Test strip detection area and test strip substrate

Abstract

The utility model relates to a test strip detection area and a test strip substrate matched with the test strip detection area. The test strip detection area is used for detecting physiological indexes in samples such as blood. According to the technical scheme, a first reaction layer is located on a first electrode layer and provided with a first reaction area; the channel layer is positioned on the first reaction layer; the test strip detection area is used for being mounted on a test strip substrate to form a test strip, and the second reaction layer is positioned on the channel layer and is provided with a second reaction area; the second electrode layer is located on the second reaction layer; the covering layer is positioned on the second electrode layer; sample channels are formed in positions, corresponding to the first reaction region and the second reaction region, on the channel layer. The test strip has the advantages that the test strip is of a split structure, even if unqualified products appear in the test strip detection area 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] A first electrode layer, located on the insulating substrate layer;

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

[0010] a channel layer, located above the first reaction layer;

[0011] The test strip detection area is used to be installed on the test strip substrate to form a test strip, and it also includes:

[0012] A second reaction layer, located above the channel layer, having a second reaction area;

[0013] A second electrode layer, located on the second reaction layer;

[0014] a covering layer, located on the second electrode layer;

[0015] The channel layer is provided with sample channels at positions corresponding to the first reaction area and the second reaction area.

[0016] Preferably, a first slide groove or a first slider is formed on a first side of the detection zone of the test strip, and a second slide groove or a second slider is formed on a second side opposite to the first side; the first side and the second side are respectively located on two sides of the sample channel.

[0017] Preferably, the projection width of the channel layer in a direction perpendicular to the insulating substrate layer is slightly smaller than the widths of the insulating substrate layer and the covering layer, so as to form the first slide groove and / or the second slide groove.

[0018] 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.

[0019] Preferably, the first electrode layer includes a first electrode and a second electrode, and the first electrode and the second electrode are respectively attached with a first conductive glue and a second conductive glue for connecting to the first conductive layer on the test strip substrate; the second electrode layer includes a third electrode and a fourth electrode, and the third electrode and the fourth electrode are respectively attached with a third conductive glue and a fourth conductive glue for connecting to the second conductive layer on the test strip substrate.

[0020] 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; 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; the second conductive glue includes conductive glue C attached to electrode C and conductive glue D attached to electrode D; the third electrode includes electrode E, electrode F, and resistor EF whose two ends are electrically connected to electrode E and electrode F respectively; the third conductive glue includes conductive glue E attached to electrode E and conductive glue F attached to electrode F; the fourth electrode includes electrode G, electrode H, and resistor GH whose two ends are electrically connected to electrode G and electrode H respectively; the fourth conductive glue includes conductive glue G attached to electrode G and conductive glue H attached to electrode H.

[0021] 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.

[0022] A test strip substrate for mounting the test strip detection area;

[0023] The test strip substrate comprises a substrate body, on which a first arm, a second arm, a first conductive layer, and a second conductive layer are formed, and a mounting position for mounting the test strip detection area is formed between the first arm and the second arm; when the test strip detection area is mounted at the mounting position, the first electrode layer and the second electrode layer of the test strip detection area are in contact with the first conductive layer and the second conductive layer of the test strip substrate, respectively.

[0024] Preferably, a first slide groove and a second slide groove are respectively formed on the first side and the second side of the test strip detection area, 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 installation of the test strip detection area on the installation position.

[0025] Preferably, the substrate body is provided with a bottom protrusion matching with the recess to close the sample channel.

[0026] Preferably, a second engaging portion adapted to 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.

[0027] The beneficial effects of the utility model are:

[0028] 1. The detection area of ​​the test strip and the test strip substrate are independent of each other, and after being installed together, a test strip for realizing physiological index detection is formed. That is, the test strip adopts a split structure. Even if the detection area of ​​the test strip is unqualified during the liquid dosing process, the unqualified detection area of ​​the test strip 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.

[0029] 2. A first reaction layer and a first electrode layer, as well as a second reaction layer and a second electrode layer are respectively arranged on both sides of the channel layer to form a double-sided detection area. The sample channel of the same channel layer is used to provide biological samples for the two detection areas, that is, double the number of detections can be achieved on the same electrode length, which not only reduces the material cost of the test strip, but also reduces the sample demand.

[0030] 3. If a single-sided detection area structure is used to achieve double the number of detections, two single-sided detection areas are required. However, the double-sided detection area structure of the utility model can save an insulating substrate layer, a double-sided adhesive layer and a covering layer (hydrophilic film), further saving costs.

[0031] 4. The first slide groove or the first slider, and the second slide groove or the second slider cooperate 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.

[0032] 5. 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.

[0033] 6. A first engaging portion is formed on the first side and / or the second side of the test strip detection zone, which can cooperate with a second engaging portion formed on the first arm and / or the second arm of the test strip substrate to achieve engaging positioning of the test strip detection zone. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 This is an exploded view of the detection area of ​​the test strip of the utility model.

[0035] Figure 2 It is a schematic cross-sectional view of the detection area of ​​the test strip of the utility model.

[0036] Figure 3 This is a diagram of the connection structure between the first electrode layer in the detection area of ​​the test strip and the first conductive layer of the test strip substrate of the utility model.

[0037] Figure 4 It is a schematic diagram of the structure of the biological sample flowing in the sample channel of the utility model.

[0038] Figure 5 This is another structural schematic diagram of the biological sample flowing in the sample channel of the utility model.

[0039] Figure 6 It is a schematic diagram of the structure of the detection area of ​​two mutually spliced ​​test strips of the utility model.

[0040] Figure 7 This is a schematic diagram of the front structure of the test strip substrate of the utility model.

[0041] Figure 8 This is a schematic diagram of the back structure of the test strip substrate of the utility model (with a test strip detection area installed).

[0042] Fig. 9 It is a cross-sectional view of the test strip detection area of ​​the utility model installed on the test strip substrate.

[0043] 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, first 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, first 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, first reaction layer-23, first insulating printed layer-231, first reagent layer-232, channel layer-24, double-sided tape A-241, double-sided tape B -242, first positioning protrusion-2411, second positioning protrusion-2421, sample channel-243, covering layer-25, protrusion-251, recess-252, first slide groove-27, second slide groove-29, second conductive layer-15', third conductive glue-18', conductive glue E-181', conductive glue F-182', fourth conductive glue-19', conductive glue G-191', conductive glue H-192', second electrode layer-22', third electrode-221', electrode E-2211', electrode F-2212', resistor EF-2213', fourth electrode-222', electrode G-2221', electrode H-2222', resistor GH-2223', second reaction layer-23', second insulating printed layer-231', second reagent layer-232'. DETAILED DESCRIPTION

[0044] 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.

[0045] like Figure 1 , Figure 2A test strip detection area shown 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 test paper for simultaneously detecting blood sugar, cholesterol and other indicators) 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, a first electrode layer 22 located on the insulating substrate layer 21, a first reaction layer 23 located on the first electrode layer 22 and having a first reaction area, a channel layer 24 located on the first reaction layer 23, a second reaction layer 23' located on the channel layer 24 and having a second reaction area, a second electrode layer 22' located on the second reaction layer 23', and a covering layer 25 located on the second electrode layer; a sample channel 243 is provided on the channel layer 24 at positions corresponding to the first reaction area and the second reaction area. In some practical applications, for the convenience of 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 realize the sliding cooperation 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 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.

[0046] The first electrode layer 22 and the second electrode layer 22' are 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 first reaction area and the second reaction area to promote the occurrence of the detection reaction, and on the other hand, transmit the electrical signal generated by the first reaction area and the second reaction area to the detection instrument. In some practical applications, the first electrode layer 22 at least 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 first conductive layer 15 on the back of 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 first conductive layer 15 on the back of 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 realize the connection between the first electrode 221 and the first contact on the back of the first conductive layer 15 on the back of the test strip substrate, and the second conductive glue 19 is used to realize the connection between the second electrode 222 and the second contact on the back of the first conductive layer 15 on the back of the test strip substrate. The second electrode layer 22' includes a third electrode 221', a fourth electrode 222', a third conductive glue 18' attached to the third electrode 221' and used to connect to the third contact of the second conductive layer 15' on the front of the test strip substrate, and a fourth conductive glue 19' attached to the fourth electrode 222' and used to connect to the fourth contact of the second conductive layer 15' on the front of the test strip substrate. The third electrode 221' and the fourth electrode 222' are respectively a working electrode and a counter electrode. The third conductive glue 18' is used to connect the third electrode 222' to the third contact on the second conductive layer 15' on the front of the test strip substrate, and the fourth conductive glue 19' is used to connect the fourth electrode 222' to the fourth contact on the second conductive layer 15' on the front of the test strip substrate. At the same time, the relative positioning of the test strip detection area and the test strip substrate is achieved. Of course, the conductive glue (including the first conductive glue, the second conductive glue, the third conductive glue, and the fourth conductive glue) can also be arranged on the first conductive layer 15 and the second conductive layer 15' of the test strip substrate. Specifically, the first conductive glue 18 is arranged on the first contact of the first conductive layer 15, the second conductive glue 19 is arranged on the second contact of the first conductive layer 15, the third conductive glue 18' is arranged on the third contact of the second conductive layer 15', and the fourth conductive glue 19' is arranged on the fourth contact of the second conductive layer 15'. The first electrode layer 22 and the first conductive layer 15 and the second electrode layer 22' and the second conductive layer 15' are connected by the conductive glue, so that the first electrode layer 22 and the second electrode layer 22' of the test strip detection area are respectively in contact with the first conductive layer 15 and the second conductive layer 15' of the test strip substrate, 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 arranged on the first electrode layer 22 and the second electrode layer 22' to being arranged on the first conductive layer 15 and the second conductive layer 15', which is a replacement method that is easier for people in this field to think of.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 and curing speed of the adhesive. The double-sided adhesive component is similar to the conductive adhesive, but the conductive particles are removed, and the ratio of each component is different from that of the conductive adhesive. The conductive adhesive and double-sided adhesive used in this scheme are both heat-sensitive, or only the conductive adhesive used is heat-sensitive, and the viscosity is not strong at low temperatures below 15°C, which is conducive to the assembly and matching of the slide grooves or sliders on the first and second sides of the test strip detection area with the first arm and second arm of the test strip substrate; above 40°C, the viscosity increases, and after applying pressure to the conductive adhesive of the test strip, the first electrode layer 22 and the second electrode layer 22' of the test strip detection area are respectively in contact with the first conductive layer 15 and the second conductive layer 15' of the test strip substrate, thereby transmitting the electrical signal from the detection instrument to the first reaction area and the second reaction area of ​​the test strip detection area. The surface of the conductive adhesive may or may not be attached with a release film. The size of the conductive adhesive 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 the following electrode B2212, electrode D2222, electrode F-2212', and electrode H-2222'. Within the optional range of those skilled in the art, the first contact and the second contact can be part of the wire printed on the test strip substrate, or can be a conductive contact connected to the wire on the test strip substrate, and both are part of the first conductive layer 15 of the test strip substrate; similarly, the third contact and the fourth contact can be part of the wire printed on the test strip substrate, or can be a conductive contact connected to the wire on the test strip substrate, and both are part of the second conductive layer 15' of the test strip substrate.

[0047] 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 third electrode 2 21' includes electrode E2211', electrode F2212', and resistor EF2213' whose two ends are electrically connected to electrode E2211' and electrode F2212' respectively; the third conductive glue 18' includes conductive glue E181' attached to electrode E2211' and conductive glue F182' attached to electrode F2212'; the fourth electrode 222' includes electrode G2221', electrode H2222', and resistor GH2223' whose two ends are electrically connected to electrode G2221' and electrode H2222' respectively; the fourth conductive glue 19' includes conductive glue G191' attached to electrode G2221' and conductive glue H192' attached to electrode H2222'. The materials of the electrode A2211, electrode B2212, electrode C2221, electrode D2222, electrode E2211', electrode F2212', electrode G2221', and electrode H2222' can be carbon ink, platinum carbon, silver, silver / silver chloride, gold, palladium, etc. The materials of the resistor AB2213, the resistor CD2223, the resistor EF2213', and the resistor GH2223' can be carbon ink, platinum carbon, silver, silver / silver chloride, gold, palladium, etc.; of course, it can also be: the first electrode 221 includes the electrode A2211 or the electrode B2212, the second electrode 222 includes the electrode C2221, the electrode D2222 and the resistor CD2223 whose two ends are electrically connected to the electrodes C2221 and D2222 respectively; or the first electrode 221 includes the electrode A2211, the electrode B2212 and the resistor AB2213 whose two ends are electrically connected to the electrodes A2211 and B2212 respectively, The electrode 222 includes the electrode C2221 or the electrode D2222; of course, it can also be: the third electrode 221' includes the electrode E2211' or the electrode F2212', and the fourth electrode 222' includes the electrode G2221', the electrode H2222' and the resistor GH2223' whose two ends are electrically connected to the electrode G2221' and the electrode H2222' respectively; or the third electrode 221' includes the electrode E2211', the electrode F2212' and the resistor EF2212' whose two ends are electrically connected to the electrode E2211' and the electrode F2212' respectively, and the fourth electrode 222' includes the electrode G2221' or the electrode H2222'.The resistance values ​​of the resistor AB2213, the resistor CD2223, the resistor EF2213', and the resistor GH2223' can be set to 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.

[0048] In order to conveniently and quickly realize the judgment of the reaction area type (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, resistor CD2223 and reaction area correspondence table described in Table 1, which is only an illustrative explanation for easy 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), resistor AB2213 and resistor CD2223 are printed with corresponding resistance values; after inserting the test strip, the detection instrument judges the reaction area type by detecting the resistance value of resistor AB2213 and / or resistor CD2223.

[0049] Table 1 Correspondence between the built-in resistance and reaction area of ​​the detection instrument

[0050] 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

[0051] 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 3As 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).

[0052] 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).

[0053] Table 2 Resistor value adjustment table

[0054]

[0055]

[0056] Similarly, the above method can also be used to determine the type of reaction area for the second reaction layer 23' and the second electrode layer 22', which will not be described in detail here. The electrode E2211' and the electrode F2212' are electrically connected to the wires 3002' and 3001' on the test strip substrate through the conductive adhesive E181' and the conductive adhesive F182', respectively, and the electrode G2221' and the electrode H2222' are electrically connected to the wires 3003' and 3004' on the test strip substrate through the conductive adhesive G191' and the conductive adhesive H192', respectively.

[0057] The first reaction layer 23 includes a first insulating printed layer 231 located on the first electrode layer 22, the middle of the first insulating printed layer 231 is hollowed out, and the first reagent layer 232 is filled in the hollow to form the first reaction area. The type of enzyme liquid added to the first 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 first insulating printed layer 231 is used to fix the area of ​​the first reaction area, which can limit the excessive diffusion of the enzyme liquid. The material is a non-conductive material, such as polyethylene ink, resin ink, etc. The structure of the second reaction layer 23' is the same as that of the first reaction layer 23, including a second insulating printed layer 231' located on the channel layer 24, the middle of the second insulating printed layer 231' is hollowed out, and the second reagent layer 232' is filled in the hollow to form the second reaction area. The enzyme liquid added to the second 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 second insulating printed layer 231' is used to fix the area of ​​the second reaction area, which can limit the excessive diffusion of the enzyme liquid. The material is a non-conductive material, such as polyethylene ink, resin ink, etc.

[0058] The channel layer 24 includes a double-sided adhesive tape A241 and a double-sided adhesive tape B242 attached to the first reaction layer 23 and the second reaction layer 23' at the same time, and a gap is left between the double-sided adhesive tape A241 and the double-sided adhesive tape B242 to form a sample channel 243, which is arranged corresponding to the first reaction area and the second reaction area, so that the biological sample flowing in the sample channel 243 can flow through the first reaction area and the second reaction area, and react in the first reaction area and the second 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 side and the second side 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 2412 can be only provided on the double-sided adhesive tape B242, so as to form a first fitting portion on the first side or the second side of the test strip detection area for cooperating with the test strip substrate to achieve fitting positioning.

[0059] The covering layer 25 is a hydrophilic film, which is disposed on the second electrode layer 22'. 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 sample channels 243 of each test strip detection area. Figure 4 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 5At 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.

[0060] For ease of understanding, Figure 6 Taking the two mutually spliced ​​test strip detection areas shown as an example, when a biological sample (such as blood, etc.) is added to the sample channel from the inlet side (the side with the protrusion) of the detection area 2002, the biological sample will flow in the sample channel due to capillary action and reach the outlet side (the side with the depression 252) of the detection area 2002. If there is no access to other detection areas on the outlet side of the detection area 2002, the biological sample will stop flowing due to the existence of surface tension. If the outlet side of the detection area 2002 is spliced ​​with the detection area 2001, and the protrusion 251 of the detection area 2001 is embedded in the depression 252 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 will continue to flow 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.

[0061] like Figure 2As shown, in some practical applications, the projection width of the channel layer 24 in the direction perpendicular to the insulating substrate layer 21 is slightly smaller than the width of the insulating substrate layer 21 and the covering layer 25 (for example, the projection width of 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 / or 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 / or the second slide groove 29 until it reaches the specified 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: 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 2Specifically, 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 2 The displacement of the detection area in the left and right directions (as shown in the figure) is limited; when all the detection areas are installed on the substrate, there is another rolling process, in the up and down directions (refer to Figure 2 The first electrode layer 22 and the second electrode layer 22' of the test strip detection area and the first conductive layer 15 and the second 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 of movement of the aforementioned test strip detection area relative to the test strip substrate is the length direction of the first arm and the second arm.

[0062] 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, a first conductive layer 15, and a second 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; when the test strip detection area is installed in the mounting position 14, the first electrode layer 22 and the second electrode layer 22' of the test strip detection area are in contact with the first conductive layer 15 and the second conductive layer 15' of the test strip substrate, respectively.

[0063] In some practical applications, when the first side and the second side of the test strip detection area are respectively formed with the first slide groove 27 and the second slide groove 29, 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 installation of the test strip detection area on the mounting position 14, and the first electrode layer 22 and the second electrode layer 22' of the test strip detection area are respectively in contact with the first conductive layer 15 and the second conductive layer 15' of the test strip substrate, so as to transmit the electrical signal from the detection instrument to the first reaction area and the second reaction area of ​​the test strip detection area to promote the occurrence of the detection reaction, and on the other hand, transmit the electrical signal generated by the first reaction area and the second reaction area to the detection instrument. In some practical applications, a first contact is provided on the first conductive layer 15 of the first arm 12 at a position corresponding to the mounting position 14, a second contact is provided on the first conductive layer 15 of the second arm 13 at a position corresponding to the mounting position 14, a third contact is provided on the second conductive layer 15' of the first arm 12 at a position corresponding to the mounting position 14, and a fourth contact is provided on the second conductive layer 15' of the second arm 13 at a position corresponding to the mounting position 14. After the test strip detection area is installed on the mounting position 14, the first conductive glue 18 on the test strip detection area contacts the first contact, the second conductive glue 19 contacts the second contact, the third conductive glue 18' contacts the third contact, and the fourth conductive glue 19' contacts the fourth contact, thereby realizing the contact between the first electrode layer 22 of the test strip detection area and the first conductive layer 15 of the test strip substrate, and the contact between the second electrode layer 22' of the test strip detection area and the second conductive layer 15' of the test strip substrate.

[0064] 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 7 , 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 12 and the second arm 13) 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 (for specific connection, refer to the two 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 fifth contact is provided on the substrate body 11 at a position corresponding to the bottom protrusion 111, and the measurement countdown starts when the biological sample reaches the fifth contact (at this time, the biological sample fills the entire sample channel), so that the detection result is more accurate. Within the optional range of those skilled in the art, the first contact, the second contact, the third contact, the fourth contact and the fifth contact may be part of the conductive wire printed on the test strip substrate, or may be conductive contacts connected to the conductive wire on the test strip substrate, and are all part of the conductive layer (including the first conductive layer and the second conductive layer) of the test strip substrate. The fifth contact may be arranged on the front or back side of the test strip substrate, and is preferably arranged on the front side of the test strip substrate.

[0065] 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.

[0066] 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. 9As 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 first conductive layer 15 of the test strip substrate by the first conductive adhesive 18, the second electrode 222 is connected to the second contact on the first conductive layer 15 of the test strip substrate by the second conductive adhesive 19, the third electrode 221' is connected to the third contact on the second conductive layer 15' of the test strip substrate by the third conductive adhesive 18', and the fourth electrode 222' is connected to the fourth contact on the second conductive layer 15' of the test strip substrate by the fourth conductive adhesive 19'. At the same time, 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 installation position, 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 to ensure 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, and 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.

[0067] 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); A first electrode layer (22) is located on the insulating substrate layer (21); A first reaction layer (23), located on the first electrode layer (22), having a first reaction area; A channel layer (24), located on the first reaction layer (23); Characterized in that the test strip detection area is used to be installed on the test strip substrate to form a test strip, and it also includes: A second reaction layer (23'), located on the channel layer (24), having a second reaction area; A second electrode layer (22'), located on the second reaction layer (23'); A covering layer (25) located on the second electrode layer (22'); The channel layer (24) has a sample channel (243) at a position corresponding to the first reaction area and the second reaction area.

2. The test strip detection zone according to claim 1, characterized in that: A first slide groove (27) or a first slider is formed on a first side of the test strip detection area, and a second slide groove (29) or a second slider is formed on a second side opposite to the first side; the first side and the second side are respectively located on two sides of the sample channel (243).

3. The test strip detection zone according to claim 2, characterized in that: The projection width of the channel layer (24) in a direction perpendicular to the insulating substrate layer (21) is slightly smaller than the width of the insulating substrate layer (21) and the covering layer (25), so as to form the first slide groove (27) and / or the second slide groove (29).

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 first electrode layer (22) comprises a first electrode (221) and a second electrode (222), and the first electrode (221) and the second electrode (222) are respectively attached with a first conductive glue (18) and a second conductive glue (19) for connecting to a first conductive layer (15) on a test strip substrate; the second electrode layer (22') comprises a third electrode (221') and a fourth electrode (222'), and the third electrode (221') and the fourth electrode (222') are respectively attached with a third conductive glue (18') and a fourth conductive glue (19') for connecting to a second 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); 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); 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); the third electrode (221') The invention comprises an electrode E (2211'), an electrode F (2212'), and a resistor EF (2213') whose two ends are electrically connected to the electrode E (2211') and the electrode F (2212'); the third conductive glue (18') comprises a conductive glue E (181') attached to the electrode E (2211') and a conductive glue F (182') attached to the electrode F (2212'); the fourth electrode (222') comprises an electrode G (2221'), an electrode H (2222'), and a resistor GH (2223') whose two ends are electrically connected to the electrode G (2221') and the electrode H (2222'); the fourth conductive glue (19') comprises a conductive glue G (191') attached to the electrode G (2221') and a conductive glue H (192') attached to the electrode H (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 to install the test strip detection area according to any one of claims 1 to 7; The test strip substrate comprises a substrate body (11), on which a first arm (12), a second arm (13), a first conductive layer (15), and a second conductive layer (15') are formed; a mounting position (14) for mounting the test strip detection zone is formed between the first arm (12) and the second arm (13); when the test strip detection zone is mounted at the mounting position (14), the first electrode layer (22) and the second electrode layer (22') of the test strip detection zone are in contact with the first conductive layer (15) and the second conductive layer (15') of the test strip substrate, respectively.

9. The test strip substrate according to claim 8, characterized in that: A first slide groove (27) and a second slide groove (29) are respectively formed on the first side and the second side 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 that the test strip detection area is installed on the installation position (14).

10. The test strip substrate according to claim 8, characterized in that: When claim 8 refers to claim 4, a bottom protrusion (111) matching with the recess (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: When claim 8 refers to claim 7, a second engaging portion adapted to the first engaging portion is formed on the first arm (12) and / or the second arm (13) to achieve engaging and positioning of the test strip detection area and the test strip substrate.

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