CN109507412B - Device and method for detecting analyzed substance in sample - Google Patents

Abstract

The invention provides a device for detecting an analyte in a sample, comprising: a solution reservoir having a first position and a second position in the test device, the solution reservoir being movable from the first position to the second position, and a piercing element, wherein the piercing element pierces the solution reservoir to release the solution when the solution reservoir is in the second position.

Description

Device and method 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

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

In one aspect, the invention provides a test device with a blood sampling device, wherein the device comprises a blood sampling device, and the blood sampling device is inserted into an insertion hole of the test device, wherein the blood sampling device comprises a protruding block, and the protruding block is positioned in a cavity of the test device and close to the inner wall of the test cavity. Preferably, the blood collection device comprises a blood collection head. Preferably, the blood collector is in an L shape. Preferably, said protruding block is located on the long arm of the "L" shape. Preferably, the insertion hole is rectangular, and the blood collection device has a tubular structure, and the height of the rectangular shape corresponds to the diameter of the tubular structure of the blood collection device. Preferably, the protruding block is a cuboid structure, and the protruding block and the tubular structure of the blood collector are in the same plane. Preferably, the long arm of the "L" shaped blood collection device is located in the detection device, and the short arm is located outside the detection device. Preferably, the detection device is characterized by further comprising a solution storage, wherein the solution storage comprises a lock hole, and the blood sampling head is positioned in the lock hole.

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 sampler comprises a blood collection head with which a blood sample is collected. Preferably, the hemostix is in an L shape. Preferably, the blood collector further comprises a fixing block. Preferably, the detection means comprises a hole for inserting the blood collection device. Preferably, the hole for inserting the cartridge is designed so that the hole allows the insertion of the tubular structure of the cartridge, but does not allow the fixing block to be aligned with the direction of insertion of the tubular structure, but requires the cartridge to be rotated so that the fixing block is inserted into said hole. Conversely, when it is necessary to take out the blood collection device, the blood collection device needs to be rotated in the opposite direction to the insertion direction to take out the blood collection device from the hole. Like this, can be fine let the hemostix fix in detection device, can not let the hemostix drop out from detection device because of long distance transportation. In some preferred embodiments, the holes in the device are rectangular and the block of the device is rectangular, but perpendicular to the tubular structure of the device. In some preferred modes, the height of the rectangular hole is adapted to the tubular structure of the blood collector, so that the tubular structure of the blood collector can or just can pass through the rectangular hole, but the fixing block cannot pass through the rectangular hole. The height of the rectangular hole is greater than that of the fixing block. Correspondingly, the length direction in rectangular hole be greater than the length direction of fixed block, like this when to the hole in insert the hemostix, need rotate the hemostix to let the fixed block pass through the hole and enter into in the hole. This allows the cartridge to be locked onto the test device.

In some preferred forms, the lancet is inserted into the aperture of the testing device and the lancet is inserted into the keyhole of the solution reservoir, such that the aperture protects the lancet tip from damage and, as described below, also serves to secure the solution reservoir in the first position against movement relative to the testing device. As the movement would allow the solution reservoir to contact the piercing head of the piercing element, causing leakage of the solution.

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 another aspect, the invention provides a test device with a solution reservoir, wherein the device comprises a solution reservoir having a first position and a second position on the test device, the solution reservoir being movable from the first position to the second position. Preferably, the solution reservoir comprises a solution chamber sealed by a readily puncturable membrane. Preferably, the solution chamber includes a solution reagent therein. Preferably, the solution reservoir is in the first position as a locked position. Preferably, the locking position is locked by the blood collector, wherein the solution storage device comprises a locking hole, and the blood collecting head is positioned in the locking hole. Preferably, the solution reservoir comprises a sliding cover, and a gap is formed between the sliding cover and the solution cavity. Preferably, the solution storage device comprises a slide rail, the detection device comprises a receiving area for accommodating the solution storage device, and a sliding groove corresponding to the slide rail is arranged in the receiving area. Preferably, the detection device comprises an input area for receiving the solution reservoir, wherein the solution reservoir has the first position and the second position in the input area.

In some embodiments, the solution reservoir is removably attachable to the test device and has a first position and a second position in the test device. Preferably, the solution reservoir is movable from a first position to a second position. Preferably, the solution reservoir moves along the longitudinal axis of the detection device. Preferably, the solution reservoir is not punctured by the puncturing element in the first position. Preferably, the solution reservoir is punctured by the puncturing element in the second position.

In some preferred forms, the solution reservoir is held against movement by a holding element when in the first position. Preferably, the fixing element is a hemostix. Preferably, the device holds the solution reservoir in place by means of a peg. Preferably, the solution reservoir has a keyhole and the blood collection device is a needle-like structure, and the blood collection device is inserted through the hole of the detection device and into the keyhole of the solution reservoir.

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. The sample application zone is adjacent to the solution reservoir. Preferably, the solution reservoir is located on the upper plate, wherein the upper plate comprises a space for accommodating the solution reservoir. The space is compatible with the solution reservoir.

In some preferred embodiments, the hole of the detection device for the blood sampling device to pass through is located on the upper plate. In another aspect, the present invention provides a test device with a lancing element, wherein the device includes a lancing element including a lancing head and a conduit connected to the lancing head. Preferably, the test device further comprises a solution reservoir and a test element, wherein the lancing element is located between the solution reservoir and the sample application zone of the test element. Preferably, the tube has two open ends, one open end of the tube being adjacent to the sample application zone of the test element and the other open end of the tube being adjacent to the solution reservoir. Preferably, the test device comprises a sample application aperture located at the sample application zone, wherein the opening of the sample application zone adjacent to the test element is upstream of the sample application aperture. Preferably, the piercing element further comprises a fixing block, by means of which it is fixed in the detection device. Preferably, the detection device comprises an upper plate and a lower plate, the test element is located in a groove of the lower plate, and the puncture element is located on the upper plate. Preferably, said piercing element is located in the detection means.

In some preferred forms, the test device further comprises a piercing element that can pierce the solution reservoir. In some preferred forms, the solution reservoir comprises a chamber having an opening sealed by a membrane which is easily punctured. The piercing element pierces the membrane to release the solution from the solution reservoir.

In some preferred forms, the lancing element is positioned between the solution reservoir and the sample application zone of the test strip, and a fluid flow is maintained between the sample application zone and the solution reservoir by the lancing element.

Preferably, the piercing element comprises a piercing head which can pierce the membrane of the solution reservoir. Preferably, the piercing head includes one or more sharp piercers thereon. Preferably, the lancing element includes a channel through which solution from the solution reservoir can flow to the sample application zone. In some preferred forms the opening at one end of the channel is located in the puncture device and the opening at the other end of the channel is in fluid communication with the sample application zone. In some preferred forms, the piercing element may pierce a membrane of the solution reservoir such that the piercing head enters a solution storage chamber of the solution reservoir. In some preferred forms, the piercing element is fixed in the test device and the solution reservoir is movably mounted relative to the test device.

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

Preferably, a method of detecting an analyte in a sample, the method comprising: there is provided a detection device comprising: a solution reservoir, a lancing device and a lancing element, wherein the solution reservoir has a first position and a second position in the testing device, the solution reservoir being movable from the first position to the second position. The solution reservoir is moved from a first position to a second position, during which movement the piercing element pierces the solution reservoir, thereby releasing the solution. Preferably, the test device includes a test element, and the released solution is allowed to flow through the conduit of the lancing element and onto the sample application zone of the test element.

In another aspect, the present invention provides a device for detecting an analyte in a sample, comprising: a solution reservoir, a lancing device and a lancing element, wherein the solution reservoir has a first position and a second position in the testing device, the solution reservoir being movable from the first position to the second position, wherein when the solution reservoir is in the second position, the lancing element punctures the solution reservoir thereby releasing the solution. Preferably, the solution storage is located at the first position and is a locking position, the locking position is locked by the blood sampling device, wherein the solution storage comprises a locking hole at the upper part, and the blood sampling head is located in the locking hole. Preferably, the test device comprises an insertion hole into which the cartridge is inserted. Preferably, the detection device further comprises a test element, wherein the puncture element comprises a puncture head and a pipeline connected with the puncture head, the pipeline is provided with openings at two ends, one opening of the pipeline is close to the sample application area of the test element, and the other opening of the pipeline is close to the solution storage. Preferably, the lancing element is located between the solution reservoir and the test sample area. Preferably, the piercing element further comprises a fixing block, by means of which it is fixed in the detection device. Preferably, the piercing head of the piercing element enters the solution chamber of the solution reservoir when the solution reservoir is in the second position. Preferably, the piercing head of the piercing element is not in contact with the solution chamber of the solution reservoir when the solution reservoir is in the first position.

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 perspective view of a solution reservoir (without a sealing film) according to an embodiment of the present invention.

Fig. 3 is a cross-sectional view of the solution reservoir of fig. 2.

Fig. 4 is a perspective view of a solution reservoir (including a sealing membrane) according to one embodiment of the present invention.

Fig. 5 is a perspective view of a lancing element according to one embodiment of the present invention.

Fig. 6 is a cross-sectional view of the lancing element shown in fig. 5.

FIG. 7 is a perspective view of a lancing device including a lancet for lancing tissue according to one embodiment of the present invention.

Fig. 8 is a schematic combined perspective view of a detection device (not including a blood sampling device) according to an embodiment of the present invention.

Fig. 9 is a schematic perspective view of the blood collection device according to an embodiment of the present invention.

Fig. 10 is a schematic combined perspective view of a detection device (including a blood sampling device) according to an embodiment of the present invention.

Fig. 11 is an enlarged view of a portion of the structure of the device shown in fig. 10.

Fig. 12 is a schematic bottom view of an upper plate of the detecting device according to an embodiment of the invention.

Fig. 13 is a schematic structural diagram of a lower plate of the detecting device in one embodiment of the present invention.

FIG. 14 is a perspective view of the detection device (including the blood collection device in a fixed position) according to an embodiment of the present invention.

Fig. 15 is an enlarged view of a portion of the detecting device shown in fig. 14.

FIG. 16 is a schematic perspective view of an embodiment of the detection device of the present invention, wherein the solution reservoir is located at a second position.

FIG. 17 is a schematic cross-sectional view of a detecting device according to an embodiment of the present invention. The solution reservoir is located at a first location.

FIG. 18 is a schematic cross-sectional view of the detecting unit of FIG. 16.

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 60 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 detection 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 at the sample application zone, reagent zone, analyte detection zone, or throughout the test strip of 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 application 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. In addition, a signal substance present in the sample application, 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: a sample application zone 601, at least one reagent zone, at least one detection result zone 602, at least one control zone, at least one adulteration detection zone and a fluid absorption zone 603. 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 particular embodiments of the present invention, the test element or test strip may be located in a test element carrier, which may be a card slot, such as lower plate 102 in FIG. 1. Preferably in a slot in the test element carrier, e.g., lower plate 102.

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 of interest 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 drugs of 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 material 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 60 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 comprises an upper plate 101 and a lower plate 102, the upper plate 101 comprising a receiving area 115 for receiving a solution reservoir, and also comprising a sample application well 104 and a test result reading well 103, the lower plate comprising a well structure in which a test element is positioned, as shown in FIG. 13. In some preferred embodiments, the test device includes an insertion aperture 106 for insertion of the cartridge 50, which is configured to allow the cartridge to be held in place in the test device while protecting the cartridge from damage, and to allow the cartridge to be positioned to hold the solution reservoir in place in the receiving area 115 of the test device.

In some preferred forms, the test device further includes a lancing device 20 for lancing tissue to release blood, the lancing device including a sharp needle that punctures tissue to puncture a blood vessel and thereby release a blood sample from the tissue (see FIG. 1, FIG. 14). In a preferred embodiment, lance 20 is positioned at one end of the test device, partially within the test device and partially exposed, such that in operation, one end of the test device is used directly to target a tissue site, such as a fingertip, for lancing, and once lanced, a blood sample is taken with the lancet head 502 of the lancet 50, e.g., while lance 20 can be removed from the test device and discarded. Alternatively, where tissue lancing is desired, the lancet 20 can be removed from the test device for tissue lancing to release blood for disposal. The results and effects will be described in detail below.

Solution storage device

In some preferred forms, the test device of the present invention includes a solution reservoir 30, and the test device includes an input area 115 for receiving the solution reservoir 30. In some preferred forms, the solution reservoir 30 has a first position and a second position in the test device that can be moved from the first position to the second position. In a preferred form, the first position is a locked position. In some preferred forms, the solution reservoir 30 is substantially square in shape, having a six-sided enclosure, and the solution chamber 303 has an opening sealed by the membrane 31. In contrast, the film 31 for sealing the opening is a easily-penetrable film, such as an aluminum foil film, a plastic film, and is sealed by laser or thermal plastic sealing. Before sealing, the chamber is filled or filled 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 a solution for removing impurities or interfering components from the sample. The solution may contain any suitable components, or suitable chemicals, and the function of the solution may be one function or multiple functions.

The solution storage device 30 further comprises a slide rail 304 and a slide cover 301, wherein the slide rail is used for matching with a slide groove corresponding to the income area of the detection device, so that the solution storage device 30 can freely enter the income area, and the solution storage device 30 can be prevented from moving left and right in the income area 115 due to the function of the slide rail. The slide cover of solution reservoir 30 has a gap 305 between the slide cover 301 and a face of the cavity for corresponding to the position of the receiving area 115 to facilitate movement of the solution reservoir 30 from the first position to the second position.

In some preferred forms, the solution reservoir 30 comprises a lock hole 302, the lock hole 302 being located on one face of the cavity and being located near the insertion hole 106 of the detection device, and serving several purposes, namely to allow the blood collection head 502 of the blood collection device to be located in the lock hole, one being to protect the blood collection head 502 from being damaged, and, in addition, since the blood collection head 502 is located in the lock hole 302, the solution reservoir 30 is prevented from moving from the first position to the second position, allowing the solution reservoir 30 to be in the locked position in the first position. In the locked position, it is not possible to move freely from the first position to the second position, and only after unlocking, for example after removing the device, is it possible to move the solution reservoir 30 freely from the first position to the second position (fig. 10, 11).

Blood sampler

In some preferred forms, the test device further comprises a blood collection device 50, wherein the blood collection device is located in the test device. In some embodiments, the blood sampling device is inserted into the insertion hole 106 of the test device, so that it is not easily dropped out of the test device. In a preferred form, the cartridge 50 is of tubular construction and includes a blood collection head 502 for collecting and applying a blood sample to a sample application area 601 of the test element after collection, the application being via a sample application aperture in the upper plate of the test device (see FIG. 16). In other forms, the device is substantially "L" -shaped (fig. 9), comprising on the long arm of the "L" -shape a protruding block 504, preferably substantially rectangular, with 4 long protruding block sides 505 and two square sides.

Correspondingly, the test device includes an insertion hole 106 for inserting the blood collection device into the test device. Such as shown in fig. 11. The insertion hole 106 is a substantially rectangular opening, and when the cartridge 50 is inserted, the height of the insertion hole is larger than the diameter of the cartridge, and the height of the protruding piece of the cartridge 50 corresponds to the diameter of the cartridge, but the height of the protruding piece is larger than the diameter of the cartridge. Alternatively, preferably, the length of the protruding block and the tubular structure of the cartridge are substantially in the same plane. Thus, when the sampler is inserted, the protruding block 504 of the sampler 50 is inserted in parallel with the insertion hole 106 (see fig. 11 and 12), and in this case, the protruding block side 505 of the sampler is parallel to the longitudinal direction of the detection device (see fig. 11), and one end of the sampler 50 (without a blood collection head) is also parallel to the longitudinal direction of the detection device. At this time, the lancet 502 is positioned in the locking hole 302 of the solution reservoir 30, and functions to fix the solution reservoir 30.

After the lancet is inserted into the insertion hole 106, the lancet is rotated counterclockwise such that one end of the lancet 50 (without a lancet) is perpendicular to the longitudinal direction of the testing device, and the protruding block 504 of the lancet 50 is positioned on the inner wall of the upper plate of the testing device as the lancet is rotated (see fig. 15), and the lancet 502 of the lancet is simultaneously rotated in the locking hole 302 of the solution storage 30. The protruding block actually rotates in one cavity 120 of the detection device, and when the protruding block approaches the inner wall of the cavity 120, the blood sampling device stops rotating, so that the blood sampling device can be fixed in the detection device by the protruding block 504 and is not easy to fall off. In addition, insertion into the lock hole 302 allows the solution reservoir 30 to be locked or secured in the first position so that it does not move to the second position.

When the device is to be removed to take a sample, the device is rotated in the opposite direction as described above, the device 50 is used to take a blood sample, and the sample is applied to the sample application area 601 after the sample is taken, and the device is removed while the solution reservoir 30 is unlocked, allowing the solution reservoir 30 to move from the first position to the second position, allowing the piercing element to pierce the membrane sealing the solution cavity of the solution reservoir 30, thereby releasing the solution to the sample application area of the test element. After the sample is applied by the blood collector 50, it can be discarded directly.

Piercing element

In some preferred forms, the present invention further includes a piercing element 40 that includes a piercing head 409 that includes sharp structures 404 that may directly contact the membrane. At the same time, piercing head 409 has a slightly larger volume than the volume of solution chamber 303 on solution reservoir 30. Thus, the piercing head will pierce the membrane and enter the chamber, and because the piercing head has a certain volume, it will force the liquid in the solution chamber 303 to flow out after entering the solution chamber 303. In some preferred forms, the piercing tip 409 is connected to a tube 405 having a hollow channel 407, one end of which is connected to the piercing tip and the other end of which is connected to the sample application zone 601 of the test element, such that the solution in the chamber of the solution reservoir 30 flows through the channel 407 of the tube 405 onto the sample application zone 601. The tubing has two openings, one opening 406 near the sample application zone and the other opening 403 through the piercing head or in the middle of the sharp structure. The piercing head enters the solution chamber 303 and the solution flows through the channel onto the sample application zone (fig. 5 and 6).

In a preferred form, the lancing element includes a securing member 402 that cooperates with a mechanism on the test device to secure the lancing head in the test device. In particular, the fixing member is a rectangular plate structure through which the duct of the puncturing element passes, and the plate structure is engaged in the detecting means (see fig. 12). Preferably, the piercing element is provided on the upper plate 101. In some preferred forms, the piercing elements are located between the sample application zone 601 and the solution reservoir 30, and so-called "between" are not separate but may overlap, i.e., the one end opening 406 of the tubing of the piercing element is located above the sample application zone and the piercing head enters the solution chamber 303 when the solution reservoir 30 is moved to the second position.

In some preferred forms, the lancing element tube end opening 406 is located above the sample application zone 601 but upstream of the sample application aperture 104 (see FIG. 12), such that the solution flows through the end opening 406 into the sample application zone 601 and then past the location of the sample application aperture 104, which may serve to process the sample.

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. 14, is prepared, including a lancet, a blood collector and a solution reservoir 30, and a puncturing member 40 provided on an upper plate of the test device. The blood sampling device is inserted into the insertion hole and the locking hole in the manner shown in fig. 14 and 15 (for example, fig. 17). The solution reservoir 30 is in the locked first position at this time.

When testing is required, the lancet 20 is first used to puncture tissue, such as a fingertip, after a blood sample has flowed, the blood sampling device 50 is taken out and a blood sample is collected, and the blood sample is applied to the sample application hole 104, and at this time, the solution reservoir 30 is in an unlocked state, and after application of the sample is complete, the solution reservoir 30 is pushed from the first position to the second position, since the piercing element 40 is stationary, as the solution reservoir 30 is pushed to the second position, the piercing element pierces the sealing membrane 31, and the piercing head, upon entering the solution chamber 303, forces the liquid or solution through the other end opening 403 of the channel into the channel, and flows onto the sample application zone through the one-end opening 406, and the solution flowing onto the application zone flows through the sample application zone corresponding to the sample application hole 104 to process the sample positioned thereon, 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 (11)

1. A device for detecting an analyte in a sample, comprising: a solution reservoir and a piercing element, wherein the solution reservoir has a first position and a second position in the device, the solution reservoir being movable from the first position to the second position, wherein the piercing element pierces the solution reservoir to release the solution when the solution reservoir is in the second position;

the device still includes the hemostix, and the hemostix includes the blood sampling head, and the solution reservoir is located the primary importance and is the latched position, latched position by the hemostix, wherein, including the lockhole on the solution reservoir, the blood sampling head be located the lockhole.

2. The device of claim 1, wherein the device includes an insertion hole into which the lancing device is inserted.

3. The device of claim 1, further comprising a test element, said test element comprising a sample application zone; the lancing element includes a lancing head and a tubing connected to the lancing head, the tubing having two open ends, one open end of the tubing being proximal to the sample application zone of the test element and the other open end being proximal to the solution reservoir.

4. The device of claim 3, wherein the lancing element is located between the solution reservoir and the sample application zone of the test element.

5. The device of claim 4, wherein the piercing member further comprises a securing block through which the piercing member is secured in the sensing device.

6. The device of claim 1, wherein the sample comprises one of a blood, serum, whole blood, saliva, urine or stool sample.

7. The device of claim 3, wherein the solution reservoir comprises a solution chamber comprising an opening sealed by a membrane susceptible to puncturing, and wherein the puncturing element punctures the solution reservoir to release the solution by puncturing the membrane seal.

8. The device of claim 7, wherein the piercing head of the piercing element is not in contact with the solution chamber of the solution reservoir when the solution reservoir is in the first position.

9. The device of claim 7, wherein the piercing head of the piercing element enters the solution chamber of the solution reservoir when the solution reservoir is in the second position.

10. A method of detecting an analyte in a sample, the method comprising:

providing an apparatus, the apparatus comprising: a solution reservoir, a blood collector and a piercing element;

the solution storage device is provided with a first position and a second position in the device, the blood collector comprises a blood collection head, the solution storage device is located at the first position and is a locking position, the locking position is locked by the blood collector, the solution storage device comprises a locking hole, and the blood collection head is located in the locking hole;

the solution reservoir is movable from a first position to a second position;

the solution reservoir is moved from a first position to a second position, during which movement the piercing element pierces the solution reservoir, thereby releasing the solution.

11. The method of claim 10, wherein the device includes a test element, and wherein the released solution is allowed to flow through the conduit of the lancing element and onto the sample application zone of the test element.

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