CN2852115Y - Apparatus for sample analysis - Google Patents

Abstract

The utility model provides a detecting apparatus for detecting whether analyzed matter exists in liquid samples or not, which comprises a sampler for collecting the liquid samples, detecting test paper containing detecting reagent generating reaction with the analyzed matter, a sampling zone receiving the liquid samples, a passage making the liquid samples communicated with the detecting test paper, a storing cavity which is communicated with the detecting apparatus and is used for storing the sampler, an observation window capable of being used for observing at least partial detecting test paper, a standard comparing card and one or more standard color comparing cards which are used for carrying out color comparison with the detect test paper and are arranged on the standard comparing card.

Description

Devices for sample analysis

technical field

The utility model relates to a device for collecting liquid samples and analyzing the samples.

Background technique

The following background art is intended to help the reader understand the present invention and should not be considered as prior art.

Alcohol consumption and illicit drug abuse is an established and rising social problem in our society. According to the 2001 National Household Drug Abuse Survey (NHSDA) in the United States, 46.6% of Americans over the age of 12 reported drinking alcohol in the past 30 days. About 20.5% participated in binge drinking. About 5.7% of people over the age of 12 are alcoholics, about 12.9 million people. In 2001, more than one in 10 Americans (25.1 million people) aged 12 and older had driven under the influence of alcohol in at least the 12 months preceding the survey.

In 2003, the U.S. Department of Health and Human Services found that an estimated 19.5 million Americans, or 8.2 percent of those over the age of 12, were using illicit drugs. "Recent illicit drug use" refers to use of an illicit drug within the month preceding the investigation by the U.S. Department of Health and Human Services. Cannabis was found to be the most commonly used illicit drug, accounting for 6.2% (14.6 million). An estimated 2.3 million individuals (1.0%) were current cocaine users, 604,000 used crack, 1 million used hallucinogens, and an estimated 119,000 used heroin.

Alcohol consumption and illicit drug use have a high cost to society. A quarter of emergency rooms say one-third of suicides, more than half of homicides and domestic violence are alcohol-related (Sobering Facts on the Dangers of Alcohol, "NY Newsday, April 24, 2002). About half of traffic fatalities Almost all alcohol consumption is associated (National Highway Traffic Safety Administration, Annual Report, 1992). Alcohol and drug abuse are a burden on the U.S. economy, with an estimated $276 billion annually spent on incapacity, health care costs, crime, motor vehicle crashes, and Other conditions ("Substance Abuse: The Nation's Number One Health Problem," Institute for Health Policy, Brandeis University, 2001). The cost of untreated hermit is more expensive than the combined treatment of heart disease, diabetes, and cancer ("Substance Abuse: The Nation's Number One Health Problem, ″Institute for Health Policy, BrandeisUniversity, 2001). Every American adult pays almost $1,000 a year for herd damage (The National Drug Control Strategy, The White House, 1997).

To combat and monitor this problem, drug and alcohol testing has become standard procedure in a variety of systems such as employment, schools, sports, law enforcement, and more. To advance this effort, an industry of drug testing has formed. This industry offers a wide variety of drug and alcohol testing products. A commonly used test product is a urine collection cup that allows the sample to be analyzed. These devices may be complex and difficult or trivial to use, or to conceal recent use of illicit drugs or alcohol, potentially creating problems with sample adulteration. In addition, urine samples cannot be collected in certain situations, such as on the side of the road or in public places.

Therefore, better methods and instruments are needed to collect and detect samples.

Utility model content

The utility model provides a liquid sample detection device, which is used for detecting whether there is an analyte in the liquid sample. In certain embodiments, the device itself is equipped to detect alcohol or other analytes present in saliva or other fluid samples. These devices consist of a test strip containing a reagent to detect the presence of alcohol; a sampler with a sampling head for collecting a saliva sample, a sample loading area to transfer the sample from the sampler to the test device; Storage chamber of the device. The device also includes a standard comparison card attached to the detection device, which can compare the color depth of the test paper with the standard color card, thereby indicating the content of alcohol in saliva (or other analyte content in liquid samples). One embodiment is that the standard comparison card can be slid on the detection device, and the standard color card can be moved to the side of the test paper for easy comparison.

Part of the content of the present invention is to provide a device for detecting whether there is an analyte or its concentration in a liquid sample. The testing device includes a sampler for collecting a sample. Test strips containing reagents that detect analytes. The sample loading area is used to collect liquid samples, and the liquid can contact the test paper through this area. The storage chamber for storing the sampler is connected with the detection device. There is an observation window through which at least a part of the detection test paper can be seen. A standard comparison card includes one or more standard color cards that can be compared with the test paper.

A specific embodiment is that the sampler of the detection device comprises a sampling head on a protruding rod. The sampling head is made of porous material such as sponge, or other porous material. The sampling head can absorb and hold a liquid sample, and transfer the sample to the detection device. The sampler has a snap-in support for easy retention of the sampler in the oral cavity (when saliva is the liquid sample being tested). Furthermore, the sample loading area has a squeeze surface for separating the sample from the sampler.

Another specific solution is that before the sample is added to the sample application area to react with the reagent, the detection test paper displays the first color. After the sample is applied to the sample application area, the test strip changes to a second color after the analyte (if present in the sample) reacts with the reagent. The depth of the second color indicates the content of the analyte in the sample (the darker the color, the higher the concentration, and the lighter the color, the lower the concentration). Further, the reagent is a reagent that changes color. Specifically, test strips contain reagents that can determine the presence or concentration of alcohol in saliva.

In another specific solution, the standard comparison card can be slid on or inside the detection device to move one or more standard color cards to the vicinity of the test paper. Further, the storage chamber includes a conduit in which the sample application area is disposed. The sample loading area may be located at one end of the pipeline. Liquid samples can be whole blood, blood products, urine, saliva, cerebrospinal body, tears, vaginal extracts, throat extracts, or nasal extracts. In a particular embodiment, the fluid sample is saliva.

In various embodiments, the analyte can be a drug or a metabolite thereof. In a specific embodiment, the analyte is alcohol. Detection reagents include alcohol oxidase, horseradish peroxidase, and tetramethylbenzidine. In another embodiment, the analyte is alcohol and the detection reagents include alcohol dehydrogenase, nicotine adenine dinucleotide, nicotine adenine dinucleotide diaphorase, and a tetrazolium dye.

The utility model also provides a method for detecting the presence or concentration of the analyte in the liquid sample. Specifically, the method includes transferring the liquid sample on the sampling head to the detection device, moving the standard comparison card so that the standard color card is located near the detection test paper, and comparing the color of the detection test paper with the standard color card to determine that the analyte is in the concentration in a liquid sample. A fluid sample can be saliva.

When the reagent reacts with the analyte, the detection test paper changes from the first color to the second color, and the depth of the second color can indicate the concentration of the analyte. More specifically, moving the standard comparison card includes linearly sliding the standard comparison card on the detection device so that the standard color card is near the test paper.

The beneficial effects of this new type of use are: due to the use of colorimetry to detect the presence or absence or content of a certain component to be tested in samples such as blood, urine or saliva, the volume is small and easy to carry, and a certain component can be detected on the spot. Quantitative or qualitative detection, simple operation, convenient result interpretation, accurate detection results.

The summary of the utility model is not limited to the above description, other features and benefits of the utility model will be manifested from the following detailed description and claims.

Description of drawings

FIG. 1 is a schematic diagram of a three-dimensional structure of a detection device 100 of the present invention.

Fig. 2 is a three-dimensional exploded structural diagram of the utility model.

Fig. 3 is a schematic cross-sectional structure diagram and an enlarged view of the utility model.

FIG. 4 is a cutaway perspective view of the detection device shown in FIG. 1 , illustrating insertion of the sampler 110 into the storage chamber 312 through the sample application area 410 .

FIG. 5 illustrates the extrusion of the collected sample from the sampling head by pressing the sampling head 210 through the pressing surface 310 .

FIG. 6 illustrates that the standard comparison card 118 slides in the standard groove 220 to compare the color intensity of the test paper 114 with the standard color card 218 .

Detailed ways

In the following detailed description, the drawings and corresponding text descriptions are only illustrated in the manner of illustrating certain specific solutions that may be implemented by the present invention. We do not rule out that the utility model can implement other specific solutions and change the structure of the utility model without violating the scope of use of the utility model.

Detection device

Referring to the accompanying drawings, the utility model provides a detection device 100 comprising a sampler 110 , a detection test paper 114 , a sampling hole 410 , an observation window 216 , and a standard comparison card 118 . The detection device may also include a detection board 112 . A specific embodiment of the detection device is introduced in Figures 1-6. Other various structures of the detection device manufactured by those skilled in the art, these designs also belong to the scope of the utility model, which is easy to understand.

sampler

A specific solution is that the detection device of the present invention includes a sampler 110 for collecting liquid samples. Referring to FIG. 2, the sampler 110 has a sampling head 210 attached to one end of a connecting rod 212 for supporting the sampling head. The sampler may also include a grip portion 120 for grasping and manipulating the sampler, and a shoulder 130 . A specific embodiment of the shoulder 130 is to fix the sampler in the storage cavity of the detection device. Shoulder 130 is properly engaged with the device, which is held in place by mechanical pressure. For example, the shoulder 130 may comprise a rubber ring or other material, and the shoulder may be sized to fit the opening of the detection device through the mechanical pressure of the rubber ring. The sampling head can be made of a porous material that absorbs liquids and resists mechanical stress during analysis. When the liquid sample is saliva, the sampling head is made of porous and non-toxic material, which can resist mechanical pressure when collecting the sample in the oral cavity. Specifically, sampling heads are made of medical grade sponge or closed cell foam, available from a variety of sources (1 eg, Avitar, Inc. Canton, Massachusetts, USA). On the other hand, the material of the sampling head is swellable when contacted and sucked up by saliva. In other designs, the sampling head can be made of absorbent paper, cotton, or any material that traps and transfers liquid from the oral cavity to the sampler. The sampling tip can also be treated with a reagent for stimulating salivation, for example, a flavoring or a dilute citric acid solution. "Saliva" refers to the secretion of the salivary glands.

When the liquid sample is saliva, the connecting rod may include a bite support 214 which provides a surface for the sampling head to adhere to and a convenient structure for easy containment in the mouth. The occlusal support seat can be a plastic ring or circle adhered to the sampling head, so that the occlusal support pad can be comfortably used to support the back of the tester's teeth. For example, polypropylene, polystyrene, and polycarbonate are suitable plastic materials. In addition, these components may be made of wood or any material having the above-mentioned properties and functions. The sampling head may be adhered to a snap-in support pad or attached to the end of a connecting rod by all convenient means (eg by medical grade oral adhesive). Suitable medical adhesives (eg UV curable adhesives) are readily available commercially (eg DYMAX Corp., Torrington, Connecticut USA). The occlusal support pad can be of any shape, such as round or oval shape, square or any shape that is easy to occlude with the teeth.

Test strip

The detection device of the present invention includes a detection test paper 114, which contains reagents that can be used to detect the substance to be detected in the sample. Any material that can absorb and transmit a liquid sample can be made into a test strip material. The liquid sample is moved on the test strip by capillary action. In various embodiments, the test strip is an absorbent material that transfers liquid by capillary action and does not cross-react with the test reagent or analyte. As an example, the test paper material is a polyamide fiber membrane. The test paper may be of any suitable thickness, for example, from 0.6 to 1.0 mm, or from 0.8 to 1.2 mm, or from 0.8 to 1.0 mm, or from 0.9 to 1.1 mm. A polyamide membrane of suitable thickness with an area of 60 mm by 10 mm can absorb 0.6 gm of liquid (+/- 0.15 gm). Such amide fiber membranes are commercially available from a variety of sources (eg, Filtrona Fibertec ^™ Colonial Heights, VA). Of course, many other water-absorbing materials can also be used as test paper. For example, the use of amine or carboxylic acid groups as surfactants added to the surface of the fibers, which are available from a variety of commercial sources (e.g., FiltronaFibertec ^™ ). In other embodiments, cotton fiber or polyester can also be used as the detection test paper. These materials are pretreated with detergents, proteins, and buffers for different assay applications. In other methods, test strips can be made from nylon fibers, nitrocellulose, polyester fibers, cellulose esters, or cellulose acetates (eg, cellulose triacetate). With reference to the present utility model, various other materials that can be imagined by those of ordinary skill in the art can also be used as the detection test paper.

The detection reagent can be added to the test paper by all convenient means, for example, the material of the test paper is soaked in the reagent and then dried. Another way is to add the reagent to the test strip by spraying it, using a pipette, or any other method and drying it. At least some of the detection reagent reacts with the analyte or a metabolite of the analyte (if present in the sample) to produce a color change on the test strip. Thus when the analyte is present in the sample, the test strip changes from the first color to the second color. Detection reagents can be adjusted according to the analyte of interest and specific application. Many chemical and enzymatic detection methods for blood chemistry or environmental chemistry can be used in the present invention. In a variety of specific scenarios, assay reagents may be chosen to examine or determine alcohol content in saliva, glucose levels in blood or urine, major components of home paint, analyte levels in water samples, and many other applications . Additionally, the reagents can be adjusted to accommodate different fluid samples, such as saliva, blood, urine, or water.

In one embodiment, when the target analyte or metabolite of the analyte is present in the liquid sample, it reacts with the reagent contained in the test strip, causing the color of the test strip to change from a first color to a second color. The intensity of the second color is related to the concentration of the analyte in the sample. For example, the sample may be white before it is added to the test strip. The color of the test paper turns blue when the sample is added and the analyte (or metabolite) reacts with the test paper. The amount of analyte in the sample correlates with the intensity of the blue color, ranging from light blue (low concentration of analyte), to medium blue, and dark blue (high concentration of analyte). The medium blue can also be divided into several steps according to the depth of the color, corresponding to the content of various analytes. Any color can be used as the first color or the second color (e.g. red, orange, yellow, etc.) as long as the first color (e.g. white or colorless) indicates that no analyte is present and the second color indicates that the analyte is being analyzed The presence of the substance or indicating its content (or metabolite), the second color has a series of different shades of color, corresponding to the content of the analyte. The choice of the first and second color of the test strip depends on the application. "Metabolite"refers to a molecule other than the target analyte itself, the presence or concentration of which is directly related to the presence or concentration of the analyte. For example, the product of an analyte may be a metabolite of the analyte.

In one embodiment, a test strip can be placed within the test plate 112 with a viewing window 216 . A form of the detection board is shown in the accompanying drawing. At least a part of the test strip is visible through the viewing window. The observation window can be an opening on the detection plate. The opening may be covered or uncovered. In an embodiment, however, the viewing window may be on the surface of the test plate on which the test strips are supported and viewed by the operator. Specifically, the viewing window has a transparent cover 116 through which the test strip can be seen. The detection test paper is protected by a transparent cover on the observation window, so that the detection test paper is prevented from being exposed to the external environment.

In some versions, the detection device has a sample well for receiving a liquid sample. The sample hole makes the sampler and the test paper communicate with each other. The sample application port 410 is the part of the detection device to which the sample is applied. Referring to FIG. 4 , the sample injection hole 410 is an area or an opening located at the bottom of the cylindrical tube of the detection device, but it can also be directly located on an outer surface of the detection device. The sampler is stored in the cylindrical tube before and after use. Sample wells can exist in various forms. For example, a sample well is an opening that guides liquid into the chamber of the test strip. The sample is squeezed out on or near the injection hole and flows through the cavity to the test paper. In some specific schemes, the observation window can also serve as a sample injection hole. In addition to adding a sample with a sample sampler, the sample can also be added to the test paper by other convenient means, such as a straw or a dropper.

In one embodiment, the sample port includes a squeeze surface 310, and the squeezed sample is transferred to the test strip. Liquid can be transferred between the sample well and the test strip (see Figure 3). When the sampler squeezes the extrusion surface, part of the saliva is squeezed out of the sampling head. Referring to Figures 3 and 4, the sample injection hole can communicate with the detection test paper through the cavity. When the liquid sample is squeezed, the extruded sample flows from the channel to be absorbed by the test paper and analyzed. In order to introduce the sample into the test strip more smoothly, a drainage device 222 can be placed between the test strip and the sample application area to transfer the liquid from the sample application area to the test strip (for example, by wicking or capillary action). The drainage device 222 can be filter paper or other absorbent material that can effectively transfer liquid. Referring to Figure 4, the drainage device is bent at an angle (eg, 90°.±10°) so that the material rests on the extrusion surface and connects to the test strip. The drainage device transfers the extruded sample from the sample injection hole to the test paper. Any absorbent material can act as a drainage means (eg, by capillary action). The drainage set is preconditioned to prevent analyte adsorption on it. For example, when the water-absorbing material is filter paper, it can be treated with buffers, surfactants, and proteins without specific binding to reduce the adsorption of pharmaceutical analytes on the filter paper. In another design, the sample opening has a special extrusion surface, such as an extrusion disk. The flat surface may take the form of a disc (and have holes in it to allow the passage of the sample) for the transfer of the squeezed liquid to the test strip. In other embodiments, the sample port does not have a separate squeeze surface, and a saturated sampler can squeeze the sample at or near the sample port. In another embodiment, the saturated sampler can directly squeeze the sample on the drainage device on the surface of the sample hole. "Liquid transfer" refers to the flow of a sufficient amount of liquid from one structure to a second structure. By "extrusion surface" is meant a surface that has sufficient strength, area, and hardness to withstand the mechanical pressure that occurs when the sample is extruded from the sampling head. The area of the extrusion surface is at least as large as the surface of the sampling head.

The detection device includes a storage cavity 312 for storing the sampler. As shown in FIG. 4 , the storage cavity 312 is located in the detection device in the form of a tube or a column in this embodiment. The cylindrical tube of the sampler and the storage chamber is properly matched, so as to be effectively protected from contamination or mechanical damage. Of course, other structures of the storage cavity can also belong to the scope of the present utility model. For example, one form of the storage chamber may be in the shape of a clip on the side of the test device into which the sampler is inserted to securely grip the test device. In another form, the sampler is stored separately from the detection device. The sampler includes a small rubber pad or ring that fits over the shoulder 130. The rubber pad fits snugly into the storage cavity and holds the sampler in place.

The detection device includes an observation window through which a part of the detection test paper can be seen. The observation window can be made of glass, plastic or other transparent material to protect the test paper from contamination. Another form is that the viewing window is a simple opening that allows the user to view the test strip.

The detection device includes at least one standard comparison card 118, which is associated with the second color produced after the reaction between the test paper and the analyte (or metabolite) present in the sample, and the content of the analyte is indicated in the standard comparison on the card. The standard comparison card includes at least one standard color card 218 representing different densities. As shown in the accompanying drawings, the detection device has a groove-like structure 220 on which the standard comparison card can slide. As shown in the attached picture, the size and shape of the standard comparison card fits into the groove and slides in it. The standard comparison card slides in the groove, so that the standard color cards are arranged next to the test paper, which facilitates the comparison between the standard color card and the test paper. The sliding direction of the standard comparison card on the detection device is parallel to the direction in which the sampler is put into the storage cavity. The standard comparison card can also be fixed on the detection device by gluing or other methods. The standard comparison card also has a pulley, and the rotation of the comparison card makes the standard color card move to the vicinity of the test paper for comparison. The standard comparison card can also be separated from the detection device. The standard comparison card is separated from the detection device, and the detection device contains an area where separate standard color cards can be stored for easy comparison. Sliding means that the standard comparison card is matched with the groove, and the card can slide in the groove to select the color closest to the test paper.

analyze

Various commonly used detection methods such as colorimetric method, enzyme detection method, and chemical detection method can be applied to the utility model. The utility model can detect any interested analyte and its concentration, as long as there is a detection method that can use the detection test paper. The detection device is used for a variety of detection objects, such as analyzing whether there is alcohol and its content in saliva, measuring the physical and chemical properties in blood (for example, pH, creatinine, glucose, alkaline phosphatase, etc.), judging whether there is alcohol in milk Presence and level of alkaline phosphatase, ammonium, phosphate, lead or arsenic in groundwater. The analyte can also be a metabolite of the analyte of interest. Therefore, when the analyte is unstable or other reasons prevent it from being the preferred analyte in actual analysis, its metabolites can be used as the actual object of analysis. Whether there is analyte and its concentration in metabolites and samples relevant.

The analyte can be a drug or its metabolites. Drugs of abuse (DOA) are the use of drugs (usually to paralyze the nerves) for non-medical purposes. Abuse of these drugs can lead to physical and mental impairment, dependence, addiction and/or death. Examples of drugs of abuse include cocaine; amphetamines (e.g., Black Beauty, White Amphetamine Tablets, Dextroamphetamine, Dextroamphetamine Tablets, Beans); methamphetamines (crank, methamphetamine, crystal, speed ); barbiturates (eg, Valium®, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (ie, sleep aids); lysergic acid diethylamide (LSD); depressants (downers, goofballs, barbs, blue devils , yellow jackets, methaphene); tricyclic antidepressants (TCA, namely imipramine, amitriptyline and doxepin); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.) opiates (ie, morphine, opium, codeine, heroin, oxycodone).

Reagent

A specific solution is that the reagent used in the present invention is a reagent that can change color. In this embodiment, the alcohol content can be determined by combining with alcohol dehydrogenase (ADH), nicotinamide adenine dinucleotide (NAD/NADH), nicotinamide adenine dinucleotide diaphorase and tetrazolium salt (when there is In the presence of alcohol, purple formazan dye produces a high brightness purple) reaction determined. In other embodiments, the alcohol content is determined by reacting with tetramethylbenzidine (TMB), alcohol oxidase and peroxidase (which produces blue or green in the presence of alcohol). Those of ordinary skill in the art may think of other chemical methods for detecting the presence and concentration of different analytes in different samples with reference to the contents disclosed in the utility model, which are suitable for the device of the utility model. By "color-variable reagent" is meant a reagent that provides a discernible color or that changes color in the presence of a substance of interest or a metabolite thereof. The color can be clearly observed and judged by the naked eye without the need for other analytical instruments.

In an example, glucose can be measured with a test strip. The test strips are pre-treated with glucose oxidase, horseradish peroxidase, and 3-methyl-2-benzothione and 3-dimethylaminobenzoic acid (MBTH-DMAB) or 3-methyl-2 - Treatment of benzothilone with any of the 8-anilino-1-naphthalene sulfonic acid ammonium compositions (MBTH-ANS). Glucose oxidase and horseradish peroxidase can also be combined with 3-methyl-2-benzothiazolinone]-N-sulfonyl benzenesulfonate monosodium and 8-anilino-1-naphthalene sulfonic acid ammonium(MBTHSB-ANS)(MBTHSB-ANS) to detect glucose content. Other metabolite assays include, but are not limited to the following examples, creatinine assay (eg US 4,529,708 to Stephens), chloride assay (eg US 4,393,142 to Stephens), xanthine oxidase assay (eg US 4,341,868 to Nakanishi) and lactate assays (eg US 4,266,022 to Lamprecht and US 4,254,222 to Owen).

In other embodiments, arsenic in groundwater can also be detected with test strips treated with zinc powder, acid, oxidizing agent, and mercury bromide. The reaction takes on a yellow-brown color when arsenic is present.

In another embodiment, certain drugs of abuse, such as THC concentration and pH, can be analyzed chemically rather than enzymatically. For example the example in U.S. Patent No. 5,728,634.

sample type

Any type of liquid specimen can be tested by the device of the present invention, including biological fluid samples collected from patients. Alternatively, fluids obtained from other types of specimens in appropriate solutions, such as buffer or water, may also be analyzed. For example, specimens may consist of finely powdered materials such as talc, carbon black, pharmaceutical agents, or gases such as argon or methane. Alternatively, the sample can be an atmospheric sample for detection of particulate matter or radioactive isotopes such as radon.

In another embodiment, the sample to be tested is a biological sample, such as an animal or human sample. Various types of samples are suitable for analysis, such as liquids, tissues, organs or combinations thereof. A biological sample can also be other biological material such as plants, bacteria, cell or tissue cultures, viruses and denatured proteins, or food, such as obtained from plants or animals or compounds. Samples may be pre-treated prior to analysis with the detection device. Alternatively, the sample and reagents can be mixed within the sample collection container. Such reagents may treat samples, such as digestion of solid samples with appropriate chemicals, such as acids or bases, or enzymes such as proteases. Other reagents can lyse the analyte from the sample, such as extracting antigens from organisms, such as antigens from well-known pathogens such as bacteria, parasites, viruses or variants.

Samples of any material collected using the present invention to detect the presence and/or concentration of an analyte can be absorbed by the water-absorbing material. The sample in this example is a liquid sample. Liquid samples that can be collected using the present invention include blood, serum, plasma, saliva, urine, tears, semen, and spinal cord; water samples, such as oceans, lakes, rivers, etc., or samples from domestic, municipal or industrial water sources , running water or sewage samples; and food samples, such as milk or wine. Viscous liquids, solutions, eluates, suspensions or extracts from semi-solid or solid specimens may also be used as samples. For example, a throat or genital swab can be suspended in a liquid solution to produce a sample. Samples may also include liquid, solid, gaseous compositions or any combination, such as cell suspensions.

Liquid samples can be prepared from solid, semi-solid or highly viscous materials such as soil, feces, tissues, organs, biological fluids or other materials that are not liquid in nature. For example, these solid or semi-solid samples can be mixed with a suitable solution, such as a buffer, such as a diluent or extraction buffer. The sample may be macerated, frozen and thawed, or otherwise extracted to form a liquid sample. Residual particulate matter can be removed or reduced by conventional means, such as filtration or centrifugation.

Instructions

In use, the sampling head on the sampler absorbs a liquid sample so that the sampler contains a sufficient amount of sample for analysis. For example, when the test subject is a human and the test sample is saliva, the sampling head is placed in the mouth of the human. When the sampling tip of the sampler becomes saturated with saliva, it expands depending on the material of the sampling tip used. When urine is the test sample, the sample can be collected by all convenient means, such as simply pouring urine over the sampling head until saturated, or using a clean urine cup and then soaking the sampling head in the collected urine sample. When the sample is blood, a part of the blood sample is collected by immersing the sampling head in the blood sample. For other devices, the method of collecting the sample will vary, depending on the sample type. For example, to detect pollution, the sampling head can be directly immersed in river water, or the water is collected into a bottle, and the sampling head is immersed in it.

After the sample is absorbed by the sampling head, the sample is transferred to the sample application area. As shown in Figures 4 and 5, the saturated sampler is squeezed against the squeeze surface to transfer the liquid to the test strip. The pressing surface is located at the bottom of the storage chamber, which is used to store the collector. In some embodiments, the sampler is inserted into the storage cavity and the sampling head is pressed by the pressing surface. As described in Figures 4 and 5, the pressing surface is located at the bottom of the storage cavity. In other embodiments, the squeeze surface is perforated to allow passage of liquid sample to the sample application area and test strip.

The test paper absorbs the liquid sample squeezed from the sampling head. As shown in the attached figure, the extruded sample is absorbed by the absorbent paper, which wicks the liquid through a channel into the test strip. When the sample reaches the test strip, the reagents on the test strip react with the analyte (if present). If the analyte is not present in the sample, the test strip remains in the first color. If an analyte is present in the sample, the analyte reacts with the reagent to give the test strip a second color, eg, a light yellow color prior to use. After the detection test paper is in contact with the sample, the detection test paper remains light yellow, indicating that the analyte does not exist in the sample, and if the detection test paper turns red, it indicates that the analyte exists in the sample. The choice of the first and second colors of the test strip depends on the reagents being reacted. Any colorimetric reaction can be used with the device of the present invention, as long as the first and second colors are visible and differentiated, and the intensity of the second color is related to the analyte content.

To illustrate the results of analytical samples, the mobile standard comparison chart makes it easy to compare the standard color chart with the test strip. In this embodiment, the standard comparison card moves along the linear direction of the detection device, so that the standard color card is near the detection test paper (for example, the standard comparison card is moved in the groove of the device). "Nearby" means that the color card that is close to the color of the test paper is closer to the test paper than the other color cards. "Linearly" means moving in a straight line along an axis. As shown in Figure 1, the user slides the standard comparison card to determine the closest color card. The color shades of the several color cards on the standard comparison card correspond to whether there is an analyte in the liquid sample and the concentration of the analyte or the concentration range of the analyte.

The assembly of embodiment 1 alcohol detection device

This example describes one form of the detection device of the present invention, which is used for alcohol detection of saliva, as shown in the figure.

In this example of the utility model, the test board and the sliding standard comparison card are separately injection molded from rigid plastic. The sampler and support base are injection molded from a more flexible plastic. Any medical grade plastic may be used for the production of the sampler provided it has an adequate surface support when pressing against the extrusion surface of the sampling head. At the same time, because of the good toughness, the sampler can be slightly bent in the patient's mouth to reduce the harm to the patient. The cover of the observation window is made of transparent plastic.

Make test strips. A 1.0 mm Filtrona Fibertec ^™ (Colonial Heights, VA) polyamide fiber material was soaked in a reagent solution for the detection of alcohol content in saliva. The solution contains alcohol dehydrogenase (ADH), nicotinyl adenine dinucleotide (NAD/NADH), NADH nicotinyl adenine dinucleotide diaphorase and tetrazolium salts such as 33-(4,5- dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide, and buffer. After the fiber material is wetted with reagents, it is dried and cut to size. Absorbent paper, such as Whatman 3MM paper (Whatman, Inc., Florham Park, New Jersey, USA), and cut to size.

A strip of absorbent paper is placed in the channel connecting the sample loading area and the test paper. So that the liquid can be transferred between the sample loading area and the test paper. The detection test paper is placed above the absorbent paper with a certain size, and the transparent plastic is covered on the detection test paper so that the detection test paper can be seen through the cover of the observation window. Standard color cards are printed and adhered to standard comparison cards. Standard comparison cards slide in grooves.

The sampling head is made of medical grade absorbent material such as polyurethane foam. The foam is soaked in a dilute solution of citric acid and dried. Cut a disc shape from the treated bulk to fit the support seat. The sampling head is attached to the support base with medical grade glue. The complete sample sampler is inserted into the storage cavity. The detection device is sealed and packaged in an aluminum thin bag.

Example 2 detects alcohol in saliva

This example describes that the laboratory utilizes the utility model to detect the alcohol content of a saliva sample.

Alcohol-free saliva was collected from normal healthy volunteers. Pool the collected saliva samples. It is then divided into four portions with final alcohol contents of 0.00%, 0.02%, 0.040% and 0.08%. The utility model is used to repeatedly detect the saliva with different concentrations of alcohol for three times. When performing each test, the sampling head is immersed in the prepared sample solution and kept for 2 minutes. The sampler is inserted into the sample loading area and squeezes out the liquid sample at the bottom of the storage chamber. The extruded liquid sample is absorbed by absorbent paper and transferred to the test paper. After 2 minutes, you can see that the color of the test paper has changed from light yellow to blue. Slide the standard comparison card to compare the color of the standard test paper with the standard color card. The color of the test paper is compared with the color card to determine the alcohol content in the sample.

The result is as follows: when the alcohol content is 0.00%, the detection test paper is still the original light yellow color. It was thus determined that the sample contained no alcohol. When the alcohol concentration is 0.02%, the color of the test paper changes to a light blue color and matches the 0.02% color block in the standard comparison card. When the content is 0.04%, the detection test paper is medium blue, which matches the 0.04% standard color card. Similarly, the 0.08% alcohol content makes the color of the test paper dark blue, which matches the 0.08% standard color card.

The utility model can operate without any element or limiting factor, which will not be described here. The terms and expressions described in the present utility model are not limited to those disclosed in the specification. And we have no intention to use these belonging and expressions to exclude expressions with the same meaning as describing the structures or features of the present utility model, and we agree with various expressions within the scope of the utility model statement. Therefore, we believe that the expression of the design disclosed in this article also requires the help of those experienced professional technicians, and these changes should be consistent with the statement attached to the utility model.

The contents of articles, patents, patent applications, and all other documents, as well as useful electronic information mentioned and cited herein, are combined and must be referenced as a whole, with any part of them being specifically identified when published this point. Applicants have the right to incorporate into this application the information and material of any and all of these articles, patents, patent applications, or other documents as part of the disclosure of this patent specification.

Claims (12)

1, a kind ofly be used for whether the test sample analyte exists or the pick-up unit of its concentration, it is characterized in that: this pick-up unit comprises: the sampler that is used to collect liquid sample and application of sample; The detection test paper that includes detectable; Receive the sample application zone of fluid sample, this sample application zone and detection test paper communicate; Be used to deposit the storage chamber of sampler; Can see at least that part detects the view window of test paper; And include one or more can with detect the standard comparison card that test paper carry out the standard color card of color contrast.

2, pick-up unit according to claim 1 is characterized in that: sampler comprises a sampling head and connecting link, and this sampling head is positioned on the connecting link.

3, pick-up unit according to claim 2 is characterized in that: sampling head also comprises an interlock supporting seat.

4, pick-up unit according to claim 2 is characterized in that: sample application zone comprises that one is used for squeezing from sampler the compressive surface of sample.

5, pick-up unit according to claim 1 is characterized in that: detect test paper and comprise a kind of absorbent material by the capillarity transmit fluid, contain the detectable of meeting the analyte changeable colour on it.

6, pick-up unit according to claim 1 is characterized in that: reagent is a kind of reagent that can variable color.

7, pick-up unit according to claim 1 is characterized in that: standard comparison card can be on pick-up unit or slides within, makes one or more standard color cards near detecting test paper.

8, pick-up unit according to claim 1 is characterized in that: storage chamber comprises a pipeline that is positioned at pick-up unit, and sampler is fixed in this pipeline.

9, pick-up unit according to claim 8 is characterized in that: sample application zone is positioned at the end of pipeline.

10, pick-up unit according to claim 1 is characterized in that: comprise the reagent that whether has alcohol and alcohol concentration in the test sample but detect test paper.

11, pick-up unit according to claim 1 is characterized in that: this pick-up unit comprises that at least one is communicated with the drainage system of sample application zone and storage chamber.

12, pick-up unit according to claim 11 is characterized in that: described drainage system is an absorbent material.

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