Biosensor test strips and methods of use and preparation thereof

Abstract

The present invention discloses a biosensor test strip and a method for using and manufacturing the same, including: a sample injection detection structure, including a bottom plate, a detection layer and a sample injection structure arranged in sequence from bottom to top, the sample injection structure is provided with a siphon guide groove, the detection area of ​​the detection layer is located in the siphon guide groove, the bottom plate is provided with a liquid suction channel communicating with the siphon guide groove; a liquid suction structure is arranged on the lower side of the bottom plate, the liquid suction structure can suck the liquid in the siphon guide groove out of the liquid suction channel. The present invention arranges the liquid suction structure on the lower side of the bottom plate and arranges the liquid suction channel communicating with the siphon guide groove on the bottom plate, so that the liquid in the siphon guide groove can be sucked out of the liquid suction channel by using the liquid suction structure, and then the siphon guide groove can be used for sample injection again, and this can be repeated to achieve multiple sample injections and multi-step detection.

Description

Technical Field

[0001] The present invention relates to the field of medical detection technology, and in particular to a biosensor test strip and a use method and a manufacturing method thereof. Background Art

[0002] Biosensor strips are a technology that conducts biochemical reactions on the sensor surface and collects the generated light and / or electrical signals for detection. Biosensor strips often integrate automatic sampling, biochemical reactions, and signal acquisition. They are highly integrated, easy to use, and easy to carry. They are widely used in bedside testing in hospitals, on-site testing of environmental pollutants, and self-testing of chronic diseases at home. A typical application case is blood glucose test strips.

[0003] Biosensor test strips are generally constructed with siphon guides that can automatically inject samples. However, in the prior art, due to the limitations of the unidirectional flow of the siphon guide and the inability of the liquid in the channel to automatically update, it is often only possible to inject samples once, and it is not possible to add samples multiple times or introduce different reagents in batches. Therefore, only one-time injection detection can be achieved, that is, it can only meet the one-step detection of fixing the reagent to be reacted on the surface of the biosensor test strip or in the siphon guide, such as blood glucose test strips, blood ketone body test strips and blood uric acid test strips that fix enzymes and electron transfer agents on the electrode surface, but cannot meet the needs of multiple injections and multi-step detection such as molecular recognition, surface cleaning, and addition of substrates.

[0004] Taking immunoassays performed by electrochemical methods as an example, antigens or antibodies are usually fixed on the surface of an electrode. When in use, the sample to be tested is first added to allow the antibody or antigen in the sample to be tested to undergo molecular recognition by affinity reaction with the antigen or antibody on the electrode surface. Then, the excess sample on the electrode surface is washed off. Then, a signal substance or substrate is added for detection. If the sandwich method is used for detection, the process of adding an enzyme-labeled secondary antibody, washing the excess enzyme-labeled secondary antibody, and adding an enzyme substrate is required to complete the detection. These tests require multiple sample additions and multiple updates of the liquid on the electrode surface, which is difficult to achieve with existing electrochemical sensor strips. Summary of the invention

[0005] The purpose of the present invention is to provide a biosensor test strip and a method for using and manufacturing the same, so as to solve the technical problem that the current biosensor test strip can only realize detection by one injection but cannot meet the requirements of multiple injections and multi-step detection.

[0006] The above-mentioned purpose of the present invention can be achieved by adopting the following technical solutions:

[0007] The present invention provides a biosensor test strip, comprising: a sample introduction detection structure, comprising a bottom plate, a detection layer and a sample introduction structure arranged in sequence from bottom to top, the sample introduction structure is provided with a siphon guide groove, the detection area of ​​the detection layer is located in the siphon guide groove, the bottom plate is provided with a liquid suction channel communicated with the siphon guide groove; a liquid suction structure, arranged on the lower side of the bottom plate, the liquid suction structure can suck the liquid in the siphon guide groove out from the liquid suction channel.

[0008] In an embodiment of the present invention, the biosensor test strip has an injection state and a liquid aspiration state. In the injection state, the liquid can be retained in the siphon guide groove; in the liquid aspiration state, the liquid aspiration structure can aspirate the liquid in the siphon guide groove from the liquid aspiration channel.

[0009] In an embodiment of the present invention, the liquid absorption structure includes a liquid absorption piece, and the liquid absorption piece can be arranged to be movably arranged along the axial direction of the liquid absorption channel; wherein, the upper end of the liquid absorption channel has a liquid absorption port communicated with the siphon guide groove, and a hydrophilic porous piece is provided at the liquid absorption port, and the hydrophilic porous piece is used to drain the liquid in the siphon guide groove to the liquid absorption port; in the injection state, the liquid absorption piece is separated from the liquid absorption port and the hydrophilic porous piece so that the liquid can be retained in the siphon guide groove; in the liquid absorption state, the liquid absorption piece moves along the axial direction of the liquid absorption channel to the liquid absorption port and contacts with the hydrophilic porous piece to absorb the liquid in the siphon guide groove.

[0010] In an embodiment of the present invention, the hydrophilic porous member covers the liquid suction port; wherein the hydrophilic porous member is a hydrophilic gauze or a hydrophilic membrane.

[0011] In an embodiment of the present invention, the hydrophilic porous member is adhered to the base plate through a first adhesive layer, and the first adhesive layer has a drainage port corresponding to the liquid suction port; wherein the first adhesive layer is made of at least one of insulating paint, double-sided tape, glue and paste.

[0012] In an embodiment of the present invention, the liquid absorption structure also includes a back plate and at least one elastic member, the back plate is connected to the lower side of the bottom plate through the elastic member, and the elastic member can elastically expand and contract under the extrusion force between the back plate and the bottom plate to make the liquid absorption member move axially along the liquid absorption channel.

[0013] In an embodiment of the present invention, the elastic member is an elastic block made of elastic rubber or elastic plastic; or the elastic member is a spring.

[0014] In an embodiment of the present invention, one end of the elastic member and one end of the absorbent member are both adhered to the back plate through a second adhesive layer, the other end of the elastic member is adhered to the bottom plate through a third adhesive layer, and the other end of the absorbent member extends into the absorbent channel.

[0015] In an embodiment of the present invention, the liquid absorbent is made of a water-absorbing material; wherein the water-absorbing material includes at least one of water-absorbing paper, water-absorbing cotton, water-absorbing sponge, water-absorbing plastic bubble film, and water-absorbing inorganic filler.

[0016] In an embodiment of the present invention, the sample introduction structure includes a siphon channel layer and a hydrophilic cover sheet, the siphon guide groove is arranged in the siphon channel layer, the hydrophilic cover sheet is arranged on the upper side of the siphon channel layer and covers the siphon guide groove, and the hydrophilic surface of the hydrophilic cover sheet is arranged toward the siphon guide groove.

[0017] In an embodiment of the present invention, the detection layer includes an electrochemical detection layer and / or a photochemical detection layer; the detection area of ​​the detection layer is fixed with an immune detection element, a nucleic acid detection element and / or a molecular recognition element; wherein the immune detection element includes an antigen and / or an antibody, the nucleic acid detection element includes a polypeptide, a nucleic acid fragment and / or a peptide nucleic acid, and the molecular recognition element is made of a molecular imprinting material.

[0018] The present invention provides a method for using a biosensor test strip, which is used to use the biosensor test strip described above; the method comprises the following steps: sample injection: sucking liquid into the siphon guide groove through the siphon guide groove; if sample injection is required again, repeating the sample injection step after the liquid suction step; wherein the liquid suction step comprises: squeezing the liquid suction structure so that the liquid suction structure sucks the liquid in the siphon guide groove until the liquid suction structure sucks all the liquid in the siphon guide groove out of the liquid suction channel, and then stopping squeezing the liquid suction structure.

[0019] The present invention provides a method for making a biosensor test strip, which is used to make the above-mentioned biosensor test strip; the method comprises the following steps: preparing a plate body, and opening the liquid absorption channel on the plate body, thereby serving as the bottom plate; arranging the detection layer on the upper side of the bottom plate; arranging the sample injection structure on the upper side of the bottom plate, and making the detection area of ​​the detection layer located in the siphon guide groove of the sample injection structure; arranging the liquid absorption structure on the lower side of the bottom plate, and making the liquid absorption piece of the liquid absorption structure correspond to the liquid absorption channel.

[0020] In an embodiment of the present invention, the manufacturing method further comprises: sticking a hydrophilic porous member on the bottom plate and making the hydrophilic porous member cover the liquid suction port communicating with the liquid suction channel and the siphon guide groove.

[0021] The characteristics and advantages of the present invention are:

[0022] The biosensor test strips and their use and manufacturing methods in some embodiments of the present invention are characterized by arranging a liquid absorption structure on the lower side of the base plate and arranging a liquid absorption channel on the base plate that is connected to the siphon guide groove, so that the siphon guide groove can absorb liquid into the detection area of ​​the siphon guide groove and the detection layer to undergo a biochemical reaction. The liquid absorption structure can also be used to absorb the liquid in the siphon guide groove from the liquid absorption channel, and then the siphon guide groove can be used to inject samples again. This can be repeated to achieve multiple injections and multi-step detection.

[0023] In other embodiments of the biosensor test strips and methods of using and manufacturing the same, a hydrophilic porous member is provided at the liquid suction port of the liquid suction channel connected to the siphon guide groove, so that when the liquid suction member is separated from the hydrophilic porous member, the liquid sucked into the siphon guide groove can be retained in the siphon guide groove, thereby facilitating a more complete reaction of the liquid in the siphon guide groove with the detection area of ​​the detection layer. When the liquid suction member contacts the hydrophilic porous member, the liquid in the siphon guide groove can be sucked out through the liquid suction member. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0025] Figure 1 Schematic diagram of the biosensor test strip of the present invention.

[0026] Figure 2 It is an exploded view of the sample injection structure in the present invention.

[0027] Figure 3 It is an exploded view of the liquid absorption structure in the present invention.

[0028] In the figure:

[0029] 1. Sampling detection structure; 11. Bottom plate; 111. Liquid aspiration channel; 112. Liquid aspiration port; 12. Detection layer; 121. Working electrode; 122. Reference electrode; 13. Sampling structure; 131. Siphon guide groove; 132. Siphon channel layer; 133. Hydrophilic cover sheet; 134. Hydrophilic porous member; 135. First bonding layer; 136. Drainage port;

[0030] 2. Liquid absorbing structure; 21. Back plate; 22. Liquid absorbing member; 23. Elastic member; 24. Second adhesive layer; 25. Third adhesive layer. DETAILED DESCRIPTION

[0031] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] Implementation Method 1

[0033] like Figure 1 As shown, the present invention provides a biosensor test strip, comprising: a sample injection detection structure 1, comprising a bottom plate 11, a detection layer 12 and a sample injection structure 13 arranged in sequence from bottom to top, the sample injection structure 13 is provided with a siphon guide groove 131, the detection area of ​​the detection layer 12 is located in the siphon guide groove 131, and the bottom plate 11 is provided with a liquid suction channel 111 communicated with the siphon guide groove 131; a liquid suction structure 2, which is arranged on the lower side of the bottom plate 11, and the liquid suction structure 2 can suck the liquid in the siphon guide groove 131 out of the liquid suction channel 111.

[0034] The biosensor test strip of the present invention is provided with a liquid suction structure 2 on the lower side of the bottom plate 11 and a liquid suction channel 111 connected with the siphon guide groove 131 is provided on the bottom plate 11, so that the liquid in the siphon guide groove 131 can be sucked out from the liquid suction channel 111 by using the liquid suction structure 2, and then the siphon guide groove 131 can be used for re-injection, and this can be repeated to achieve multiple injections and multi-step detection.

[0035] like Figure 1 As shown, specifically, the bottom plate 11 can be made of a plastic plate, a glass plate, a silicon wafer or other plates with a certain thickness and deformation resistance, preferably a 5 mm thick organic glass (PMMA) plate. The detection layer 12 includes an electrochemical detection layer and / or a photochemical detection layer; the detection area of ​​the detection layer 12 is fixed with an immune detection element, a nucleic acid detection element and / or a molecular recognition element; wherein the immune detection element includes an antigen and / or an antibody, the nucleic acid detection element includes a polypeptide, a nucleic acid fragment and / or a peptide nucleic acid, and the molecular recognition element is made of a molecular imprinting material.

[0036] Wherein, the electrochemical detection layer 12 includes a detection electrode, and the detection electrode includes at least a working electrode 121 and a reference electrode 122. The detection electrode can be made of any good conductive electrode such as a carbon ink electrode, a carbon nanotube electrode, a graphene electrode, a gold electrode, a copper electrode, etc., and the detection electrode can also be loaded on the base plate 11 by methods such as screen printing technology, magnetron sputtering technology, and electrochemical etching. Preferably, the electrode is made by printing conductive carbon ink on the base plate 11 by screen printing technology. The photochemical detection layer 12 includes but is not limited to being made of NC film, polyester film or magnetic beads, and can also directly use a part of the base plate 11, that is, integrally formed on the upper side of the base plate 11. The method of fixing the immune detection element, nucleic acid detection element and molecular recognition element to the detection area of ​​the detection layer 12 includes but is not limited to adsorption method, cross-linking method, self-assembly method or other fixing methods of the prior art. The working principle involved in the detection of the liquid to be tested by the electrochemical detection layer 12 and the photochemical detection layer 12 is the same as the prior art, which is not described in detail here.

[0037] In addition, if Figure 1 and Figure 2 As shown, in order to make the siphon channel 131 better absorb liquid, the sample introduction structure 13 includes a siphon channel layer 132 and a hydrophilic cover sheet 133. The siphon channel 131 is arranged on the siphon channel layer 132, and the hydrophilic cover sheet 133 is arranged on the upper side of the siphon channel layer 132 and covers the siphon channel 131, and the hydrophilic surface of the hydrophilic cover sheet 133 is arranged toward the siphon channel 131. The siphon channel layer 132 can be made of double-sided tape or curing paint.

[0038] refer to Figure 1 and Figure 2 As shown, in some embodiments of the present invention, the liquid can automatically flow into the liquid absorption channel 111 along the siphon guide groove 131 under the action of siphon, and then be absorbed by the liquid absorption structure 2. At the same time, the liquid can react with the detection area of ​​the detection layer 12 or clean the siphon guide groove 131 and the detection area during the process of flowing along the siphon guide groove 131.

[0039] like Figure 1 and Figure 2 As shown, in other embodiments of the present invention, in order to allow the liquid in the siphon guide groove 131 to fully react with the detection area of ​​the detection layer 12, the biosensor test strip has an injection state and a liquid aspiration state. In the injection state, the liquid can be retained in the siphon guide groove 131; in the liquid aspiration state, the liquid aspiration structure 2 can suck the liquid in the siphon guide groove 131 out of the liquid aspiration channel 111.

[0040] When the biosensor test strip of the present invention is used for multiple injections and multi-step detection, after completing one injection, the biosensor test strip can be switched from the injection state to the aspiration state by squeezing the aspiration structure 2, and the aspiration structure 2 can be made to perform aspiration operation until the aspiration structure 2 completely aspirates the liquid in the siphon guide groove 131 from the aspiration channel 111, and then the squeezing of the aspiration structure 2 is stopped to switch the biosensor test strip from the aspiration state to the injection state, and then the sample can be injected again through the siphon guide groove 131. The liquid injected each time can be a liquid that undergoes a biochemical reaction with the detection area of ​​the detection layer 12, or a cleaning liquid that is used for cleaning but does not react. Of course, the biosensor test strip of the present invention is also suitable for one-step detection with only one injection.

[0041] like Figure 1 As shown, in the embodiment of the present invention, the liquid absorbing structure 2 includes a liquid absorbing member 22. The liquid absorbing channel 111 passes through the lower side of the bottom plate 11, so that the liquid absorbing member 22 can extend into the liquid absorbing channel 111, or can be correspondingly arranged at the opening of the lower end of the liquid absorbing channel 111. Specifically, the liquid absorbing member 22 is made of a water-absorbing material; wherein the water-absorbing material includes at least one of water-absorbing paper, water-absorbing cotton, water-absorbing sponge, water-absorbing plastic bubble film, and water-absorbing inorganic filler.

[0042] like Figure 1 As shown, in an embodiment of the present invention, the liquid absorption member 22 can be arranged to be movable along the axial direction of the liquid absorption channel 111; wherein the liquid absorption channel 111 has a liquid absorption port 112 communicated with the siphon guide groove 131; in the injection state, the liquid absorption member 22 is separated from the liquid absorption port 112 so that the liquid can be retained in the siphon guide groove 131; in the liquid absorption state, the liquid absorption member 22 moves along the axial direction of the liquid absorption channel 111 to the liquid absorption port 112 and absorbs the liquid in the siphon guide groove 131.

[0043] Specifically, the liquid absorption channel 111 may be a hole or a groove opened on the bottom plate 11. In order to facilitate the liquid absorption member 22 to absorb liquid more fully, the shape of the liquid absorption member 22 matches the liquid absorption channel 111, and the diameter of the liquid absorption member 22 is preferably equal to or slightly smaller than the inner diameter of the liquid absorption channel 111. For example, in a specific embodiment, the liquid absorption channel 111 is a circular hole with a diameter of 5 mm, and the liquid absorption member 22 is generally cylindrical, and the diameter is equal to or slightly smaller than 5 mm.

[0044] like Figure 1 and Figure 2As shown, in some embodiments of the present invention, the sample introduction structure 13 further includes a hydrophilic porous member 134, which is disposed at the liquid suction port 112 and is used to drain the liquid in the siphon guide groove 131 to the liquid suction port 112. The hydrophilic porous member 134 is a hydrophilic gauze or a hydrophilic membrane. By providing the hydrophilic porous member 134, when the liquid absorbing member 22 has not moved to the liquid absorbing port 112, that is, when the liquid absorbing member 22 has not contacted the hydrophilic porous member 134, the liquid in the siphon guide groove 131 will not be sucked out by the liquid absorbing member 22 through the hydrophilic porous member 134, so that the liquid can be retained in the siphon guide groove 131 and fully react with the detection area of ​​the detection layer 12; when the liquid absorbing member 22 moves to the liquid absorbing port 112 along the axial direction of the liquid absorbing channel 111 and contacts the hydrophilic porous member 134, the liquid in the siphon guide groove 131 can be sucked out by the liquid absorbing member 22 through the hydrophilic porous member 134 through the drainage effect of the hydrophilic porous member 134, thereby ensuring that the liquid in the siphon guide groove 131 is fully sucked out by the liquid absorbing member 22 so as to carry out the next sampling through the siphon guide groove 131.

[0045] It should be noted that the shape of the hydrophilic porous member 134 is not specifically limited, as long as it can connect the liquid absorbing member 22 and the liquid in the siphon guide groove 131 to play a drainage role when the liquid absorbing member 22 moves axially along the liquid absorbing channel 111 to the liquid absorbing port 112; as in the present embodiment, the hydrophilic porous member 134 can be generally in the shape of a sheet, covering the liquid absorbing port 112, and the hydrophilic porous member 134 can cover the entire liquid absorbing port 112 or only partially cover the liquid absorbing port 112; as in another embodiment, the hydrophilic porous member 134 can be generally in the shape of a strip, one end of which is overlapped above the liquid absorbing port 112; it can also be set to other shapes as in other embodiments.

[0046] Specifically, the hydrophilic porous member 134 is adhered to the base plate 11 through a first adhesive layer 135, and the first adhesive layer 135 has a drainage port 136 corresponding to the liquid suction port 112, and the liquid can automatically flow into the drainage port 136 along the siphon guide groove 131; wherein, the first adhesive layer 135 is made of at least one of insulating paint, double-sided tape, glue and paste.

[0047] refer to Figure 1 As shown, in some other embodiments of the present invention, by designing the caliber, surface characteristics and / or shape of the liquid suction port 112, when the liquid suction member 22 has not moved to the liquid suction port 112, the liquid at the liquid suction port 112 can remain stable under the action of surface tension and adhesion and will not fall into the liquid suction channel 111; when the liquid suction member 22 moves to the liquid suction port 112 along the axial direction of the liquid suction channel 111, the hydrophilic porous member 134 plays a role in draining the liquid in the siphon guide groove 131 to the liquid suction port 112, so that the liquid suction member 22 continuously absorbs the liquid until the liquid in the siphon guide groove 131 is completely sucked out.

[0048] like Figure 1 and Figure 3 As shown, in an embodiment of the present invention, the liquid absorbing structure 2 also includes a back plate 21, and the liquid absorbing member 22 is arranged on the upper side of the back plate 21. The back plate 21 is installed on the lower side of the bottom plate 11. The liquid absorbing member 22 is driven to move upward along the axial direction of the liquid absorbing channel 111 by squeezing the back plate 21 toward one side of the bottom plate 11, and the liquid absorbing member 22 is driven to move downward along the axial direction of the liquid absorbing channel 111 by stopping squeezing the back plate 21.

[0049] like Figure 1 and Figure 3 As shown, in some embodiments of the present invention, the liquid absorbing structure 2 further includes at least one elastic member 23, and the back plate 21 is connected to the lower side of the bottom plate 11 through the elastic member 23. The elastic member 23 can be elastically expanded and contracted under the extrusion force between the back plate 21 and the bottom plate 11 to make the liquid absorbing member 22 move along the axial direction of the liquid absorbing channel 111. By providing the extrusion force, the elastic member 23 is contracted, the back plate 21 and the bottom plate 11 are relatively close, and the liquid absorbing member 22 moves toward the liquid absorbing port 112 along the axial direction of the liquid absorbing channel 111, and then can move to the liquid absorbing port 112 and absorb the liquid in the siphon guide groove 131 through the drainage effect of the hydrophilic porous member 134; by removing the extrusion force, the elastic member 23 is reset, the back plate 21 and the bottom plate 11 are relatively far away, and the liquid absorbing member 22 moves away from the liquid absorbing port 112 along the axial direction of the liquid absorbing channel 111, and then can be separated from the liquid absorbing port 112, so as to facilitate the next injection through the siphon guide groove 131.

[0050] Specifically, the elastic member 23 is an elastic block made of elastic rubber or elastic plastic; or the elastic member 23 is a spring. One end of the elastic member 23 and one end of the liquid absorbing member 22 are both adhered to the back plate 21 through the second adhesive layer 24, the other end of the elastic member 23 is adhered to the bottom plate 11 through the third adhesive layer 25, and the other end of the liquid absorbing member 22 extends into the liquid absorbing channel 111. Among them, it is preferred that a plurality of elastic members 23 are provided, and the plurality of elastic members 23 are evenly distributed around the liquid absorbing member 22. The first adhesive layer 135 and the second adhesive layer 24 can be made of at least one of double-sided tape, glue, adhesive paste, and curing paint. The back plate 21 can be made of plastic plate, glass plate, metal plate, wooden plate or other plate with a certain degree of deformation resistance.

[0051] In some other embodiments of the present invention, the back plate 21 can also be made of a plate material with a certain deformation ability. The elastic deformation ability of the back plate 21 itself is utilized to make the liquid absorbing component 22 move axially along the liquid absorbing channel 111 under the extrusion force between the back plate 21 and the bottom plate 11. Therefore, the back plate 21 can also be connected to the lower side of the bottom plate 11 through a rigid component.

[0052] Implementation Method 2

[0053] The present invention also provides a method for using a biosensor test strip, which is used to use the biosensor test strip; the specific structure, working principle and beneficial effects of the biosensor test strip in this embodiment are the same as those of the biosensor test strip in embodiment 1, and will not be repeated here.

[0054] The method of use of the present invention comprises the following steps: sampling: sucking liquid into the siphon guide groove 131 through the siphon guide groove 131; if sampling is required again, repeating the sampling step after the liquid suction step; wherein the liquid suction step comprises: squeezing the liquid suction structure 2 so that the liquid suction structure 2 sucks the liquid in the siphon guide groove 131 until the liquid suction structure 2 sucks all the liquid in the siphon guide groove 131 out of the liquid suction channel 111, and then stopping squeezing the liquid suction structure 2.

[0055] For ease of understanding, a specific embodiment of the method of use is provided as follows:

[0056] First injection: the sample to be tested is sucked through the siphon guide groove 131, so that the sample to be tested fills the siphon guide groove 131, the drainage port 136 and the hydrophilic porous member 134, and then the antigen in the sample to be tested reacts with the antibody on the surface of the detection electrode;

[0057] First liquid absorption: by squeezing the back plate 21, the liquid absorption member 22 is pushed to move upward along the axial direction of the liquid absorption channel 111, so that the liquid absorption member 22 passes through the liquid absorption channel 111 and contacts the hydrophilic porous member 134 to absorb the liquid in the siphon guide groove 131, until the sample to be tested after the immune reaction is completely discharged from the siphon guide groove 131, and then the squeezing of the back plate 21 is stopped, so that the back plate 21 drives the liquid absorption member 22 to move downward along the axial direction of the liquid absorption channel 111 under the action of the elastic restoring force of the elastic member 23 and separates from the hydrophilic porous member 134;

[0058] Second injection: the enzyme-labeled antibody solution is sucked through the siphon guide groove 131, so that the enzyme-labeled antibody solution fills the siphon guide groove 131, the drainage port 136 and the hydrophilic porous member 134, and then the enzyme-labeled antibody solution performs an antibody-antigen-enzyme-labeled antibody immune reaction on the surface of the detection electrode;

[0059] Second aspiration: The operation is the same as the first aspiration, until the enzyme-labeled antibody solution after the immune reaction is completely discharged from the siphon guide groove 131, and then the back plate 21 is squeezed;

[0060] The third injection: the substrate additive liquid is sucked into the siphon groove 131 so that the substrate additive liquid fills the siphon groove 131, the drainage port 136 and the hydrophilic porous member 134, and then the substrate in the substrate additive liquid reacts with the enzyme on the antibody-antigen-enzyme labeled antibody complex on the surface of the detection electrode, so that the detection electrode generates a detectable electrochemical signal and transmits it to the instrument.

[0061] Implementation Method 3

[0062] The present invention also provides a method for making a biosensor test strip, which is used to make the biosensor test strip. The specific structure, working principle and beneficial effects of the biosensor test strip in this embodiment are the same as those of the biosensor test strip in the first embodiment, and will not be repeated here.

[0063] The manufacturing method of the present invention includes the following steps: preparing a plate body, and opening a liquid absorption channel 111 on the plate body, thereby serving as a bottom plate 11; arranging a detection layer 12 on the upper side of the bottom plate 11; arranging a sample injection structure 13 on the upper side of the bottom plate 11, and making the detection area of ​​the detection layer 12 located in the siphon guide groove 131 of the sample injection structure 13; arranging a liquid absorption structure 2 on the lower side of the bottom plate 11, and making the liquid absorption part 22 of the liquid absorption structure 2 correspond to the liquid absorption channel 111.

[0064] In an embodiment of the present invention, the manufacturing method further comprises: sticking a hydrophilic porous member 134 on the bottom plate 11 and making the hydrophilic porous member 134 cover the liquid suction channel 111 and the liquid suction port 112 communicating with the siphon guide groove 131 .

[0065] For ease of understanding, a specific manufacturing method is provided as follows:

[0066] Take a 5mm thick organic glass plate, open a hole with a diameter of 5mm at a position 6mm away from the edge of the plate as a liquid absorption channel 111, so as to serve as the bottom plate 11;

[0067] Conductive carbon paste is printed on the bottom plate 11 by screen printing, and dried at 90°C for 30 minutes to form a detection electrode; wherein the detection electrode includes a working electrode 121 and a reference electrode 122. When screen printing the detection electrode, the detection electrode avoids the liquid absorption channel 111 on the bottom plate 11, and the end of the detection electrode close to the liquid absorption channel 111 is the detection area, and the end of the detection electrode far from the liquid absorption channel 111 is the interface connected to the instrument;

[0068] A hydrophilic gauze with a diameter of 7 mm is covered on the upper opening of the liquid suction channel 111 of the bottom plate 11 (i.e., the liquid suction port 112), so that the outer edge of the hydrophilic gauze exceeds the edge of the liquid suction port 112 by 1 mm, and then the outer edge of the hydrophilic gauze that exceeds the liquid suction port by 1 mm is sealed on the bottom plate 11 by screen printing insulating paint; wherein, when screen printing insulating paint, the portion of the hydrophilic gauze in the hole area of ​​the bottom plate 11 corresponding to the liquid suction port 112 is not printed with insulating paint, so that the upper side of the hydrophilic gauze without insulating paint forms a drainage port 136;

[0069] Immobilize the antibody on the part of the working electrode 121 located in the detection area: drip the antibody solution on the surface of the working electrode 121 located in the detection area, then leave it at room temperature for 30 minutes, then wash the surface of the working electrode 121 with pure water, then add 1% BSA (bovine serum albumin) solution to block the surface of the working electrode 121, and then wash the surface of the working electrode 121 with pure water again; dry it at 40°C and set it aside;

[0070] A double-sided film is cut into a U-shaped groove that exposes the liquid suction port 112 of the bottom plate 11 and the detection area, and is pasted on the upper side of the bottom plate 11 to serve as a siphon channel layer 132 having a siphon guide groove 131;

[0071] A hydrophilic cover sheet 133 is covered on the upper side of the siphon channel layer 132, and the hydrophilic side of the hydrophilic cover sheet 133 faces the siphon guide groove 131;

[0072] A double-sided adhesive sheet is attached to the lower side of the bottom plate 11, i.e., the side where no detection electrodes are provided, as a third adhesive layer 25;

[0073] A hard plastic plate is used as the back plate 21, and a double-sided adhesive film is attached to the upper side of the back plate 21 as the second adhesive layer 24;

[0074] Cut a piece of absorbent cotton into a cylindrical shape with a diameter of 4.5 mm and a height of 10 mm as the liquid absorbent member 22;

[0075] Adhere one end of the liquid-absorbing member 22 to the second adhesive layer 24;

[0076] Cut an elastic rubber block into two squares with a length of 10 mm, a width of 10 mm, and a height of 8 mm to serve as two elastic members 23;

[0077] One end of the two elastic members 23 is pasted on the second adhesive layer 24, and the other end of the two elastic members 23 is pasted on the third adhesive layer 25 pasted on the lower side of the base plate 11, and the other end of the absorbent member 22 is aligned with the absorbent channel 111 of the base plate 11 and partially extends into the absorbent channel 111, thereby assembling the absorbent structure 2 and the base plate 11 together.

[0078] The above are only several embodiments of the present invention. Those skilled in the art may make various changes or modifications to the embodiments of the present invention based on the contents disclosed in the application documents without departing from the spirit and scope of the present invention.

Claims

1. A biosensor test strip, characterized in that: include: The sample introduction detection structure comprises a bottom plate, a detection layer and a sample introduction structure which are sequentially arranged from bottom to top, the sample introduction structure is provided with a siphon guide groove, the detection area of ​​the detection layer is located in the siphon guide groove, and the bottom plate is provided with a liquid suction channel which is communicated with the siphon guide groove; The liquid suction structure is arranged on the lower side of the bottom plate, and the liquid suction structure can suck the liquid in the siphon guide groove out from the liquid suction channel.

2. The biosensor test strip according to claim 1, wherein The biosensor test strip has a sample injection state and a liquid aspiration state. In the sample injection state, the liquid can be retained in the siphon guide groove; in the liquid aspiration state, the liquid aspiration structure can aspirate the liquid in the siphon guide groove from the liquid aspiration channel.

3. The biosensor test strip according to claim 2, wherein: The liquid absorbing structure comprises a liquid absorbing member, and the liquid absorbing member is movably arranged along the axial direction of the liquid absorbing channel; Among them, the upper end of the liquid suction channel has a liquid suction port communicated with the siphon guide groove, and a hydrophilic porous component is provided at the liquid suction port, and the hydrophilic porous component is used to drain the liquid in the siphon guide groove to the liquid suction port; in the injection state, the liquid suction component is separated from the liquid suction port and the hydrophilic porous component so that the liquid can be retained in the siphon guide groove; in the liquid suction state, the liquid suction component moves along the axial direction of the liquid suction channel to the liquid suction port and contacts with the hydrophilic porous component to suck out the liquid in the siphon guide groove.

4. The biosensor test strip according to claim 3, wherein: The hydrophilic porous member covers the liquid suction port; wherein the hydrophilic porous member is a hydrophilic gauze or a hydrophilic membrane.

5. The biosensor test strip according to claim 4, wherein The hydrophilic porous member is adhered to the bottom plate through a first adhesive layer, and the first adhesive layer has a drainage port corresponding to the liquid suction port; Wherein, the first bonding layer is made of at least one of insulating paint, double-sided tape, glue and paste.

6. The biosensor test strip of claim 3, wherein: The liquid absorbing structure also includes a back plate and at least one elastic member, wherein the back plate is connected to the lower side of the bottom plate through the elastic member, and the elastic member can elastically expand and contract under the squeezing force between the back plate and the bottom plate to make the liquid absorbing member move axially along the liquid absorbing channel.

7. The biosensor test strip of claim 6, wherein: The elastic member is an elastic block made of elastic rubber or elastic plastic; or the elastic member is a spring.

8. The biosensor test strip of claim 6, wherein: One end of the elastic member and one end of the liquid absorbent member are both adhered to the back plate through a second adhesive layer, the other end of the elastic member is adhered to the bottom plate through a third adhesive layer, and the other end of the liquid absorbent member extends into the liquid absorption channel.

9. The biosensor test strip of claim 3, wherein: The liquid-absorbing member is made of a water-absorbing material; wherein the water-absorbing material includes at least one of water-absorbing paper, water-absorbing cotton, water-absorbing sponge, water-absorbing plastic bubble film, and water-absorbing inorganic filler.

10. The biosensor test strip according to any one of claims 1 to 9, characterized in that The sample introduction structure includes a siphon channel layer and a hydrophilic cover sheet, the siphon guide groove is arranged on the siphon channel layer, the hydrophilic cover sheet is arranged on the upper side of the siphon channel layer and covers the siphon guide groove, and the hydrophilic surface of the hydrophilic cover sheet is arranged toward the siphon guide groove.

11. The biosensor test strip according to any one of claims 1 to 9, characterized in that The detection layer includes an electrochemical detection layer and / or a photochemical detection layer; The detection area of ​​the detection layer is fixed with immune detection elements, nucleic acid detection elements and / or molecular recognition elements; wherein the immune detection elements include antigens and / or antibodies, the nucleic acid detection elements include polypeptides, nucleic acid fragments and / or peptide nucleic acids, and the molecular recognition elements are made of molecular imprinting materials.

12. A method for using a biosensor test strip, characterized in that: Used for using the biosensor test strip according to any one of claims 1 to 11; the method of use comprises the following steps: Injection: sucking liquid into the siphon guide groove through the siphon guide groove; If another injection is required, repeat the injection step after the aspiration step; Wherein, the liquid absorbing step includes: squeezing the liquid absorbing structure to make the liquid absorbing structure absorb the liquid in the siphon guide groove, until the liquid absorbing structure sucks all the liquid in the siphon guide groove out of the liquid absorbing channel, and then stopping squeezing the liquid absorbing structure.

13. A method for preparing a biosensor test strip, characterized in that: Used to make a biosensor test strip according to any one of claims 1 to 11; the manufacturing method comprises the following steps: Prepare a plate body, and open the liquid absorption channel on the plate body to serve as the bottom plate; The detection layer is arranged on the upper side of the bottom plate; The sample introduction structure is arranged on the upper side of the bottom plate, and the detection area of ​​the detection layer is located in the siphon guide groove of the sample introduction structure; The liquid absorbing structure is arranged on the lower side of the bottom plate, and the liquid absorbing piece of the liquid absorbing structure corresponds to the liquid absorbing channel.

14. The method for making a biosensor test strip according to claim 13, wherein: The manufacturing method further comprises: sticking a hydrophilic porous member on the bottom plate and making the hydrophilic porous member cover the liquid suction port communicating with the liquid suction channel and the siphon guide groove.

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