CN120741843A

CN120741843A - Test strip and preparation method thereof

Info

Publication number: CN120741843A
Application number: CN202410301020.6A
Authority: CN
Inventors: 李百川; 杨哲曜; 杨清刚
Original assignee: Hangzhou Weice Biotechnology Co ltd
Current assignee: Hangzhou Weice Biotechnology Co ltd
Priority date: 2024-03-15
Filing date: 2024-03-15
Publication date: 2025-10-03

Abstract

The present invention relates to a test strip and a method for preparing the same, for use in detecting physiological indicators in samples such as blood. The test strip comprises a detection area and a test strip substrate that are independent of each other and, when assembled together, form a test strip for detecting physiological indicators. Specifically, the test strip utilizes a split structure. Even if a test strip's detection area fails during the liquid dispensing process, the failed test strip detection area can be discarded without requiring the test strip substrate to be discarded. This significantly reduces production costs compared to existing technologies.

Description

Test strip and method for producing same

Technical Field

The invention relates to a test strip and a preparation method thereof, which are used for detecting physiological indexes in samples such as blood and the like.

Background

Along with the improvement of the living standard of people, people pay more attention to self health, many users have the requirement of monitoring a plurality of different physiological indexes (such as blood sugar, blood ketone, cholesterol and the like), if the single index test paper is used for detection, a plurality of different single index test papers and matched instruments are required to be prepared, and the carrying and using processes are complex. Even if a plurality of different test papers are matched with one instrument for use, the operation process of a single person is troublesome. Therefore, multi-index test papers with various different structures gradually appear in the market.

The production process of the common multi-index test paper is similar to that of single-index test paper, and the common multi-index test paper needs to be printed, spotted, assembled and other processes. Different from a single detection area of single-index test paper, the multi-index test paper integrates a plurality of different detection areas on a card, so that one test paper can detect a plurality of different indexes, and scenes and crowds with multi-index detection requirements are greatly facilitated.

The liquid dispensing process of the common multi-index test paper is improved based on single-index test paper, and can be used for dispensing liquid in a plurality of detection areas at one time or respectively dispensing liquid in a plurality of detection areas. For dispensing a plurality of detection areas at a time, the dispensing device needs to be upgraded, namely, the number of pumps and the number of solution conveying pipelines are increased, the clamp of the dispensing needle is redesigned, and a control system of the dispensing device also needs to be upgraded, so that the cost is increased. The method comprises the steps of respectively carrying out liquid dispensing on a plurality of detection areas, wherein the exposure time of the detection area for the first liquid dispensing is different from the exposure time of the detection area for the last liquid dispensing in the environment, the state of the dried solution can be influenced, the bottom plate needs to be moved in the process of carrying out liquid dispensing for a plurality of times, the state of the solution in the detection area can be damaged, the shape of a dried reagent layer is irregular, the test paper can be scrapped in both cases, and therefore, the scrapping rate of the test paper can be improved in a mode of respectively carrying out liquid dispensing on the plurality of detection areas.

In addition, due to the influences of errors in positioning of liquid dispensing equipment, tolerance of equipment, solution surface tension and the like, unqualified products can be generated in the liquid dispensing process, the unqualified products of liquid dispensing can be directly removed for single-index test paper, and for multi-index test paper, any one of a plurality of detection areas is unqualified in liquid dispensing, and the whole multi-index test paper can be removed. Therefore, the liquid dropping failure rate of the multi-index test paper is far greater than that of the single-index test paper.

Disclosure of Invention

The invention aims to solve the problems, and provides a test strip and a preparation method thereof, which reduce the rejection rate and the cost in the production process.

In order to achieve the above purpose, the present invention is realized by the following technical scheme:

a test strip comprises a test strip substrate, and at least two test strip detection areas respectively arranged on the test strip substrate, wherein each test strip detection area is used for detecting different physiological indexes,

A test strip detection zone having an insulating substrate layer, a first electrode layer on the insulating substrate layer, a first reaction layer on the first electrode layer and having a first reaction region, a channel layer on the first reaction layer, a second reaction layer on the channel layer and having a second reaction region, a second electrode layer on the second reaction layer, a cover layer on the second electrode layer, wherein the channel layer has sample channels at positions corresponding to the first reaction region and the second reaction region;

The test strip substrate is provided with a substrate body, wherein a first arm, a second arm, a first conducting layer and a second conducting layer are formed on the substrate body, an installation position for installing the test strip detection area is formed between the first arm and the second arm, and when the test strip detection area is installed at the installation position, a first electrode layer and a second electrode layer of the test strip detection area are respectively contacted with the first conducting layer and the second conducting layer of the test strip substrate.

Preferably, the first electrode layer comprises a first electrode and a second electrode, and the second electrode layer comprises a third electrode and a fourth electrode.

Preferably, the first electrode comprises an electrode A, an electrode B and a resistor AB with two ends respectively electrically connected with the electrode A and the electrode B, the second electrode comprises an electrode C, an electrode D and a resistor CD with two ends respectively electrically connected with the electrode C and the electrode D, the third electrode comprises an electrode E, an electrode F and a resistor EF with two ends respectively electrically connected with the electrode E and the electrode F, and the fourth electrode comprises an electrode G, an electrode H and a resistor GH with two ends respectively electrically connected with the electrode G and the electrode H.

Preferably, a first sliding groove or a first sliding block is formed on a first edge of the test strip detection area, a second sliding groove or a second sliding block is formed on a second edge opposite to the first edge, the first edge and the second edge are respectively positioned at two sides of the sample channel, the first arm is matched with the first sliding groove or the first sliding block, and the second arm is matched with the second sliding groove or the second sliding block, so that sliding fit between the test strip detection area and the test strip substrate is realized.

Preferably, a first chute and a second chute are respectively formed on the first edge and the second edge, the first arm is at least partially embedded in the first chute, and the second arm is at least partially embedded in the second chute, so that the sliding fit between the test strip detection area and the test strip substrate is realized.

Preferably, the projection width of the channel layer in the direction perpendicular to the insulating substrate layer is slightly smaller than the widths of the insulating substrate layer and the covering layer, so as to form the first sliding groove and/or the second sliding groove.

Preferably, a protrusion is arranged on the cover layer at the inlet corresponding to the sample channel, and a recess matched with the protrusion is arranged on the cover layer at the outlet corresponding to the sample channel.

Preferably, the substrate body is provided with a bottom protrusion matched with the recess to close the sample channel.

Preferably, a first embedding part is formed on a first side and/or a second side of the test strip detection area, a second embedding part which is matched with the first embedding part and is used for realizing embedding and positioning of the test strip detection area and the test strip substrate is formed on the first arm and/or the second arm, and the first side and the second side are respectively positioned at two sides of the sample channel.

Preferably, the sample channels of each test strip detection zone mounted on the test strip substrate are in communication with one another.

Preferably, the front surface of the test strip substrate is provided with a second conductive layer, and the back surface of the test strip substrate is provided with a first conductive layer.

A method of preparing a test strip comprising:

Preparing the test strip detection area and the test strip substrate respectively;

each test strip detection zone is respectively arranged on the mounting position of the test strip substrate, so that the first electrode layer and the second electrode layer of each test strip detection zone are respectively contacted with the first conductive layer and the second conductive layer of the test strip substrate.

Preferably, preparing said test strip detection zone comprises:

The method comprises the steps of printing a first electrode layer on an insulating substrate layer, arranging a first reaction layer on the first electrode layer, and carrying out drying treatment after liquid is dispensed in a first reaction area of the first reaction layer;

printing a second electrode layer on the cover layer, arranging a second reaction layer on the second electrode layer, and carrying out drying treatment after liquid is poured into a second reaction area of the second reaction layer to obtain a semi-finished product D of the detection area;

Attaching the semi-finished product C of the detection area to the semi-finished product D of the detection area, so that the first reaction area and the second reaction area are respectively positioned at the upper side and the lower side of the sample channel, and obtaining a plurality of mutually connected detection areas of the test strip;

And cutting along the third cutting line to obtain a plurality of mutually independent test strip detection areas.

Preferably, preparing said test strip detection zone comprises:

The method comprises the steps of printing a first electrode layer on an insulating substrate layer, arranging a first reaction layer on the first electrode layer, carrying out drying treatment after liquid is dispensed in a first reaction area of the first reaction layer, arranging a channel layer on the first reaction layer, and arranging a sample channel on the channel layer at a position corresponding to the first reaction area;

The second electrode layer is printed on the covering layer, a second reaction layer is arranged on the second electrode layer, and drying treatment is carried out after liquid is dispensed in a second reaction area of the second reaction layer;

Attaching the semi-finished product E of the detection area to the semi-finished product F of the detection area so that the first reaction area and the second reaction area are respectively positioned at the upper side and the lower side of the sample channel to obtain a plurality of mutually connected detection areas of the test strip;

Preferably, double faced adhesive tape A and double faced adhesive tape B are respectively stuck on the first reaction layer, and a gap is reserved between the double faced adhesive tape A and the double faced adhesive tape B, so that a channel layer with a sample channel is formed.

Preferably, preparing the test strip detection zone further comprises:

respectively pasting a first conductive adhesive and a second conductive adhesive on the first conductive layer, and respectively pasting a third conductive adhesive and a fourth conductive adhesive on the second conductive layer;

or the first conductive adhesive and the second conductive adhesive are respectively stuck on the first electrode layer, and the third conductive adhesive and the fourth conductive adhesive are respectively stuck on the second electrode layer (22').

The invention has the beneficial effects that:

1. The test strip detection area and the test strip substrate are mutually independent, and the test strip for realizing the detection of the physiological index is formed after the test strip detection area and the test strip substrate are matched and installed, namely, the test strip adopts a split type structure, even if the test strip detection area is unqualified in the liquid dropping process, the unqualified test strip detection area is scrapped, the test strip substrate does not need to be scrapped, and compared with the prior art, the production cost is greatly reduced.

2. Because the test strip adopts a split type structure, the test strip detection areas are independently produced, the existing liquid-dispensing process of the single-index test paper can be adopted, the liquid-dispensing process is simple, the liquid-dispensing process of a plurality of different detection areas does not need to be upgraded, equipment investment is saved, and the cost is reduced.

3. The first reaction layer, the first electrode layer, the second reaction layer and the second electrode layer are respectively arranged on two sides of the channel layer, so that double-sided detection areas are formed, biological samples are provided for the two detection areas by using the sample channels of the same channel layer, namely, double detection quantity can be realized on the same electrode length, the material cost of the test strip is reduced, and the demand of the samples is also reduced.

4. If the double detection quantity is realized by the single-sided detection area structure, two single-sided detection areas are needed, and by the double-sided detection area structure, one insulating substrate layer, one double-sided adhesive layer and one covering layer (hydrophilic film) can be saved, so that the cost is further saved.

5. The first sliding groove or the first sliding block is utilized, and the second sliding groove or the second sliding block is matched with the test strip substrate, namely, the test strip detection area slides into the test strip substrate to realize the installation of the test strip detection area and the test strip substrate, so that the installation is convenient and quick.

6. When the two test strip detection areas are spliced, the sample channels in the two test strip detection areas are connected with each other, the bulge on one test strip detection area is embedded into the recess in the other test strip detection area, and the flow of biological samples can be assisted until the biological samples are filled in the reaction areas of the two test strip detection areas.

7. The first edge and/or the second edge of the detection area of the test strip are/is provided with a first jogging part which can be matched with a second jogging part formed on the first arm and/or the second arm of the substrate of the test strip to realize jogging and positioning of the detection area of the test strip.

Drawings

FIG. 1 is a schematic view of the structure of a test strip of the present invention.

FIG. 2 is a cross-sectional view of a test strip detection zone of the present invention mounted to a test strip substrate.

FIG. 3 is an exploded view of the detection zone of the test strip of the present invention.

FIG. 4 is a schematic cross-sectional view of the detection zone of a test strip of the present invention.

FIG. 5 is a diagram showing the structure of the connection between the first electrode layer of the test strip detection zone and the first conductive layer of the test strip substrate according to the present invention.

FIG. 6 is a schematic diagram of the flow of a biological sample in a sample channel according to the present invention.

FIG. 7 is a schematic diagram of another embodiment of the biological sample flowing in the sample channel according to the present invention.

FIG. 8 is a schematic view of the structure of two mutually-spliced test strip detection zones according to the present invention.

FIG. 9 is a schematic diagram of the front structure of a test strip substrate according to the present invention.

FIG. 10 is a schematic view of the back side structure of a test strip substrate of the present invention (with a test strip detection zone mounted thereon).

FIG. 11 is a schematic illustration of a test strip detection zone production process of the present invention.

FIG. 12 is a second illustration of a test strip detection zone production process of the present invention.

Reference numerals: a substrate body-11, a bottom protrusion-111, a first arm-12, a first positioning recess-121, a second arm-13, a second positioning recess-131, a mounting position-14, a first conductive layer-15, a first conductive paste-18, a conductive paste A-181, a conductive paste B-182, a second conductive paste-19, a conductive paste C-191, a conductive paste D-192, an insulating substrate layer-21, a first electrode layer-22, a first electrode-221, an electrode A-2211, an electrode B-2212, a resistor AB-2213, a second electrode-222, an electrode C-2221, an electrode D-2222, a resistor CD-2223, a first reaction layer-23, a first insulating print layer-231, a first reagent layer-232, channel layer-24, double-sided tape A-241, double-sided tape B-242, first positioning protrusion-2411, second positioning protrusion-2421, sample channel-243, cover layer-25, protrusion-251, recess-252, first slide groove-27, second slide groove-29, second conductive layer-15 ', third conductive tape-18', conductive tape E-181', conductive tape F-182', fourth conductive tape-19 ', conductive tape G-191', conductive tape H-192', second electrode layer-22', third electrode-221 ', electrode E-2211', electrode F-2212', resistor EF-2213', fourth electrode-222 ',electrodeG-2221', electrode H-2222', resistor GH-2223', second reaction layer-23 ' second insulating print layer-231 ', second reagent layer-232 '.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the following description will be made in detail with reference to the technical solutions in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by a person skilled in the art without any inventive effort, are intended to be within the scope of the present invention, based on the embodiments of the present invention.

The test strip shown in fig. 1 and 2 comprises a test strip substrate and at least two test strip detection areas respectively arranged on the test strip substrate, wherein each test strip detection area is used for detecting different physiological indexes to form a multi-index test strip (such as test paper for simultaneously detecting indexes of blood sugar, cholesterol and the like) for detecting the physiological indexes (including but not limited to glucose, cholesterol, blood ketone and the like). The test strip is a biochemical sensor or an electrochemical sensor.

As shown in fig. 3, the test strip detection zone is produced independently of the test strip substrate and is used for being mounted on the test strip substrate to form a test strip for realizing the detection of the physiological index. The test strip detection zone has an insulating substrate layer 21, a first electrode layer 22 on the insulating substrate layer 21, a first reaction layer 23 on the first electrode layer 22 and having a first reaction region, a channel layer 24 on the first reaction layer 23, a second reaction layer 23 'on the channel layer 24 and having a second reaction region, a second electrode layer 22' on the second reaction layer 23', and a cover layer 25 on the second electrode layer 22', wherein the channel layer 24 has sample channels 243 at positions corresponding to the first reaction region and the second reaction region. As shown in fig. 9 and 10, the test strip substrate has a substrate body 11, on which a first arm 12, a second arm 13, a first conductive layer 15, and a second conductive layer 15' are formed on the substrate body 11, a mounting location 14 for mounting the test strip detection area is formed between the first arm 12 and the second arm 13, and when the test strip detection area is mounted on the mounting location 14, the first electrode layer 22 and the second electrode layer 22' of the test strip detection area are respectively contacted with the first conductive layer 15 and the second conductive layer 15' of the test strip substrate, so that an electric signal from a test instrument (such as a blood glucose meter, a cholesterol meter, a blood ketone meter, etc.) is transferred to a reaction area (including a first reaction area and a second reaction area) of the test strip detection area, so as to promote the occurrence of a detection reaction, and an electric signal generated by the reaction area (including the first reaction area and the second reaction area) is transferred to the test instrument. In some practical applications, for installation convenience, at least one of the first side and the second side of the test strip detection area has a sliding groove or a sliding block, specifically, the first side has a first sliding groove 27 and the second side has a second sliding groove 29, or the first side has a first sliding block and the second side has a second sliding groove 29, or the first side has a first sliding groove 27 and the second side has a second sliding groove 29, or only the first side has a first sliding groove 27, or only the second side has a second sliding groove 29, or only the first side has a first sliding groove, or only the second side has a second sliding groove, and the above-mentioned embodiments are merely illustrative, and not limiting to the invention. The first and second sides are located on either side of the sample channel 243, respectively, and in some implementations, the sliding fit mounting of the test strip detection zone and the test strip substrate is achieved by the cooperation of the first chute 27 or the first slider, and the second chute 29 or the second slider with the test strip substrate. In some practical applications, the first sliding groove 27 and/or the second sliding groove 29 are formed by a gap between the cover layer 25 and the insulating substrate layer 21, specifically, a gap between the lower surface of the cover layer 25 and the upper surface of the insulating substrate layer 21, and the first sliding block and/or the second sliding block may be a structure that sticks out of the test strip detection area at the gap between the cover layer 25 and the insulating substrate layer 21 as a sliding block, where the structure may be a double-sided adhesive tape, an insulating layer or a conductive adhesive tape, or the first sliding block and/or the second sliding block are structures between two sides of the test strip detection area, that is, the upper surface of the cover layer 25 and the lower surface of the insulating substrate layer 21, as the first sliding block and/or the second sliding block.

The first electrode layer 22 and the second electrode layer 22' are used to transfer electrical signals from a detection instrument (e.g., a blood glucose meter, a cholesterol meter, a blood ketone meter, etc.) to the first reaction region and the second reaction region to facilitate the occurrence of a detection reaction, on the one hand, and to transfer electrical signals generated in the first reaction region and the second reaction region to the detection instrument, on the other hand. In some practical applications, the first electrode layer 22 at least includes a first electrode 221, a second electrode 222, a first conductive adhesive 18 attached to the first electrode 221 and used for connecting with a first contact of the first conductive layer 15 on the back surface of the test strip substrate, and a second conductive adhesive 19 attached to the second electrode 222 and used for connecting with a second contact of the first conductive layer 15 on the back surface of the test strip substrate, wherein the first electrode 221 and the second electrode 222 are respectively a working electrode and a counter electrode, the connection between the first electrode 221 and the first contact of the first conductive layer 15 on the back surface of the test strip substrate is realized by using the first conductive adhesive 18, and the connection between the second electrode 222 and the second contact of the first conductive layer 15 on the back surface of the test strip substrate is realized by using the second conductive adhesive 19. The second electrode layer 22' includes a third electrode 221', a fourth electrode 222', a third conductive adhesive 18' attached to the third electrode 221' and used for connecting with a third contact of the second conductive layer 15' on the front surface of the test strip substrate, and a fourth conductive adhesive 19' attached to the fourth electrode 222' and used for connecting with a fourth contact of the second conductive layer 15' on the front surface of the test strip substrate, wherein the third electrode 221' and the fourth electrode 222' are respectively a working electrode and a counter electrode. The third electrode 222 'is connected with a third contact on the second conductive layer 15' on the front surface of the test strip substrate by using the third conductive adhesive 18', and the fourth electrode 222' is connected with a fourth contact on the second conductive layer 15 'on the front surface of the test strip substrate by using the fourth conductive adhesive 19'. And meanwhile, the relative positioning of the test strip detection area and the test strip substrate is realized. Of course, the conductive adhesive (including the first conductive adhesive, the second conductive adhesive, the third conductive adhesive, Fourth conductive glue) may also be disposed on the first conductive layer 15 and the second conductive layer 15' of the test strip substrate, specifically, the first conductive glue 18 is disposed on the first contact of the first conductive layer 15, the second conductive glue 19 is disposed on the second contact of the first conductive layer 15, the third conductive glue 18' is disposed on the third contact of the second conductive layer 15', the fourth conductive glue 19' is disposed on the fourth contact of the second conductive layer 15', and the first electrode layer 22 and the second electrode layer 22' and the second conductive layer 15' are connected by conductive glue, so that the first electrode layer 22 and the second electrode layer 22' of the test strip detection area are respectively contacted with the first conductive layer 15 and the second conductive layer 15' of the test strip substrate, and meanwhile, the relative positioning of the test strip detection area and the test strip substrate is realized, and the conductive glue is converted from being disposed on the first electrode layer 22 and the second electrode layer 22' to being disposed on the first conductive layer 15 and the second conductive layer 15', which is a relatively easy replacement manner for those skilled in the art. The conductive adhesive mainly comprises a resin matrix, conductive particles and other auxiliary additives, wherein the matrix mainly comprises epoxy resin, acrylic resin, polychlorinated ester and the like, the conductive particles can be gold, silver, copper, aluminum, zinc, iron and nickel powder, graphite and some conductive compounds, and the other auxiliary additives mainly aim to adjust the viscosity and the curing speed of the adhesive. The double-sided adhesive tape has similar components to the conductive adhesive, but conductive particles therein are removed, and the proportions of the components are different from those of the conductive adhesive. The conductive adhesive and the double-sided adhesive used in the scheme are both heat-sensitive, or the conductive adhesive is only heat-sensitive, the adhesiveness of the conductive adhesive at the temperature below 15 ℃ is not strong, the assembly and the matching of the sliding grooves or the sliding blocks on the first side and the second side of the detection area of the test strip and the first arm and the second arm of the substrate of the test strip are facilitated, the adhesiveness of the conductive adhesive above 40 ℃ is increased, and after the pressure is applied to the conductive adhesive of the test strip, the first electrode layer 22 and the second electrode layer 22 'of the detection area of the test strip are respectively contacted with the first conductive layer 15 and the second conductive layer 15', so that the electric signals from the detection instrument are transmitted to the first reaction area and the second reaction area of the detection area of the test strip. The surface of the conductive adhesive can be attached with a release film or not attached with a release film. The size of the conductive adhesive should be kept from being too small to prevent the adhesion from being unstable, and should be kept from being too large to prevent the adjacent two electrodes from being conducted and shorted, and the size of the conductive adhesive is preferably consistent with the sizes of the electrode B2212, the electrode D2222, the electrode F-2212', and the electrode H-2222', which are described below. The first contact and the second contact may be part of a wire printed on the test strip substrate, or may be conductive contacts connected to a wire on the test strip substrate, and are all part of the first conductive layer 15 of the test strip substrate, and similarly, the third contact and the fourth contact may be part of a wire printed on the test strip substrate, or may be conductive contacts connected to a wire on the test strip substrate, and are all part of the second conductive layer 15' of the test strip substrate.

In some practical applications, the first electrode 221 includes an electrode a2211, an electrode B2212, a resistor AB2213 with two ends electrically connected to the electrode a2211 and the electrode B2212, respectively, the first conductive paste 18 includes a conductive paste a181 attached to the electrode a2211 and a conductive paste B182 attached to the electrode B2212, the second electrode 222 includes an electrode C2221, an electrode D2222, a resistor CD2223 with two ends electrically connected to the electrode C2221 and the electrode D2222, respectively, the second conductive paste 19 includes a conductive paste C191 attached to the electrode C2221 and a conductive paste D192 attached to the electrode D2222, and the third electrode 221 'includes an electrode E2211', a third electrode, a fourth electrode, a fifth electrode, and a fourth electrode, The electrode F2212 'and the resistor EF2213' with two ends respectively electrically connected with the electrode E2211 'and the electrode F2212', the third conductive adhesive 18 'comprises a conductive adhesive E181' attached to the electrode E2211 'and a conductive adhesive F182' attached to the electrode F2212', the fourth electrode 222' comprises an electrode G2221', an electrode H2222', and the resistor GH2223 'with two ends respectively electrically connected with the electrode G2221' and the electrode H2222', and the fourth conductive adhesive 19' comprises a conductive adhesive G191 'attached to the electrode G2221' and a conductive adhesive H192 'attached to the electrode H2222'. the materials of the electrode a2211, the electrode B2212, the electrode C2221, the electrode D2222, the electrode E2211', the electrode F2212', the electrode G2221', and the electrode H2222' may be carbon ink, platinum carbon, silver/silver chloride, gold, palladium, and the like. The materials of the resistor AB2213, the resistor CD2223, the resistor EF2213 and the resistor GH2223 'can be carbon ink, platinum carbon, silver/silver chloride, gold, palladium and the like, and certainly, the first electrode 221 comprises an electrode A2211 or an electrode B2212, the second electrode 222 comprises an electrode C2221, an electrode D2222 and a resistor CD2223 with two ends electrically connected with the electrode C2221 and the electrode D2222 respectively, or the first electrode 221 comprises an electrode A2211, an electrode B2212 and a resistor AB2213 with two ends electrically connected with the electrode A2211 and the electrode B2212 respectively, the second electrode 222 comprises an electrode C2221 or an electrode D2222, and certainly, the third electrode 221' comprises an electrode E2211 'or an electrode F2212', the fourth electrode 222 'comprises an electrode G2221' The electrode H2222' and the resistor GH2223' with both ends electrically connected to the electrode G2221', the electrode H2222', respectively, or the third electrode 221' includes the electrode E2211', the electrode F2212', and the resistor EF2212' with both ends electrically connected to the electrode E2211', the electrode F2212', respectively, and the fourth electrode 222' includes the electrode G2221' or the electrode H2222'. The resistances of the resistor AB2213, the resistor CD2223, the resistor EF2213', and the resistor GH2223' may be set to 0 to infinity, and in some specific implementations, different resistance values can be realized by controlling the type and the printing width of the printing resistor ink.

In order to facilitate and quickly realize the judgment of the type of the reaction area (i.e. the detection content), in some practical applications, the detection instrument is already built with corresponding tables (such as the resistor AB2213, the resistor CD2223 and the reaction area corresponding table described in table 1, which are only illustrative for easy understanding and not limiting the invention) before leaving the factory, according to the foregoing corresponding tables, the resistor AB2213 and the resistor CD2223 are printed with corresponding resistance values for different reaction areas (the reaction areas are different and the detection content is also different), and after the test strip is inserted, the detection instrument realizes the judgment of the type of the reaction area by detecting the resistance values of the resistor AB2213 and/or the resistor CD 2223.

TABLE 1 correspondence table of built-in resistance and reaction area of detecting instrument

Resistance AB2213	Resistance CD2223 resistance value	Reaction zone
			1	0	Blood sugar
1	1	Blood ketone
			1	2	Uric acid
1	3	X1
			......	......	......
2	0	Xn
			2	1	Xn+1
......	......	......
			N	N	Xn+n

In practical application, after the assembled test strip (including the test strip substrate and the test strip detection area installed on the test strip substrate) is inserted into the detection instrument, the detection instrument can obtain the resistance information of the resistor AB2213 and/or the resistor CD2223 by applying an electric signal, and according to the difference of resistance values of the resistors, the type (i.e. detection content) of the reaction area of the test strip detection area is judged, and corresponding detection signals are applied, so that the detection content of the current test strip detection area can be accurately identified. The following examples are presented for ease of understanding, but are not to be construed as limiting the invention. As shown in FIG. 5, after a certain test strip detection area is assembled on a test strip substrate, an electrode A2211 and an electrode B2212 are respectively electrically connected with wires 3002 and 3001 on the test strip substrate through a conductive adhesive A181 and a conductive adhesive B182, an electrode C2221 and an electrode D2222 are respectively electrically connected with wires 3003 and 3004 on the test strip substrate through a conductive adhesive C191 and a conductive adhesive D192, a detection instrument is used for respectively detecting the current on a resistor AB2213 and a resistor CD2223 to be 0.5A and 0.25A by applying a direct current of 0.5V between the wires 3001 and 3002 and respectively obtaining the resistance values of the resistor AB2213 and the resistor CD2223 to be 1 ohm and 2 ohm by dividing the voltage by the current. As can be seen from the query in table 1, the detection content of the detection area of the current test strip is uric acid, the detection instrument will call the detection parameters of uric acid, act on the wires 3002 and 3003, and collect and process the current results at the two ends of the wires 3002 and 3003, so as to finally obtain the concentration of uric acid in the analyte. Of course, in some practical applications, instead of the foregoing method of judging the type of the reaction area by using the built-in correspondence table and performing the detection, different test strip detection areas may be mounted on the test strip substrate according to a preset sequence, so as to ensure the accuracy of the detection, for example, the detection contents corresponding to the test strip detection areas of the three mounting positions 14 on the test strip substrate are respectively blood sugar, blood ketone and uric acid, and then the three test strip detection areas are mounted on the three mounting positions 14 according to the sequence, so as to ensure the accuracy of the detection (the detection parameters of the three mounting positions 14 have been preset by the instrument).

In some practical applications, on the one hand, the control of the resistance value is realized by blending the ink with strong conductivity and the ink with poor conductivity, such as the ink containing conductive substances such as gold, silver, copper, carbon, platinum carbon and the like, and the ink with poor conductivity, such as the ink containing other organic substances such as titanium dioxide, organic amine black and the like, is non-conductive or has poor conductivity. On the other hand, by controlling the printing width or thickness of the resistor AB2213 and the resistor CD2223, further adjustment of the resistance value of the resistor can be realized. According to the formula r=ρl/S for the resistance, ρ is the resistivity of the material from which the resistance is made, L is the length of the wire of the resistance (in this case, L is the distance between two carbon electrodes of the connection resistance, for example, the distance between the electrode a2211 and the electrode B2212, the length of which is constant), S is the cross-sectional area of the wire of the resistance (s=z×d, Z is the thickness of the printed resistance, d is the width of the printed resistance), and R is the resistance value. The rho value can be changed by changing the proportion of the conductive paste (the proportion of the ink with strong conductivity and the ink with poor conductivity), the resistance cross-sectional area can be changed by changing Z or d, and the aim of adjusting the resistance value can be realized by all three modes. For example, different printed resistances may be achieved according to the ratio adjustments in table 2 (for illustrative purposes only for ease of understanding and not for limitation of the present invention).

Table 2 table for adjusting resistance of resistors

Similarly, the foregoing method may be adopted for the second reaction layer 23 'and the second electrode layer 22' to determine the type of the reaction region, which is not described herein again. The electrode E2211 'and the electrode F2212' are electrically connected with the wires 3002 'and 3001' on the test strip substrate through the conductive adhesive E181 'and the conductive adhesive F182', respectively, and the electrode G2221 'and the electrode H2222' are electrically connected with the wires 3003 'and 3004' on the test strip substrate through the conductive adhesive G191 'and the conductive adhesive H192', respectively.

The first reaction layer 23 includes a first insulating printed layer 231 disposed above the first electrode layer 22, a hollow is formed in the middle of the first insulating printed layer 231, and a first reagent layer 232 is filled in the hollow to form the first reaction region. The enzyme liquid added to the first reagent layer 232 may be glucose dehydrogenase, β -hydroxybutyrate dehydrogenase, urate oxidase, lactate dehydrogenase, or the like, and is used for detecting blood glucose, blood ketone, uric acid, lactic acid, or the like. The first reaction region area is fixed by the first insulating print layer 231, and the excessive diffusion of the enzyme solution can be restricted, and the material is a nonconductive material such as polyethylene ink, resin ink, or the like. The second reaction layer 23 'has the same structure as the first reaction layer 23, and includes a second insulating printed layer 231' disposed on the channel layer 24, wherein a hollow is formed in the middle of the second insulating printed layer 231', and a second reagent layer 232' is filled in the hollow to form the second reaction region. The enzyme liquid added to the second reagent layer 232' may be glucose dehydrogenase, β -hydroxybutyrate dehydrogenase, urate oxidase, lactate dehydrogenase, etc., for detecting blood glucose, blood ketone, uric acid, lactic acid, etc. The second reaction region area is fixed by the second insulating print layer 231', and the excessive diffusion of the enzyme solution can be restricted, and the material is a nonconductive material such as polyethylene ink, resin ink, or the like.

The channel layer 24 includes a double-sided tape a241 and a double-sided tape B242 attached to the first reaction layer 23 and the second reaction layer 23' at the same time, and a gap is left between the double-sided tape a241 and the double-sided tape B242 to form a sample channel 243, which is arranged corresponding to the first reaction region and the second reaction region, so that a biological sample flowing in the sample channel 243 can flow through the first reaction region and the second reaction region and react in the first reaction region and the second reaction region, thereby realizing detection of a physiological index. In some practical applications, the double-sided tape a241 is formed with a first positioning protrusion 2411, the double-sided tape B242 is formed with a second positioning protrusion 2421, the first positioning protrusion 2411 and the second positioning protrusion 2421 are respectively located at two sides of the sample channel 243 and protrude towards a direction away from the sample channel 243, and the double-sided tape has a certain softness and supporting force, so that a first fitting part for realizing fitting positioning with the test strip substrate is formed at a first edge and a second edge of the test strip detection area. To ensure accuracy of the test strip detection zone assembly, the first and second positioning protrusions 2411 and 2421 are asymmetrically disposed on both sides of the sample channel 243. Of course, within the scope of the skilled person, the first positioning protrusions 2411 and the second positioning protrusions 2421 may also be symmetrically arranged on both sides of the sample channel 243, and furthermore, it is also possible to provide only the first positioning protrusions 2411 on the double-sided tape a241 or only the second positioning protrusions 2412 on the double-sided tape B242, thereby forming the first fitting portion for fitting and positioning with the test strip substrate on the first side or the second side of the test strip detection area.

The cover layer 25 is a hydrophilic film and is disposed over the second electrode layer 22'. In some practical applications, a protrusion 251 is disposed on the cover layer 25 corresponding to the inlet of the sample channel 243, and a recess 252 adapted to the protrusion 251 is disposed on the cover layer 25 corresponding to the outlet of the sample channel 243. When two or more test strip detection zones are spliced, the sample channels 243 of adjacent two test strip detection zones are connected to each other, and the protrusions 251 on one test strip detection zone are embedded into the recesses 252 of the other test strip detection zone, so that the flow of biological samples can be assisted until the biological samples fill the sample channels 243 of each test strip detection zone. As shown in fig. 6, the flow of the biological sample is achieved by capillary action of the sample channel 243, specifically, since the insulating substrate layer 21 and the cover layer 25 have hydrophilicity, the biological sample tends to spread rightward on the surfaces of the insulating substrate layer 21 and the cover layer 25, and thus two rightward forces m1 and m2 are generated to the biological sample, under which the biological sample continues to flow rightward. When the biological sample flows to the position ① shown in fig. 7, a break point (where the cover layers of two adjacent test strip detection areas are joined) occurs at the cover layer 25, the force m1 weakens until it disappears, but the force m2 still exists, so that the biological sample can still continue to flow to the right. Until the biological sample contacts the cover layer 25 of the second test strip detection zone (located after the break point described above), the force m1 reappears. After the biological sample is completely filled in the sample channel, the applied forces m1 and m2 completely disappear, and the biological sample stops flowing.

For ease of understanding, taking the example of two mutually-spliced test strip detection zones shown in FIG. 8, when a biological sample (e.g., blood, etc.) is added to the sample channel from the inlet side (the side with the protrusions) of detection zone 2002, the biological sample will flow within the sample channel due to capillary action to the outlet side (the side with the recesses 252) of detection zone 2002. If the exit side of the detection zone 2002 is not accessible to other detection zones, the biological sample will cease to flow due to the presence of surface tension. If the detection zone 2001 is spliced on the outlet side of the detection zone 2002, and the protrusions 251 of the detection zone 2001 are embedded in the recesses 252 of the detection zone 2002, the biological sample will continue to flow into the sample channel of the detection zone 2001 under capillary action and flow all the way to the outlet side of the detection zone 2001, although the last test strip detection zone abutting the test strip substrate may also have no recess 252.

In some practical applications, the sample channels 243 of the test strip detection areas mounted on the test strip substrate are mutually communicated, and a user can fill all the sample channels with the biological sample by utilizing the capillary action only by adding the biological sample to the sample inlet of the test strip detection area at the outermost end, without adding the biological sample to each test strip detection area respectively, so that the use is more convenient.

As shown in fig. 4, in some practical applications, the projected width of the channel layer 24 in the direction perpendicular to the insulating substrate layer 21 is slightly smaller than the width of the insulating substrate layer 21 and the cover layer 25 (for example, the projected width of the channel layer in the direction perpendicular to the insulating substrate layer 21 is about 1mm-3mm smaller than the widths of the insulating substrate layer 21 and the cover layer 25), so that the first sliding groove 27 and the second sliding groove 29 respectively located on both sides of the sample channel 243 are formed between the insulating substrate layer 21 and the cover layer 25. When installed, the test strip substrate is at least partially embedded in the first chute 27 and/or the second chute 29 such that the test strip detection zone can only move relative to the test strip substrate along the length of the first chute 27 and/or the second chute 29 until a designated position is reached. Of course, within the scope of the skilled person, the connection structure between the test strip detection area and the test strip substrate may be that a, a first sliding groove 27 is formed on a first edge of the test strip detection area, a second sliding block is formed on a second edge opposite to the first edge, and the inner side of the second arm 13 of the test strip substrate matched with the second sliding block is partially hollowed out, when the test strip substrate (for example, the first arm) is installed, the test strip substrate is at least partially embedded into the first sliding groove 27, and the second sliding block is at least partially embedded into the test strip substrate, so that the test strip detection area can only move relative to the test strip substrate along the length direction of the first sliding groove 27 until reaching a designated position. b. a first sliding block is formed on a first edge of the test strip detection area, the inner side of a first arm 12 of the test strip substrate matched with the first sliding block is partially hollowed out, a second sliding groove 29 is formed on a second edge opposite to the first edge, when the test strip detection area is installed, the first sliding block is at least partially embedded into the test strip substrate, and the test strip substrate (such as a second arm) is at least partially embedded into the second sliding groove 29, so that the test strip detection area can only move relative to the test strip substrate along the length direction of the second sliding groove 29 until reaching a designated position. c. A first sliding block is formed on a first edge of the test strip detection area, a second sliding block is formed on a second edge opposite to the first edge, the inner side parts of a first arm 12 and a second arm 13 of the test strip substrate matched with the first sliding block and the second sliding block are hollowed out, and when the test strip detection area is installed, the first sliding block and the second sliding block are at least partially embedded into the test strip substrate, so that the test strip detection area can only move relative to the test strip substrate along the direction parallel to the first sliding block and the second sliding block (the length direction of the first arm and the second arm) until reaching a designated position. d. A slider is formed on only one side of the test strip detection area, and the slider is at least partially embedded into the test strip substrate when the test strip detection area is installed. e. The test strip detection zone has a chute formed on only one side thereof, and the test strip substrate (e.g., the first arm or the second arm) is at least partially embedded in the chute such that the test strip detection zone can only move relative to the test strip substrate along the length of the chute until a specified position is reached. Specifically, the double-sided tape A241 and the double-sided tape B242 of the test strip detection area can be used as sliding blocks, when the double-sided tape A241 and the double-sided tape B242 are embedded into the hollow space of the inner part of the test strip substrate, the hollow space can limit the movement of the test strip detection area in the left-right direction (refer to the left-right direction shown in fig. 4), specifically, the space between the insulating layer substrate 21 and the cover layer 25 of the test strip detection area can be used as a sliding groove, after the arms (the first arm and the second arm) at the two ends of the test strip substrate are embedded into the sliding groove, the displacement in the left-right direction (refer to the left-right direction shown in fig. 4) is limited, and when all the detection areas are installed on the substrate, a rolling process is further carried out, the first electrode layer 22 of the test strip detection area is pressed in the up-down direction (refer to the up-down direction shown in fig. 4), The second electrode layer 22 'is firmly adhered to the first conductive layer 15 and the second conductive layer 15' on the test strip substrate, the conductive adhesive can conduct the electrodes on two sides, and meanwhile, the conductive adhesive firmly adheres the test strip detection area to the test strip substrate, so that the displacement of the detection area can be limited. The direction of the movement of the test strip detection area relative to the test strip substrate is the length direction of the first arm and the second arm.

In some practical applications, when the first side and the second side of the test strip detection area are respectively formed with the first chute 27 and the second chute 29, the first arm 12 is at least partially embedded in the first chute 27, the second arm 13 is at least partially embedded in the second chute 29, so as to implement the mounting of the test strip detection area on the mounting position 14, and the first electrode layer 22 and the second electrode layer 22 'of the test strip detection area are respectively contacted with the first conductive layer 15 and the second conductive layer 15' of the test strip substrate, so that the electrical signals from the detection instrument are transferred to the first reaction area and the second reaction area of the test strip detection area to promote the occurrence of the detection reaction, and the electrical signals generated in the first reaction area and the second reaction area are transferred to the detection instrument. In some practical applications, a first contact is disposed on the first conductive layer 15 of the first arm 12 at a position corresponding to the mounting position 14, a second contact is disposed on the first conductive layer 15 of the second arm 13 at a position corresponding to the mounting position 14, a third contact is disposed on the second conductive layer 15 'of the first arm 12 at a position corresponding to the mounting position 14, a fourth contact is disposed on the second conductive layer 15' of the second arm 13 at a position corresponding to the mounting position 14, after the test strip detection area is mounted on the mounting position 14, the first conductive adhesive 18 on the test strip detection area contacts the first contact, the second conductive adhesive 19 contacts the second contact, the third conductive adhesive 18 'contacts the third contact, the fourth conductive adhesive 19' contacts the fourth contact, and the contact between the first electrode layer 22 of the test strip detection area and the first conductive layer 15 of the test strip substrate and the contact between the second electrode layer 22 'of the test strip detection area and the second conductive layer 15' of the test strip substrate are realized.

In some implementations, the base plate body 11 is provided with a bottom protrusion 111 that mates with the recess 252 of the test strip detection zone to close the sample channel 243. When the last test strip detection zone abutting the test strip substrate does not have the recess 252, the substrate body 11 may not be provided with the bottom protrusion 111. As shown in fig. 9 and 10, when the test strip substrate has five mounting positions, the bottom protrusions 111 are disposed at the mounting positions 14 (at the side far from the free ends of the first arm 12 and the second arm 13) on the substrate body 11 and at the tail ends, after the five test strip detection regions are sequentially mounted at the five mounting positions, the five test strip detection regions are connected end to end (specifically, the two mutually spliced test strip detection regions are referred to), the sample channels 243 of the five test strip detection regions are sequentially connected, and the bottom protrusions 111 are embedded into the recesses 252 of the tail end test strip detection regions to seal the sample channels 243 and prevent the biological samples from continuing to flow outwards. In other practical applications, the substrate body 11 is provided with a fifth contact at a position corresponding to the bottom protrusion 111, and the measurement count-down is started only when the biological sample reaches the fifth contact (when the biological sample fills the whole sample channel), so that the detection result is more accurate. The first, second, third, fourth and fifth contacts may be part of a wire printed on the test strip substrate, or may be conductive contacts connected to a wire on the test strip substrate, all being part of a conductive layer (including the first and second conductive layers) of the test strip substrate, and the fifth contact may be disposed on the front or back side of the test strip substrate, preferably on the front side of the test strip substrate, within the scope of the skilled artisan.

In other practical applications, the first arm 12 is formed with a first positioning recess 121 matching the first positioning protrusion 2411, and the second arm 13 is formed with a second positioning recess 131 matching the second positioning protrusion 2421, so that a second fitting portion matching the first fitting portion of the test strip detection area to achieve the fitting positioning of the test strip detection area and the test strip substrate is formed on the first arm 12 and the second arm 13, for ensuring that the test strip detection area is fitted in place, and the specific first fitting portion refers to the first positioning protrusion 2411 and the second positioning protrusion 2421, and the second fitting portion refers to the first positioning recess 121 and the second positioning recess 131.

In the assembly process, the test strip detection area slides into the space between the first arm 12 and the second arm 13 along the direction parallel to the first arm 12 and the second arm 13, at this time, the first arm 12 is at least partially embedded into the first chute 27, the second arm 13 is at least partially embedded into the second chute 29, the test strip detection area can only move relative to the test strip substrate along the length direction of the first chute 27 and the second chute 29 until reaching a designated position, the first electrode 221 is connected with a first contact on the first conductive layer 15 of the test strip substrate by using the first conductive adhesive 18, the second electrode 222 is connected with a second contact on the first conductive layer 15 of the test strip substrate by using the second conductive adhesive 19, the third electrode 221 'is connected with a third contact on the second conductive layer 15' of the test strip substrate by using the third conductive adhesive 18', the fourth electrode 222' is connected with a fourth contact on the second conductive layer 15 'of the test strip substrate, and the test strip detection area is positioned relative to the test strip substrate by using the fourth conductive adhesive 19', so that the assembly of the test strip is completed. When the test strip substrate has only one mounting position, the bottom protrusions 111 are embedded into the recesses 252 of the test strip detection area to close the sample channel 243, and meanwhile, the first positioning protrusions 2411 are embedded into the first positioning recesses 121, and the second positioning protrusions 2421 are embedded into the second positioning recesses 131, so that the test strip detection area is ensured to be embedded into place. When the test strip substrate has a plurality of mounting positions, the first positioning protrusions 2411 of each test strip detection area are embedded into the first positioning recesses 121, the second positioning protrusions 2421 are embedded into the second positioning recesses 131, so that the test strip detection areas are embedded into place, and meanwhile, the bottom protrusions 111 are embedded into the recesses 252 of the tail end test strip detection areas, so that the sample channel 243 is closed, and the biological sample is prevented from continuing to flow outwards.

The preparation method of the test strip comprises the following steps:

Each test strip detection zone is mounted on the mounting location 14 of the test strip substrate such that the first electrode layer 22 and the second electrode layer 22 'of each test strip detection zone are in contact with the first conductive layer 15 and the second conductive layer 15' of the test strip substrate, respectively, to obtain the test strip.

In some practical applications, the method for preparing the test strip detection zone includes:

S1, preparing a semi-finished product A of the detection area.

S1.1, printing a first electrode layer 22 on the insulating substrate layer 21.

Specifically, the first electrode 221, the second electrode 222 and the resistor are printed on the insulating substrate layer 21, the electrode a2211, the electrode B2212, the electrode C2221 and the electrode D2222 are printed on the insulating substrate layer 21, and are used for transmitting the electric signals from the detection instrument to the first reaction area and collecting the electric signals generated in the first reaction area, wherein the materials can be carbon ink, platinum carbon, silver/silver chloride, gold, palladium and the like, the resistor AB22113 is printed between the electrode a2211 and the electrode B2212, the resistor CD2223 is printed between the electrode C2221 and the electrode D2222, and the materials can be carbon ink, platinum carbon, silver/silver chloride, gold, palladium and the like.

Preferably, the first conductive paste 18 and the second conductive paste 19 are respectively adhered to the first electrode layer 22. Specifically, the electrode A2211, the electrode B2212, the electrode C2221 and the electrode D2222 are respectively stuck with conductive adhesive A181, conductive adhesive B182, conductive adhesive C191 and conductive adhesive D192, the conductive adhesive has viscosity, can bond two substrates together, has the function similar to double-sided adhesive, and can conduct electricity to serve as a lead.

S1.2, a first reaction layer 23 positioned above the first electrode layer 22 is arranged on the basis of the step S1.1, and drying treatment is carried out after liquid is poured into a first reaction area of the first reaction layer 23.

Specifically, a first insulating printed layer 231 is first disposed on the first electrode 221 and the second electrode 222, and a hollow is formed in the middle of the first insulating printed layer 231 to fix the area of the first reaction area, wherein the material for limiting excessive diffusion of enzyme liquid may be non-conductive material such as polyethylene ink or resin ink, and then the hollow is filled with liquid at the middle of the first insulating printed layer 231 and then dried, and the enzyme liquid may be glucose dehydrogenase, β -hydroxybutyrate dehydrogenase, urate oxidase, lactate dehydrogenase, etc.

S1.3, a channel layer 24 is provided on the first reaction layer 23 to form a sample channel 243 opposite to the first reaction region.

Specifically, a double-sided adhesive layer is adhered on the first reaction layer 23, and the double-sided adhesive a241 and the double-sided adhesive B242 may be adhered respectively, or the double-sided adhesive a241 and the double-sided adhesive B242 may be adhered simultaneously, and a gap is left between the double-sided adhesive a241 and the double-sided adhesive B242 to form the channel layer 24 with the sample channel 243, where a release film is adhered on the upper surfaces of the double-sided adhesive a241 and the double-sided adhesive B242, so as to prevent the double-sided adhesive from being stained with dust, and the processing is easier.

S2, preparing a semi-finished product B of the detection area.

S2.1, printing a second electrode layer 22' on the cover layer 25.

Specifically, the third electrode 221', the fourth electrode 222' and the resistor are printed on the cover layer 25, the electrodes E2211', F2212', G2221', and H2222' are printed on the cover layer 25, the electric signals from the detection device are transmitted to the second reaction area, and the electric signals generated in the second reaction area are collected, wherein the materials can be carbon ink, platinum carbon, silver/silver chloride, gold, palladium and the like, the resistor EF22113 'is printed between the electrodes E2211 and F2212', and the resistor GH2223 'is printed between the electrodes G2221 and H2222', and the materials can be carbon ink, platinum carbon, silver/silver chloride, gold, palladium and the like.

Preferably, a third conductive paste 18' and a fourth conductive paste 19' are respectively adhered to the second electrode layer 22 '. Specifically, the electrode E2211', the electrode F2212', the electrode G2221', and the electrode H2222' are respectively adhered with conductive adhesive E181', conductive adhesive F182', conductive adhesive G191', and conductive adhesive H192', and the conductive adhesive has viscosity, can bond two substrates together, and is similar to the function of double-sided adhesive, and in addition, the conductive adhesive can conduct electricity and serve as a lead.

S2.2, setting a second reaction layer 23 'on the third electrode 221' and the fourth electrode 222 'on the basis of the step S2.1, and carrying out drying treatment after the second reaction region of the second reaction layer 23' is dripped.

Specifically, a second insulating printed layer 231 'is first disposed on the third electrode 221' and the fourth electrode 222', and a hollow is formed in the middle of the second insulating printed layer 231' for fixing the area of the second reaction area, so as to limit excessive diffusion of enzyme liquid, which may be made of non-conductive material such as polyethylene ink or resin ink, and then the second insulating printed layer 231 'is subjected to drying treatment after the liquid is spotted on the middle of the second insulating printed layer 231', wherein the enzyme liquid may be glucose dehydrogenase, β -hydroxybutyrate dehydrogenase, urate oxidase, lactate dehydrogenase, etc.

S3, preparing a finished product test strip detection area.

S3.1, attaching the semi-finished product A of the detection area to the semi-finished product B of the detection area (for example, after tearing off the release film, attaching the semi-finished product A of the detection area to the semi-finished product B of the detection area by utilizing the double faced adhesive tape A241 and the double faced adhesive tape B242) so that the first reaction area and the second reaction area are respectively positioned on the upper side and the lower side of the sample channel 243 to obtain the detection area of the test strip.

The order of S1 and S2 in the preceding steps may be reversed within the scope of the skilled person. The first conductive adhesive 18 and the second conductive adhesive 19 are respectively adhered to the first electrode layer 22, and this step may be performed at any time after the printing of the electrodes a2211, B2212, C2221, D2222, the resistor AB22113, and the resistor CD22123 is completed in step S1. The third conductive paste 18' and the fourth conductive paste 19' are respectively adhered to the second electrode layer 22', and this step may be performed at any time after the printing of the electrodes E2211', F2212', G2221', H2222', and the resistors EF22113', GH2223' is completed in step S2.

As shown in fig. 12, in some practical applications, in order to improve the production efficiency, the preparation method of the test strip detection area includes:

s10, preparing a semi-finished product C of the detection area.

S10.1, the specific implementation manner is the same as S1.1, and will not be repeated.

S10.2, the specific implementation manner is the same as S1.2, and will not be repeated.

S10.3, the specific implementation manner is the same as S1.3, and will not be repeated.

S20, preparing a semi-finished product D of the detection area.

S20.1, the specific implementation manner is the same as that of S2.1, and the detailed description is omitted.

S20.2, the specific implementation manner is the same as S2.2, and will not be repeated.

S30, preparing a finished product test strip detection area.

S30.1, attaching the semi-finished product C in the detection area to the semi-finished product D in the detection area (for example, after the release film is torn off, attaching the semi-finished product C in the detection area to the semi-finished product D in the detection area by using the double faced adhesive tape A241 and the double faced adhesive tape B242) so that the first reaction area and the second reaction area are respectively located on the upper side and the lower side of the sample channel 243, and obtaining a plurality of test strip detection areas which are connected with each other.

S30.2, cutting along the third cutting line 3 to obtain a plurality of mutually independent test strip detection areas.

The order of S10 and S20 in the preceding steps may be reversed within the scope of the skilled person. The first conductive adhesive 18 and the second conductive adhesive 19 are respectively adhered to the first electrode layer 22, and this step may be performed at any time after the printing of the electrodes a2211, B2212, C2221, D2222, the resistor AB22113, and the resistor CD22123 is completed in step S10. The third conductive paste 18' and the fourth conductive paste 19' are respectively adhered to the second electrode layer 22', and this step may be performed at any time after the printing of the electrodes E2211', F2212', G2221', H2222', and the resistors EF22113', GH2223' is completed in step S20.

As shown in fig. 11-12, in practical application, in order to further improve the production efficiency, the preparation method of the test strip detection area includes:

s11, preparing a semi-finished product E of the detection area.

S11.1, the specific implementation manner is the same as S1.1, and will not be repeated.

S11.2, the specific implementation manner is the same as S1.2, and will not be repeated.

S11.3, the specific implementation manner is the same as S1.3, and will not be repeated.

S11.4, cutting along the first cutting line 1 to enable the size of the cutting line to be matched with the test strip substrate, and obtaining a detection area semi-finished product E;

S12, preparing a semi-finished product F of the detection area.

S12.1, the specific implementation manner is the same as that of S2.1, and the detailed description is omitted.

S12.2, the specific implementation manner is the same as S2.2, and will not be repeated.

S12.3, cutting along the second cutting line 2 to enable the size of the second cutting line to be matched with the test strip substrate, and obtaining a semi-finished product F of the detection area.

S13, preparing a finished product test strip detection area.

S13.1, attaching the semi-finished product E of the detection area to the semi-finished product F of the detection area (for example, after tearing off the release film, attaching the semi-finished product E of the detection area to the semi-finished product F of the detection area by using a double faced adhesive tape A241 and a double faced adhesive tape B242) so that the first reaction area and the second reaction area are respectively located on the upper side and the lower side of the sample channel 243, and obtaining a plurality of mutually connected test strip detection areas.

S13.2, cutting along the third cutting line 3 to obtain a plurality of mutually independent test strip detection areas.

The order of S11 and S12 in the preceding steps may be reversed within the scope of the skilled person. The first conductive adhesive 18 and the second conductive adhesive 19 are respectively adhered to the first electrode layer 22, and this step may be performed at any time after the printing of the electrodes a2211, B2212, C2221, D2222, the resistor AB22113, and the resistor CD22123 is completed in step S11. The third conductive paste 18' and the fourth conductive paste 19' are respectively adhered to the second electrode layer 22', and this step may be performed at any time after the printing of the electrodes E2211', F2212', G2221', H2222', and the resistors EF22113', GH2223' is completed in step S12.

The preparation method of the test strip substrate comprises the steps of printing a first conductive layer 15 on one surface of the test strip substrate and printing a second conductive layer 15' on the other surface of the test strip substrate.

Within the scope of choice of a person skilled in the art, when the conductive glue is adhered to the first conductive layer 15 and the second conductive layer 15 'of the test strip substrate, under a low temperature environment (0-15 ℃), the first conductive glue 18 and the second conductive glue 19 are adhered to the first contact and the second contact on the first conductive layer 15 of the test strip substrate, respectively, and the third conductive glue 18' and the fourth conductive glue 19 'are adhered to the third contact and the fourth contact on the second conductive layer 15' of the test strip substrate, respectively.

In other practical applications, the conductive adhesive is disposed on the test strip substrate, and the step of disposing the conductive adhesive is deleted during the process of preparing the test strip detection area, and the step of disposing the conductive adhesive is added in the process of preparing the test strip substrate, in which the first conductive adhesive 18 is disposed on the first contact of the first conductive layer 15, the second conductive adhesive 19 is disposed on the second contact of the first conductive layer 15, the third conductive adhesive 18 'is disposed on the third contact of the second conductive layer 15', and the fourth conductive adhesive 19 'is disposed on the fourth contact of the second conductive layer 15'.

The test strip is assembled by inserting the first arm 12 and the second wall 13 of the test strip substrate into the first slide channel 27 and the second slide channel 29 of the test strip detection zone in a low temperature environment (0-15 ℃) such that the first engagement portion engages the second engagement portion and the recess 252 of the test strip detection zone engages the bottom protrusion 111 of the test strip substrate. The product is transferred to a high temperature environment (40-60 ℃), at this time, the viscosity of the conductive glue (the first conductive glue, the second conductive glue, the third conductive glue and the fourth conductive glue) and the viscosity of the double-sided glue (the double-sided glue A and the double-sided glue B) are increased, after the pressure is applied to the conductive glue of the test strip, the detection area of the test strip can be fixed on the substrate of the test strip, and the conductive glue communicates the first electrode layer 22 and the second electrode layer 22 'of the detection area of the test strip with the first conductive layer 15 and the second conductive layer 15' of the substrate of the test strip respectively. The remaining test strip detection zones are sequentially mounted on the test strip substrate using the methods described above such that the sample channels 243 of each test strip detection zone are in communication with one another. Of course, it is within the purview of one skilled in the art to assemble the test strip detection zones in sequence by sliding each test strip detection zone into the mounting location 14 in a low temperature environment (0-15℃) such that the first arm 12 and the second wall 13 of the test strip substrate nest within the first chute 27 and the second chute 29 of the test strip detection zone, the first detent projections 2411 of each test strip detection zone nest within the first detent recesses 121 and the second detent projections 2421 nest within the second detent recesses 131 to secure the test strip detection zone in place, while the bottom projections 111 nest within the recesses 252 of the end test strip detection zones to close the sample channels 243 to prevent further outward flow of biological samples, and the sample channels 243 of each test strip detection zone are in communication with one another. The product is transferred to a high temperature environment (40-60 ℃), at this time, the viscosity of the conductive adhesive (the first conductive adhesive, the second conductive adhesive, the third conductive adhesive and the fourth conductive adhesive) and the viscosity of the double-sided adhesive (the double-sided adhesive A and the double-sided adhesive B) are increased, after the conductive adhesive is applied with pressure, the detection area of the test strip can be fixed on the substrate of the test strip, and the conductive adhesive communicates the first electrode layer 22 and the second electrode layer 22 'of the detection area of the test strip with the first conductive layer 15 and the second conductive layer 15' of the substrate of the test strip respectively.

The foregoing examples of the embodiments are provided to further illustrate the present invention and are not to be construed as limiting the scope of the present invention, and although the present invention has been described in detail with reference to the foregoing examples, it will be understood by those skilled in the art that the technical solutions described in the foregoing examples may be modified or some of the technical features may be substituted for those illustrated in the foregoing examples without departing from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A test strip, comprising a test strip substrate and at least two test strip detection areas mounted on the test strip substrate, each test strip detection area being used to detect a different physiological indicator; wherein:

A test strip detection area comprises an insulating substrate layer (21), a first electrode layer (22) located on the insulating substrate layer (21), a first reaction layer (23) located on the first electrode layer (22) and having a first reaction area, a channel layer (24) located on the first reaction layer (23), a second reaction layer (23') located on the channel layer (24) and having a second reaction area, a second electrode layer (22') located on the second reaction layer (23'), and a covering layer (25) located on the second electrode layer (22'); a sample channel (243) is provided on the channel layer (24) at positions corresponding to the first reaction area and the second reaction area;

A test strip substrate comprises a substrate body (11), wherein a first arm (12), a second arm (13), a first conductive layer (15), and a second conductive layer (15') are formed on the substrate body (11); a mounting position (14) for mounting the test strip detection area is formed between the first arm (12) and the second arm (13); when the test strip detection area is mounted at the mounting position (14), the first electrode layer (22) and the second electrode layer (22') of the test strip detection area are in contact with the first conductive layer (15) and the second conductive layer (15') of the test strip substrate, respectively.

2. The test strip according to claim 1, characterized in that: the first electrode layer (22) includes a first electrode (221) and a second electrode (222); the second electrode layer (22') includes a third electrode (221') and a fourth electrode (222').

3. The test strip according to claim 2, characterized in that: the first electrode (221) includes an electrode A (2211), an electrode B (2212), and a resistor AB (2213) whose two ends are electrically connected to the electrode A (2211) and the electrode B (2212); the second electrode (222) includes an electrode C (2221), an electrode D (2222), and a resistor CD (2223) whose two ends are electrically connected to the electrode C (2221) and the electrode D (2222); the third electrode (221') includes an electrode E (2211'), an electrode F (2212'), and a resistor EF (2213') whose two ends are electrically connected to the electrode E (2211') and the electrode F (2212'); the fourth electrode (222') includes an electrode G (2221'), an electrode H (2222'), and a resistor GH (2223') whose two ends are electrically connected to the electrode G (2221') and the electrode H (2222').

4. The test strip according to claim 1 is characterized in that: a first slide groove (27) or a first slider is formed on a first side of the test strip detection area, and a second slide groove (29) or a second slider is formed on a second side opposite to the first side, and the first side and the second side are respectively located on both sides of the sample channel (243); the first arm (12) is adapted to the first slide groove (27) or the first slider, and the second arm (13) is adapted to the second slide groove (29) or the second slider, so as to realize the sliding fit between the test strip detection area and the test strip substrate.

5. The test strip according to claim 4 is characterized in that: a first slide groove (27) and a second slide groove (29) are respectively formed on the first side and the second side, the first arm (12) is at least partially embedded in the first slide groove (27), and the second arm (12) is at least partially embedded in the second slide groove (29), so as to realize sliding cooperation between the test strip detection area and the test strip substrate.

6. The test strip according to claim 4, characterized in that the projection width of the channel layer (24) in a direction perpendicular to the insulating substrate layer (21) is slightly smaller than the width of the insulating substrate layer (21) and the covering layer (25), so as to form the first slide groove (27) and/or the second slide groove (29).

7. The test strip according to claim 1, characterized in that a protrusion (251) is provided on the covering layer (25) corresponding to the inlet of the sample channel (243), and a recess (252) adapted to the protrusion (251) is provided on the covering layer (25) corresponding to the outlet of the sample channel (243).

8. The test strip according to claim 7, characterized in that a bottom protrusion (111) is provided on the substrate body (11) and matches the recess (252) to close the sample channel (243).

9. The test strip according to claim 1 is characterized in that: a first engaging portion is formed on the first side and/or the second side of the test strip detection area, and a second engaging portion is formed on the first arm (12) and/or the second arm (13) to match the first engaging portion so as to achieve the engaging positioning of the test strip detection area and the test strip substrate; the first side and the second side are respectively located on both sides of the sample channel (243).

10. The test strip according to claim 1, characterized in that the sample channels (243) of the detection areas of the test strips installed on the test strip substrate are interconnected.

11. A method for preparing the test strip according to any one of claims 1 to 10, comprising:

Separately preparing the test strip detection area and the test strip substrate;

Each test strip detection area is respectively installed on the installation position (14) of the test strip substrate, so that the first electrode layer (22) and the second electrode layer (22') of each test strip detection area are respectively in contact with the first conductive layer (15) and the second conductive layer (15') of the test strip substrate.

12. The method for preparing a test strip according to claim 11, wherein preparing the test strip detection area comprises:

A first electrode layer (22) is printed on an insulating substrate layer (21); a first reaction layer (23) is provided on the first electrode layer (22), and a liquid is applied to a first reaction area of the first reaction layer (23) and then dried; a channel layer (24) is provided on the first reaction layer (23), wherein a sample channel (243) is provided on the channel layer (24) at a position corresponding to the first reaction area; and a detection area semi-finished product C is obtained;

Printing a second electrode layer (22') on the covering layer (25); arranging a second reaction layer (23') on the second electrode layer (22'), and applying liquid to the second reaction area of the second reaction layer (23') and then drying the liquid; obtaining a detection area semi-finished product D;

Laminating the detection area semi-finished product C and the detection area semi-finished product D so that the first reaction area and the second reaction area are respectively located on the upper and lower sides of the sample channel (243), thereby obtaining a plurality of interconnected test strip detection areas;

Cutting is performed along the third cutting line to obtain a plurality of independent test strip detection areas.

13. The method for preparing a test strip according to claim 11, wherein preparing the detection area of the test strip comprises:

A first electrode layer (22) is printed on an insulating substrate layer (21); a first reaction layer (23) is provided on the first electrode layer (22), and a liquid is applied to a first reaction area of the first reaction layer (23) and then dried; a channel layer (24) is provided on the first reaction layer (23), wherein a sample channel (243) is provided on the channel layer (24) at a position corresponding to the first reaction area; and cutting is performed along a first cutting line so that the size thereof can adapt to the test strip substrate, thereby obtaining a detection area semi-finished product E;

Printing a second electrode layer (22') on the covering layer (25); arranging a second reaction layer (23') on the second electrode layer (22'), and applying liquid to the second reaction area of the second reaction layer (23') and then drying the liquid; cutting the liquid along the second cutting line so that the size can fit the test strip substrate, thereby obtaining a detection area semi-finished product F;

Laminating the detection area semi-finished product E and the detection area semi-finished product F so that the first reaction area and the second reaction area are respectively located on the upper and lower sides of the sample channel (243), thereby obtaining a plurality of interconnected test strip detection areas;

14. The method for preparing a test strip according to claim 12 or 13, characterized in that double-sided tape A (241) and double-sided tape B (242) are respectively adhered on the first reaction layer (23), and a gap is left between the double-sided tape A (241) and the double-sided tape B (242) to form a channel layer (24) having a sample channel (243).

15. The method for preparing a test strip according to claim 12 or 13, wherein preparing the test strip detection area further comprises:

A first conductive adhesive (18) and a second conductive adhesive (19) are respectively pasted on the first conductive layer (15), and a third conductive adhesive (18') and a fourth conductive adhesive (19') are respectively pasted on the second conductive layer (15');

Alternatively, a first conductive adhesive (18) and a second conductive adhesive (19) are respectively pasted on the first electrode layer (22), and a third conductive adhesive (18') and a fourth conductive adhesive (19') are respectively pasted on the second electrode layer (22').