WO2017084540A1

WO2017084540A1 - Collection and detection device for fluid samples

Info

Publication number: WO2017084540A1
Application number: PCT/CN2016/105622
Authority: WO
Inventors: Lijan GOU
Original assignee: Abon Biopharm (Hangzhou) Co., Ltd.
Priority date: 2015-11-21
Filing date: 2016-11-14
Publication date: 2017-05-26

Abstract

A collection and detection device (100) for fluid samples includes a sample collector (120) for receiving and containing a fluid sample, wherein the collector (120) includes a rigid receiving part (121) for receiving a fluid sample and flexible container body (124) for containing a fluid sample; the receiving part (121) is located at the sample collector (120) opening; the container body (124) is located below the sample collector (120); the receiving part (121) is connected to the container body (124).

Description

COLLECTION AND DETECTION DEVICE FOR FLUID SAMPLES

FIELD OF THE INVENTION

The present invention relates to a collection and detection device for fluid samples, and in particular, to a collection and detection device used for collecting urine samples.

BACKGROUND

The following background art is provided to help readers to understand this invention and is not considered as prior art.

This technique of detecting the presence of analyte in a sample using the immunobinding principle is widely used in various fields, which can be used to detect analytes in various kinds of biological samples (saliva, blood, urine, serum, sweat, etc. ) , so as to monitor diseases and human health conditions (early pregnancy, cancer, infectious diseases, drugs, etc. ) . The basic principle of this detection technique is to establish the specific binding between the immune molecules, for example, antibodies and antigens, hapten/antibody, biotin and antibiotics, etc..

It is a common method to collect and detect liquid samples using a detection device or detection cup and judge whether the liquid sample contains analytes in the field of medical diagnosis. Generally the samples are collected in a sample container for such detection device or detection cup, and skilled technicians can insert a detection reagent strip and submerges a portion of the strip in the sample, after a period of time, take out the reagent strip and read the test results. In an improved way, a closed cover body is added on the sample collector for operation. At present, there are a number of closed devices, such as the devices disclosed in U.S. Patents US 4976923, US 5429804, and US6726879. In these devices, the testing element is fixed on the cover of the detection device； and during use, the container is inversed or tilted so that the detection reagent strip is immersed by the sample for detection.

The U.S. Patent Application US2003/0027359A1 published on February 6, 2003 disclosed a urine cup for detection. When the cover of the urine cup is covered to the opening of the cup, it still needs to push the column-type piston with a push rod to flow out the fluid sample from the cup chamber and wet the detection element. The Chinese patent application No. 200510113911.5 disclosed a detection device used for liquid sample, and in the device, a detection reagent strip is located on a cup cover, and a tube is located between the cup cover and the cup body, and the liquid sample is pressed into the tube to enter the cup cover for detection.

When the liquid sample detection becomes regular and routine, the home detections are increasing. But the detection devices disclosed have the shortcomings such as large dimension, high transport cost and inconvenience for carry. China Patent No. CN102338799 discloses a new collection device using a bag body as a collection device, which is easy to carry. But the samples must be detected in the detection device immediately after collected, which is not suitable for the circumstance that the samples are needed to collect and then transport to the detection site for detection.

SUMMARY

For the aforesaid problems, this invention provides an improved collection and detection device for fluid samples. Through combination of rigid cup mouth and flexible cup body and a special structure, this device can collect samples more conveniently； moreover, the sample detection time can be selected.

In the present invention, a collection and detection device for fluid samples, including a sample collector for receiving and containing a fluid sample, where the sample collector includes a rigid receiving part for receiving a fluid sample and flexible container body for containing a fluid sample； the receiving part is located at the sample collector opening； the container body is located below the sample collector； the receiving part is connected to the container body.

The term "rigid" as used in the invention means that it has hardness and a fixed shape and it is not easy to bend or fold under the external force. The materials are metals with hardness such as iron, steel, etc., and the plastic material with certain hardness, such as PVC with “rigidness” characteristics. But the “flexibility” is relative to the “rigidity” , that is , the object itself has a certain degree of flexibility and elasticity and their shapes will change under external force, such as folding, bending, etc.. The soft plastic, film, paper, etc. in the materials have the characteristics of “flexibility” . In the invention, the materials for the rigid receiving part and flexible container body in the collector are not limited, which should meet the characteristics of rigidity and flexibility and conform to the standards of medical materials. In some specific embodiments, the rigid receiving part is made of plastic having certain hardness, such as PVC. The flexible container body can be made of soft plastic or thin film.

In some preferred embodiments, the receiving part and the container body may be an integrated structure or detachable sub-structures, which should ensure that the two portions can form a complete collector and are capable of carrying samples without leakage； that is, the connection between the two portions must be sealed.

In some preferred embodiments, the receiving part includes a cup mouth for receiving a fluid sample. In some specific embodiments, in order to facilitate to receiving samples, the cup mouth is cylinder with specified opening size, such as cylindrical, oval cylindrical, etc..

In some preferred embodiments, the receiving part further includes a hollow cup body located below the cup mouth； and the cup mouth is connected to the cup body, and the cup body is connected to the container body. More specifically, the cup body is connected with the container body, and the container body is flexible, which can be folded or deformed. In order to facilitate the connection between the container body and the receiving part, the hollow cup body is a flat, elongated structure.

In some preferred embodiments, the cup body includes a groove at the inner side wall of the cup body. The groove is located one side of the inner side wall of the cup body. In some more specific embodiments, the shape of the groove is adapted to the flat, elongated shape of the cup body, which is in a flat, elongated shape.

In some preferred embodiments, the flexible container body is a foldable bag body； and the bag body is connected to the cup body. The bag body can be folded or compressed to reduce the volume of the collector, particularly when no fluid sample is carried, it can facilitate the transport of the device before detection and the treatment of the device after detection.

In some preferred embodiments, the device further includes a detecting plate used for detection.

In some preferred embodiments, the detecting plate is located in the bag body and is not connected with the liquid in the bag body.

In some preferred embodiments, the detecting plate is an integrated structure, only one end is open for inserting a testing element. The detecting plate is an integrated structure with opening at only one end, which is not merely used for placing testing element, besides, fluid sample can enter the detection plate from the opening end only, that is, enter the sample receiving area of the testing element, to prevent fluid sample from entering other areas of the testing element, that may affect the test results.

In some preferred embodiments, one end of the detecting plate opening is engaged in the groove.

In some preferred embodiments, the groove has a front protrusion for fixing a detecting plate and a rear protrusion for fixing and sealing the detecting plate. Through the coordination of the groove, the protrusions in the groove and the detecting plate, fluid sample flow through the gap between the front protrusion of the groove and the detecting plate, to reach the opening end of the detecting plate and ultimately reach the testing element, to finish the detection. In some preferred embodiments, the bag body further includes a sheet, and the sheet and the bag body form a sealed chamber； the detecting plate is located in the sealed chamber. The sheet can be made of the same material as the bag body, or some materials slightly harder than the bag body.

In some preferred embodiments, one end of the sheet is located in the groove. That is, the opening end of the chamber formed by the bag body is located in the groove. The sheet is located between the detecting plate and the front protrusion, that is, the opening end of the sealed hollow chamber formed by the sheet and the bag body is located in the groove so that the detecting plate in the chamber is connected with the fluid in the groove.

In some preferred embodiments, the device further includes a cover body, and the cover body covers and seals the sample collector.

In another aspect, the invention provides a method of detecting an analyte in a fluid sample, which is provided a detection device as mentioned in any one embodiment above. The method including: collecting the fluid sample into the flexible bag body of the detection device, cover the cover body and seal the cup mouth； and then reversing the device, so that the liquid in the bag body enters the groove of the cup body and contacts with the sample receiving area of the testing element at the opening end of the detecting plate.

In some preferred embodiments, when samples are collected in the bag body of the device, the device is not reversed, and the sample is unable to contact the testing element in the groove of the cup body, and thus it is unable to detect the sample.

In some preferred embodiments, the detecting plate is located in the bag body, which is not connected with liquid in the bag body.

In the present invention, when a sample is collected in the sample collector, i.e., when a sample is in the bag body, cover the cover body and seal the cup mouth to form an enclosed device, and then reverse the device so that the liquid in the bag body enters the groove of the cup body, and then enter the bottom of the groove through the gap between the front protrusion of groove and detecting plate or sheet, then enter the sample receiving area of testing element at the opening end of the detecting plate, flow through the testing element successively, to finish the detection. When sample is collected in the device, if the device is not reversed, the sample is unable to contact the testing element in the cup body groove at the opening end, thus it is unable to detect the sample. Therefore, after collection, the samples can be detected immediately or at other times, to facilitate the detection.

BENIFICIAL EFFECTS

Through combination of the rigid cup mouth and the flexible cup body, the collection and detection device in the invention can achieve receiving of samples quickly and conveniently and the separation of sample collection and detection, and thus, samples can be detected at any time after collected； in addition, the device adopts flexible container body, with small transportation volume, low transportation cost, so it is convenient to transport, facilitating large-scale detection.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of a sample collection and detection device of the present invention；

FIG. 2 is a schematic diagram of a sample collection and detection device of the present invention；

FIG. 3 is a schematic diagram of a receiving part of a sample collection and detection device of the present invention；

FIG. 4 is a cross-sectional view of a sample collection and detection device of the present invention；

FIG. 5 is a partially enlarged schematic view of FIG. 4；

Notes:

Sample collection and detection device 100； cover body110； sample collector 120； receiving part 121； container body (bag body) 124； cup mouth 122； cup body123； sheet125； detecting plate130； upper cover of detecting plate 132； lower cover of detecting plate 133； testing element 131； groove 1231, front protrusion of groove 1232； rear protrusion of groove 1233； outside concave-convex of cup body 1235； outside thread of cup mouth 1221； chamber formed by sheet and bag body126

DETAILED DESCRIPTION

The structure or technical terms used in the invention are further described below. In the following detailed description, the text in the drawing is a part herein. The specific solution is described in the embodiments of the invention. The invention can employ other specific technical solutions and the devices can be varied without departing from the scope of the invention.

Detection

The detection means the assay or testing of the presence or absence of a substance or material, such as, including but not limited to, chemical substances, organic compounds, inorganic compounds, metabolites, drugs or drug metabolites, organic tissues or metabolites thereof, nucleic acids, proteins or polymers. In addition, the detection also means the quantitative testing of test substance or material. Furthermore, the assays also include immunoassays, chemical assays, enzyme assays, etc..

Samples

A sample referred to in the present invention is the one that can be used to detect, assay or diagnose the presence of interested analytes or a pure sample. The sample may be, for example, a fluid sample, which can be a liquid sample, and the liquid sample may include urine, blood, plasma, serum, urine, saliva, and various secretions, or include the liquid solution formed by solid and semisolid samples after pre-treatment. The liquid sample may be untreated, or treated, etc.. The collected samples can be used for detecting the presence of analytes through such methods as immunoassay, chemical detection and enzyme detection, etc..

Testing Element

Testing element can be horizontal flow testing element, which can be used to detect a variety of analytes. Of course, other appropriate testing elements may also be used in the present invention.

Various testing elements can be used in combination in the present invention. One form is a test strip. The test strips used for detection of analytes in the sample (such as a drug or a metabolite that indicates the condition of the body) may be in various forms, for example, immunoassays or chemical analysis. The analysis modes of the test strips may be non-competitive or competitive method. The test strip includes a water-absorbing material having a sample loading zone, a reagent zone and a test zone. Samples were added to the sample loading zone and flowed through the capillary to the reagent zone. In the reagent zone, if an analyte is present, the sample binds to the reagent. The sample then continues to flow to the detection zone. Other reagents, such as molecules specifically bound to the analyte, are immobilized in the detection zone. These reagents react with the analyte (if any) in the sample and bind the analyte to that zone, or bind a reagent in the reagent zone. A marker for displaying the detection signal is present in the reagent zone or in a separate labeling zone. A typical noncompetitive analysis model: a signal will be generated if a sample contains the analyte, and no signal will be generated if a sample does not contain the analyte. In the competitive method, if the analyte is not present in the sample, the signal is generated； and if the analyte is present in the sample, no signal will be generated. The testing element is a test strip, which can be absorbent or non-absorbent material. The test strip may include a variety of materials for liquid sample delivery. One material of a kind of test strip can be covered with another material, for example, filter paper covered on the nitrocellulose membrane. One zone of the test strip may adopt one or more kind of materials, and the other zone may adopt different material (s) . The test strip may be adhered to a support or hard surface to enhance the strength of the test strip. The analyte is detected by a signal generating system, for example, by using one or more enzymes that specifically react with the analyte and immobilizing the specific binding substance on the test strip as described above, one or more compositions of signal generating system are immobilized on the analyte detection zone of the test strip. The substance that generates the signal may be in the sample loading zone, reagent zone or detection zone, or the entire test strip, which may be filled with one or more materials of the test strip. The solution containing the signal substance is applied to the surface of the test paper or one or more materials of the test paper are immersed in the solution containing the signal substance, and then the test paper with the solution containing the signal substance is dried.

All zones of the test strip can be arranged in the following way: loading zone, reagent zone, detection zone, control zone, zone for identifying adulteration, and liquid sample absorption zone. The control zone is behind the detection zone. All zones can be arranged on a single test strip using only one kind of material, or different materials are used in different zones. Each zone may be directly in contact with the liquid sample, or different zones may be arranged according to the flow direction of the liquid sample, and the end of one zone is connected and overlapped with the front end of another zone. The materials used may be a water-absorbing material such as a filter paper, a glass fiber or a nitrocellulose membrane, etc.. The test strip may adopt other forms.

Commonly used reagent strips are nitrocellulose membrane reagent strips, namely, the detection zone includes the nitrocellulose membrane, and specific binding molecules are immobilized on the nitrocellulose membrane to show the test results； it can also be cellulose acetate membrane or nylon membrane, etc., for example the test strips or devices containing test strips as described in the following patents: US 4857453； US 5073484； US 5119831； US 5185127； US 5275785； US 5416000； US 5504013； US 5602040； US 5622871； US 5654162； US 5656503； US 5686315； US 5766961； US 5770460； US 5916815； US 5976895； US 6248598； US 6140136； US 6187269； US 6187598； US 6228660； US 6235241； US 6306642； US 6352862； US 6372515； US 6379620； and US 6403383. The test strips and similar devices containing test strips disclosed in the above patent documents can be applied to the testing element or detection device of the present invention for detection of analytes, for example, detection of analytes in the sample.

The detection reagent strip applied to the present invention may be a lateral flow reagent strip. The specific structure and detection principle of these detection reagent strips are well known to ordinary technicians skilled in the art. The ordinary detection reagent strip includes a sample receiving area, a marking area, a detection area and a water absorption area； the sample collection area includes a sample receiving pad, the marking area includes a marking pad, the water absorption area includes an absorbent pad, and the sample collection area has necessary chemical substances for detecting the presence or absence of the analytes, such as an immunological reagent or an enzyme chemical reagent. Commonly used detection reagent strip is nitrocellulose membrane reagent strip, namely the detection area includes a nitrocellulose membrane, which shows the test results by immobilizing specific binding molecules on the nitrocellulose membrane； or it can be a cellulose acetate membrane or nylon membrane； of course, a detection result control area may be included at the downstream of the detection area, and usually the detection line or control line appears on the control area and detection area in the form of horizontal lines. This kind of detection reagent strip is a conventional reagent strip, of course, it can be other type of reagent strips that are tested by the capillary action. In addition, usually the detection reagent strip is provided with a dry chemical reagent component, such as a fixed antibody or other reagent. When it is in contact with the liquid, the liquid will flow along the reagent strip with capillary action, to dissolve the dry reagent component in the liquid, and in the next area, the dry reagent has reaction, to achieve necessary detection. Liquid flow mainly relies on the capillary action. These testing elements are described and documented in the following documents: Li Fugang, Study on the regeneration of nitrocellulose membrane and its adsorption capacity of protein； Ma Hongya, Li Qiang, et al., Chromatography membrane material performance analysis of colloidal gold diagnostic kit； Wang Yong, Wang Luhai, et al. A new type of colloidal gold immunochromatographic testing element. Here, these elements can be applied to the detection device or arranged in the detection chamber to contact with the liquid sample, or used to detect the presence or absence of an analyte in the liquid sample and the amount of analyte.

Analyte

Examples that the analytes can be used in the present invention include some haptenic substances, including drugs (such as drugs of abuse) . "Drug of abuse" (DOA) refer to the use of drugs in a non-medical purposes (usually leading to nerve paralysis) . Abuse of these drugs can lead to physical and mental damage, and produce dependence, addiction and/or death. Examples of drug abuse include cocaine； amphetamines AMP (e.g., black beauties, white amphetamine tablets, dextroamphetamine, dextroamphetamine tablets, Beans) ； methamphetamine MET (crank, anaphthalene, crystal, speed) ； Barbiturates BAR (e.g., Valium , Roche Pharmaceuticals, Nutley, New Jersey) ； sedatives (i.e., sleep aids) ； lysergic acid diethylamide (LSD) ； inhibitors ( (downers， goofballs， barbs， blue devils， yellow jackets， methaqualone) ； Tricyclic antidepressants (TCA, imipramine, amitriptyline, and doxepin) ； methylenedioxymethylaniline MDMA； phenylcyclohexylamine (PCP) ； Tetrahydrocannabinol (THC 、pot， dope， hash， weed， etc. ) ； opioids (such as Morphine MOP or opium, cocaine COC ； heroin, hydrocodone) ； Anxiolytic drugs and sedative hypnotics, anxiolytic drugs is a class of drugs mainly used to reduce anxiety, tension, fear, stabilize emotion , hypnotic sedative, including BZO (benzodiazepines) , atypical BZ, fused dinitrogen NB23C, benzazepine, BZ receptor ligands, open-loop BZ, diphenylmethane derivatives, piperazine carboxylic acid salts, piperidinecarboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocyclics, imidazole-type sedative/analgesic drugs (such as hydroxycodeinone OXY, methadone MTD) , propylene glycol derivatives -carbamates, aliphatic compounds, anthracene derivatives, etc.. This detection device in the invention can be used to detect the drugs with medical purposes that are prone to overdose, such as tricyclic antidepressants (imipramine or analogues) and acetaminophen, etc.. These drugs are decomposed into different small molecular substances after absorbed in human body, and these small molecules are present in the blood, urine, saliva, sweat and other body fluids or part of them.

Sample collection and detection device

Referring to FIG. 2 and FIG. 1, the sample collection and detection device 100 of the present invention mainly includes a sample collector 120 and a cover body 110 that covers and seals the sample collector 110. After the cover body 110 is placed over the sample collector 120, the device 100 is in a sealed condition, and no fluid sample leaks from the device 100 whether rotating, shaking, or even overturning the device. In some specific embodiments, the cover body 110 has screw threads on the inner side wall, and the coordinated screw thread 1221 exists on the sample collector 120, both of which are covered and sealed in a thread engagement way. In order to enhance the sealing effect, usually a gasket is provided at the apex of the inner side wall of the cover body 110, to form a further seal with the opening of the collector 120 and prevent the leakage of liquid sample.

In order to make the device 100 achieve convenient carry and transport and facilitate the operation for sample collection, the opening 121 of the collector 120 is made of non-deformable plastic material, which is used for receiving sample, and the container body 124 of the collector connected with the opening used for carrying liquid sample is made of deformable flexible film, so that the volume of the collector 120 can be varied, and through compressing or folding, the volume of the container body 124 is reduced even to zero, substantially reducing the space, easy to carry and transport, etc..

In a more specific embodiment, referring to FIG. 3, the rigid receiving part 121 includes two parts: a cup mouth 122 having a larger opening and a cup body 123 for facilitating connection of the container body. More specifically, the cup mouth 122 is cylindrical, while the cup body 123 is a flat, elongated chamber, and the cup mouth and the cup body are connected by a funnel-shaped cylinder. The outside of the cup mouth 122 is provided with a screw thread 1221 fitted to the cover body 110, and a concavo-convex 1235 connected to the flexible container body 124 is provided on the external side of the cup body 123.

The device 100 further includes a detecting plate 130 for detecting a collected fluid sample. Referring to FIG. 1, the detecting plate 130 further includes a testing element 131 used for testing, and the testing element 131 is sandwiched in the detecting plate 130 through the upper cover of the detecting plate 132 and the lower cover of detecting plate 133. In a more specific embodiment, the detecting plate 130 is located in the detection device 100, to become an integral structure. Usually during the detection process, it is desirable that the samples flow from the sample receiving area to the downstream marking area and detection area in sequence, to finish the detection effectively. Thus, only one end of testing element 131 (sample receiving area) in the detecting plate 130 receives the fluid sample, and the detecting plate 130 with testing element is located in the container body 124 of the collector. Therefore, in some embodiments, the detecting plate 130 is a sealed structure, with opening in one end only, used for receiving testing element and keep connected with the outside.

Referring to FIG. 3, on the side of the inner side wall of the cup body 123, a groove 1231 is provided, which is used for engaging and fixing the detecting plate 130. The end of detecting plate 130 with opening is located in the groove 1231, that is, the opening end of the detecting plate 130 is connected with the groove 1231. In some more specific embodiments, referring to the cross-section views in FIG. 4 and FIG. 5, the groove 1231 further includes a front protrusion 1232 and a rear protrusion 1233, and the detecting plate 130 is engaged and fixed by the two protrusions, moreover, the rear protrusion 1233 at the inner side wall of the cup body 123 and the detecting plate 130 form a sealing, to block fluid flow.

The groove 1231 of the cup body 123 further includes a slot 1236, and the low cover 133 of the detecting plate 130 has an end with opening on the surface and a latch 134 which matches with the slot 1236； through the matching between the latch 134 on the detecting plate and the slot 1236 on the groove 1231, the detecting plate 130 and the cup body 123 can maintain relatively fixed.

The container body of the device 100 can be a bag body 124 made of a plastic film. In order to facilitate sample observation and observe the test results, the bag body 124 may be transparent. The “transparent” means that the shape and color of the object in the transparent body can be observed by naked eyes, for example, you can observe the amount of samples collected, the color displayed, etc.. The opening of the bag body 124 is deformed and bonded to the concavo-convexes 1235 outside the cup body by heating, and then fixed after cooling, to form a fixed whole body-sample collector 120. Of course, the cup body 123 and bag body 124 can also be detachably connected, to facilitate the recycling of the collection and detection device 100.

In some preferred embodiments, the bag body 124 further includes a sheet 125, which forms only one opening with one side of the bag body 124, and the sealed chamber 126 for the rest. The opening end of the chamber 126 is located in the groove 1231 of the cup body 123. After the detecting plate is placed in the chamber 126, the detecting plate 130 communicates with the groove 1231 and the outside of the groove 1231 only through the opening of the chamber 126 in the groove 1231. In a more specific embodiment, the sheet 125 is located between the front protrusion 1232 of the groove 1231 and the detecting plate 130, by this way, when reaching the groove 1231, the sample flows in the opening end of the chamber 126 formed by the sheet 125 and the bag body 124 through the gap between the front protrusion 1232 and the sheet 125, that is, the bottom of the groove 1231, and then enters into the testing element 131 of the detecting plate, to finish the detection. In the present invention, the sheet may be made of the flexible plastic or film material same as the bag body, or may be made of a relatively rigid sheet plastic.

In the invention, the sample required for detection of testing element 131 is small, usually no more than 1 ml, while the liquid sample collected in the bag body 124 is generally 5 to 20 ml, when the device 100 is reversed and a large amount of liquid flows into the testing element 131, it will lead to failure of detection. Therefore, the gap between the groove front protrusion 1232 that control the liquid flow and outflow and the detecting plate 130 or sheet 125 (if any) should not be excessively large, in some specific embodiment, the gap is between 0.1mm and 0.5 mm, so that liquid can flow through the gap when reaching the gap, or can be driven to the opening end of the detecting plate 130 and the detecting element 131 by the capillary action.

The collection and detection process of the sample collection and detection device 100 of the present invention is described below.

First, the cover body 110 on the cup mouth 122 is unscrewed, and the urine sample is injected to the bag body 124 through the cup mouth 122. Normally, it is appropriate when the sample collection amount reaches 2/3 of the volume of the bag body 124.

Second, the cover body 110 is covered so that the entire device 100 forms a seal.

Third, when detection is necessary, the sample collection and detection device 100 is reversed, at this time, the liquid flows into the groove 1231 of the cup body 123, and then flows into the detecting plate 130 through the gap between the front protrusion 1232 and the sheet 125, to finish the detection.

All patents and publications mentioned in the description of the invention are public technologies in the art, which can be used in the invention. All patents and publications cited herein are also listed in the references, same as listed in each publication separately. The invention described herein may be achieved in the absence of any one element or elements, one limitation or multiple limitations, and such limitations are not specifically described herein. For example, one of the terms "including", "substantially consisting of" and "consisting of" in each embodiment can be replaced by the other two terms. The terms and expressions used herein are for the purpose of description rather than limitation, and it is not intended to specify that the terms and interpretations described herein rule out other equivalent features, it should be understood that, any appropriate modifications or changes can be made within the scope of the invention and the claims. It is to be understood that the described embodiments of the present invention are preferred embodiments and features, and that those skilled in the art can make modifications and variations within the spirit of the invention, and such modifications and variations can be deemed within the scope of the invention and scope limited by the independent claims and dependent claims.

Claims

A collection and detection device for fluid samples, comprising a sample collector for receiving and containing a fluid sample, wherein the sample collector comprises a rigid receiving part for receiving a fluid sample and flexible container body for containing a fluid sample； the receiving part is located at the sample collector opening； the container body is located below the sample collector； the receiving part is connected to the container body.
The collection and detection device according to claim 1, wherein the receiving part comprises a cup mouth for receiving a fluid sample.
The collection and detection device according to claim 2, wherein the receiving part further comprises a hollow cup body located below the cup mouth； and the cup mouth is connected to the cup body.
A collection and detection device according to claim 3, wherein the cup body comprises a groove at the inner side wall of the cup body.
The collection and detection device according to any one of claims 1 to 4, wherein the flexible container body is a foldable bag body； and the bag body is connected to the cup body.
The collection and detection device according to claim 5, further comprising a detecting plate used for detection.
The collection and detection device according to claim 6, wherein the detecting plate is located in the bag body and is not connected with the liquid in the bag body.
The collection and detection device according to claim 7, wherein the detecting plate is an integrated structure, only one end is open for inserting a testing element.
A collection and detection device according to claim 8, wherein one end of the detecting plate opening is engaged in the groove.
The collection and detection device according to claim 9, wherein the groove has a front protrusion for fixing a detecting plate and a rear protrusion for fixing and sealing the detecting plate.
The collection and detection device according to claim 10, wherein the bag body further comprises a sheet, and the sheet and the bag body form a sealed chamber； the detecting plate is located in the sealed chamber.
The collection and detection device according to claim 11, wherein one end of the sheet is located in the groove.
The collection and detection device according to claim 12, wherein the device further comprises a cover body, and the cover body covers and seals the sample collector.
A method of detecting an analyte in a fluid sample, comprising:

providing a detection device comprising a sample collector and a detecting plate； the sample collector is used for receiving and containing fluid samples, wherein the sample collector comprises a rigid receiving part for receiving a fluid sample and a flexible container body for containing a fluid sample； the receiving part is located at the sample collector opening； the container body is located below the sample collector； the receiving part is connected with the container body；

the detecting plate comprises a detection reagent strip, and the sample receiving area of which is close to the opening of the collector；

Collecting the fluid sample into the flexible bag body of the detection device, cover the cover body and seal the cup mouth；

reversing the device, so that the liquid in the bag body contacts with the sample receiving area of the testing element at the opening end of the detecting plate.
The method according to claim 14, the device is not reversed when the flexible container body has a fluid sample as such the sample is unable to contact the sample receiving area of the testing element on the detecting plate.
The method according to claim 14, wherein the collecting device comprises a groove, the detecting plate is an integrated structure, only one end is open for inserting a testing element； and one end of the detecting plate opening is engaged in the groove.
The method according to claim 16, wherein, after the reversing the device, the liquid in the bag body flows into the groove and comes into contact with the sample receiving area of the testing element at the opening end of the detecting plate.