Test strip and preparation method thereof

Abstract

The invention relates to a test strip and a preparation method thereof. The test strip is used for detecting physiological indexes in samples such as blood. According to the technical scheme, a test strip detection area is provided with an insulating substrate layer, an electrode layer located on the insulating substrate layer, a reaction layer located on the electrode layer and provided with a reaction area, a channel layer located on the reaction layer and a covering layer located on the channel layer, and a sample channel is formed in the position, corresponding to the reaction area, of the channel layer; the test strip substrate is provided with a substrate body, and at least two mounting positions for mounting test strip detection areas are formed between a first arm and a second arm on the substrate body; a conductive layer is arranged on the substrate body, and when the test strip detection area is mounted at the mounting position, the electrode layer of the test strip detection area is in contact with the conductive layer of the test strip substrate. The test strip has the beneficial effects that the test strip adopts a split structure, and the test strip detection area is independently produced and then mounted on the test strip substrate, so that the unqualified test strip detection area is scrapped even if unqualified products appear in the liquid dispensing process.

Description

Technical Field

[0001] The invention relates to a test strip and a preparation method thereof, which are used for detecting physiological indicators in samples such as blood. Background Art

[0002] As people's living standards improve, they are paying more and more attention to their own health. Many users have the need to monitor multiple different physiological indicators (such as blood sugar, blood ketones, cholesterol, etc.). If single-indicator test strips are used for testing, it is necessary to prepare multiple different single-indicator test strips and supporting instruments, which are complicated to carry and use. Even if multiple different test strips are matched with one instrument, the operation process for a single person is still cumbersome. Therefore, multi-indicator test strips with various structures have gradually appeared on the market.

[0003] The production process for common multi-indicator test strips is similar to that of single-indicator test strips, requiring printing, dispensing, and assembly processes. Unlike single-indicator test strips, which have a single detection zone, multi-indicator test strips integrate multiple detection zones onto a single card, enabling a single test strip to detect multiple indicators. This greatly facilitates scenarios and populations requiring multi-indicator testing.

[0004] The common multi-indicator test strip dispensing process is an improvement on the single-indicator test strip. It can dispense liquid to multiple test areas at once, or dispense liquid to multiple test areas separately. For dispensing liquid to multiple test areas at once, the dispensing equipment needs to be upgraded: the number of pumps and the number of solution transport pipelines need to be increased, the fixture of the dispensing needle needs to be redesigned, and the control system of the dispensing equipment may also need to be upgraded, resulting in increased costs. For dispensing liquid to multiple test areas separately, the first test area to be dispensed liquid and the last test area to be dispensed liquid are exposed to the environment for different times, which will affect the state of the solution after drying; and the bottom plate needs to be moved during multiple dispensing processes. This process may destroy the solution state of the test area, resulting in an irregular shape of the reagent layer after drying; the above two situations will cause the test strip to be scrapped, so the method of dispensing liquid to multiple test areas separately will increase the scrap rate of the test strip.

[0005] Furthermore, due to errors in the positioning of the dispensing equipment, equipment tolerances, and the surface tension of the solution, unqualified products are bound to appear during the dispensing process. For single-index test strips, unqualified products are directly rejected. For multi-index test strips, if any of the multiple test areas fails the dispensing process, the entire multi-index test strip will be rejected. Therefore, the dispensing failure rate for multi-index test strips is much higher than that for single-index test strips. Summary of the Invention

[0006] The purpose of the present invention is to address the above-mentioned problems and provide a test strip and a preparation method thereof to reduce the scrap rate and cost in the production process.

[0007] In order to achieve the above object, the present invention is implemented through the following technical solutions:

[0008] A test strip comprises a test strip substrate and at least two test strip detection areas respectively mounted on the test strip substrate, wherein each test strip detection area is used to detect a different physiological index; wherein,

[0009] The test strip detection area comprises an insulating substrate layer, an electrode layer located on the insulating substrate layer, a reaction layer located above the electrode layer and having a reaction area, a channel layer located above the reaction layer, and a cover layer located above the channel layer, wherein a sample channel is provided on the channel layer at a position corresponding to the reaction area;

[0010] The test strip substrate comprises a substrate body, a first arm and a second arm formed on the substrate body, and at least two mounting positions for mounting the test strip detection area are formed between the first arm and the second arm; a conductive layer is provided on the substrate body, and when the test strip detection area is mounted in the mounting position, the electrode layer of the test strip detection area contacts the conductive layer of the test strip substrate.

[0011] Preferably, the electrode layer includes a first electrode and a second electrode, the first electrode is attached with a first conductive glue for connecting to the conductive layer on the test strip substrate, and the second electrode is attached with a second conductive glue for connecting to the conductive layer on the test strip substrate.

[0012] Preferably, the first electrode includes electrode A, electrode B, and resistor AB whose two ends are electrically connected to electrode A and electrode B respectively, and the first conductive glue includes conductive glue A attached to electrode A and conductive glue B attached to electrode B; the second electrode includes electrode C, electrode D, and resistor CD whose two ends are electrically connected to electrode C and electrode D respectively, and the second conductive glue includes conductive glue C attached to electrode C and conductive glue D attached to electrode D.

[0013] Preferably, a first slide groove or a first slider is formed on the first side of the test strip detection area, and a second slide groove or a second slider is formed on the 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; the first arm is adapted to the first slide groove or the first slider, and the second arm is adapted to the second slide groove or the second slider, so as to realize the sliding fit between the test strip detection area and the test strip substrate.

[0014] Preferably, a first slide groove and a second slide groove are formed on the first side and the second side of the test strip detection area respectively, the first arm is at least partially embedded in the first slide groove, and the second arm is at least partially embedded in the second slide groove, so as to realize the sliding assembly of the test strip detection area and the test strip substrate.

[0015] Preferably, the projection width of the reaction layer and / or channel layer in a direction perpendicular to the insulating substrate layer is slightly smaller than the width of the insulating substrate layer and the covering layer, so as to form the first slide groove and / or the second slide groove.

[0016] Preferably, a protrusion is provided on the cover layer corresponding to the inlet of the sample channel, and a depression matching the protrusion is provided on the cover layer corresponding to the outlet of the sample channel.

[0017] Preferably, the substrate body is provided with a bottom protrusion that matches the recess to close the sample channel.

[0018] Preferably, 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 and / or the second arm to match the first engaging portion to achieve the engaging positioning of the test strip detection area and the test strip substrate.

[0019] Preferably, the sample channels of the detection areas of the test strips mounted on the test strip substrate are interconnected.

[0020] A method for preparing a test strip, comprising:

[0021] Separately preparing the test strip detection area and the test strip substrate;

[0022] The detection areas of each test strip are respectively mounted on the mounting positions of the test strip substrate so that the electrode layer of each test strip detection area contacts the conductive layer of the test strip substrate.

[0023] Preferably, preparing the test strip detection area comprises:

[0024] printing an electrode layer on the insulating substrate layer;

[0025] providing a reaction layer on the electrode layer;

[0026] A channel layer is provided on the reaction layer to form a sample channel opposite to the reaction area of ​​the reaction layer;

[0027] Pasting a first conductive adhesive and a second conductive adhesive on the electrode layer;

[0028] cutting the obtained semi-finished product along a first cutting line;

[0029] attaching a cover layer to the channel layer of the semi-finished product obtained after cutting to obtain a plurality of interconnected test strip detection areas;

[0030] The plurality of interconnected test strip detection areas are cut along a second cutting line to obtain a plurality of independent test strip detection areas.

[0031] Preferably, preparing the test strip detection area comprises:

[0032] printing an electrode layer on the insulating substrate layer;

[0033] providing a reaction layer on the electrode layer;

[0034] A channel layer is provided on the reaction layer to form a sample channel opposite to the reaction area of ​​the reaction layer;

[0035] Pasting a first conductive adhesive and a second conductive adhesive on the electrode layer;

[0036] attaching the cover layer to the channel layer to obtain a plurality of interconnected test strip detection areas;

[0037] The plurality of interconnected test strip detection areas are cut along a third cutting line to obtain a plurality of independent test strip detection areas.

[0038] The beneficial effects of the present invention are:

[0039] 1. At least two test strip detection areas for detecting different physiological indicators are respectively installed on the test strip substrate to obtain a multi-indicator test strip. That is, the test strip adopts a split structure, and the test strip detection areas are independently produced and installed on the test strip substrate. Even if unqualified products are found during the liquid dispensing process, the unqualified test strip detection areas can be scrapped, and the test strip substrate does not need to be scrapped. The situation where the entire test strip is scrapped due to the unqualified liquid dispensing of a certain detection area will not occur, thereby reducing the scrap rate and improving the yield rate.

[0040] 2. Since the test strip adopts a split structure and the test area of ​​the test strip is produced independently, the existing liquid dispensing process of the single-indicator test paper can be used. The liquid dispensing process is simple and does not need to be upgraded to a liquid dispensing process for multiple different test areas. There is no need to upgrade the equipment, which saves equipment investment and reduces costs.

[0041] 3. A protrusion is provided on the covering layer corresponding to the entrance of the sample channel, and a depression is provided on the covering layer corresponding to the exit of the sample channel; when the detection areas of two test strips are spliced ​​together, the sample channels of the detection areas of the two test strips are connected to each other, and the protrusion on the detection area of ​​one test strip is embedded in the depression of the detection area of ​​the other test strip, which can assist the flow of the biological sample until the biological sample fills the sample channels of the detection areas of both test strips.

[0042] 4. 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 adapted to the first engaging portion is formed on the first arm and / or the second arm of the test strip substrate, thereby achieving engaging positioning of the test strip detection area.

[0043] 5. When testing multiple indicators, users do not need to prepare multiple test strips and instruments. One machine and one paper are convenient to operate, which improves user experience, reduces user costs, and is convenient for users with multiple indicator testing needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Figure 1 Schematic diagram of the structure of the test strip of the present invention.

[0045] Figure 2 This is a cross-sectional view of the test strip of the present invention after the detection area slides into the test strip substrate.

[0046] Figure 3 This is a cross-sectional view of the test strip detection area of ​​the present invention installed on the test strip substrate.

[0047] Figure 4 This is an exploded view of the detection area of ​​the test strip of the present invention.

[0048] Figure 5 This is a diagram of the connection structure between the electrode layer in the detection area of ​​the test strip and the conductive layer of the test strip substrate of the present invention.

[0049] Figure 6 Schematic diagram of the structure of the biological sample flowing in the sample channel of the present invention.

[0050] Figure 7 FIG. 4 is another structural schematic diagram of the biological sample flowing in the sample channel of the present invention.

[0051] Figure 8 This is a schematic structural diagram of three mutually connected test strip detection areas of the present invention.

[0052] Figure 9 Schematic diagram of the cross section of the detection area of ​​the test strip of the present invention.

[0053] Figure 10 This is a schematic diagram of the front structure of the test strip substrate of the present invention.

[0054] Figure 11 This is a schematic diagram of the back structure of the test strip substrate of the present invention (with a test strip detection area installed).

[0055] Figure 12 The figure illustrates the production process of the detection area of ​​the test strip of the present invention.

[0056] Figure 13 FIG2 is another diagram illustrating the production process of the detection area of ​​the test strip of the present invention.

[0057] Figure markings: substrate body-11, bottom protrusion-111, first arm-12, first positioning recess-121, second arm-13, second positioning recess-131, mounting position-14, conductive layer-15, first conductive adhesive-18, conductive adhesive A-181, conductive adhesive B-182, second conductive adhesive-19, conductive adhesive C-191, conductive adhesive D-192, insulating substrate layer-21, electrode layer-22, first electrode-221, electrode A-2211, electrode B-2212 , resistor AB-2213, second electrode-222, electrode C-2221, electrode D-2222, resistor CD-2223, reaction layer-23, insulating printed layer-231, 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, covering layer-25, protrusion-251, recess-252, first slide groove-27, second slide groove-29. DETAILED DESCRIPTION

[0058] To make the purpose, technical solutions, and advantages of the embodiments of the present invention more clear, the following will be a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work shall fall within the scope of protection of the present invention.

[0059] like Figure 1-Figure 3 A test strip is shown, comprising a test strip substrate and at least two test strip detection areas (only one test strip detection area is shown in the figure) mounted on the test strip substrate. Each test strip detection area is used to detect a different physiological indicator, forming a multi-indicator test strip (e.g., a test strip that simultaneously detects indicators such as blood sugar and cholesterol) for detecting physiological indicators (including but not limited to glucose, cholesterol, and blood ketones). The test strip is a biochemical sensor or an electrochemical sensor.

[0060] like Figure 4 、 Figure 9 As shown, the test strip detection area is produced independently of the test strip substrate and is used to be installed on the test strip substrate to form a test strip for detecting physiological indicators. The test strip detection area comprises an insulating substrate layer 21, an electrode layer 22 located on the insulating substrate layer 21, a reaction layer 23 located above the electrode layer 22 and having a reaction area, a channel layer 24 located above the reaction layer 23, and a covering layer 25 located above the channel layer 24; wherein, a sample channel 243 is provided on the channel layer 24 at a position corresponding to the reaction area. Figure 10 、 Figure 11As shown, the test strip substrate has a substrate body 11, on which a first arm 12 and a second arm 13 are formed, and at least two mounting positions 14 for mounting the test strip detection area are formed between the first arm 12 and the second arm 13; a conductive layer 15 is provided on the back of the substrate body 11, and when the test strip detection area is installed in the mounting position 14, the electrode layer 22 of the test strip detection area contacts the conductive layer 15 of the test strip substrate, thereby transmitting the electrical signal from the detection instrument (such as a blood glucose meter, a cholesterol meter, a blood ketone meter, etc.) to the reaction area of ​​the test strip detection area to promote the occurrence of the detection reaction, and on the other hand, transmitting the electrical signal generated in the reaction area to the detection instrument. In some practical applications, to facilitate installation, at least one of the first and second sides of the test strip detection area is provided with a slot or slider. Specifically, the first side has a first slot 27 and the second side has a second slot 29; or the first side has a first slider and the second side has a second slider; or the first side has a first slider and the second side has a second slot 29; or the first side has a first slot 27 and the second side has a second slider; or the first side has a first slot 27 and the second side has a second slider; or the first side has a first slot 27 and the second side has a second slider; or the first side has the first slot 27 and the second side has a second slider; or the first side has the first slot 27 and the second side has a second slider; or the first side has the first slider and the second side has a second slider; the aforementioned schemes are merely illustrative and are not intended to limit the present invention. The first and second sides are located on either side of the sample channel 243, respectively. In some practical applications, the first arm 12 is adapted to the first slot 27 or the first slider, and the second arm 13 is adapted to the second slot 29 or the second slider, to achieve sliding fit installation between the test strip detection area and the test strip substrate. In some practical applications, the first slide groove 27 and / or the second slide groove 29 are formed by the gap between the covering layer 25 and the insulating substrate layer 21, specifically, the gap between the lower surface of the covering layer 25 and the upper surface of the insulating substrate layer 21; the first slider and / or the second slider can be a structure extending from the test strip detection area pasted in the gap between the covering layer 25 and the insulating substrate layer 21 as a slider, where the structure can be double-sided tape, an insulating layer or conductive tape, or the first slider and / or the second slider are structures on both sides of the test strip detection area, i.e., between the upper surface of the covering layer 25 and the lower surface of the insulating substrate 21 as the first slider and / or the second slider.

[0061] The electrode layer 22 is used to transmit electrical signals from the detection instrument to the reaction area to promote the occurrence of the detection reaction, and to transmit electrical signals generated in the reaction area to the detection instrument. The electrode layer 22 includes a first electrode 221, a second electrode 222, a first conductive adhesive 18 attached to the first electrode 221 for connecting to the first contact of the conductive layer 15 on the test strip substrate, and a second conductive adhesive 19 attached to the second electrode 222 for connecting to the second contact of the conductive layer 15 on the test strip substrate. The first electrode 221 and the second electrode 222 are respectively connected to the working electrode and the counter electrode. The first conductive adhesive 18 is used to connect the first electrode 221 to the first contact of the conductive layer 15 on the test strip substrate, and the second conductive adhesive 19 is used to connect the second electrode 222 to the second contact of the conductive layer 15 on the test strip substrate. This ensures that the electrode layer 22 in the detection area of ​​the test strip contacts the conductive layer 15 of the test strip substrate, thereby achieving relative positioning between the detection area of ​​the test strip and the test strip substrate. Of course, the conductive adhesive can also be provided on the conductive layer 15 of the test strip substrate. Specifically, the first conductive adhesive 18 is provided on the first contact of the conductive layer 15, and the second conductive adhesive 19 is provided on the second contact of the conductive layer 15. The conductive adhesive is used to connect the electrode layer 22 and the conductive layer 15, so that the electrode layer 22 of the test strip detection area contacts the conductive layer 15 of the test strip substrate, and the relative positioning of the test strip detection area and the test strip substrate is achieved. Changing the conductive adhesive from being provided on the electrode layer 22 to being provided on the conductive layer 15 is an alternative method that is relatively easy to think of by those skilled in the art. The conductive adhesive and double-sided tape used in this solution are both heat-sensitive, or only the conductive adhesive is heat-sensitive. The viscosity is not strong at low temperatures below 15°C, which facilitates the assembly and mating of the slide grooves on the first and / or second sides of the test strip detection area with the first and / or second arms of the test strip substrate. The viscosity increases above 40°C, and after pressure is applied to the electrodes, the electrode layer of the test strip detection area contacts the conductive layer of the test strip substrate, thereby transmitting the electrical signal from the detection instrument to the reaction area of ​​the test strip detection area. Conductive adhesive is mainly composed of resin matrix, conductive particles and other auxiliary additives; the matrix mainly includes epoxy resin, acrylate resin, polyvinyl chloride, etc.; the conductive particles can be gold, silver, copper, aluminum, zinc, iron, nickel powder and graphite and some conductive compounds; the main purpose of other auxiliary additives is to adjust the viscosity of the adhesive and the curing speed.

[0062] In some practical applications, the first electrode 221 includes an electrode A2211, an electrode B2212, and a resistor AB2213 whose two ends are electrically connected to the electrode A2211 and the electrode B2212 respectively; the first conductive glue 18 includes a conductive glue A181 attached to the electrode A2211 and a conductive glue B182 attached to the electrode B2212; the second electrode 222 includes an electrode C2221, an electrode D2222, and a resistor CD2223 whose two ends are electrically connected to the electrode C2221 and the electrode D2222 respectively; the second conductive glue 19 includes a conductive glue C191 attached to the electrode C2221 and a conductive glue D192 attached to the electrode D2222. The materials of the electrodes A2211, B2212, C2221, and D2222 can be carbon ink, platinum carbon, silver, silver / silver chloride, gold, palladium, etc.; of course, it is also possible that: the first electrode 221 includes electrode A2211 or electrode B2212, the second electrode 222 includes electrode C2221, electrode D2222, and a resistor CD2223 electrically connected at both ends to electrodes C2221 and D2222 respectively; or the first electrode 221 includes electrode A2211, electrode B2212, and a resistor AB2213 electrically connected at both ends to electrodes A2211 and B2212 respectively, and the second electrode 222 includes electrode C2221 or electrode D2222. The materials of the resistors AB2213 and CD2223 can be carbon ink, platinum carbon, silver, silver / silver chloride, gold, palladium, etc. The resistance values ​​of the resistors AB2213 and CD2223 can be set from 0 to infinity. In some specific implementations, different resistance values ​​can be achieved by controlling the type and printing width of the printed resistor ink. In order to quickly and easily determine the type of reaction area (i.e., the detection content), in some practical applications, the detection instrument has a built-in correspondence table before leaving the factory (e.g., the resistor AB2213, resistor CD2223, and reaction area correspondence table described in Table 1, which is only an exemplary explanation for ease of understanding and is not a limitation of the present invention). According to the aforementioned correspondence table, for different reaction areas (different reaction areas have different detection contents), the resistors AB2213 and CD2223 are printed as corresponding resistance values; after inserting the test strip, the detection instrument determines the type of reaction area by detecting the resistance values ​​of the resistors AB2213 and / or CD2223.

[0063] Table 1 Correspondence between built-in resistance and reaction area of ​​the detection instrument

[0064] Resistor AB2213 resistance Resistor CD2223 resistance Reaction area 1 0 blood sugar 1 1 Blood ketones 1 2 uric acid 1 3 X1 …… …… …… 2 0 Xn 2 1 Xn+1 …… …… …… N N Xn+n

[0065] In actual 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 electrical signal. According to the different resistance values, the reaction area type (i.e., detection content) of the test strip detection area is judged and the corresponding detection signal is applied, which can accurately identify the detection content of the current test strip detection area. For ease of understanding, the following examples are given for illustration, but they are not considered to be limitations of the present invention. Figure 5 As shown, after a test strip detection area is assembled on the test strip substrate, electrode A2211 and electrode B2212 are electrically connected to the wires 3002 and 3001 on the test strip substrate through conductive adhesive A181 and conductive adhesive B182, respectively, and electrode C2221 and electrode D2222 are electrically connected to the wires 3003 and 3004 on the test strip substrate through conductive adhesive C191 and conductive adhesive D192, respectively; the detection instrument applies a 0.5V DC current between the wires 3001 and 3002 and a 0.5V DC current between the wires 3003 and 3004, and will detect that the currents on resistors AB2213 and CD2223 are 0.5A and 0.25A respectively; then, dividing the voltage by the current can determine that the resistance values ​​of resistors AB2213 and CD2223 are 1 ohm and 2 ohms respectively. According to Table 1, the detection content of the current test strip detection area is uric acid. The detection instrument will call the detection parameters of uric acid, act on the wires 3002 and 3003, and simultaneously collect the current results at both ends of the wires 3002 and 3003 for processing, and finally derive the concentration of uric acid in the analyte. Of course, in some practical applications, it is also possible not to adopt the aforementioned scheme of using a built-in correspondence table to determine the type of reaction area and perform detection. Instead, different test strip detection areas can be installed on the test strip substrate in a pre-set order 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 pre-set to be blood glucose, blood ketones, and uric acid, respectively. Then, three test strip detection areas are installed on the three mounting positions 14 in this order to ensure the accuracy of the detection (the instrument has pre-set the detection parameters of these three mounting positions 14).

[0066] In some practical applications, the resistor value can be controlled by blending highly conductive inks with less conductive / weakly conductive inks. Highly conductive inks include those containing conductive materials such as gold, silver, copper, carbon, and platinum carbon. Less conductive / weakly conductive inks include those containing titanium dioxide, organic amine black, and other organic materials, which are non-conductive or have poor conductivity. Furthermore, the resistor value can be further adjusted by controlling the printing width or thickness of resistors AB2213 and CD2223. This is based on the resistor formula R = ρL / S, where ρ is the resistivity of the material making up the resistor, L is the length of the resistor wire (in this embodiment, L is the distance between the two carbon electrodes connecting the resistor, such as the distance between electrode A2211 and electrode B2212, which remains unchanged), S is the cross-sectional area of ​​the resistor wire (S = Z*d, where Z is the thickness of the printed resistor and d is the width of the printed resistor), and R is the resistance value. By varying the conductive paste ratio (the ratio of highly conductive ink to less conductive ink), the p value can be changed. By varying Z or d, the resistor cross-sectional area can be altered. All three methods can achieve the goal of adjusting the resistance value. For example, by adjusting the ratios shown in Table 2 (for ease of understanding only, and not intended to limit the present invention), different printed resistors can be achieved.

[0067] Table 2 Resistor value adjustment table

[0068]

[0069]

[0070] The reaction layer 23 includes an insulating printed layer 231 positioned above the electrode layer 22. A hollowed-out portion is formed in the center of the insulating printed layer 231, and a reagent layer 232 is filled in this hollowed-out portion to form the reaction area. The enzymes added to the reagent layer 232 can include glucose dehydrogenase, β-hydroxybutyrate dehydrogenase, urate oxidase, lactate dehydrogenase, and others, and are used to detect blood glucose, blood ketones, uric acid, lactate, and other enzymes. The insulating printed layer 231 stabilizes the reaction area and limits excessive diffusion of the enzyme. It is made of a non-conductive material, such as polyethylene ink or resin ink.

[0071] The channel layer 24 includes double-sided tape A241 and double-sided tape B242 attached to the reaction layer 23, and a gap is left between the double-sided tape A241 and the double-sided tape B242 to form a sample channel 243. The sample channel 243 is located directly above the reaction area so that the biological sample flowing in the sample channel 243 can flow through the reaction area and react in the reaction area, thereby realizing the detection of physiological indicators. In some practical applications, a first positioning protrusion 2411 is formed on the double-sided tape A241, and a second positioning protrusion 2421 is formed on the double-sided tape B242. The first positioning protrusion 2411 and the second positioning protrusion 2421 are respectively located on both sides of the sample channel 243 and protrude in a direction away from the sample channel 243. The double-sided tape has a certain degree of softness and supporting force, thereby forming a first interlocking portion on the first and second sides of the test strip detection area for cooperating with the test strip substrate to achieve interlocking positioning. To ensure accurate assembly of the test strip detection area, the first positioning protrusion 2411 and the second positioning protrusion 2421 are asymmetrically arranged on either side of the sample channel 243. Of course, within the scope of options available to those skilled in the art, the first positioning protrusion 2411 and the second positioning protrusion 2421 can also be symmetrically arranged on either side of the sample channel 243. Furthermore, the first positioning protrusion 2411 can be provided only on the double-sided tape A 241, or the second positioning protrusion 2421 can be provided only on the double-sided tape B 242, thereby forming a first engaging portion on the first side and / or the second side of the test strip detection area for engaging and positioning with the test strip substrate.

[0072] The covering layer 25 is a hydrophilic film, which is attached to the upper surface of the double-sided adhesive tape A241 and the double-sided adhesive tape B242. In some practical applications, a protrusion 251 is provided on the covering layer 25 corresponding to the entrance of the sample channel 243, and a depression 252 adapted to the protrusion 251 is provided on the covering layer 25 corresponding to the exit of the sample channel 243. When two or more test strip detection areas are spliced ​​together, the sample channels 243 of the two adjacent test strip detection areas are connected to each other, and the protrusion 251 on one test strip detection area is embedded in the depression 252 of the other test strip detection area, which can assist the flow of the biological sample until the biological sample fills the sample channels 243 of each test strip detection area. Figure 6 As shown, the flow of the biological sample is achieved by the capillary action of the sample channel 243. Specifically, after the biological sample enters the sample channel 243, due to the hydrophilicity of the insulating substrate layer 21 and the cover layer 25, the biological sample tends to diffuse to the right on the surface of the insulating substrate layer 21 and the cover layer 25. Therefore, two rightward forces m1 and m2 are generated on the biological sample, and the biological sample continues to flow to the right under these forces. Figure 7At position ① shown, a breakpoint appears in the cover layer 25 (the junction of the cover layers of two adjacent test strip detection zones). Force m1 weakens and eventually disappears, but force m2 persists, allowing the biological sample to continue flowing to the right. Force m1 reappears when the biological sample contacts the cover layer 25 of the second test strip detection zone (located after the breakpoint). Once the biological sample completely fills the sample channel 243, forces m1 and m2 completely disappear, and the biological sample stops flowing.

[0073] For ease of understanding, Figure 8 Taking the three interconnected test strip detection zones shown as an example, when a biological sample (e.g., blood) is introduced into sample channel 243 from the inlet side (the side with the protrusion) of detection zone 2003, the biological sample will flow within sample channel 243 due to capillary action and reach the outlet side (the side with the depression) of detection zone 2003. If no other detection zone is connected to the outlet side of detection zone 2003, the biological sample will stop flowing due to surface tension. If detection zone 2002 is connected to the outlet side of detection zone 2003, and the protrusion of detection zone 2002 is embedded in the depression of detection zone 2003, the biological sample will continue to flow into the sample channel of detection zone 2002 due to capillary action and flow all the way to the outlet side of detection zone 2002. Similarly, if the outlet side of the detection area 2002 is spliced ​​with the detection area 2001, and the protrusion of the detection area 2001 is embedded in the depression of the detection area 2002, the biological sample will continue to flow into the sample channel of the detection area 2001 under the capillary action, and flow all the way to the outlet side of the detection area 2001. Of course, the last test strip detection area that abuts the test strip substrate may not have the depression 252.

[0074] In some practical applications, the sample channels 243 of the test strip detection areas installed on the test strip substrate are interconnected. The user only needs to add the biological sample to the sample inlet of the outermost test strip detection area to utilize the aforementioned capillary action to fill all the sample channels with the biological sample, without having to add the biological sample to each test strip detection area separately, which is more convenient to use.

[0075] like Figure 9As shown, in some practical applications, the projected width of the reaction layer 23 and / or 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 cover layer 25 (for example, the projected width of the reaction layer 23 and / or channel layer 24 in a direction perpendicular to the insulating substrate layer 21 is approximately 1 mm to 3 mm smaller than the width of the insulating substrate layer 21 and the cover layer 25). Thus, the first slide groove 27 and the second slide groove 29 are formed between the insulating substrate layer 21 and the cover layer 25, respectively, on either side of the sample channel 243. During installation, the first arm 12 is at least partially embedded in the first slide groove 27, and the second arm 13 is at least partially embedded in the second slide groove 29, achieving sliding fit between the test strip detection area and 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 slide groove 27 and the second slide groove 29 until it reaches a designated position. Of course, within the optional scope of those skilled in the art, the connection structure between the test strip detection area and the test strip substrate can also be:

[0076] a. A first slide groove 27 is formed on a first side of the test strip detection area, and a second slider is formed on a second side opposite the first side. The inner portion of the second arm 13 of the test strip base plate, which cooperates with the second slider, is hollowed out. During installation, the test strip base plate (e.g., the first arm) is at least partially embedded in the first slide groove 27, and the second slider is at least partially embedded in the test strip base plate, so that the test strip detection area can only move relative to the test strip base plate along the length of the first slide groove 27 until it reaches a specified position. b. A first slider is formed on a first side of the test strip detection area, and the inner portion of the first arm 12 of the test strip base plate, which cooperates with the first slider, is hollowed out. A second slide groove 29 is formed on a second side opposite the first side. During installation, the first slider is at least partially embedded in the test strip base plate, and the test strip base plate (e.g., the second arm) is at least partially embedded in the second slide groove 29, so that the test strip detection area can only move relative to the test strip base plate along the length of the second slide groove 29 until it reaches a specified position. c. A first slider is formed on the first side of the test strip detection area, and a second slider is formed on the second side opposite to the first side. The inner sides of the first arm 12 and the second arm 13 of the test strip substrate that cooperate with the first and second sliders are hollowed out. When installed, the first and second sliders are at least partially embedded in the test strip substrate, so that the test strip detection area can only move relative to the test strip substrate along a direction parallel to the first and second sliders (the length direction of the first and second arms) until it reaches a specified position. d. The test strip detection area has a slider formed on only one side. When installed, the slider is at least partially embedded in the test strip substrate. e. The test strip detection area has a slide groove formed on only one side. The test strip substrate (such as the first arm or the second arm) is at least partially embedded in the slide groove, so that the test strip detection area can only move relative to the test strip substrate along the length direction of the slide groove until it reaches a specified position. Specifically, for the test strip substrate, the double-sided tape A241 and the double-sided tape B242 of the test strip detection area can serve as sliders. When they are embedded in the hollowed-out inner side of the test strip substrate, the hollowing can limit the left and right directions of the test strip detection area (refer to Figure 9 Specifically, the insulating layer substrate 21 and the cover layer 25 of the test strip detection area can be used as a slide groove, and the arms (first arm and second arm) at both ends of the test strip substrate are embedded in the slide groove, and the left and right directions (refer to Figure 9 When all the test strip detection areas are installed on the test strip substrate, there is another rolling process in the up and down directions (refer to Figure 9 The conductive adhesive securely adheres the electrode layer 22 of the test strip's detection area and the conductive layer 15 of the test strip's substrate to the conductive adhesive (in the vertical direction shown). The conductive adhesive provides electrical connection between the electrodes on both sides and securely bonds the test strip's detection area to the substrate, limiting displacement of the detection area. The direction of movement of the test strip's detection area relative to the substrate is along the length of the first and second arms.

[0077] In some practical applications, a first contact is provided on the first arm 12 at a position corresponding to the mounting position 14, and a second contact is provided on the second arm 13 at a position corresponding to the mounting position 14. After the test strip detection area is installed on the mounting position 14, the first conductive adhesive 18 on the test strip detection area contacts the first contact, and the second conductive adhesive 19 contacts the second contact, thereby achieving contact between the electrode layer 22 of the test strip detection area and the conductive layer 15 of the test strip substrate.

[0078] like Figure 10 、 Figure 11 As shown, in some practical applications, the substrate body 11 is provided with a bottom protrusion 111 that mates with the recess 252 of the test strip detection zone to seal the sample channel 243. If the last test strip detection zone abutting the test strip substrate does not have a recess 252, the substrate body 11 may not have the bottom protrusion 111. If the test strip substrate has five mounting locations, the substrate body 11 is provided with the bottom protrusion 111 at the terminal mounting location 14 (on the side away from the free ends of the first arm 12 and the second arm 13). After the five test strip detection zones are sequentially installed in the five mounting locations, the five test strip detection zones are connected end to end (for specific connection, refer to the three spliced ​​test strip detection zones described above). The sample channels 243 of the five test strip detection zones are sequentially connected, and the bottom protrusion 111 engages with the recess 252 of the terminal test strip detection zone, sealing the sample channel 243 and preventing further outflow of the biological sample. In other practical applications, a third contact is provided on the substrate body 11 at a position corresponding to the bottom protrusion 111. The measurement countdown begins only when the biological sample reaches the third contact (at which point the biological sample fills the entire sample channel), resulting in more accurate test results. Within the scope of options available to those skilled in the art, the first, second, and third contacts can be part of a conductive line printed on the test strip substrate, or can be conductive contacts connected to the conductive line on the test strip substrate, all of which are part of the test strip substrate conductive layer 15.

[0079] like Figure 10 、 Figure 11 As shown, in some practical applications, a first positioning recess 121 matching the first positioning protrusion 2411 is formed on the first arm 12, and a second positioning recess 131 matching the second positioning protrusion 2421 is formed on the second arm 13, thereby forming a second fitting portion on the first arm 12 and the second arm 13 that is adapted to 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, and is used to ensure that the test strip detection area is embedded in place. Specifically, the 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.

[0080] During the assembly process, the test strip detection area is slid between the first arm 12 and the second arm 13 in a direction parallel to the first arm 12 and the second arm 13; Figure 2 As shown, at this time, the first arm 12 is at least partially embedded in the first slide groove 27, and the second arm 13 is at least partially embedded in the second slide groove 29. The test strip detection area can only move relative to the test strip base plate along the length direction of the first slide groove 27 and the second slide groove 29 until it reaches the specified position; Figure 3 As shown, the first conductive adhesive 18 is used to connect the first electrode 221 to the first contact on the conductive layer 15 of the test strip substrate, and the second conductive adhesive 19 is used to connect the second electrode 222 to the second contact on the conductive layer 15 of the test strip substrate. This simultaneously achieves the relative positioning of the test strip detection area and the test strip substrate, thereby completing the assembly of the test strip. When the test strip detection area reaches the designated position, the first positioning protrusion 2411 of each test strip detection area engages with the first positioning recess 121, and the second positioning protrusion 2421 engages with the second positioning recess 131, ensuring that the test strip detection area is properly seated. Simultaneously, the bottom protrusion 111 engages with the recess 252 of the terminal test strip detection area, sealing the sample channel 243 and preventing the biological sample from continuing to flow outward.

[0081] The method for preparing the aforementioned test strip comprises:

[0082] Separately preparing the test strip detection area and the test strip substrate;

[0083] Each test strip detection area is mounted on the mounting position 14 of the test strip substrate, so that the electrode layer 22 of each test strip detection area contacts the conductive layer 15 of the test strip substrate.

[0084] In some practical applications, the method for preparing the test strip includes:

[0085] S1, prepare the test strip detection area (such as Figure 12 shown).

[0086] S1.1. Printing a first electrode 221 and a second electrode 222 on the insulating substrate layer 21.

[0087] Specifically, electrodes A2211, electrode B2212, electrode C2221, and electrode D2222 are first printed on the insulating substrate layer 21 to transmit electrical signals from the detection instrument to the reaction area and to collect electrical signals generated in the reaction area. The materials may be carbon ink, platinum carbon, silver, silver / silver chloride, gold, palladium, etc.; then resistor AB2213 is printed between electrode A2211 and electrode B2212, and resistor CD2223 is printed between electrode C2221 and electrode D2222. The materials may be carbon ink, platinum carbon, silver, silver / silver chloride, gold, palladium, etc.

[0088] S1.2. On the basis of step S1.1, a reaction layer 23 is provided on the first electrode 221 and the second electrode 222.

[0089] Specifically, an insulating printed layer 231 is first provided on the first electrode 221 and the second electrode 222. A hollow portion is formed in the middle of the insulating printed layer 231 to fix the reaction area and limit excessive diffusion of the enzyme solution. The material may be a non-conductive material, such as polyethylene ink or resin ink. Liquid is then applied to the hollow portion in the middle of the insulating printed layer 231 and dried. The enzyme solution may be glucose dehydrogenase, β-hydroxybutyrate dehydrogenase, urate oxidase, lactate dehydrogenase, or the like.

[0090] S1.3. Paste the first conductive adhesive 18 and the second conductive adhesive 19 on the first electrode 221 and the second electrode 222 respectively.

[0091] Specifically, conductive adhesive A181, conductive adhesive B182, conductive adhesive C191, and conductive adhesive D192 are respectively applied to electrode A2211, electrode B2212, electrode C2221, and electrode D2222. The conductive adhesive is sticky and can bond the two substrates together, similar to the function of double-sided tape. In addition, the conductive adhesive can also conduct electricity and act as a conductor. The size of the conductive adhesive (including conductive adhesive A181, conductive adhesive B182, conductive adhesive C191, and conductive adhesive D192) should not be too small to prevent loose adhesion, and should not be too large to prevent short circuits between adjacent electrodes. The size of the conductive adhesive is preferably consistent with the size of electrode B2212 and electrode D2222.

[0092] S1.4. A channel layer 24 is provided on the reaction layer to form a sample channel 243 opposite to the reaction area.

[0093] Specifically, the double-sided tape layer can be pasted by pasting double-sided tape A241 and double-sided tape B242 separately, or pasting double-sided tape A241 and double-sided tape B242 at the same time, and leaving a gap between the double-sided tape A241 and the double-sided tape B242 to form a channel layer with a sample channel 243; the double-sided tape A241 and the double-sided tape B242 are attached with a release film on the upper surface to prevent the double-sided tape from being stained with dust, making it easier to process.

[0094] S1.5, cutting the semi-finished product obtained in step S1.4 along the first cutting line 1 so that its size can fit the test strip substrate.

[0095] S1.6. After removing the release film, attach the cover layer 25 to the channel layer 24, that is, to the upper surface of the double-sided tape A 241 and the double-sided tape B 242, to obtain multiple interconnected test strip detection areas.

[0096] S1.7. Cut the semi-finished product obtained in step S1.6 along the second cutting line 2 to obtain a plurality of independent test strip detection areas, and the sizes of the areas are adapted to the test strip substrate.

[0097] In the above steps, S1.3 and S1.4 can be interchanged.

[0098] S2. Prepare a test strip substrate.

[0099] Specifically, a conductive layer 15 is printed on one side of the test strip substrate; when the conductive adhesive (first conductive adhesive and second conductive adhesive) is not adhered to the detection area of ​​the test strip, conductive adhesive needs to be adhered to the conductive layer 15 .

[0100] S3. Assemble the test strip.

[0101] Specifically, in a low-temperature environment (0-15°C), the first arm 12 and the second wall 13 of the test strip substrate are embedded in the first slide groove 27 and the second slide groove 29 of the test strip detection area, so that the first interlocking portion cooperates with the second interlocking portion, and the recess 252 of the test strip detection area cooperates with the bottom protrusion 111 of the test strip substrate. The product is transferred to a high-temperature environment (40-60°C). At this time, the viscosity of the conductive glue (the first conductive glue and the second conductive glue) and the double-sided glue (double-sided glue A and double-sided glue B) increases. After applying pressure to the conductive glue, the test strip detection area can be fixed to the test strip substrate. The conductive glue connects the electrode layer 22 of the test strip detection area and the conductive layer 15 of the test strip substrate. The remaining test strip detection areas are installed on the test strip substrate in sequence using the above method, so that the sample channels 243 of each test strip detection area are connected to each other. Of course, within the optional scope of technicians in this field, the following method can also be used for assembly: in a low-temperature environment (0-15°C), each test strip detection area is slid into the installation position 14 in turn, so that the first arm 12 and the second wall 13 of the test strip substrate are embedded in the first slide groove 27 and the second slide groove 29 of the test strip detection area, and the first positioning protrusion 2411 of each test strip detection area is embedded in the first positioning recess 121, and the second positioning protrusion 2421 is embedded in the second positioning recess 131 to ensure that the test strip detection area is embedded in place; at the same time, the bottom protrusion 111 is embedded in the recess 252 of the end test strip detection area to close the sample channel 243 to prevent the biological sample from continuing to flow outward; and the sample channels 243 of each test strip detection area are connected to each other. The product is transferred to a high temperature environment (40-60°C). At this time, the viscosity of the conductive glue (the first conductive glue and the second conductive glue) and the double-sided tape (double-sided tape A and double-sided tape B) increases. After applying pressure to the conductive glue, the test strip detection area can be fixed to the test strip substrate. The conductive glue connects the test strip detection area electrode layer 22 and the test strip substrate conductive layer 15.

[0102] like Figure 13 As shown, in some other practical applications, the method for preparing the detection area of ​​the test strip includes:

[0103] S10 , printing a first electrode 221 and a second electrode 222 on the insulating substrate layer 21 .

[0104] Specifically, electrodes A2211, electrode B2212, electrode C2221, and electrode D2222 are first printed on the insulating substrate layer 21 to transmit electrical signals from the detection instrument to the reaction area and to collect electrical signals generated in the reaction area. The materials may be carbon ink, platinum carbon, silver, silver / silver chloride, gold, palladium, etc.; then resistor AB2213 is printed between electrode A2211 and electrode B2212, and resistor CD2223 is printed between electrode C2221 and electrode D2222. The materials may be carbon ink, platinum carbon, silver, silver / silver chloride, gold, palladium, etc.

[0105] S20 , on the basis of step S10 , a reaction layer 23 is provided on the first electrode 221 and the second electrode 222 .

[0106] Specifically, an insulating printed layer 231 is first provided on the first electrode 221 and the second electrode 222. A hollow portion is formed in the middle of the insulating printed layer 231 to fix the reaction area and limit excessive diffusion of the enzyme solution. The material may be a non-conductive material, such as polyethylene ink or resin ink. Liquid is then applied to the hollow portion in the middle of the insulating printed layer 231 and dried. The enzyme solution may be glucose dehydrogenase, β-hydroxybutyrate dehydrogenase, urate oxidase, lactate dehydrogenase, or the like.

[0107] S30 , pasting the first conductive adhesive 18 and the second conductive adhesive 19 on the first electrode 221 and the second electrode 222 respectively.

[0108] Specifically, conductive adhesive A181, conductive adhesive B182, conductive adhesive C191, and conductive adhesive D192 are respectively applied to electrode A2211, electrode B2212, electrode C2221, and electrode D2222. The conductive adhesive is sticky and can bond the two substrates together, similar to the function of double-sided tape. In addition, the conductive adhesive can also conduct electricity and act as a conductor. The size of the conductive adhesive (including conductive adhesive A181, conductive adhesive B182, conductive adhesive C191, and conductive adhesive D192) should not be too small to prevent loose adhesion, and should not be too large to prevent short circuits between adjacent electrodes. The size of the conductive adhesive is preferably consistent with the size of electrode B2212 and electrode D2222.

[0109] S40 , disposing a channel layer 24 on the reaction layer to form a sample channel 243 opposite to the reaction area.

[0110] Specifically, the double-sided tape layer can be pasted by pasting double-sided tape A241 and double-sided tape B242 separately, or pasting double-sided tape A241 and double-sided tape B242 at the same time, and leaving a gap between the double-sided tape A241 and the double-sided tape B242 to form a channel layer with a sample channel 243; the double-sided tape A241 and the double-sided tape B242 are attached with a release film on the upper surface to prevent the double-sided tape from being stained with dust, making it easier to process.

[0111] S50 , after removing the release film, attach the cover layer 25 to the channel layer 24 , that is, to the upper surfaces of the double-sided adhesive tape A 241 and the double-sided adhesive tape B 242 , to obtain a plurality of interconnected test strip detection areas.

[0112] S60 , cutting the semi-finished product obtained in step S50 along the third cutting line 3 to obtain a plurality of independent test strip detection areas, and the sizes of the test strip detection areas are adapted to the test strip substrate.

[0113] In the above steps, S30 and S40 can be interchanged. If a die-cutting process is used for cutting, the cutting depth of the third cutting line 3 can be adjusted so that the third cutting line 3 just cuts through the channel layer 24 and the covering layer 25, and the insulating substrate layer 21 is not cut; if a laser cutting process is used for cutting, the number of laser cutting times or energy can be adjusted so that the third cutting line 3 just cuts through the channel layer 24 and the covering layer 25, and the insulating substrate layer 21 is not cut.

[0114] The examples in the above-mentioned embodiments are intended to further help understand the solutions of the present invention, and are not intended to limit the technical solutions of the present invention. Although the present invention has been described in detail with reference to the above-mentioned embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the above-mentioned embodiments, or make equivalent replacements for some of the technical features therein; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A test strip, characterized in that: It includes a test strip substrate and at least two test strip detection areas respectively installed on the test strip substrate, each test strip detection area is used to detect different physiological indicators; wherein, A test strip detection area comprises an insulating substrate layer (21), an electrode layer (22) located on the insulating substrate layer (21), a reaction layer (23) located on the electrode layer (22) and having a reaction area, a channel layer (24) located on the reaction layer (23), and a covering layer (25) located on the channel layer (24), wherein a sample channel (243) is provided on the channel layer (24) at a position corresponding to the reaction area; A test strip substrate comprises a substrate body (11), wherein a first arm (12) and a second arm (13) are formed on the substrate body (11), and at least two mounting positions (14) for mounting the test strip detection area are formed between the first arm (12) and the second arm (13); a conductive layer (15) is provided on the substrate body (11), and when the test strip detection area is mounted at the mounting position (14), an electrode layer (22) of the test strip detection area contacts the conductive layer (15) of the test strip substrate.

2. The test strip according to claim 1, wherein: The electrode layer (22) comprises a first electrode (221) and a second electrode (222); the first electrode (221) is affixed with a first conductive adhesive (18) for connecting to a conductive layer (15) on a test strip substrate; and the second electrode (222) is affixed with a second conductive adhesive (19) for connecting to a conductive layer (15) on a test strip substrate.

3. The test strip according to claim 2, wherein: The first electrode (221) comprises 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), respectively; the first conductive adhesive (18) comprises a conductive adhesive A (181) attached to the electrode A (2211) and a conductive adhesive B (182) attached to the electrode B (2212); the second electrode (222) comprises 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), respectively; the second conductive adhesive (19) comprises a conductive adhesive C (191) attached to the electrode C (2221) and a conductive adhesive D (192) attached to the electrode D (2222).

4. The test strip according to claim 1, wherein: 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 sliding cooperation between the test strip detection area and the test strip substrate.

5. The test strip according to claim 4, wherein: A first slide groove (27) and a second slide groove (29) are respectively formed on the first side and the second side of the test strip detection area, the first arm (12) is at least partially embedded in the first slide groove (27), and the second arm (13) is at least partially embedded in the second slide groove (29), so as to realize the sliding assembly of the test strip detection area and the test strip substrate.

6. The test strip according to claim 4, wherein: The projection width of the reaction layer (23) and / or 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 chute (27) and / or the second chute (29).

7. The test strip according to claim 1, wherein: 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, wherein: The substrate body (11) is provided with a bottom protrusion (111) that matches the recess (252) to close the sample channel (243).

9. The test strip according to claim 1, wherein: 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 engaging and positioning of the test strip detection area and the test strip substrate.

10. The test strip according to claim 1, wherein: The sample channels (243) of the test strip detection areas installed on the test strip substrate are communicated with each other.

11. A method for preparing the test strip according to any one of claims 1 to 10, characterized in that include: 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 electrode layer (22) of each test strip detection area is in contact with the 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 includes: Printing an electrode layer (22) on an insulating substrate layer (21); A reaction layer (23) is provided on the electrode layer (22); A channel layer (24) is provided on the reaction layer (23) to form a sample channel (243) opposite to the reaction area of ​​the reaction layer (23); Pasting a first conductive adhesive (18) and a second conductive adhesive (19) on the electrode layer (22); cutting the obtained semi-finished product along a first cutting line; affixing a covering layer (25) to the channel layer (24) of the semi-finished product obtained after cutting to obtain a plurality of interconnected test strip detection areas; The plurality of interconnected test strip detection areas are cut along a second 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 test strip detection area includes: Printing an electrode layer (22) on an insulating substrate layer (21); A reaction layer (23) is provided on the electrode layer (22); A channel layer (24) is provided on the reaction layer (23) to form a sample channel (243) opposite to the reaction area of ​​the reaction layer (23); Pasting a first conductive adhesive (18) and a second conductive adhesive (19) on the electrode layer (22); attaching a cover layer (25) to the channel layer (24) to obtain a plurality of interconnected test strip detection areas; The plurality of interconnected test strip detection areas are cut along a third cutting line to obtain a plurality of independent test strip detection areas.

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