing test elements can also be used. Generally, test elements have a test area, which typically contains or has immobilized chemical substances, antibodies, or antigens. When a sample flows through or comes into contact with the test area, antibodies directly or indirectly capture the analyte in the sample, or the chemical substance reacts with the liquid sample, producing a color change, thereby detecting the presence or quantity of the analyte in the test area.

[0056] Various forms of test elements can be combined and used in this invention (described in detail later). In some embodiments, the test element of this invention is a transversely flowing test strip or transversely flowing test element. A "transversely flowing test element" refers to a method where liquid flows from one zone to another to test the properties of the analyte or liquid sample in a liquid sample. This flow typically involves one end contacting the liquid sample, and the liquid sample flows along the test element due to capillary force, testing the properties of the analyte or liquid sample during the flow. In some embodiments, the transversely flowing test strip or first test element includes a test area, through which liquid flows to and passes, thereby obtaining test results. Generally, the transversely flowing test area does not directly contact the sample but receives liquid from upstream of the test area, such as a labeled area or sample application area, allowing the liquid to flow through the test area and react, such as antibody-antigen binding, antibody-antibody binding, or the test area being treated with chemicals, thereby analyzing the analyte in the liquid through the reaction in the test area. Generally, such a transversely flowing test element includes a labeled area and a test area located downstream of the labeled area. This means that the test element can be used to distinguish between upstream and downstream flow of liquid.

[0057] For example, Figure 5 As shown, such a first test element 20 includes a sample application area 201 for contacting a liquid sample, a downstream marking area 202, a downstream test area 203, a test result area and a test result control area on the test area, and a water-absorbing area 204 downstream of the test area. When the sample application area 201 receives liquid, the liquid flows along the test strip from upstream to downstream, sequentially passing through the marking area 202 to dissolve the marking substance, and then completing the test on the downstream test area 203. In such a test element, each area is composed of water-absorbing material and is disposed on a support sheet.

[0058] The transverse flow test element used to analyze analytes (such as drugs or metabolites indicating physical condition) in a sample can take various forms, such as immunoassay or chemical analysis. The test element can employ non-competitive or competitive analytical methods. A transverse flow test strip 20 typically includes a labeled region 202 and a test region 203. The labeled region includes a first receptor, such as a first antibody, that can specifically bind to the analyte. If the sample contains the analyte, the first receptor binds to the analyte to form a complex. The first antibody on the labeled region and the formed complex can flow with the liquid to the downstream test region 203. A second receptor, such as a second antibody, is immobilized on the test region to capture the complex. Detecting the amount of the complex indicates the quantity of the analyte. The labeled region typically contains a labeling substance, such as a colored substance or a luminescent substance. Colored substances include gold particles, latex particles, or dyes, while luminescent substances can be rays, fluorescence, etc. By testing the amount of colored substance, the color concentration, and the intensity of the light emission, the quantity or presence of the analyte can be indicated. The labeled region is generally located upstream of the test element. When the labeled substance is shared, it can have a first test element and a second test element. If it is a chemical reaction, the liquid flows through each test area, and a chemical reaction occurs in the test area to produce a colored substance (redox reaction).

[0059] In some configurations, the transverse flow test strip comprises an absorbent material in a sample application area 201, a reagent area (located upstream of the labeling area), and a test area 203 (located on the test element). A fluid or liquid sample is applied to the sample application area 201 and flows capillarily to the reagent area. In the labeling area 202, if an analyte is present, the sample binds to a reagent. The sample then continues to flow to the detection area 203. Other reagents, such as molecules that specifically bind to the analyte, are immobilized in the detection area 203. These reagents react with the analyte in the sample (if present) and bind the analyte in that area, or bind to a reagent in the reagent area. A marker used to display the detection signal is present in the reagent area or a separate labeling area.

[0060] In a typical non-competitive analysis model, a signal is generated if the analyte is present in the sample, and no signal is generated if the analyte is not present. In a competitive method, a signal is generated if the analyte is not present in the sample, and no signal is generated if the analyte is present.

[0061] The transverse flow test element can be a test strip, made of absorbent or non-absorbent material. The test strip can include various materials for liquid sample transfer. One material of the test strip can be overlaid on another, such as filter paper over a nitrocellulose membrane. One area of ​​the test strip can be made of one or more materials, while another area can be made of a different one or more materials. The test strip can be adhered to a support or rigid surface to improve its grip strength.

[0062] The analyte is detected by a signal generation system, such as using one or more enzymes that specifically react with the analyte, or by immobilizing a specific binding substance on a test strip as described above, to fix a composition of one or more signal generation systems onto the analyte detection area of ​​the test strip. The signal-generating substance may be in the sample application area, reagent area, detection area, or the entire test strip, and may fill one or more materials of the test strip. A solution containing the signal substance is added to the surface of the test strip or one or more materials of the test strip are immersed in a solution containing the signal substance. The test strip containing the signal substance solution is then dried.

[0063] The most commonly used reagent strips are nitrocellulose membrane reagent strips, where the test element includes a nitrocellulose membrane (NC). This NC membrane serves as the material for the test area 203. Specific binding molecules are fixed on the nitrocellulose membrane (the fixed specific binding molecules are the test area on the test element) to display the detection results. Other options include cellulose acetate membranes or nylon membranes, etc. For example, the following patents describe reagent strips or devices containing reagent strips: US 4857453; US 5073484; US5119831; US ​​5185127; US 5275785; US 5416000; US 5504013; US 5602040; US 5622871; US5654162; US 5656503; US 5686315; US 5766961; US ​​5770460; US 5916815; US 5976895; US6248598; US 6140136; US 6187269; US 6187598; US 6228660; US 6235241; US US 6306642; US 6352862; US 6372515; US 6379620; and US 6403383. The transverse flow test strips and similar devices with transverse flow test strips disclosed in the above patent documents can be used in the first test element or detection device of the present invention to detect the analyte, such as the analyte in a sample.

[0064] The first test element or first reagent strip used in this invention can be a lateral flow test strip, as commonly known. These test strips include a test element, and their specific structure and detection principle are well known to those skilled in the art. A typical conventional test strip includes a sample collection area or sample application area 201, a labeling area 202, a detection area 203, and an absorbent area 204. The sample collection area includes a sample receiving pad, the labeling area includes a labeling pad, and the absorbent area may include an absorbent pad. The detection area includes the necessary chemical substances to detect the presence of the analyte, such as immunoassay reagents or enzyme reagents. Commonly used test strips are nitrocellulose membrane strips, where the detection area includes a nitrocellulose membrane or a nitrocellulose membrane as the test element, and a test area is included thereon. Specific binding molecules are immobilized on the nitrocellulose membrane to display the detection result area. Other options include cellulose acetate membranes or nylon membranes, etc. Downstream of the detection area, a result control area may also be included. Typically, the control area and the detection area appear as horizontal lines, serving as detection lines or control lines. Such test strips are traditional test strips, but other types of test strips utilizing capillary action can also be used. Furthermore, test strips typically contain dry chemical reagents, such as fixed antibodies or other reagents. When these reagents come into contact with liquid, the liquid flows along the strip due to capillary action. As they flow, the dry reagents dissolve in the liquid, allowing them to react in the next area and perform the necessary detection. The liquid flow is primarily achieved through capillary action. All of these can be applied to the detection device of this invention, either by placing it in the detection chamber to contact the liquid sample, or by detecting the presence or quantity of the analyte in the liquid sample entering the detection chamber.

[0065] Besides the aforementioned test strips or transverse flow test strips being used to contact liquid samples to test whether the liquid sample contains the analyte, the test element of this invention can itself serve as a detection device to detect the analyte in the sample. Therefore, the detection device itself is equivalent to the test element. For example, after the fluid sample is mixed with the processing liquid, it can be directly detected using the test element, as described in detail below. When describing the receiving device contacting the fluid sample, the test element can be used alone for detection. Of course, in some cases, the test device can be the test strip, or any device and container containing the test strip. The above is a definition and description of a single test element. In specific embodiments of this invention, two or more test elements are combined to test or detect multiple analytes.

[0066] The antibody used in this invention can be any antibody capable of specifically binding to the analyte in a sample. The antibody that can be used as a binding agent can be any antibody known to those skilled in the art. "Antibody" can be an immunoglobulin molecule and the antigen-binding portion of an immunoglobulin molecule, i.e., a molecule containing an antigen-binding site that specifically binds to an analyte, analyte analog, or ligand ("immunoreaction"). This term also includes derivatives of antibodies in which binding ability is maintained, and any protein containing a binding domain homologous to or largely homologous to the binding domain of an immunoglobulin. These proteins may be derived from natural substances or may be partially or wholly synthetic. An antibody may be monoclonal or polyclonal. An antibody may be a member of any immunoglobulin type, including any human immunoglobulin type: IgG, IgM, IgA, IgD, and IgE. An "antibody fragment" is a derivative of an antibody or a portion of an antibody less than its full length. An antibody fragment is capable of retaining at least one significant binding site of the full-length antibody. Examples of antibody fragments include Fab, Fab', F(ab')2, scFv, Fv, dsFv dimers, and Fd fragments, but are not limited to these. Antibody fragments can be generated in any way. For example, antibody fragments can be generated by enzymatic digestion or chemical cleavage of a complete antibody, or by recombination from a gene encoding a partial antibody sequence. In other words, antibody fragments can be generated by partial or complete recombination. Antibody fragments can be any single-chain antibody fragment. In other words, antibody fragments can contain multiple interconnected peptide chains, for example, linked by disulfide bonds. Antibody fragments can also be any kind of multi-molecular complex. A functional antibody fragment typically contains at least about 50 amino acids, while more antibody fragments typically contain at least about 200 amino acids. Single-chain Fvs (scFvs) are recombinant antibody fragments that consist only of variable light chains (V... L ) and variable heavy chain (V H They are covalently linked by polypeptide chains. L and V H One of the peptides has an amino-terminal region. The length and composition of the polypeptide chain are variable; its length allows the two variable domains to bridge each other without significantly affecting the atomic arrangement. The polypeptide chain is typically composed primarily of glycine and serine residues, with some glutamic acid and lysine residues scattered throughout to increase its solubility. A "dimer" refers to a dimer of a single-chain Fvs. The monomers of dimers typically contain shorter peptide chains than most single-chain Fvs, and they exhibit a tendency to form dimers.

[0067] The “Fv” segment consists of a V H And a V L The domains are composed of non-covalently interconnected units. The term "dsFv" here refers to a domain containing a stable V.H -V L The Fv of the intermolecular disulfide bond. The “F(ab’)” fragment is an antibody fragment, essentially the same as the fragment obtained by digesting immunoglobulins (usually IgG) with pepsin at pH 4.0-4.5. This fragment can also be recombinantly synthesized. The “Fab’” fragment is an antibody fragment, essentially the same as the fragment obtained by reducing the disulfide bonds connecting the two heavy chains on the F(ab’) fragment. The Fab’ fragment can also be recombinantly synthesized. The “Fab” fragment is an antibody fragment essentially the same as the fragment obtained by digesting immunoglobulins (usually IgG) with papain. The Fab fragment can also be recombinantly synthesized. The heavy chain fragment on the Fab fragment is the Fd fragment.

[0068] The antibodies here can be any type of antibody in the analyte, and these antibodies can also be used as the analyte.

[0069] The collector of the present invention is a container 10 for collecting or receiving liquid samples. The container has a cavity and an opening 101 through which the liquid sample is received and flows into the cavity. In some embodiments, the collector of the present invention allows women to collect urine at home and then test the analytes on the urine sample. "At home" here does not mean testing at home, but rather that testing can be conducted in any location, including in a room, or even outdoors. For example, while traveling, if one wishes to continuously test the analytes in urine to monitor their health or ovulation, such testing can be performed in a hotel room or a public restroom. When working in the field, urine can also be collected directly using the collector of the present invention for testing.

[0070] In some embodiments, the collector provided by the present invention has a cavity with an opening 101, which is foldable. When the cavity is folded, its volume is reduced, making it convenient for storage, especially during travel, and reducing its size. When urine collection is required, the folded portion can be opened or pulled up to expand the cavity, thereby increasing its volume or forming a complete cavity for urine collection.

[0071] In some ways, for example Figure 1A-1BAs shown, a collector 10 is provided, including a cavity 106 for collecting urine. The cavity 106 is formed by an opening 101, sidewalls 201, and a bottom 202. Urine is received through the opening 101 into the cavity 106 for subsequent analyte testing. In some embodiments, the sidewalls have a foldable region 105 that can be folded to reduce the height 400 or thickness of the cavity, thus reducing the unused volume and space occupation. In some embodiments, the entire sidewall may be foldable, either longitudinally or laterally, allowing the cavity to form a regular, fixed shape with both height and width reduced simultaneously. When in use, the folded portion unfolds to form the cavity for receiving urine. In some designs, the folding structure includes folded panels and fold lines. The folded panels are connected together by the fold lines. When folded, the panels fold along the fold lines, and the angles 50°1 and 50° between the panels decrease. When opened, the folded panels are connected by the fold lines, but the relative angles between the panels increase, thus forming a large cavity. In some designs, the cavity can collect 50-100 ml or 40-30 ml of urine when open, but when folded, it may be unable to collect urine or collect very little, such as 5-10 ml. (Specific details are omitted as they are not relevant to the design description.) Figure 1B As shown, the folded area 105 on the sidewall includes a first folded piece 1051 and a second folded piece 1052. The first and second folded pieces are connected by a fold line 1053, and the second folded piece 1052 is connected to a third folded piece 103 by a fold line 1054. Generally, the thickness of the folded piece is greater than the thickness of the fold line. When the sidewall forms a cavity, the folded piece surrounds the entire sidewall of the cavity, and the fold line also surrounds the entire sidewall of the cavity. When folding, for example by pressing the bottom 102 of the cavity (e.g., ... Figure 1B As shown by the arrow), the bottom 102 of the cavity enters the cavity 106. This allows the bottom 102 and the connected third folding piece 103 to enter the cavity 106, reducing the original height 400 of the cavity to a new, lower height 300. At this point, the second folding piece 1052 and the third folding piece 103 fold together through the fold line 1054. Before folding, the angle between the two folding pieces was approximately 120-130 degrees; after folding, the angle is between 40-20 degrees (e.g., ...). Figure 9B(As shown) or smaller, at this time, the second folding piece 1052 and the first folding piece 1051 are folded together by the fold line 1053, from an angle of 160-170 degrees before folding to 30-40 degrees or smaller after folding. Through this folding method, the height of the originally unfolded cavity 106 is reduced, almost to one-third, one-quarter, or one-eighth of the original unfolded height. This greatly reduces the height of the cavity, compressing it longitudinally, thus reducing the volume of the cavity and minimizing its space occupation during travel. To facilitate folding, the side wall of the base at the bottom of the cavity, also known as the base cavity 1034 (including the bottom 202, 1031 of the cavity) formed by the third folding piece 103, is smaller than the width or area of ​​the cavity 1035 formed by the second folding piece and the first folding piece, thus forming a "bowl" shape (as shown). Figure 1B In fact, the cavity 106 of the present invention comprises a partial cavity formed by the third folded piece 103 and the bottom 1031, referred to as the base cavity 1034, and a partial cavity formed by the folded area 105 above the base cavity, referred to as the folded cavity 1035. This design, with a small bottom and a large top, causes the second folded piece 1052 and the third folded piece 103 connected by the folding line 1054 to fold when pressure is applied inward from the bottom 102 of the cavity. Since the third folded piece and the base are made of relatively rigid hard plastic, while the folding line is made of relatively soft or thin plastic, under such force, the base cavity 1034 is obviously pushed into the upper folded cavity 1035, thereby compressing the entire cavity 106. Generally speaking, the folded sheet is relatively rigid, thicker (approximately 1-2 mm) than the fold line, and about 5-10 mm wide, while the fold line is a thin line, similar to a sheet about 1-2 mm wide and about 0.1-0.2 mm thick. Thus, under the same force, relative folding can occur first (e.g., as...). Figure 9A and 9B As shown), the folded piece 103 moves closer to the cavity opening 101. Similarly, the first folded piece 1051 and the second folded piece 1052 change their relative positions through the fold line 1052, resulting in folding. In this way, the bottom 1031 moves synchronously closer to the cavity opening. If the bottom is flat, then the bottom will also be flat after folding. This equidistant movement is because the width of the folded pieces is equal; that is, the folded pieces forming the sidewalls around the cavity are of equal width. It can also be considered that the distance between the folded pieces and the cavity bottom 1031 is equal in height. This folding creates a structure like... Figure 1B , Figures 9A-9B This is the approach.

[0072] The flat bottom design allows the collection chamber to stand upright on a testing platform, such as a flat tabletop, facilitating subsequent testing. In some designs, the bottom of the chamber is not flat but has a small recess 1032 (after contacting the tabletop). If the bottom 1033 is made of relatively soft plastic (silicone base), when the entire chamber is placed on a flat surface, the small recess 1032 forms a sealed cavity with the surface (due to the weight of the urine inside the collector and the chamber itself). This sealed cavity contains gas, allowing the collector to stand stably on the tabletop. The soft silicone surface here is part of the bottom 1033. The entire chamber can be injection molded in one piece, and then a layer of silicone, including the small recess 1032, can be adhered to the bottom. When the collector is placed on a flat tabletop, the recess 1032 forms a seal with the surface, sealing the gas. This prevents the collector from tipping over and leaking liquid even with slight shaking.

[0073] In some designs, the bottom 1031 of the cavity is desired to be sloped by folding or unfolding. This folding helps to collect the liquid at the bottom of the cavity. If a sloped design is used, only one fold line can be designed. For example, only the third fold 103 and the second fold 1052, along with the fold line 1054 connecting them, can be retained, while other areas cannot be folded. For instance, the sidewall 104 forming the cavity opening cannot be folded. In this case, the width of the second folded piece can be non-uniform, gradually decreasing in width. For example, the circumference around the sidewall is approximately 15-20 cm, while the width of the folded piece can gradually decrease from 3 cm to 5 mm. If the width of the second folded piece 103 (height from the bottom 1031) remains constant, after folding, an inclined bottom surface is formed. The lowest point of the inclined surface is near the narrower width of the second folded piece 1051, and the highest point is near the wider width. After collecting urine using the inclined cavity, a collection area is formed at the lowest point, allowing the test element to directly contact the liquid in the collection area for testing. After the test is completed, the bottom 1031 can be pulled outward to return to the non-inclined state. In this case, the folding function is to collect the sample, without considering the reduction in volume.

[0074] In some methods, a single test element typically requires a urine volume of approximately 100 microliters to 1 milliliter. However, the collected urine volume is usually much larger than this. The volume of chamber 106 is approximately 50-100, or 40-50 milliliters, while a woman's urine output is approximately 400-800 milliliters, far exceeding the maximum volume of chamber 106. Thus, if the height of the collected urine from the entire chamber is approximately 10-15 centimeters, directly inserting the test strip into the chamber might cause the urine to flood the marked area, resulting in test failure. Clearly, collecting only 100 microliters or 1 milliliter at a time is impractical and could easily contaminate the collector. Women typically need to collect their own urine using the collector of this invention, usually only when they need to urinate. As mentioned above, a typical urine output is approximately 500-800 milliliters or more, but it's impossible to collect all of it using the collector of this invention. Collecting all of it would obviously increase the chamber volume, making it inconvenient for travel. If, during urination, after collecting a portion of urine (for example, when the entire cavity is filled with approximately 200 ml or 100 ml), the collector needs to be removed to continue urinating, this operation is still not very user-friendly. Furthermore, during removal, the collected urine may overflow or spill, causing contamination to the collector, such as contaminating their hands or other surfaces. This can be uncomfortable or embarrassing for women. In some methods, urine can be allowed to fill the cavity 106 and then flow out from the opening 101, ensuring the appropriate liquid level for testing is reached, such as by pouring the liquid out through the outlet 109. However, this collection method is clearly not user-friendly and is very inconvenient. If too much urine is collected, it may overflow from the opening 101, leaving urine residue at the opening, such as urine dripping onto the inner wall near the opening 101. When a test element is inserted into the cavity to absorb the urine (e.g., ...), this can cause problems. Figure 4 The test element is typically placed against the side wall (inner wall) of the cavity 106. Urine adhering to this cavity wall may prematurely wet the test element, for example, prematurely wet the test area. This prevents the liquid absorbed by the sample application area 401 from flowing through the test area, causing test failure. One example of this invention is the use of a lateral test element. However, for a lateral test element to be effective, liquid must sequentially wet each area to obtain test results. If some areas are prematurely wetted, such as the test area, the liquid from the sample application area cannot flow through the marked area to the test area, resulting in test failure.

[0075] To avoid such embarrassing situations or to make the operation more user-friendly and increase the success rate of the test, an opening or a drainage hole 118 is provided on the side wall of the collector's cavity. This hole position allows excess sample to be drained. For example, the hole 118 can be positioned below the fold line 1054 on the first folded plate 103. When a woman uses the device, once the urine rises to the position of the hole 118, excess urine sample is drained through the hole, usually into a urinal or toilet, ensuring that the cavity is not filled with urine. This method ensures that a suitable sample can be collected without allowing urine to overflow from the cavity opening 101, contaminating the environment or prematurely wetting the test element by adhering to the side wall. Thus, women do not need to worry about the collector overflowing during urination, nor do they need to remove it midway through the process; the collector can be removed only after the entire urination process is complete. The location of the hole can be arbitrary, as long as it is above the bottom surface 1031 of the cavity. The size of the hole can also be arbitrarily set, for example, a diameter of 1 to 2 centimeters is acceptable. It is generally placed on the folded plate or on the non-folded sidewall, so that folding will not affect the hole's structure. Furthermore, there is no particular limitation on the number of drainage holes; one, two, three, or four can all be placed on the sidewall of the cavity 106. Of course, the larger the hole size and the more holes there are, the faster the drainage speed, ensuring that the cavity 106 retains a sample volume sufficient for testing or at a suitable height. For example, the height is generally below the marked area 202 of the test element.

[0076] In some embodiments, the folded area is part of the sidewall, for example, as Figure 1A As shown in Figure 1B, a non-foldable area is provided below the foldable area 105. For example, the side wall 103 (third folding piece) (second non-foldable area) of the lower base portion and the side wall 104 (first non-foldable area) above the first folding piece 1051 are both non-foldable areas. In this way, the cavity can be folded by simultaneously applying relative forces to the first and second non-foldable areas. In addition, the first non-foldable area has a fixed shape, which facilitates the formation of the cavity opening 101, thereby increasing the safety of urine collection. This fixed shape is generally elliptical, which matches the shape of the female vagina, making it convenient to collect urine and allowing urine to easily enter the cavity. Therefore, the handle is generally set on the longer end.

[0077] In addition, for convenient collection, a handle 107 is provided on the cavity of the collector. This handle is rotatably connected; when collecting, the handle rotates and extends (e.g., Figure 6(The arrow indicates that) when collection is not needed, the handle can be rotated to the opening 101 of the cavity 106 or located inside the cavity, still reducing the storage volume during travel (e.g., ...). Figure 3 (The arrow). The first end 1079 of the handle has a hole 108 for easy carrying, such as by using a hook or rope to attach it to a backpack or other suitcase, keeping the collector in a fixed position. In some embodiments, the handle's rotation is not arbitrary but has a fixed position, ensuring the handle remains in place during urine collection. When collection is complete or not (e.g., for storage), the handle 1079 folds, reducing the collector's size and making it easy to carry. In some embodiments, the second end 1080 of the handle has a through hole or shaft hole, and opposing shaft platforms 1071, 1072 are provided along the side wall of the cavity. A pair of holes 1077 are provided on the shaft platforms, allowing the shaft 1073 to pass through. During installation, first align the hole at the end 1080 of the handle with the hole 1077 on the shaft platform, then pass the shaft 1073 through the hole 1077 and the shaft hole of the handle, allowing the handle to rotate and connect to the cavity (e.g., ...). Figure 1A-1B When urine needs to be collected, the collector typically holds the handle 107 and inserts the cavity 106 under the urethra to collect the urine (for female collectors), with the cavity opening 101 positioned below the urethra to receive the urine. Of course, it is also possible for men to collect urine using this collector, with the cavity opening 101 positioned below the male urethra. The handle is rotated to a fixed position to ensure collection stability. Therefore, in some embodiments, an extended limiting platform 1076 is provided at the front end of the shaft hole between the shafts. When the handle rotates, a portion of the structure 1075 at the end 1080 of the handle contacts the platform, restricting further rotation and thus fixing the handle in a fixed position. After collecting the liquid and completing the test, the handle can be rotated towards the opening 101 of the cavity 106, either below the opening or inside the cavity. At this point, the length of the handle is less than the width of the cavity, allowing the handle to rotate into the cavity (e.g., Figure 3 , Figure 8 , Figure 10(As shown), this reduces the volume and facilitates storage. When in use, for example, when collecting urine, the handle 107 is rotated again to move it away from the opening 101 of the cavity 106. Then, part of the structure 1075 at the end 1080 of the handle contacts the limiting platform 1076, restricting further rotation of the handle and thus fixing it in a fixed position. The limiting platform is generally located on the outer wall of the non-folding area 104 and close to the opening 101. It has a protruding thickness 1089 on the outer wall and forms a platform 1076 in front of the shaft 1073 to restrict the rotation of the handle 107.

[0078] In some embodiments, to allow for immediate testing after urine collection via a cavity, the present invention provides a testing element, such as a test strip 20, having a sample application area 201, a marking area 202, a test area 203, and an absorbent area 204, these areas being sequentially connected. Liquid can flow from the sample application area to the marking area and then through the test area, sequentially wetting these dry areas to complete the test. Figure 4-7 As shown, when the cavity 106 of the collector 10 collects urine, and the depth of the urine is less than the length of the sample application area 201 and cannot exceed the height of the marking area 202 (for example, the function of the drain hole to control the depth or to collect and pour out some liquid while maintaining a certain depth), this is why, as described earlier, although urine is collected using the cavity, the urine can only be kept at a suitable height within the cavity. At this time, the sample application area 201 of the test strip 20 can be directly inserted into the urine sample, resting against the edge of the cavity, without having to hold the test element continuously. Figure 4 As shown, allow the test strip to absorb liquid for 1-3 minutes, allowing the liquid to flow on the test strip through capillary action. For example, the insertion time is 1 minute or 2 minutes. Then, remove the test strip 20 from the cavity 106 and place it flat on the opening 101. To ensure the test strip is safely in a fixed position, a pair of notches 110 and 111 are provided on the opening 101, allowing the test strip to be positioned within the notches. The test results, such as the T-line results, can then be read visually or by taking a picture with a mobile phone. The built-in APP automatically analyzes the photographed results to obtain digital results.

[0079] Generally, when they are manufactured and sold, they are sold in a folded manner, for example... Figure 8 9A-9B Figure 10The test strips are sold in a folded state, with the handle either covering the opening or inside the cavity. This method aims to reduce packaging volume, allowing users to carry them in a suitcase or other luggage. Test strips can also be purchased in advance, at OTC stores or pharmacies, or sold with the collector. When testing is required, the folded state is changed to an open state by stretching the bottom 102 of the cavity 101, or by stretching the bottom 102 and the non-folded area 104 of the opening in the opposite direction, or by restoring the cavity to its open state. For example... Figure 3 As shown, then rotate handle 107 to the fixed position, as indicated. Figure 1A-1B The operator then holds handle 107 and inserts it into the urethra to collect urine. A drainage hole 118 is provided within the cavity; excess urine is drained through this hole, maintaining a suitable level of urine within the cavity. The urine collector with the required level of urine is then placed on a flat table or any other surface. The test strip is then inserted into the cavity, contacting the liquid sample and held for 1-3 minutes. During this time, the operator does not need to continuously hold the test strip. Figure 4 As shown, after a period of contact, the collector is removed from cavity 106 and placed flat in the recesses 110, 111 of cavity opening 101 for test result reading. After the test is completed, the collector can be cleaned, then folded again and the handle rotated in the opposite direction and positioned inside cavity 106, as shown. Figure 8 As shown in 9A. This allows for repeated use, making it particularly suitable for travelers to conduct targeted tests and monitor their health status during their travels.

[0080] 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. An apparatus for testing the properties of a sample or an analyte, the apparatus comprising: A liquid sample collection container, wherein the collection container includes a collection cavity with an opening for receiving a liquid sample, the collection cavity being surrounded by sidewalls and a bottom, wherein the sidewalls include partially foldable sidewalls, thereby reducing the volume of the collection cavity by folding; and a testing device for inserting into the cavity of the container to contact the liquid sample, the testing device being configured to test the analyte in the liquid sample.

2. The apparatus according to claim 1, wherein, When the folded sidewall is folded, the volume of the collection chamber is reduced, making it easier to store. When the folded sidewall is extended and not folded, the volume of the collection chamber is increased, enabling the collection of liquid samples.

3. The apparatus according to claim 2, wherein, The volume of the collection chamber in its unfolded state is 1-8 times that in its folded state.

4. The apparatus according to claim 3, wherein, The folded or extended sidewalls are made of flexible plastic material.

5. The apparatus according to claim 3, wherein, The folded sidewall includes a first folded piece and a second folded piece, wherein the first folded piece and the second folded piece are connected by a fold line. When the first folded piece and the second folded piece are folded together by the fold line, the included angle between the first and second folded pieces becomes smaller.

6. The apparatus according to claim 5, wherein, The folded sidewall also includes a third folded piece, which is connected to the second folded piece by a fold line. The third folded piece forms part of the cavity and serves as the base of the cavity. The cavity formed by the first and second folded pieces is located on the base.

7. The apparatus according to claim 6, wherein, The cross-sectional area of ​​the cavity formed by the third folded piece and serving as the base of the cavity is smaller than the cross-sectional area of ​​the cavity formed by the first and second folded pieces, or the diameter of the cavity formed by the third folded piece and serving as the base of the cavity is smaller than the diameter of the cavity formed by the first and second folded pieces.

8. The apparatus according to claim 7, wherein, The cavity also includes a first non-folding sidewall and a second non-folding sidewall, wherein the folding sidewall is located between the first and second non-folding sidewalls.

9. The apparatus according to claim 8, wherein, The third folded piece is the second non-folded sidewall.

10. The apparatus according to claim 9, wherein, A drain hole is provided on the side wall of the cavity. The height of the liquid sample collected in the cavity is controlled by the design of the drain hole, which facilitates the insertion of the sample absorption area of ​​the test element into contact with the sample.

11. The apparatus according to claim 10, wherein, The drain hole is higher than the bottom of the cavity but lower than the opening of the cavity.

12. The apparatus according to claim 11, wherein, The cavity also includes a handle that is rotatably connected to the first non-folding sidewall of the cavity.

13. The apparatus according to claim 12, wherein, A limiting platform is provided on the side wall of the cavity to limit the range of rotation of the handle, so that the handle can be rotated to a fixed position and can no longer be rotated.

14. The apparatus according to claim 13, wherein, The handle can be rotated toward the opening of the cavity or into the cavity, or it can be rotated away from the opening of the cavity until it reaches a fixed position.

15. The apparatus according to claim 14, wherein, The cavity opening is provided with a pair of notches, which allow the testing device to lie flat on the opening, thus facilitating the reading of test results.

16. The apparatus according to claim 15, wherein, The testing device is a transverse flow test strip.

17. The apparatus according to claim 16, wherein, The liquid sample mentioned is urine.

18. The apparatus according to claim 17, wherein, The cavity is made of plastic and is formed by injection molding in one go.

19. The apparatus according to claim 18, wherein, The bottom of the cavity has a recess, which allows the base to be stably fixed on the plane of the test bench by venting air through the recess.

20. The apparatus according to claim 12, wherein, The first non-folding sidewall includes an opening for the cavity.

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