Electrochemiluminescence lateral flow gene detection reagent strip and kit

Abstract

The utility model discloses an electrochemical luminescence lateral flow gene detection reagent strip and a kit, the electrochemical luminescence lateral flow gene detection reagent strip comprises an electrode and two hydrophilic channels A and B, and the electrode and the two hydrophilic channels are partially overlapped; the hydrophilic channels A and B are distributed on the sample adding sheet, the combination sheet, the detection sheet and the absorption sheet; the electrodes comprise an integrated bipolar electrode and a pair of driving electrodes; the integrated bipolar electrode comprises a cathode and at least two anodes which are connected in parallel; wherein the integrated bipolar electrode anode close to the sample adding sheet is called a quality control anode, and the integrated bipolar electrode anode close to the absorption sheet is called a detection anode. The electrode plate of the detection reagent strip is a closed bipolar electrode, and the anodes of the two bipolar electrodes are symmetrically distributed in parallel, so that the area of the electrode is reduced, the occupied space of the electrode is reduced, a plurality of detection anodes can be arranged, and the detection reagent strip has the potential of multi-path multi-element detection.

Description

Technical Field

[0001] The utility model belongs to the field of microfluidic detection, and specifically relates to an electrochemiluminescent lateral flow gene detection reagent strip and a reagent kit. Background Art

[0002] Microfluidics is a technology that can precisely control and manipulate microscale fluids, and can achieve automation and efficiency in the entire process of analysis and processing. Microfluidics detection devices based on this technology have the advantages of low sample consumption, fast detection speed, simple operation, multi-functional integration, small size and portability. Therefore, it has developed very rapidly in recent years and has become a research hotspot in the field of point-of-care testing (POCT). It has played an increasingly important role in many on-site instant detection fields, and has also shown great prospects for application in disease diagnosis.

[0003] Genetic testing refers to the technology of testing genes through blood or other body fluids. In many infectious diseases, the quantification of pathogens has been proven to be a useful prognostic indicator and an important reference for monitoring treatment response. Most of the existing genetic testing technologies have cumbersome steps, long testing cycles, and high operating requirements. They cannot meet the requirements of rapid screening and quantitative testing, and it is also difficult to test large quantities of samples. Therefore, it is necessary to develop a pathogen gene detection device that can meet the needs of hospital diagnosis and home self-examination.

[0004] Analytical sensing technologies based on physics and chemistry have been developing continuously along with scientific progress and have shown extremely high application value. At present, the electrochemiluminescence detection device based on microfluidic technology combines the advantages of low electrochemiluminescence background, high sensitivity, wide detection range and good controllability with the portability and high integration of microfluidics, and has developed into a powerful analytical sensing technology, which has been widely used in basic research, environmental monitoring, clinical diagnosis, immunoassay and food safety.

[0005] Reagent strips based on lateral flow detection (i.e. lateral flow reagent strips or chromatography reagent strips) have been widely used in rapid detection. The principle is mainly based on capillary forces and the specific interaction between target molecules and labeled probes (or antibodies, antigens). Lateral flow reagent strips are paper materials that integrate advanced materials such as nanomaterials, polymers, and biomaterials to achieve basic operations in the analysis process. This detection method is low-cost and easy to use. It is widely used in medical diagnosis, home testing, POCT or laboratory use. It also provides ideas for building a low-cost, efficient and convenient new analysis platform. Summary of the invention

[0006] The utility model aims to provide an electrochemiluminescent lateral flow gene detection reagent strip and kit, which solves the problems of complex operation, high cost and long time consumption in the current nucleic acid detection process, and can realize rapid quantification and high specificity and high sensitivity detection of pathogens.

[0007] The purpose of the utility model is achieved through the following technical solutions:

[0008] An electrochemiluminescent lateral flow gene detection reagent strip comprises an electrode and two hydrophilic channels A and B, wherein the electrode and the two hydrophilic channels partially overlap;

[0009] The hydrophilic channels A and B are distributed on the sample adding sheet, the binding sheet, the detection sheet and the absorption sheet;

[0010] The sample adding sheet is used to drop the sample solution to be tested and make the sample solution to be tested flow to the binding sheet;

[0011] The binding sheet is used to dry the signal probe marked with electrochemical luminescent material, one end of which is connected to the detection sheet and the other end is connected to the sample addition sheet;

[0012] The electrodes are located on the electrode sheet;

[0013] The electrode comprises an integrated bipolar electrode and a pair of driving electrodes (a negative electrode and a positive electrode); the integrated bipolar electrode comprises a cathode and at least two anodes connected in parallel; wherein the integrated bipolar electrode anode close to the sample adding sheet is called a quality control anode, and the integrated bipolar electrode anode close to the absorption sheet is called a detection anode;

[0014] During sample addition detection, the anode of the integrated bipolar electrode and the corresponding negative electrode of the driving electrode are located in the reporting channel, and the cathode of the integrated bipolar electrode and the corresponding positive electrode of the driving electrode are located in the supporting channel;

[0015] The detection sheet overlaps with the integrated bipolar electrode; wherein the one overlapping with the anode of the integrated bipolar electrode is called hydrophilic channel A, and the other hydrophilic channel is hydrophilic channel B;

[0016] The portion of the hydrophilic channel A that overlaps with the quality control anode is called the quality control zone (C zone), and the portion of the hydrophilic channel A that overlaps with the detection anode is called the detection zone (T zone). The C zone and the T zone are used to modify and fix the capture probes in the quality control zone and the capture probes in the detection zone, respectively, so as to monitor the feasibility of the reagent strip and the concentration of the target DNA (T-DNA);

[0017] A bottom plate may be arranged under the sample adding sheet, the binding sheet, the detection sheet, the electrode sheet or the absorption sheet.

[0018] An electrochemiluminescent lateral flow gene detection kit, comprising the above-mentioned detection reagent strip;

[0019] The detection kit further comprises an upper cover, a transparent cover plate and a lower cover;

[0020] The reagent strip is fixed on the lower cover, and the transparent cover plate covers the binding sheet, the detection sheet, the electrode sheet and the absorption sheet (partially covered) of the reagent strip;

[0021] The upper cover is covered on the transparent cover plate;

[0022] The upper cover is provided with a sample addition hole, a buffer addition hole, an observation window and an electrode contact area;

[0023] The sample addition hole and buffer addition hole correspond to the hydrophilic channel A and the hydrophilic channel B on the sample addition sheet respectively;

[0024] The observation window corresponds to the quality control area and the detection area located in the hydrophilic channel A on the test piece;

[0025] The electrode contact area corresponds to the driving electrode.

[0026] The principle of the detection reagent strip of the utility model to achieve detection is:

[0027] The capture probe modified with biotin and streptavidin are incubated at room temperature, and the capture probe is modified on the corresponding area on the detection sheet by streaking with a film streaker. The affinity between biotin and streptavidin fixes the capture probe on the detection sheet, thereby improving the fixation efficiency and stability of the capture probe. The fixed capture probe hybridizes with T-DNA, thereby fixing the finally formed hybrid complex on the detection area.

[0028] When the sample solution containing T-DNA is dripped onto the sample adding sheet of the reagent strip, the solution flows through the binding sheet, and the T-DNA hybridizes with the modified T-region signal probe on the binding sheet to form a "T-region signal probe-T-DNA" complex; the complex further flows to the detection sheet, and after sufficient hybridization reaction, a "T-region signal probe-T-DNA-T-region capture probe" hybridization complex is formed. At the same time, the C-region signal probe hybridizes with the C-region capture probe to form a "C-region signal probe-C-region capture probe" hybridization complex; after the reaction is completed, a buffer solution is dripped into the hydrophilic channel A on the sample adding sheet to wash away the unbound signal probes in the detection zone on the one hand, and to fill the hydrophilic channel A with the solution on the other hand; at the same time, a buffer solution is dripped into the hydrophilic channel B to connect the circuit; finally, the positive and negative electrodes of the driving electrode of the reagent strip are connected to the power supply, and an appropriate voltage is applied to trigger the electrochemical luminescence reaction.

[0029] The self-enhanced electrochemiluminescent probe in the hybrid complex is coupled with a terpyridine ruthenium-polylysine complex, which is enriched with a large number of luminescent groups and can effectively amplify the electrochemiluminescent signal to achieve ultra-sensitive quantitative detection of T-DNA.

[0030] Compared with the prior art, the utility model has the following advantages and effects:

[0031] 1. The detection piece of the detection reagent strip of the utility model adopts nitrocellulose membrane. Compared with the traditional electrochemical luminescence chip, the modification operation is simple, the reaction is fast and sensitive, the detection result is more stable, and the false positive result caused by solution residue is avoided to a certain extent.

[0032] 2. In addition to the test piece, the test reagent strip of the utility model can use cloth, paper, glass fiber membrane and other materials as the substrate. The materials are simple, easy to obtain and environmentally friendly, with lower costs and convenient for mass production.

[0033] 3. The electrode sheet of the detection reagent strip of the utility model is a closed bipolar electrode, and the two bipolar electrode anodes are symmetrically distributed in parallel, which not only reduces the electrode area, but also reduces the space occupied by the electrode. Multiple detection anodes can be arranged, and it has the potential for multi-channel multi-electrode detection.

[0034] 4. The detection reagent strip and kit of the utility model are small and portable, and do not require large instruments as the basis for detection. Compared with traditional electrochemiluminescence analyzers, they are simple to operate and easy to carry. They can be used for POCT applications in different scenarios and meet the needs of home self-test kits. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 This is a schematic diagram of the structural decomposition of the electrochemiluminescent lateral flow gene detection reagent strip.

[0036] Figure 2 This is a schematic diagram of the overall structure of the electrochemiluminescent lateral flow gene detection reagent strip.

[0037] Figure 3 This is a schematic diagram of the composition and structure of the electrode sheet of the electrochemiluminescent lateral flow gene detection reagent strip.

[0038] Figure 4 This is a schematic diagram of the structural decomposition of the electrochemiluminescent lateral flow gene detection kit.

[0039] Figure 5 This is a schematic diagram of the overall structure of the electrochemiluminescent lateral flow gene detection kit.

[0040] Figure 6 This is a bar graph showing the electrochemiluminescence T / C values ​​of CRISPR / Cas12a cis-cleavage products of PCR amplification products at different concentrations.

[0041] Figure 7 This is a bar graph of the electrochemiluminescence T / C values ​​of the convection PCR amplification product at different dilution multiples.

[0042] Figure 8This is a bar graph of the electrochemiluminescence T / C values ​​of the convection PCR amplification products at different amplification times after 100-fold dilution.

[0043] Among them: 1-sample adding sheet; 2-binding sheet; 3-detection sheet; 4-electrode sheet; 5-absorption sheet; 6-bottom plate; 7-support channel; 8-reporting channel; 9-bipolar electrode quality control anode; 10-bipolar electrode detection anode; 11-driving electrode negative electrode; 12-driving electrode positive electrode; 13-bipolar electrode cathode; 14-upper cover; 15-transparent cover; 16-electrochemiluminescent lateral flow gene detection reagent strip; 17-lower cover; 18-sample adding hole; 19-buffer adding hole; 20-observation window; 21-electrode contact area. DETAILED DESCRIPTION

[0044] The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments, but the implementation methods of the present invention are not limited thereto.

[0045] Example 1

[0046] The design and production of electrochemiluminescent lateral flow gene detection reagent strips and kits include the following steps:

[0047] (1) Design of test strips

[0048] The electrochemiluminescent lateral flow gene detection reagent strip comprises an electrode and two hydrophilic channels A and B, such as Figure 1 and Figure 2 As shown, the electrode partially overlaps with the two hydrophilic channels;

[0049] The hydrophilic channels A and B are distributed on the sample adding sheet 1, the binding sheet 2, the detection sheet 3 and the absorption sheet 5;

[0050] The sample adding sheet 1 is used to drop the sample solution to be tested, and can perform chromatography filtration on the sample solution to be tested, quickly absorb the sample solution to be tested and flow to the binding sheet 2;

[0051] The binding sheet 2 is used to dry the signal probe marked with electrochemical luminescent material. One end of the binding sheet is connected to the detection sheet 3 and the other end is connected to the sample adding sheet 1, thus constructing a good flow channel for the sample to be tested.

[0052] The electrodes are located on the electrode sheet 4;

[0053] The electrodes include an integrated bipolar electrode and a pair of driving electrodes (a cathode 11 and a cathode 12). Figure 3 As shown; the integrated bipolar electrode comprises a cathode (13) and at least two anodes (9 and 10) connected in parallel; wherein the integrated bipolar electrode anode close to the sample adding sheet 1 is called the quality control anode 9, and the integrated bipolar electrode anode close to the absorption sheet 5 is called the detection anode 10;

[0054] During sample addition detection, the anode (9 and 10) of the integrated bipolar electrode and the corresponding driving electrode cathode 11 are located in the reporting channel 8, and the cathode 13 of the integrated bipolar electrode and the corresponding driving electrode cathode 12 are located in the supporting channel 7;

[0055] The detection sheet 3 overlaps with the integrated bipolar electrode; the one overlapping with the anode (9 and 10) of the integrated bipolar electrode is called the hydrophilic channel A, and the other hydrophilic channel is the hydrophilic channel B.

[0056] The portion of the hydrophilic channel A corresponding to the quality control anode 9 is called the quality control zone (C zone), and the portion of the hydrophilic channel A corresponding to the detection anode 10 is called the detection zone (T zone). The C zone and the T zone are respectively used to modify the capture probe of the fixed quality control zone (i.e., the C zone capture probe) and the capture probe of the detection zone (i.e., the T zone capture probe) for monitoring the feasibility of the reagent strip and the T-DNA concentration.

[0057] A bottom plate 6 may be arranged under the sample adding sheet 1 , the binding sheet 2 , the detection sheet 3 , the electrode sheet 4 and the absorption sheet 5 .

[0058] (2) Preparation of test strips

[0059] The shapes of the hydrophilic channels and electrodes in the sample adding sheet 1, the binding sheet 2, the detection sheet 3, the electrode sheet 4 and the absorption sheet 5 were designed using the drawing software Adobe Illustrator CS6, and a 300-mesh polyester microchannel screen and an electrode screen were made accordingly.

[0060] The sample sheet 1, the binding sheet 2 and the absorption sheet 5 are made by PP ink screen printing technology, and a hydrophilic channel surrounded by hydrophobic ink is formed by screen printing non-woven fabric with ink; the detection sheet 3 is made by cutting nitrocellulose membrane into a specific size; the electrode sheet 4 is made by screen printing hydrophobic cloth with conductive carbon ink.

[0061] (3) Structure of the electrochemiluminescent lateral flow gene detection kit

[0062] The structure of the electrochemiluminescent lateral flow gene detection kit is as follows Figure 4 and Figure 5 As shown, it includes an upper cover 14, a transparent cover plate 15, a reagent strip 16 and a lower cover 17.

[0063] The reagent strip 16 is fixed on the lower cover 17, and the transparent cover plate 15 covers the binding sheet 2, the detection sheet 3, the electrode sheet 4 and the absorption sheet 5 (partially covered) of the reagent strip 16;

[0064] The upper cover 14 covers the transparent cover plate 15;

[0065] The upper cover 14 is provided with a sample addition hole 18, a buffer addition hole 19, an observation window 20 and an electrode contact area 21;

[0066] The sample addition hole 18 and the buffer addition hole 19 correspond to the sample addition sheet 1 of the hydrophilic channel A and the hydrophilic channel B respectively;

[0067] The observation window 20 corresponds to the C area and the T area located in the hydrophilic channel A on the detection sheet 3;

[0068] The electrode contact area 21 corresponds to the driving electrodes (the cathode 11 and the anode 12 ).

[0069] Example 2

[0070] The application of the electrochemiluminescent lateral flow gene detection reagent strip and kit of Example 1 in detecting CRISPR / Cas12a cis-cleavage products is as follows:

[0071] (1) DNA extraction

[0072] The strain to be tested was cultured, and the DNA of Escherichia coli O157:H7 was extracted using a magnetic bead method. The obtained DNA solution was stored at -20°C for future use.

[0073] (2) Polymerase chain reaction (PCR) amplification

[0074] Take a PCR tube, add 5μL DNA solution, 5μL Taq buffer (10×), 4μL dNTP (2.5mM), 0.24μL Taq enzyme (5U / μL), 1μL upstream and downstream primers (10μM) (designed according to the target sequence), mix well and place in a common PCR instrument for amplification. The amplification parameters are set to 2min thermal denaturation at 95℃, followed by 35 thermal cycles (95℃, 15s; 60℃, 30s). After the cycle is completed, the temperature is lowered to 4℃ and maintained for a period of time. The concentration of the obtained PCR amplification product is measured by UV spectrophotometer to be 460μg / μL, and the obtained amplification product is stored at -20℃ for standby use.

[0075] (3) CRISPR / Cas12a cis-cleavage

[0076] Take a PCR tube, add 2 μL reaction buffer (10×), 2 μL crRNA (2 μM) (designed according to the target sequence), 2 μL Cas12a (1 mM), 12 μL nuclease-free water, and then add 2 μL amplification product (T-DNA) (460, 46 or 4.6 μg / μL), mix well and place at 45 ° C for 3 min, then heat to 95 ° C to inactivate the Cas protein, and immediately put on ice after 3 min to prevent the cut product (sequencing) from reforming the double-stranded structure, and store the solution of CRISPR / Cas12a cis-cut product at -20 ° C for subsequent detection.

[0077] (4) Designing the DNA sequence required for the gene detection reagent strip according to the CRISPR / Cas12a cis-cleavage product sequence, including the C region signal probe S1, the T region signal probe S2, the C region capture probe CP1 and the T region capture probe CP2.

[0078] (5) Modification of test strips

[0079] 6 μL of signal probe solution (mixed solution of C-region signal probe S1 and T-region signal probe S2) was added dropwise to the hydrophilic channel A of the pretreated binding sheet 2 and placed in a vacuum dryer at 37°C for about 30 minutes; the signal probe was coupled with a terpyridine ruthenium-polylysine complex.

[0080] For detection sheet 3, firstly, 5% sucrose, 5% trehalose, and 0.5 mg / mL streptavidin were mixed with C-region capture probe CP1 and T-region capture probe CP2 (50 μM each), and placed at room temperature for 30 min; then, the two mixed solutions were streaked on the hydrophilic channel A of detection sheet 3 using a film streaker, thereby fixing the capture probes on the C and T regions of detection sheet 3.

[0081] (6) Assembling the test kit

[0082] like Figure 1 As shown, the detection reagent strip is based on a bottom plate 6 with adhesive on one side, and is assembled by stacking an absorption sheet 5, an electrode sheet 4, a detection sheet 3, a binding sheet 2, and a sample adding sheet 1 in sequence.

[0083] like Figure 4 , 5 As shown, the assembled detection reagent strip 16 is placed in the lower cover 17 of the housing, and the transparent cover plate 15 covers the reagent strip 16 to fix the reagent strip and provide a stable detection environment, and the upper cover 14 is pressed to assemble the detection kit.

[0084] (7) Electrochemiluminescence detection

[0085] Take 20 μL of CRISPR / Cas12a cis-cleavage product solution and drip it onto the sample plate 1 through the sample hole 18. After the solution flows to and fills the detection plate 3, wait for the hybridization reaction for 3 minutes. Add 30 μL of phosphate buffer (PBS) to the sample plate 1 through the sample hole 18. On the one hand, wash away the unbound signal probe on the detection area, and on the other hand, fill the reporting channel 8 with solution; at the same time, add 20 μL of PBS to the support channel 7 through the buffer addition hole 19 to connect the circuit. Then, the driving electrode cathode 11 and the cathode 12 of the electrode plate 5 are connected to the DC power supply through the alligator clip wire, and 8.5V voltage is applied to trigger the electrochemical luminescence reaction.

[0086] (8) Data collection and processing

[0087] The luminescent images were collected and analyzed by the instrument (invention patent application number 202210518683.4), and the obtained data were imported into the Origin software for further analysis and processing, and the data relationship between the T / C value (the ratio of the luminescent intensity in the T zone to the luminescent intensity in the C zone) and the concentration of the PCR amplification product was obtained (each data point was calculated using 5 repeated experiments).

[0088] The test results are as follows Figure 6 As shown, it can be seen that: with the increase of the concentration of PCR amplification product, the T / C value gradually increases, and the T / C values ​​between different concentrations are clearly distinguished. It can be seen that the electrochemiluminescent lateral flow gene detection reagent strip and kit of the utility model have the ability to detect CRISPR / Cas12a cis-cleavage products.

[0089] Example 3

[0090] The application of the electrochemiluminescent lateral flow gene detection reagent strip and kit of Example 1 in detecting convection PCR products is as follows:

[0091] (1) DNA extraction

[0092] The strain to be tested was cultured, and the DNA of Escherichia coli O157:H7 was extracted using a bacterial genomic DNA rapid extraction kit (Shanghai Sangon Biotechnology Co., Ltd.), diluted 100 times with ultrapure water, and the obtained DNA solution was stored at -20°C for future use.

[0093] (2) Convection PCR amplification

[0094] Take a PCR tube and add 2 μL 10× PCR buffer (containing Mg 2+), 1 μL dNTP (2.5mM), 1.6 μL upstream and downstream primers (2.5 μM) (designed according to the target sequence), 0.16 μL Ex Taq DNA polymerase (5U / μL), 1.6 μL DNA solution and 12.24 μL ultrapure water, mixed evenly. After centrifugation, the solution was transferred to a convection tube, and 2 μL silicone oil was added after another centrifugation to complete the preparation of the reaction solution in the convection tube. Next, the convection tube was placed in a convection PCR instrument and heated at a constant temperature for several minutes for PCR amplification. After the PCR is completed, the amplified product is aspirated and diluted to the corresponding multiple by adding ultrapure water. The obtained amplified product dilution is melted by heating at 98°C for 4 minutes, and then the product after high temperature heating is quickly transferred to ice to obtain a single-stranded amplified product and stored at -20°C for subsequent detection.

[0095] (3) The DNA sequence required for the gene detection reagent strip is designed according to the amplification product sequence of the convection PCR, including the T region signal probe S3 and the T region capture probe CP3 (the C region signal probe S1 and the capture probe CP1 are the same as those in Example 2).

[0096] (4) Modification of test strips

[0097] The modification process is similar to that of Example 2, and the probes used are as follows: C-region signal probe S1, T-region signal probe S3; C-region capture probe CP1, T-region capture probe CP3.

[0098] (5) The detection kit was assembled as in Example 2

[0099] (6) Electrochemiluminescence detection is the same as in Example 2

[0100] (7) Data collection and processing are the same as in Example 2

[0101] Different dilutions of the convection PCR amplification product were tested. The convection PCR amplification time was 35 min, and the dilution factors of the amplification product were 10, 10 2 , 10 3 , 10 4 times, the corresponding electrochemiluminescence detection results are as follows Figure 7 As shown, it can be seen that: as the dilution multiple of the convective PCR amplification product increases, the T / C value shows a gradually decreasing trend, which indicates that the electrochemiluminescent lateral flow gene detection reagent strip and kit of the utility model patent have the potential to detect convective PCR amplification products.

[0102] The convection PCR amplification products with different amplification times were detected. The convection PCR amplification times were 35min, 30min, 25min, 20min, 15min and 10min, respectively. The obtained amplification products were diluted 100 times. The corresponding electrochemiluminescence detection results are shown as follows: Figure 8 As shown, the change of T / C value in the figure shows that: on the one hand, within 25 minutes, as the amplification time gradually increases, the number of amplified products tends to increase gradually, and basically reaches a plateau after 25 minutes. On the other hand, even if the amplification time is 10 minutes and the amplified product is diluted 100 times, the corresponding electrochemiluminescence intensity is much higher than the background value, which shows that the electrochemiluminescence lateral flow gene detection reagent strip and kit of the utility model patent combined with convection PCR have the potential for rapid detection.

[0103] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited by the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principle of the present invention should be equivalent replacement methods and are included in the protection scope of the present invention.

Claims

1. An electrochemiluminescent lateral flow gene detection reagent strip, characterized in that: It includes an electrode and two hydrophilic channels A and B, and the electrode partially overlaps with the two hydrophilic channels; The hydrophilic channels A and B are distributed on the sample adding sheet, the binding sheet, the detection sheet and the absorption sheet; The electrode comprises an integrated bipolar electrode and a pair of driving electrodes; the integrated bipolar electrode comprises a cathode and at least two anodes connected in parallel; wherein the integrated bipolar electrode anode close to the sample adding sheet is called a quality control anode, and the integrated bipolar electrode anode close to the absorption sheet is called a detection anode; The detection sheet overlaps with the integrated bipolar electrode; wherein the one overlapping with the anode of the integrated bipolar electrode is called hydrophilic channel A, and the other hydrophilic channel is hydrophilic channel B.

2. The detection reagent strip according to claim 1, characterized in that: The electrodes are located on the electrode sheet.

3. The detection reagent strip according to claim 1, characterized in that: During sample addition detection, the anode of the integrated bipolar electrode and the corresponding negative electrode of the driving electrode are located in the reporting channel, and the cathode of the integrated bipolar electrode and the corresponding positive electrode of the driving electrode are located in the supporting channel.

4. The detection reagent strip according to claim 1, characterized in that: The portion of the hydrophilic channel A that overlaps with the quality control anode is called the quality control area, and the portion of the hydrophilic channel A that overlaps with the detection anode is called the detection area.

5. The detection reagent strip according to claim 1, characterized in that: A bottom plate is arranged under the sample adding sheet, the combining sheet, the detecting sheet, the electrode sheet or the absorbing sheet.

6. An electrochemiluminescent lateral flow gene detection kit, characterized in that: A detection reagent strip comprising any one of claims 1 to 5.

7. The detection kit according to claim 6, characterized in that: The detection kit also includes an upper cover, a transparent cover plate and a lower cover.

8. The detection kit according to claim 7, characterized in that: The reagent strip is fixed on the lower cover, and the transparent cover plate covers the binding sheet, the detection sheet, the electrode sheet and the absorption sheet of the reagent strip; The upper cover is covered on the transparent cover plate.

9. The detection kit according to claim 7, characterized in that: The upper cover is provided with a sample addition hole, a buffer addition hole, an observation window and an electrode contact area.

10. The detection kit according to claim 9, characterized in that: The sample addition hole and buffer addition hole correspond to the hydrophilic channel A and the hydrophilic channel B on the sample addition sheet respectively; The observation window corresponds to the quality control area and the detection area located in the hydrophilic channel A on the detection sheet.

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