CN107874767B

CN107874767B - Device for detecting analyzed substance in sample

Info

Publication number: CN107874767B
Application number: CN201710948539.3A
Authority: CN
Inventors: 周凯军; 洪亮
Original assignee: Hangzhou Biotest Biotech Co Ltd
Current assignee: Hangzhou Biotest Biotech Co Ltd
Priority date: 2017-10-12
Filing date: 2017-10-12
Publication date: 2020-11-24
Anticipated expiration: 2037-10-12
Also published as: CN107874767A

Abstract

The invention provides a device for detecting an analyte in a sample, which is characterized by comprising a solution reservoir and a puncturing element, wherein the puncturing element punctures the solution reservoir to release a solution, wherein the solution reservoir exists independently outside a detection device, the detection device comprises a channel, and the channel comprises an opening with one end outside the channel and an opening with one end leading to the inside of the detection device; the puncture structure is positioned on the channel of the detection device.

Description

Device for detecting analyzed substance in sample

Technical Field

The present invention relates to a device and a method for detecting an analyte in a fluid sample, and in particular, to a device and a method for detecting an analyte in a blood sample.

Background

The following background is provided to aid the reader in understanding the present invention and is not admitted to be prior art.

Blood has been a frequently used sample in the field of testing because blood contains many biological indicators or analytes. In POCT, if the analyte substance of blood is to be detected, it is generally necessary to collect the blood, for example, to puncture a capillary vessel on the skin with a blood collection needle, collect a blood sample with a blood collection tool, and then analyze the blood sample. When an individual performs a blood sample test, a blood collection needle, a blood collection tool, and a test device are generally required, and a solution reagent for treating blood is generally provided. Generally, these appliances are packaged together, which is not only disadvantageous to packaging, but also causes troubles in use or damages to human body.

There is a need for an improved conventional device for testing blood samples to overcome the above drawbacks and to provide convenience and convenience to the user.

Disclosure of Invention

In order to solve the problems of the prior art, the present invention provides a device for detecting an analyte in a fluid sample, in particular a blood sample, the device comprising: a solution reservoir for puncturing the puncturing element of the solution reservoir. Puncturing of the puncturing element allows the solution reservoir to release the solution.

In some preferred forms, the device further comprises a blood collector for collecting a blood sample and/or a puncture device (needle or sharp structure) for puncturing tissue.

In some preferred modes, the blood collector is a tubular structure. Preferably, the blood collection device comprises a blood collection head, with which a blood sample is collected. Preferably, the blood collection device is in an L shape. Preferably, one end of the hemostix is connected with a blood collecting head, and the other end of the hemostix is of a rod-shaped structure. Preferably, the detection device includes a fixing structure for allowing the rod-like structure at the other end of the blood collection device to rotate.

In some preferred embodiments, the blood sampling device is disposed near the sample application hole of the detection device. In some preferred modes, the hemostix comprises a rod-shaped structure and a blood collecting head positioned at one end of the rod-shaped structure.

In some preferred modes, the other end of the rod-shaped structure comprises a plug, and the detection device comprises a jack, and the plug is positioned in the jack.

In some preferred forms, the latch is rotatable within the socket. In some preferred forms, the detecting means includes two protruding structures, and the insertion hole is located on the two protruding structures.

In some preferred forms, the other end of the rod-like structure is located between two projections. In some preferred modes, the blood sampling head is positioned in the sample adding hole.

In some preferred embodiments, the device further comprises a test element by which the presence or amount of an analyte in a blood sample can be detected.

In some embodiments, the solution reservoir or reservoir is a device for storing solution reagents, the reservoir comprising a chamber for receiving the solution treatment substance, the opening of the chamber being sealed by a membrane which is easily punctured.

In some preferred modes, the cavity of the solution storage device is enclosed by a bottom and a side wall, and the opening of the cavity is sealed by a thin film.

In some preferred modes, the side wall is provided with a groove structure, and the groove structure is directly arranged on the edge of the cavity opening of the side wall, in other words, the groove can extend from the edge to the bottom of the cavity.

In some preferred forms the membrane seals the opening and also seals the trench opening of the trench, thereby forming a hidden trench in the sidewall of the cavity.

In some preferred embodiments, the grooves may be a plurality of grooves, and may be uniformly distributed on the sidewall of the chamber, and preferably, are located inside the sidewall of the chamber, and may be directly contacted with the treatment solution reagent.

In some preferred modes, the cross section of the groove is in a shape like a V, a shape like a Z, an shape like an O and an shape like an L.

In some preferred forms, the trench has a "V" shaped opening, a "Z" shaped opening, an "O" shaped opening, and an "L" shaped opening, which is located along the opening of the cavity.

In some preferred modes, the film covers the opening of the groove.

In some preferred modes, the inner side wall of the cavity comprises one or more groove structures.

In some preferred forms, the cavity is a rectangular cavity, the opening of the cavity is also rectangular, and the inner side walls corresponding to the two short sides include the groove structures.

In some preferred modes, the groove structure is arranged in the middle of the inner side wall corresponding to the two short sides. In some preferred modes, the device further comprises a containing cavity for containing the solution reservoir, and the bottom of the containing cavity comprises a fixing structure for fixing the solution reservoir. In some preferred modes, the fixing structure is located at the middle position of the bottom of the accommodating cavity.

In some preferred forms, the test device includes an upper plate and a lower plate, and the test element is located between the upper plate and the lower plate. Preferred test elements include a sample application zone, a reagent test zone.

In some preferred forms, the device includes a test element, and the test device includes an upper plate and a lower plate, the upper plate and the lower plate having a slot element therebetween, and the test element is located in the slot element, wherein the slot element is removably disposed in the test device.

In some preferred forms, the test device includes a channel having an opening at one end in communication with the exterior and an opening at the other end in communication with the interior of the test device, wherein the first end of the card slot element is disposed in the channel.

In some preferred forms, the channel comprises two channel elements, one of which is located on the upper plate and the other of which is located on the lower plate.

In some preferred forms, the outer surface of the channel includes a piercing element. The puncture element is formed by the outward bulge of the channel element to form a separated blade structure. The very cut surface of the blade structure corresponds to the cross section of the groove, so that the blade structure can be inserted into the groove structure to puncture the film and release the solution reagent.

In some preferred forms, the sample application region of the test element is located within the card slot, wherein the sample application region is proximate to the first end of the card slot element.

In some preferred forms, the slot member includes a latch, and the lower plate includes a receptacle into which the latch can be inserted, or from which the latch can be removed.

In some preferred modes, the bolt and the clamping groove are of an integral structure.

In some preferred modes, the plug pin and the clamping groove are integrally formed by injection molding.

In some preferred forms, the channels are rectangular in cross-section.

In some preferred forms, the device further comprises a solution reservoir, the reservoir comprising a membrane-sealed chamber having a rectangular cross-section and corresponding piercing means on the outer surface of the channel

In some preferred forms, the test device includes a lancet disposed within the test device, typically with one end secured to the test device and the other end exposed, the exposed portion including a lancet for puncturing tissue to release blood therefrom. Lancing devices are commonly used lancing mechanisms, and typically include a sharp needle for lancing the tissue for bleeding. These structures are common structures, and conventional structures are sufficient. In some preferred forms, the lancet is a "T" shaped structure and includes a catch structure on the testing device, the lancet snapping over the catch structure, thereby securing the lancet to the testing device.

In another aspect, the present invention provides a method for detecting an analyte in a blood sample, the method comprising: providing a testing device comprising a test element, a solution reservoir, a piercing element capable of piercing the reservoir, wherein the solution reservoir has a first fixed position and a second position in the testing device;

moving the solution reservoir from a first location to a second location;

during the movement, the piercing element is allowed to pierce the solution reservoir, thereby releasing the solution in the solution reservoir.

Advantageous effects

The device of the invention integrates the blood sampling, buffer solution and detection device into a whole structure, and can finish the collection and detection of blood samples in one step.

Drawings

Fig. 1 is a schematic perspective exploded view of a detection device according to an embodiment of the present invention.

Fig. 2 is a schematic perspective view of an upper plate mechanism according to an embodiment of the present invention.

Fig. 3 is an enlarged view of the rotary blood collection device according to an embodiment of the present invention.

Fig. 4 is a schematic perspective view of a blood collection device according to an embodiment of the present invention.

Fig. 5 is an enlarged view of a portion of the blood collection device and the rotational fixing device of fig. 1 according to one embodiment of the present invention.

Fig. 6 is an assembled structure of the detecting device shown in fig. 1.

Fig. 7 is a schematic perspective view of a puncture instrument according to an embodiment of the present invention.

FIG. 8 is a schematic view of a fixed perspective structure of a lancing device and a detection device containing a punctured tissue according to one embodiment of the present invention.

FIG. 9 is a schematic view of a stationary assembly of a lancing device and a detection device including a punctured tissue according to one embodiment of the present invention.

Fig. 10 is a perspective view of a removable card slot element and lower plate in accordance with an embodiment of the invention.

Fig. 11 is a schematic perspective view of a solution storage container according to an embodiment of the present invention (the opening is not sealed by the sealing film).

Fig. 12 is a schematic perspective view of a solution tank according to an embodiment of the present invention (the opening is sealed by a sealing film).

Fig. 13 is a perspective view of a holding device for holding a solution reservoir.

Fig. 14 is a schematic perspective view of the position of the solution storage in the containing device.

Fig. 15 is a schematic perspective view (assembled) of the position of the solution reservoir (opening not sealed by the sealing film) in the containment device.

FIG. 16 is a schematic perspective view of an embodiment of the detecting device (without a solution storage device).

Fig. 17 is an enlarged view of a part of the detecting device shown in fig. 16.

FIG. 18 is a schematic structural view of a state in which a puncturing element of the detecting device punctures the solution storage to release the liquid in one embodiment of the present invention.

FIG. 19 is a schematic diagram of a test device according to the present invention.

Detailed Description

The present invention will be further described with reference to the structures or terms used herein. The description is given for the sake of example only, to illustrate how the invention may be implemented, and does not constitute any limitation on the invention.

Detection of

Detection refers to assaying or testing for the presence of a substance or material, such as, but not limited to, a chemical, organic compound, inorganic compound, metabolic product, drug or drug metabolite, organic tissue or a metabolite of organic tissue, nucleic acid, protein, or polymer. In addition, detection indicates the amount of the test substance or material. Further, the assay means immunodetection, chemical detection, enzyme detection, and the like.

Test element

A variety of test elements 70 may be used in combination with the present invention. The test element comprises a test strip, which may take a variety of forms, such as an immunological or chemical test form, for detecting an analyte in a sample, such as a drug or a related metabolite indicative of a physical condition. In some forms, the test strip is a bibulous material having a sample application zone, a reagent zone, and a test result zone. The sample is applied to the sample application zone and flows into the reagent zone by capillary action. In the reagent zone, the sample dissolves the reagent and mixes with it for detection of the analyte (if present in the sample). The sample with the reagent now continues to flow to the detection result zone. Additional reagents are immobilized in the detection result zone. The reagent immobilized on the detection zone reacts with and binds to the analyte (if present) or the first reagent of the reagent zone. In a non-competitive assay format, 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 assay format, a signal is generated if the analyte is not present in the sample and no signal is generated if the analyte is present. The invention is applicable to a variety of assay formats.

When the test element is a test strip, it may be made of absorbent or non-absorbent materials, and multiple materials may be used for fluid communication with a single test strip. One material of the test strip may be superimposed on another test strip material, for example, filter paper superimposed on nitrocellulose. Alternatively, one region of the test strip containing at least one material is positioned behind another region containing at least one different material. In this case, the liquid flows between the zones, which may or may not be superimposed on each other. The material on the test strip may be immobilized on a support such as a plastic backing or a hard surface to enhance the test strip holding power.

In some embodiments in which the analyte is detected by the signal producing system (e.g., at least one enzyme specifically reacts with the analyte), at least one signal producing substance may be adsorbed to the analyte detection zone of the test strip as described above, specifically to the material of the test strip. In addition, the signal-producing substance present in the sample application zone, reagent zone, analyte detection zone, or throughout the test strip may be pre-treated on one or more materials of the test strip in advance. This can be accomplished by applying a solution of the signal-producing substance to the surface of the application area or by immersing one or more materials of the test strip in the signal solution. After the test strip is added to the signal solution or soaked in the solution, the test strip is dried. In addition, the above methods may be present in the sample addition zone, the reagent zone, the analyte detection zone of the test strip, or the signal-producing substance may be pre-treated on one or more materials of the test strip in advance throughout the test strip. Alternatively, a signal substance present in the sample, reagent, or detection zone of the test strip may be applied to one or more surfaces of the test strip material as a labeled reagent.

The test strip regions may be arranged as follows: as shown in FIG. 19, the sample addition region 701, at least one reagent region, at least one detection result region 702, at least one control region, at least one adulteration detection region and a liquid absorption region 703. If the detection zone comprises a control zone, it is preferred that the control zone is located after the analyte detection zone in the detection result zone. All of these zones or combinations thereof may be on a single strip containing one material. In addition, the zones are made of different materials and are joined together in the direction of liquid transfer. For example, the different zones may be in direct or indirect fluid communication. In this example, the different zones may be end-to-end connected in the direction of liquid transfer, or superimposed on each other in the direction of liquid transfer, or connected by other materials, such as a connecting medium material (preferably a water-absorbent material such as filter paper, glass fibers or nitrocellulose). In the case of a connecting material, the connecting material allows liquid communication to be formed by a material including regions in which the ends are in contact with each other, a material including regions in which the ends are in contact with each other but liquid does not flow, or a material including regions in which the regions overlap with each other (for example, but not limited to, overlapping from end to end) but liquid does not flow.

If the test strip contains an adulteration control zone, this zone may be placed before or after the result detection zone. When the result determination region contains a control region, the adulteration control region is preferably placed before the control region, which may not be the case. In one embodiment of the present invention, the test strip is a control test strip for adulteration assay determination and/or control, and the adulteration control zone may be located before or after the control zone, preferably before the control zone.

In embodiments of the present invention, the test element or test strip may be located in a test element carrier, which may be a removable card slot element 40, such as the lower plate 11 of FIG. 1. Preferably, the slot elements 40 are located on the lower plate, or between the upper plate 10 and the lower plate 11.

Sample(s)

The sample that can be detected with the detection device of the present invention includes a biological fluid (e.g., a case fluid or a clinical sample). Liquid or fluid samples may be derived from solid or semi-solid samples, including fecal matter, biological tissue, and food samples. The solid or semi-solid sample may be converted to a liquid sample by any suitable method, such as mixing, triturating, macerating, incubating, dissolving, or enzymatically digesting a solid sample in a suitable solution (e.g., water, phosphate solution, or other buffered solution). "biological samples" include samples derived from animals, plants and food, including, for example, urine, saliva, blood and components thereof, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures and media derived from humans or animals. Preferably the biological sample is urine. Food samples include food processing materials, end products, meat, cheese, wine, milk and drinking water. Plant samples include those derived from any plant, plant tissue, plant cell culture and medium. An "environmental sample" is derived from the environment (e.g., a liquid sample from a lake or other body of water, a sewage sample, a soil sample, groundwater, seawater, and a waste liquid sample). The environmental sample may also include sewage or other wastewater. Any analyte can be detected using the present invention and a suitable detection element. The present invention is preferably used to detect analytes in blood.

Analyte substance

Examples of analytes that can be used in the present invention include haptenic substances, including drugs of abuse (e.g., drugs of abuse). By "drug of abuse" (DOA) is meant the use of a drug (usually acting to paralyze nerves) at a non-medical destination. Abuse of these drugs can result in physical and mental damage, dependence, addiction and/or death. Examples of drug abuse include cocaine; amphetamine AMP (e.g., black americane, white amphetamine tablets, dextroamphetamine tablets, Beans); methamphetamine MET (crank, methamphetamine, crystal, speed); barbiturate BAR (e.g., Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleep-aid drugs); lysergic acid diethylamide (LSD); inhibitors (downs, goofballs, barbs, blue devils, yellow jacks, hypnones); tricyclic antidepressants (TCAs, i.e., imipramine, amitriptyline and doxepin); dimethyldioxymethylaniline MDMA; phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e., morphine, or opiates, cocaine, COC; heroin, dihydrocodeinone); anxiolytic and sedative hypnotic, anxiolytic is a kind of mainly used for relieving anxiety, stress, fear, stabilize mood, have hypnotic sedative effects at the same time, including benzodiazepine BZO (benzodiazepines), atypical BZ, fuse dinitrogen NB23C, benzodiazepine, BZ receptor ligand, ring-opening BZ, diphenylmethane derivatives, piperazine carboxylate, piperidine carboxylate, quinazolone, thiazine and thiazole derivatives, other heterocycles, imidazole type sedative/analgesic (such as dihydrocodeinone OXY, methadone MTD), propylene glycol derivative-carbamate, aliphatic compound, anthracene derivatives, etc.. The detection device of the invention can also be used for detecting the detection which belongs to the medical application and is easy to take overdose, such as tricyclic antidepressant (imipramine or the like) and acetaminophen. After being absorbed by human body, the medicines are decomposed into different small molecular substances, and the small molecular substances exist in body fluids such as blood, urine, saliva, sweat and the like or exist in partial body fluids.

Analytes to be detected using the present invention include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone hormone, follicle stimulating hormone, etc.), blood, leukocytes, sugars, heavy metals or toxins, bacterial material (e.g., proteins or carbohydrate material directed against a specific bacterium, such as e.g., e.coli 0157: H7, staphylococcus, salmonella, clostridium, campylobacter, l.monocytogenes, vibrio, or cactus), and substances associated with physiological characteristics in urine samples, such as pH and specific gravity. Any other clinical urine chemistry assay can be tested using a lateral flow assay format in conjunction with the device of the present invention.

Detection device

The test device of the present invention includes a test element 70 that can be used to detect the presence of an analyte in a sample, such as a blood sample. In some embodiments, the test device includes an upper plate 10 and a lower plate 11, the upper plate 10 including a sample application hole 102 and a test result reading hole 101, and the lower plate including insertion holes into which the card slot elements 40 are inserted, the test elements being located in the slot structures of the card slots 40.

Blood sampler

In some preferred embodiments, the test device includes a cartridge 20 that can be attached to the well 102. Preferably, the blood sampling device is rotatable about the detection means, such that when the device is required to sample a blood sample, the sampling head 202 is rotated to sample the sample, and then rotated in the opposite direction to add a sample, such as blood, serum, plasma or other type of sample, to the sample addition well 102. After the blood sample is added, the solution in the solution reservoir is punctured to process the sample for subsequent testing.

In a preferred manner, the edge of the upper plate 10 of the detection device comprises two raised block-shaped structures 104,105 (fig. 3). The two block-like structures have a distance between them, which in particular is slightly larger than the diameter of the tubular structure 203 of the cartridge 20. There are two rotation holes 106 on the continuous block-like structure. As shown in fig. 4, the blood collection device includes a blood collection head 202 and a tubular structure 203, the blood collection head is located at one end of the tubular structure 203, the tubular structure 203 at the other end includes a plug-like 204 structure, and the plug or bolt 204 is located in the rotary hole 106, so that the blood collection device is rotatably fixed on the detection device. For ease of assembly and use, the blood collection head 202 is connected to the tubular structure 203 by a connecting rod 201 to form an "L" shaped blood collection vessel. When assembled, the applicator tip 202 is positioned in the well 102, which protects the tip from damage by the well 102. When a sample is to be taken, the blood sampling device is rotated outwards along the rotation hole 106 and away from the sample application hole, so that the blood sampling head takes the sample, and after the collection is finished, the blood sampling head 202 is rotated in the opposite direction to enter the sample application hole 102, and the sample application area 701 of the test element corresponding to the sample application hole is formed, so that the sample is applied to the application area 701 of the test element (as shown in fig. 5).

Puncture outfit

In some preferred forms, the test device further includes a lancing device 50 for forcefully lancing the tissue to release blood, the lancing device including a sharp needle 53 for lancing the tissue to puncture a blood vessel and thereby release a blood sample from the tissue (see FIGS. 7, 8 and 9). And the penetrator 50 resembles a "T" shape. Having a clamp rail 51 and a body 52. In a preferred embodiment, lancing device 20 is located at one end of the test device, partially within the test device and partially exposed, such that one end of the lancing device is used directly to target a tissue site, such as a fingertip, for lancing and a blood sample is taken immediately after lancing by using the sampling head 202 of the lancing device 20. To secure the puncture device 50 and the detection device, a snap structure having a snap 116 and an opening 115 may be disposed at one end of the lower plate 11. The lancet's catch rail 51 can be slid into the catch structure 116 and the body snapped into the opening 115, thereby securing the lancet in the testing device (shown in FIG. 9). When it is desired to puncture the tissue, the end of the puncture device with the needle is directed against the tissue for puncturing, thereby releasing the blood sample.

Detachable card slot element

The test device comprises an assembly of an upper plate 10 and a lower plate 11, wherein the test element is positioned in the test device, in particular, such that the test element 70 is positioned between the upper plate and the lower plate. In some preferred forms, the detecting device includes a detachable card slot component 40, the component 40 is clipped on the lower board 11, and the testing component 70 is located in the card slot 403 of the card slot component 40 (as shown in fig. 1). The slot element 40 includes a slot body including a slot 403 therein, and a plurality of pin structures 405,406,407 in the bottom of the body that are inserted into corresponding receptacles 112,113,117 in the lower plate, such that the slot element 40 is not located below the plane of the lower plate, but rather is located above the plane of the lower plate. The card slot body may be provided with some form of cross beam 404,402 that connects the

pins

406 and 407. Thus, the pins 407 are inserted into the insertion holes 112 of the lower plate, the pins 406 are inserted into the insertion holes 113 of the lower plate, and the pins 405 are inserted into the insertion holes 117 of the lower plate; this secures the card slot element. While the slot elements are at a certain height from the lower plate in order to allow the slots in the slot elements to be located in the middle of the channel 210 and close to the upper part of the channel. The positional relationship of the channel and the slot is explained in detail below.

Piercing element and channel

As shown in fig. 16-17, the detection device includes a lancing element. The piercing element is located on the outer surface of the channel 90. Specifically, the detection device comprises an upper plate 10 and a lower plate 11, the channel 90 is also composed of two parts, an upper plate channel element 103 and a lower plate channel element 114, and the channel 90 is formed by assembling two structures similar to a clamping groove, one end of the channel is open to the outside, and the other end of the channel is open to the inside of the detection device. The shape of the two elements forming the channel combined into a channel may be any shape, such as a circle, square, rectangle, oval or diamond shape. In either case, the shape corresponds to the shape of the chamber of the solution reservoir, which facilitates the shape of the channels 90 into the chamber, thereby occupying the volume of the chamber and allowing the solution to be released. The channel projects from one end of the test device but is located substantially at the midpoint of the transverse plane of the test device (see figure 16). In some embodiments, the channel is formed to have a volume substantially equal to the shape of the channel 301 in the chamber of the solution reservoir in order to force the liquid to flow through the channel 90 into the detection device as much as possible. Furthermore, it is preferable that the channels have the same shape but different sizes, so that the channels occupy all the volume of the chamber 301, and the liquid can only flow from the channel 90 to the detecting device without leaking out, which will be described in detail below.

The channel 90 has an opening 210 through which the solution flows into the detection device. The purpose of the solution flowing into the detection device is to process the sample on the test element, so in the present invention, the test element is located in the slot of the slot element 40, and in order to facilitate the solution flowing into the slot, therefore, the slot 403 at one end of the slot element is located in the channel and near the upper end of the channel, i.e. near the inner surface of the upper plate channel element 103, so that when the channel enters the solution cavity, the slot 403 at one end of the slot element also enters the solution cavity along with the channel. The solution thus entered into the channel also flows easily into the card slot, thereby allowing the sample application area of the test element to be absorbed by the solution, thereby processing the blood sample.

In order to allow the passage into the solution chamber, the opening of the solution chamber is typically sealed by a membrane, which requires a piercing element to be provided on the outer surface of the passage to pierce the membrane. As shown in fig. 17, the upper plate channel member 103 and the lower plate channel member 114, which constitute the channel, combine to form the channel 90. The upper channel member has a protruding edge flap 211 and the lower channel member also has a protruding edge flap 250, and when the two elements are combined and overlapped, the two

edge flaps

211 and 250 are overlapped to form a knife-edge-shaped piercing structure 212. The piercing structure blade-like structure 212 has a sharp blade structure and the blade structure is longitudinally distributed on the outer surface of the channel for piercing the membrane sealing the solution chamber.

Of course, the piercing structure may be any other sharp structure than the one provided with an outer surface of the channel that allows the piercing element to pierce the membrane at or before or at the same time as the channel is allowed to enter the solution chamber, thereby making it easier to allow the channel to enter the solution chamber. The shape of the cross-section of the blade structure may be a variety of different shapes, such as "V", "Z", "O" and "L". Correspondingly, the solution storage cavity is also provided with a corresponding groove structure suitable for the insertion of the blade structure, so that the blade structure is smoothly inserted, on one hand, the effect of puncturing the sealing film is achieved, and on the other hand, the channel structure can smoothly enter the cavity.

Solution storage device

In some preferred forms, the test device of the present invention includes a holding solution reservoir 30. In some preferred embodiments, the solution reservoir 30 is in the shape of a substantially cube having a six-sided enclosure 308, the enclosure 308 having an opening 301, the opening 301 being sealed by a membrane 305. In contrast, the film 305 for sealing the opening is a readily penetrable film, such as an aluminum foil film, a plastic film, or a film sealed by laser or thermal plastic. Before sealing, the chamber 308 is filled or flushed with a solution for treating the sample, such as a blood sample, which may be a solution for changing the PH of the sample or may be a solution for removing impurities or interfering components from the sample. The solutions may contain any suitable components, or suitable chemicals, and the functions of the solutions may be one function or multiple functions.

In some preferred forms, one or more groove structures 311 are provided on the inner side wall of the chamber body, which groove structures are adapted to the blade structure of the outer surface of the channel structure. Correspondingly, the groove structure is arranged on the inner side wall of the cavity and has a certain depth and a certain shape, the depth can be inserted into the groove structure, the shape of the cross section is adapted to the cross section of the blade structure, the blade structure can be conveniently and smoothly inserted, the guide channel normally enters the cavity 308 to remove liquid, so that the liquid enters the access, enters the clamping groove in the clamping groove element in the channel, and the sample application area of the test element is wetted. Preferably, one end of the channel structure is open at the rim 310 of the cavity, so that a gap 303 is formed at the rim 310, part of the seal being required to seal with the rim 310 when the sealing membrane seals the cavity opening 301, and the gap 303 and the other channel opening 302 (fig. 12) are also sealed at the same time when the sealing rim seals, thus substantially hiding the channel opening and the channel itself.

In one embodiment of the present invention, the solution chamber is substantially rectangular in shape, and the cross section of the chamber is also rectangular in shape, for example, as shown in fig. 11 and 12, a groove structure is respectively provided on the inner side walls of the two short sides, and the cross section of the chamber is also rectangular in shape substantially the same as the shape of the very cut surface of the channel. Thus, when the channel is inserted into the cavity 301, the raised blade structures 212 located on the outer surface of the channel, and the front faces of the blade structures formed by 205 and 211, are first inserted over the

openings

303 and 302 of the channel, thereby piercing the membrane sealing the cavity opening 301, and with further insertion of the channel 90, the blade acts as a navigation reach guide, guiding the channel along a fixed trajectory into the cavity, forcing the solution in the cavity into the channel as the channel 90 enters, thereby into the well of the well element located within the channel, thereby wetting the sample application area of the test element.

Referring to fig. 16 and 13-15, the solution chamber 308 is disposed in the containment structure 60, the containment structure 60 also being a generally rectangular chamber that includes a securing structure 602 at the bottom of the chamber, the securing structure 602 being shaped to conform to the shape of the solution chamber 308 so that the solution chamber 308 may be easily installed in the containment structure 60 (fig. 14 and 15). In the cavity of the accommodating structure, the fixing structure is positioned in the middle, and redundant spaces are reserved on two sides. Typically, the containment structure 60 including the solution chamber is present alone and is inserted into one end of the channel of the test device when it is desired to apply a solution to the test element, such that the open end 210 of the channel is aligned with the solution chamber in the containment structure 60 and corresponds to the sealing membrane that seals the solution chamber. With further insertion, the containment structure allows the passage into the solution chamber 308, with space reserved on the remaining two sides of the containment structure, thereby better allowing the passage to align with the open position of the solution chamber.

As described above, with the channel inserted, the piercing structure at the edge of the channel is first inserted into the

channel openings

303 and 302, thereby piercing the membrane sealing the chamber opening 301, and with further channel 90 inserted, the knife edge acts as a guide to guide the channel along a fixed trajectory into the chamber, forcing the solution in the chamber into the channel as the channel 90 enters, thereby into the well of the well element located within the channel, thereby wetting the sample application area of the test element (as shown in fig. 18). The lack of space and size within the receiving structure cooperates with the shape of the end 801 of the test device containing the channel 90 so that the receiving structure is stably secured to the end.

Puncture outfit

In some preferred forms, the test device includes a lancet 20 disposed at the other end of the solution reservoir 30 (fig. 1 and 14). Lancing devices are commonly used lancing mechanisms, and typically include a sharp needle for lancing the tissue for bleeding. These structures are common structures, and conventional structures are sufficient.

Detection method

The following describes how to perform the detection of an analyte in a fluid sample with reference to the drawings.

A test device, such as the test device shown in fig. 16 or fig. 9, is prepared, comprising a lancet 50 (as shown in fig. 10 and 9), a blood collection vessel 20 and a solution reservoir 30, as well as lancing elements disposed on both sides of a channel structure on the test device. The device is articulated to the upper plate of the test device in the manner according to fig. 5 and 6, for example fig. 16, when the head of the device is in the well and is thus protected. In addition, the channel is exposed outside the detection device, and the solution reservoir 30 alone is held in a fixed position in the holding device 60 as shown in FIG. 15, and the solution storage chamber 30 is sealed by a thin film that is easily punctured as shown in FIG. 12.

When the test is needed, the lancing device 50 is first used to puncture a tissue, such as a fingertip, and a blood sample flows out, the blood sampling head is rotated out of the loading hole 102, for example, by moving or moving the rod 203 of the lancing device, so that the blood sampling head collects the blood sample, and then the blood sampling head is rotated in the opposite direction to apply the blood sample to the sample application hole 102, and after the loading is completed, the blood sampling head is still located in the loading hole.

At this time, the solution reservoir 30 is in a state of being separated from the detecting device, after the application of the sample is finished, the holding device (fig. 15) holding the solution reservoir 30 is fitted over the channel structure, one end of the channel is aligned with one end of the solution containing cavity sealed by the film, the solution reservoir 30 is pushed from the first position to the second position, the piercing structure is inserted into the sealing ports on both sides of the solution containing cavity due to the piercing member being located on the channel, the piercing structure is further inserted into the solution containing cavity as the channel is further inserted, the piercing structure is inserted deeply, thereby the solution is forced into the channel from the opening of the channel, the solution entering through the opening of the channel also enters the card slot due to the card slot member being close to the opening of the channel, and then flows into the sample application region, the solution flowing into the application region flows through the sample application region corresponding to the sample application hole 10, and the sample located thereon is processed, thereby completing the test or assay.

The above method is directed to a blood sample, and when the blood sample is not the blood sample, the sample can be collected by a blood collector directly without a puncture device, such as saliva, feces, etc., as described above for the sample.

The invention shown and described herein may be practiced in the absence of any element or elements, limitation or limitations, which is specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, and it is recognized that various modifications are possible within the scope of the invention. It should therefore be understood that although the present invention has been specifically disclosed by various embodiments and optional features, modification and variation of the concepts herein described may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.

The contents of the articles, patents, patent applications, and all other documents and electronically available information described or cited herein are hereby incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. Applicants reserve the right to incorporate into this application any and all materials and information from any such articles, patents, patent applications, or other documents.

Claims

1. A device for detecting an analyte in a sample, the device comprising: a test device comprising a solution reservoir and a test element for detecting an analyte in a sample, wherein the test device comprises an upper plate and a lower plate, and the test element is positioned between the upper plate and the lower plate; wherein the solution reservoir is present alone; the solution reservoir comprises a cavity for containing a solution reagent and a film for sealing the cavity; the detection device also comprises a puncture structure in the shape of a knife edge; the blade-shaped puncture structure can puncture the film of the sealed cavity and enter the cavity, so that the solution in the reservoir is released; the detection device also comprises a channel, wherein the channel comprises an opening with one end opening to the outside and an opening with one end opening to the inside of the detection device; the puncture structure with the shape of the knife edge is positioned on the channel of the detection device; wherein the channel is composed of a channel element positioned on the upper plate and a channel element positioned on the lower plate; the upper plate channel element comprises a protruding edge sheet, the lower plate channel element comprises a protruding edge sheet, and the two edge sheets are overlapped to form the puncture structure with the shape of the knife edge: the cavity for containing the solution reagent comprises a side wall which is enclosed to form the cavity, and a groove structure which is used for allowing the puncture structure in the shape of a knife edge to be inserted and guided into the cavity is arranged on the inner side wall.

2. The device of claim 1 wherein said cutting edges are longitudinally disposed on the outer surface of said channel.

3. The apparatus of claim 2, wherein the cross-section of the channel structure is "V" -shaped, "Z" -shaped, "O" -shaped, "L" -shaped.

4. The device of claim 3, wherein the channel has a "V" shaped opening, a "Z" shaped opening, an "O" shaped opening, and an "L" shaped opening, the openings being located along the opening of the chamber.

5. The apparatus of claim 4, wherein the membrane covers the opening of the trench structure.

6. The apparatus of claim 5, wherein the inner sidewall of the chamber comprises one or more of the groove structures.

7. The device of claim 6, wherein the chamber is rectangular, the opening of the chamber is also rectangular, and the inner side walls corresponding to the short sides comprise the groove structure.

8. The apparatus of claim 7, wherein the groove structure is disposed at a middle position of the inner sidewall corresponding to the two short sides.

9. The device of claim 8, wherein said knife-edge shaped piercing structure is "V" -shaped, "Z" -shaped, "O" -shaped, "L" -shaped in cross-section.