Test strip detection area and test strip substrate

Abstract

The utility model relates to a test strip detection area and a test strip substrate, which are used for detecting physiological indexes in samples such as blood. The utility model comprises: an insulating substrate layer; the electrode layer is positioned on the insulating substrate layer; the reaction layer is positioned on the electrode layer and is provided with a reaction region; the channel layer is positioned on the reaction layer and is provided with a sample channel at a position corresponding to the reaction area; a capping layer over the channel layer; the test strip detection area is used for being installed on a test strip substrate to form a test strip, at least one of a first edge and a second edge of the test strip detection area is provided with a sliding groove or a sliding block, and the first edge and the second edge are located on the two sides of the sample channel respectively. The test strip has the advantages that the test strip is of a split structure, even if unqualified products appear in the liquid dispensing process, the unqualified test strip detection area can be scrapped, the test strip substrate does not need to be scrapped, and compared with the prior art, the production cost is greatly reduced.

Description

Technical Field

[0001] The utility model relates to a test strip detection area and a matching test strip substrate, which are used for detecting physiological indicators in samples such as blood. Background Art

[0002] Electrochemical test strips with electrode systems have been widely used for rapid detection of biological samples, such as for detecting various physiological indicators such as glucose, cholesterol, and blood ketones in blood samples. In the prior art, electrochemical test strips all adopt an integral structure, which has the following defects:

[0003] At present, common electrochemical test strips require printing, dispensing, assembly and cutting processes in the production process. Due to the positioning error of the dispensing equipment, the tolerance of the equipment, the surface tension of the solution, etc., defective products will inevitably appear in the dispensing process. In this case, the test strips will be scrapped as a whole, resulting in an increase in production costs. Summary of the invention

[0004] The purpose of the utility model is to provide a test strip detection area and a test strip substrate to reduce production costs in view of the above-mentioned problems.

[0005] In order to achieve the above object, the utility model is implemented through the following technical solutions:

[0006] A test strip detection area, comprising:

[0007] Insulating substrate layer;

[0008] An electrode layer, located on the insulating substrate layer;

[0009] A reaction layer, located above the electrode layer, having a reaction area;

[0010] A channel layer, located above the reaction layer, having a sample channel at a position corresponding to the reaction area;

[0011] a cover layer, located above the channel layer;

[0012] The test strip detection zone is used to be installed on a test strip substrate to form a test strip, at least one of the first side and the second side of the test strip detection zone has a slide groove or a slider, and the first side and the second side are respectively located on both sides of the sample channel.

[0013] Preferably, both the first side and the second side of the test strip detection area have a slide groove; or both the first side and the second side of the test strip detection area have a slider; or one of the first side and the second side of the test strip detection area has a slider and the other has a slide groove.

[0014] Preferably, the projection width of the reaction layer and / or the 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 slide groove.

[0015] 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.

[0016] 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.

[0017] 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.

[0018] Preferably, a first engaging portion for cooperating with the test strip substrate to achieve engaging positioning is formed on the first side and / or the second side of the test strip detection area.

[0019] A test strip substrate, used for mounting a test strip detection area, the test strip detection area comprising an insulating substrate layer, an electrode layer located on the insulating substrate layer, a reaction layer located on the electrode layer and having a reaction area, a sample channel located on the reaction layer and arranged corresponding to the reaction area, and a slide groove or a slider formed on at least one of a first side and a second side of the test strip detection area; the first side and the second side are respectively located on both sides of the sample channel;

[0020] The test strip substrate comprises a substrate body, on which a first arm, a second arm and a conductive layer are formed, a mounting position for mounting the test strip detection area is formed between the first arm and the second arm, at least one of the first arm and the second arm is adapted to a slide groove or a slider to achieve the installation of the test strip detection area on the mounting position, and the electrode layer is in contact with the conductive layer.

[0021] Preferably, a first slide groove and a second slide groove are formed on the first side and the second side 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 that the detection area of ​​the test strip is installed on the installation position, and the electrode layer and the conductive layer are in contact.

[0022] Preferably, a depression is provided on the detection area of ​​the test strip corresponding to the outlet end of the sample channel, and a bottom protrusion matching with the depression to close the sample channel is provided on the substrate body.

[0023] Preferably, a first engaging portion is formed on the first side and / or the second side, and a second engaging portion matched with the first engaging portion is formed on the first arm and / or the second arm to achieve engaging and positioning of the test strip detection area and the test strip substrate.

[0024] The beneficial effects of the utility model are:

[0025] 1. At least one of the first side and the second side of the sample channel on both sides of the test strip detection area has a slide groove or a slider, which is used to cooperate with the test strip substrate to form a test strip for physiological index detection, that is, the test strip adopts a split structure, even if unqualified products appear during the liquid dispensing process, the unqualified test strip detection area can be scrapped, and the test strip substrate does not need to be scrapped, which greatly reduces the production cost compared with the existing technology. In addition, the slide groove or the slider cooperates with the test strip substrate, that is, 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, which is convenient and quick to install.

[0026] 2. 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, 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 reaction areas of the detection areas of the two test strips.

[0027] 3. 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 of the test strip substrate. The first engaging portion can be matched with the second engaging portion to achieve engaging positioning of the test strip detection area. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 This is an exploded view of the detection area of ​​the test strip of the utility model.

[0029] Figure 2 It is a schematic 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 utility model.

[0030] Figure 3 It is a schematic diagram of the structure of the biological sample flowing in the sample channel of the utility model.

[0031] Figure 4 This is another structural schematic diagram of the biological sample flowing in the sample channel of the utility model.

[0032] Figure 5 It is a schematic diagram of the structure of the detection area of ​​three test strips spliced ​​together in the utility model.

[0033] Figure 6 It is a schematic cross-sectional view of the detection area of ​​the test strip of the utility model.

[0034] Figure 7 This is a schematic diagram of the front structure of the test strip substrate of the utility model.

[0035] Figure 8 This is a schematic diagram of the back structure of the test strip substrate of the utility model.

[0036] Fig. 9 This is a cross-sectional view of the test strip of the utility model after the detection area slides into the test strip substrate.

[0037] Fig.10 It is a cross-sectional view of the test strip detection area of ​​the utility model installed on the test strip substrate.

[0038] Figure numerals: 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 glue-18, conductive glue A-181, conductive glue B-182, second conductive glue-19, conductive glue C-191, conductive glue 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

[0039] In order to make the purpose, technical solution and advantages of the embodiments of the utility model clearer, the following will be described clearly and completely in combination with the technical solution in the embodiments of the utility model. Obviously, the described embodiments are partial embodiments of the utility model, not all embodiments. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the protection scope of the utility model.

[0040] like Figure 1A test strip detection area is shown, which is independent of the test strip substrate and is used to be installed on the test strip substrate to form a test strip (such as a blood sugar test strip, a cholesterol test strip, etc.) for detecting physiological indicators (including but not limited to glucose, cholesterol, blood ketones, etc.), and the test strip is a biochemical sensor or an electrochemical sensor. The test strip detection area has 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. In order to facilitate installation, at least one of the first side and the second side of the test strip detection area has a slide groove or a slider, specifically, the first side has a first slide groove 27 and the second side has a second slide groove 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 slide groove 29; or the first side has a first slide groove 27 and the second side has a second slider; or only the first side has the first slide groove 27, or only the second side has the second slide groove 29; or only the first side has the first slider, or only the second side has the second slider; the above-mentioned schemes are only exemplary descriptions and are not limitations of the present invention. The first side and the second side are respectively located on both sides of the sample channel 243; in some practical applications, the first slide groove 27 or the first slider, and the second slide groove 29 or the second slider cooperate with the test strip substrate to achieve the installation of 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 a double-sided tape, an insulating layer or a conductive tape, or the first slider and / or the second slider is a structure 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.

[0041] The electrode layer is used to transmit the electrical signal from the detection instrument (such as a blood glucose meter, a cholesterol tester, a blood ketone meter, etc.) to the reaction area to promote the occurrence of the detection reaction, and to transmit the electrical signal 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 glue 18 attached to the first electrode 221 and used to connect with the first contact of the conductive layer 15 on the test strip substrate, and a second conductive glue 19 attached to the second electrode 222 and used to connect with the second contact of the conductive layer 15 on the test strip substrate. The first electrode 221 and the second electrode 222 are respectively a working electrode and a counter electrode; the first conductive glue 18 is used to connect the first electrode 221 with the first contact of the conductive layer 15 on the test strip substrate, and the second conductive glue 19 is used to connect the second electrode 222 with the second contact of the conductive layer 15 on the test strip substrate, so that the electrode layer 22 of the test strip detection area is in contact with 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. Of course, the conductive glue can also be set on the conductive layer 15 of the test strip substrate. Specifically, the first conductive glue 18 is set on the first contact of the conductive layer 15, and the second conductive glue 19 is set on the second contact of the conductive layer 15. The electrode layer 22 and the conductive layer 15 are connected by the conductive glue, so that the electrode layer 22 of the test strip detection area is in contact with 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 at the same time; the conductive glue is changed from being set on the electrode layer 22 to being set on the conductive layer 15, which is a replacement method that is easier for people in this field to think of. The conductive glue and double-sided adhesive used in this scheme are both thermosensitive, or only the conductive glue used is thermosensitive, and the viscosity is not strong at low temperatures below 15°C, which is conducive to the assembly and matching of the slide groove on the first side and / or second side of the test strip detection area with the first arm and / or second arm of the test strip substrate; the viscosity increases above 40°C, and after pressure is applied to the electrode, the electrode layer of the test strip detection area and the conductive layer of the test strip substrate are in contact, 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.

[0042] 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 electrode A2211, electrode B2212, electrode C2221, and electrode D2222 can be carbon ink, platinum carbon, silver, silver / silver chloride, gold, palladium, etc.; of course, it can also be: the first electrode 221 includes electrode A2211 or electrode B2212, and the second electrode 222 includes electrode C2221, electrode D2222, and a resistor CD2223 whose two ends are electrically connected to electrodes C2221 and D2222 respectively; or the first electrode 221 includes electrode A2211, electrode B2212, and a resistor AB2213 whose two ends are electrically connected to electrodes A2211 and B2212 respectively, and the second electrode 222 includes electrode C2221 or electrode D2222. The materials of the resistor AB2213 and the resistor CD2223 can be carbon ink, platinum carbon, silver, silver / silver chloride, gold, palladium, etc. The resistance values ​​of the resistor AB2213 and the resistor 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 facilitate and quickly 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 (for example, the resistor AB2213, the resistor CD2223 and the 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 utility model). According to the aforementioned correspondence table, for different reaction areas (different reaction areas have different detection contents), the resistor AB2213 and the resistor 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 resistor AB2213 and / or the resistor CD2223.

[0043] Table 1 Correspondence between the built-in resistance and reaction area of ​​the detection instrument

[0044] 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

[0045] In actual applications, 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 resistor AB2213 and / or resistor CD2223 by applying an electrical signal, and judge the reaction area type (i.e., detection content) of the test strip detection area according to the different resistance values ​​and apply the corresponding detection signal, so as to accurately identify the detection content of the current test strip detection area. For ease of understanding, the following examples are used for illustration, but they are not to be regarded as limitations of the present invention. Figure 2 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 direct current between the wires 3001 and 3002 and a 0.5V direct 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; and then dividing the voltage by the current can yield 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 collect the current results at both ends of the wires 3002 and 3003 for processing, and finally obtain 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 the built-in corresponding table to judge the type of reaction area and perform detection, but to install different test strip detection areas 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 installation positions 14 on the test strip substrate are pre-set to be blood sugar, blood ketones, and uric acid, respectively. Then, three test strip detection areas are installed on the three installation positions 14 in this order to ensure the accuracy of the detection (the instrument has pre-set the detection parameters of these three installation positions 14).

[0046] In some practical applications, on the one hand, the control of the resistance value is achieved by blending ink with strong conductivity and ink with poor / weak conductivity. The ink with strong conductivity is for example ink containing conductive materials such as gold, silver, copper, carbon, platinum carbon, etc.; the ink with poor / weak conductivity is for example containing titanium dioxide, organic amine black and other organic substances, which are non-conductive or have poor conductivity. On the other hand, by controlling the printing width or printing thickness of resistor AB2213 and resistor CD2223, further adjustment of the resistance value can also be achieved. The basis is the formula of resistance R=ρL / S, ρ is the resistivity of the material made of the resistor, L is the length of the wire of the resistor (in this scheme, L is the distance between the two carbon electrodes connecting the resistor, such as the distance between electrode A2211 and electrode B2212, and its length remains unchanged), S is the cross-sectional area of ​​the wire of the resistor (S=Z*d, Z is the thickness of the printed resistor, d is the width of the printed resistor), and R is the resistance value. By changing the ratio of the conductive paste (the ratio of the ink with strong conductivity to the ink with poor conductivity), the ρ value can be changed, and by changing Z or d, the cross-sectional area of ​​the resistor can be changed. The above three methods can all achieve the purpose of adjusting the resistance value. For example, different printed resistors can be achieved by adjusting the ratio in Table 2 (only for illustrative purposes, not for the purpose of limiting the present invention).

[0047] Table 2 Resistor value adjustment table

[0048]

[0049] The reaction layer 23 includes an insulating printed layer 231 located on the electrode layer 22, and a hollow is formed in the middle of the insulating printed layer 231, and the reagent layer 232 is filled in the hollow to form the reaction area. The enzyme liquid added to the reagent layer 232 can be glucose dehydrogenase, β-hydroxybutyrate dehydrogenase, urate oxidase, lactate dehydrogenase, etc., which are used to detect blood sugar, blood ketones, uric acid, lactic acid, etc. The insulating printed layer 231 is used to fix the reaction area, which can limit the excessive diffusion of the enzyme liquid, and the material is a non-conductive material, such as polyethylene ink, resin ink, etc.

[0050] The channel layer 24 includes double-sided adhesive tape A241 and double-sided adhesive tape B242 attached to the reaction layer 23, and a gap is left between the double-sided adhesive tape A241 and the double-sided adhesive tape B242 to form a sample channel 243, which 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 adhesive tape A241, and a second positioning protrusion 2421 is formed on the double-sided adhesive 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 adhesive tape has a certain degree of softness and support, so that a first fitting portion for cooperating with the test strip substrate to achieve fitting positioning is formed on the first and second sides of the test strip detection area. In order to ensure the accuracy of the assembly of the test strip detection area, the first positioning protrusion 2411 and the second positioning protrusion 2421 are asymmetrically arranged on both sides of the sample channel 243. Of course, within the optional range of those skilled in the art, the first positioning protrusion 2411 and the second positioning protrusion 2421 can also be symmetrically arranged on both sides of the sample channel 243. In addition, the first positioning protrusion 2411 can be only provided on the double-sided adhesive tape A241, or the second positioning protrusion 2421 can be only provided on the double-sided adhesive tape B242, so as to form a first fitting portion for cooperating with the test strip substrate to achieve fitting positioning on the first side and / or the second side of the test strip detection area.

[0051] The covering layer 25 is a hydrophilic film, which is attached to the upper surface of double-sided adhesive A241 and double-sided adhesive 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, the sample channels 243 of 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 another test strip detection area, which can assist the flow of the biological sample until the biological sample fills the reaction area of ​​each test strip detection area. Figure 3 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, thus generating two forces m1 and m2 to the right on the biological sample, and the biological sample continues to flow to the right under these forces. Figure 4At position ① shown in the figure, a breakpoint appears at the cover layer 25 (the joint of the cover layers of the detection areas of two adjacent test strips), and the force m1 weakens until it disappears, but the force m2 still exists, so the biological sample can continue to flow to the right. Until the biological sample contacts the cover layer 25 of the detection area of ​​the second test strip (located after the aforementioned breakpoint), the force m1 appears again. After the biological sample completely fills the sample channel, the forces m1 and m2 completely disappear, and the biological sample stops flowing.

[0052] For ease of understanding, Figure 5 Taking the three mutually spliced ​​test strip detection areas shown as an example, when a biological sample (such as blood, etc.) is added to the sample channel 243 from the inlet side (the side with the protrusion) of the detection area 2003, the biological sample will flow in the sample channel 243 due to capillary action and reach the outlet side (the side with the depression) of the detection area 2003. If there is no access to other detection areas on the outlet side of the detection area 2003, the biological sample will stop flowing due to the existence of surface tension. If the outlet side of the detection area 2003 is spliced ​​with the detection area 2002, and the protrusion of the detection area 2002 is embedded in the depression of the detection area 2003, the biological sample will continue to flow into the sample channel of the detection area 2002 under the capillary action, and will flow all the way to the outlet side of the detection area 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 against the test strip substrate may not have the depression 252.

[0053] like Figure 6 As shown, in some practical applications, the projection width of the reaction layer 23 and / or 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 covering layer 25 (for example, the projection width of the reaction layer and / or the channel layer in the direction perpendicular to the insulating substrate layer 21 is about 1mm-3mm smaller than the width of the insulating substrate layer 21 and the covering layer 25), so that the first slide groove 27 and the second slide groove 29 located on both sides of the sample channel 243 are formed between the insulating substrate layer 21 and the covering layer 25. During installation, the test strip substrate is at least partially embedded in the first slide groove 27 and the second slide groove 29, 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 the specified position. Of course, within the optional range of those skilled in the art, the connection structure between the test strip detection area and the test strip substrate can also be:

[0054] a. A first slide groove 27 is formed on the first side of the test strip detection area, a second slider is formed on the second side opposite to the first side, and the inner side of the second arm 13 of the test strip substrate matched with the second slider is hollowed out. When installed, the test strip substrate (such as 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 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 until it reaches the specified position. b. A first slider is formed on the first side of the test strip detection area, and the inner side of the first arm 12 of the test strip substrate matched with the first slider is hollowed out, and a second slide groove 29 is formed on the second side opposite to the first side. When installed, the first slider is at least partially embedded in the test strip substrate, and the test strip substrate (such as 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 substrate along the length direction of the second slide groove 29 until it reaches the 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 side of the first arm 12 and the second arm 13 of the test strip substrate that cooperate with the first slider and the second slider are hollowed out. When installed, the first slider and the second slider 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 the direction parallel to the first slider and the second slider (the length direction of the first arm and the second arm) until it reaches the 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 the specified position. Specifically, for the test strip substrate, the double-sided adhesive A241 and the double-sided adhesive B242 of the test strip detection area can be used as sliders. When it is embedded in the hollowed-out inner part of the test strip substrate, the hollowing can limit the left and right directions of the test strip detection area (refer to Figure 6 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 6 When all the test strip detection areas are installed on the test strip substrate, there is another rolling process in the up and down direction (refer to Figure 6 The electrode layer 22 of the test strip detection area and the conductive layer 15 on the test strip substrate are firmly adhered to the conductive glue by pressure, and the conductive glue can conduct the electrodes on both sides. At the same time, the conductive glue firmly adheres the test strip detection area and the test strip substrate to limit the displacement of the detection area. The direction in which the test strip detection area moves relative to the test strip substrate is the length direction of the first arm and the second arm.

[0055] like Figure 7 , Figure 8 A test strip substrate is shown, which is used to install the aforementioned test strip detection area, so as to form a test strip (such as a blood sugar test strip, a cholesterol test strip, etc.) for detecting physiological indicators (including but not limited to glucose, cholesterol, blood ketones, etc.). The test strip substrate includes a substrate body 11, on which a first arm 12, a second arm 13 and a conductive layer 15 are formed, and a mounting position 14 for mounting the test strip detection area is formed between the first arm 12 and the second arm 13. When a first slide groove 27 and a second slide groove 29 are formed on the first side and the second side of the test strip detection area, respectively, 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 that the test strip detection area is installed on the mounting position 14, and the electrode layer 22 of the test strip detection area is in contact with the conductive layer 15 on the test strip substrate, so as to transmit the electrical signal from the detection instrument to the reaction area of ​​the test strip detection area to promote the occurrence of the detection reaction, and on the other hand, transmit the electrical signal generated in the reaction area to the detection instrument. 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 glue 18 on the test strip detection area contacts the first contact, and the second conductive glue 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.

[0056] In some practical applications, the substrate body 11 is provided with a bottom protrusion 111 that matches the depression 252 of the test strip detection zone to close the sample channel 243. When the last test strip detection zone that abuts the test strip substrate does not have a depression 252, the substrate body 11 may not be provided with the bottom protrusion 111. When the test strip substrate has only one mounting position 14, the bottom protrusion 111 is provided on the substrate body 11 at a position corresponding to the mounting position 14; after the test strip detection zone is installed on the test strip substrate, the bottom protrusion 111 is embedded in the depression 252 of the test strip detection zone to close the sample channel 243 and prevent the biological sample from continuing to flow outward. Figure 8As shown, when the test strip substrate has five installation positions, the bottom protrusion 111 is provided at the installation position 14 at the end (on the side away from the free ends of the first arm and the second arm) on the substrate body 11; after the five test strip detection areas are installed in the five installation positions in sequence, the five test strip detection areas are connected end to end (the specific connection refers to the three mutually spliced ​​test strip detection areas mentioned above), and the sample channels 243 of the five test strip detection areas are connected in sequence, and the bottom protrusion 111 is embedded in the depression 252 of the end test strip detection area to close the sample channel 243 to prevent the biological sample from continuing to flow outward. In other practical applications, a third contact is provided on the substrate body 11 at a position corresponding to the bottom protrusion 111, and the measurement countdown is started when the biological sample reaches the third contact (at this time, the biological sample fills the entire sample channel), and the detection result is more accurate. Within the optional range of those skilled in the art, the first contact, the second contact and the third contact can be a part of the wire printed on the test strip substrate, or a conductive contact connected to the wire on the test strip substrate, and are all part of the conductive layer 15 of the test strip substrate.

[0057] In other 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 engaging portion on the first arm 12 and the second arm 13 that is adapted to the first engaging portion of the test strip detection area to achieve the engaging 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 engaging portion refers to the first positioning protrusion 2411 and the second positioning protrusion 2421, and the second engaging portion refers to the first positioning recess 121 and the second positioning recess 131.

[0058] During the assembly process, the detection area of ​​the test strip 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; Fig. 9 , Fig.10As 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 substrate along the length direction of the first slide groove 27 and the second slide groove 29 until it reaches the specified position; the first electrode 221 is connected to the first contact on the test strip substrate by the first conductive adhesive 18, and the second electrode 222 is connected to the second contact on the test strip substrate by the second conductive adhesive 19, and the relative positioning of the test strip detection area and the test strip substrate is achieved, thereby completing the assembly of the test strip. When the test strip substrate has only one mounting position 14, when the test strip detection area reaches the specified position, the bottom protrusion 111 is embedded in the recess 252 of the test strip detection area to close the sample channel 243, and at the same time, the first positioning protrusion 2411 is embedded in the first positioning recess 121, and the second positioning protrusion 2421 is embedded in the second positioning recess 131, ensuring that the test strip detection area is embedded in place. When the test strip substrate has multiple installation positions, when the test strip detection area reaches the specified position, 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.

[0059] The examples in the above-mentioned implementation schemes are intended to further help understand the solutions of the utility model, and are not intended to limit the technical solutions of the present invention. Although the utility model 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 make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the utility model.

Claims

1. A test strip detection zone, comprising: An insulating substrate layer (21); An electrode layer (22) is located on the insulating substrate layer (21); A reaction layer (23), located on the electrode layer (22), having a reaction area; A channel layer (24), located above the reaction layer (23), having a sample channel (243) at a position corresponding to the reaction area; A cover layer (25) located on the channel layer (24); The invention is characterized in that: the test strip detection area is used to be installed on the test strip substrate to form a test strip, at least one of the first side and the second side of the test strip detection area has a slide groove or a slider, and the first side and the second side are respectively located on both sides of the sample channel (243).

2. The test strip detection zone according to claim 1, characterized in that: The first side and the second side of the test strip detection area both have slide grooves; or the first side and the second side of the test strip detection area both have sliders; or one of the first side and the second side of the test strip detection area has a slider and the other has a slide groove.

3. The test strip detection zone according to claim 1, characterized in that: 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 slide groove.

4. The test strip detection zone according to claim 1, characterized in that: A protrusion (251) is provided on the cover layer (25) corresponding to the inlet of the sample channel (243), and a depression (252) matching the protrusion (251) is provided on the cover layer (25) corresponding to the outlet of the sample channel (243).

5. The test strip detection zone according to claim 1, characterized in that: The electrode layer comprises a first electrode (221) and a second electrode (222); the first electrode (221) is attached with a first conductive adhesive (18) for connecting to a conductive layer (15) on a test strip substrate; the second electrode (222) is attached with a second conductive adhesive (19) for connecting to a conductive layer (15) on a test strip substrate.

6. The test strip detection zone according to claim 5, characterized in that: 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 glue (18) comprises a conductive glue A (181) attached to the electrode A (2211) and a conductive glue 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 glue (19) comprises a conductive glue C (191) attached to the electrode C (2221) and a conductive glue D (192) attached to the electrode D (2222).

7. The test strip detection zone according to claim 1, characterized in that: A first engaging portion for cooperating with the test strip substrate to achieve engaging positioning is formed on the first side and / or the second side of the test strip detection area.

8. A test strip substrate, characterized in that: Used for installing a test strip detection area, the test strip detection area comprising 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 sample channel (243) located on the reaction layer (23) and arranged corresponding to the reaction area, and a slide groove or a slider formed on at least one of a first side and a second side of the test strip detection area; the first side and the second side are respectively located on two sides of the sample channel (243); The test strip substrate comprises a substrate body (11), on which a first arm (12), a second arm (13) and a conductive layer (15) are formed, a mounting position (14) for mounting the test strip detection area is formed between the first arm (12) and the second arm (13), at least one of the first arm (12) and the second arm (13) is matched with a slide groove or a slider to realize the mounting of the test strip detection area on the mounting position (14), and the electrode layer (22) and the conductive layer (15) are in contact.

9. The test strip substrate according to claim 8, characterized in that: A first slide groove (27) and a second slide groove (29) are formed on the first side and the second side respectively; the first arm (12) is at least partially embedded in the first slide groove (27); the second arm (13) is at least partially embedded in the second slide groove (29); the test strip detection area is installed on the installation position (14); and the electrode layer (22) and the conductive layer (15) are in contact.

10. The test strip substrate according to claim 8, characterized in that: A depression (252) is provided on the detection area of ​​the test strip corresponding to the outlet end of the sample channel (243), and a bottom protrusion (111) matching the depression (252) to close the sample channel (243) is provided on the substrate body (11).

11. The test strip substrate according to claim 8, characterized in that: A first engaging portion is formed on the first side and / or the second side, 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.

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