CN215415461U - Novel lateral chromatography detects device - Google Patents

Abstract

The utility model provides a novel lateral chromatography detection device. Specifically, the novel lateral flow assay comprises a reagent strip; the reagent strip comprises a plurality of reagent strips arranged in sequence along the chromatography direction: (a) a release pad; (b) a marker pad; (c) a fibrous membrane; the fiber membrane is sequentially provided with the following components in the chromatography direction: (c1) a washing liquid addition zone; (c2) a sample adding area; and (c3) a test zone comprising: detecting lines; and (d) a water absorbent pad. The detection device has the advantages of higher sensitivity, specificity and the like.

Description

Novel lateral chromatography detects device

Technical Field

The utility model belongs to the field of detection, and particularly relates to a novel lateral chromatography detection device.

Background

The existing lateral chromatography detection reagent (strip) is characterized in that a secondary antibody, namely anti-human IgM or IgG, is coated on an NC membrane in a linear mode, an antigen (such as recombinant protein N or S protein of neocoronary pneumonia) is labeled by colloidal gold, when a human blood sample is added, if a specific antibody (anti-N or anti-S) is contained, the specific antibody can be combined with the labeled protein and begins to flow along the NC membrane chromatography, the secondary antibody solidified on the membrane is captured and develops color due to the colloidal gold to form a detection line, the detection line is positive, and the detection line is negative.

However, the signal intensity of the detection line is linear with the antibody content in the sample, normal serum samples contain a large amount of various IgG antibodies, when the detection of so-called specific antibodies in the sample stimulated by a specific virus (or other test substance) is required to be less than one tenth, after the serum sample is added, the specific antibodies are bound with the labeled proteins, when the sample flows to the coated area, the secondary antibody coated on the membrane captures the non-specific antibodies in the sample in addition to the colloidal gold, and the two have a competitive relationship, and the non-specific antibodies are more than 10 times more than the specific antibodies in quantity, so that when the specific antibody content in the sample is low, it is difficult to detect positivity even if the sample quantity is increased.

In view of the foregoing, there is a strong need in the art to develop a new detection device capable of more sensitively and accurately detecting a small amount of an antibody to be detected in a sample.

SUMMERY OF THE UTILITY MODEL

The utility model aims to provide a novel detection device which can detect a small amount of an antibody to be detected in a sample more sensitively and accurately.

In a first aspect of the present invention, there is provided a detection apparatus, comprising: a reagent strip (1);

the reagent strip comprises a plurality of reagent strips arranged in sequence along the chromatography direction:

(a) a release pad (11); the release pad (11) is provided with a release liquid adding area (111) for adding a marker release liquid;

(b) a marker pad (12); the label pad is a label pad loaded with a label, wherein the label is a secondary antibody or an analogue-signal substance complex thereof; and the signal substance is detectable, and the secondary antibody or the analog thereof is a secondary antibody capable of binding to the target antibody or a protein similar to the secondary antibody;

(c) a fibrous membrane (13); the fiber membrane is sequentially provided with the following components in the chromatography direction:

(c1) a wash liquid addition zone (131) for adding wash liquid;

(c2) the sample adding area (132) is used for adding a sample to be detected, and the sample to be detected is a sample possibly containing a target antibody; and

(c3) a test zone (133), the test zone comprising: a detection line (1331); the detection line is a detection line (T line) coated with an antigen, and the detection line is used for indicating whether the sample to be detected contains a target antibody or not;

and (d) a water absorbent pad (14); the absorbent pad (14) is used for driving liquid added to the reagent strip to move along the chromatographic direction.

In another preferred example, the detection device is a detection device for detecting a target antibody in a sample to be detected.

In another preferred embodiment, said detecting for detecting the target antibody in the sample comprises quantitative detection and/or qualitative detection.

In another preferred embodiment, said detecting in said detecting the target antibody in the sample is a qualitative detection.

In another preferred example, the detection device is a detection device for determining whether the target antibody is present in a sample to be detected.

In another preferred embodiment, the antibody of interest is a specific antibody.

In another preferred embodiment, the antibody of interest is a specific antibody produced by a virus (e.g., a neocoronavirus).

In another preferred example, the test zone further comprises a quality control line (1332); the quality control line is a detection line (C line) carrying a substance (e.g., an antibody) capable of binding to a secondary antibody or the like, and is disposed downstream of the detection line.

In another preferred embodiment, the detectable means capable of emitting or presenting a signal (e.g., color, light, fluorescence, etc.) that is detectable, recognizable and/or observable by a person and/or an instrument.

In another preferred embodiment, the signal substance refers to a substance that can emit a signal (such as color, light, fluorescence, etc.) by itself or under a certain condition of stimulation, which can be detected, identified or observed by a person or an instrument.

In another preferred embodiment, the signal substance is colloidal gold.

In another preferred embodiment, the antigen refers to an antigen capable of specifically binding to the target antibody.

In another preferred embodiment, the secondary antibody or analog thereof refers to a secondary antibody (anti-antibody) or a protein similar to a secondary antibody capable of binding (preferably, non-specific binding) to the antibody of interest.

In another preferred embodiment, the secondary antibody is a secondary antibody (anti-antibody) selected from the group consisting of: immunoglobulin m (igm), immunoglobulin g (igg), or a combination thereof.

In another preferred embodiment, the protein similar to the secondary antibody comprises: streptococcal Protein (Streptococcus Protein) G, A and L Protein (i.e. SPG, SPA and SPL).

In another preferred example, the fiber membrane is a nitrocellulose membrane (NC membrane).

In another preferred example, the reagent strip further comprises: a base plate, and the release pad (11), the marker pad (12), the fibrous membrane (13), and the absorbent pad (14) are disposed on the base plate.

In another preferred example, the bottom plate is a PVC bottom plate.

In another preferred embodiment, the marker pad is made of glass fiber, non-woven fabric, synthetic polyester fiber or a combination thereof.

In another preferred example, the absorbent pad is made of a material with strong water absorption (such as water absorbent pad).

In another preferred example, the distance between the sample adding region (132) and the detection line (1331) is L4, and L4 is 5-6 mm.

In another preferred example, the distance between the washing solution addition region (131) and the sample addition region (132) is L3, and L3 is 2-3 mm.

In another preferred embodiment, the distance between the washing liquid addition region (131) and the downstream edge of the marker pad (12) is L2, and L2 is 0.5-1.5 mm.

In another preferred example, L2 is 1 ± 0.1 mm.

In another preferred example, the distance between the release liquid addition region (111) and the upstream edge of the marker pad (12) is L1, and L1 is 1.5-2.0 mm.

In another preferred example, L1 is 1.7 ± 0.1 mm.

In another preferred example, the distance between the detection line (1331) and the quality control line (1332) is L5, and L5 is 3.5-4.5 mm.

In another preferred example, L5 is 4 ± 0.1 mm.

In another preferred embodiment, the detection device further includes: a housing (2).

In another preferred example, the housing is provided with:

a marker-releasing liquid hole (21) for adding a marker releasing liquid to the releasing liquid adding region (111);

a washing liquid addition hole (231) for adding washing liquid to the washing liquid addition region (131); and

a loading well (232) for adding a sample to be tested to the loading region (132).

In another preferred embodiment, the housing further comprises an observation window (233) for observing the condition of the test zone.

In a second aspect of the present invention, there is provided a method for detecting an object to be detected in a sample, the method comprising the steps of:

(1) providing a detection apparatus as described in the first aspect;

(2) adding a sample to be tested to a sample addition zone (132) of the detection device;

(3) adding a washing liquid to a washing liquid addition zone (131) of the detection device;

(4) adding a label-releasing liquid to a releasing liquid-adding area (111) of the detecting unit; and

(5) the detection result is acquired through a test zone (133) of the detection device.

In another preferred embodiment, the detection result is positive or negative.

In another preferred example, after the sample to be tested is added in the step (2), the step (3) is performed after the time t 1.

In another preferred example, t1 is 30-40 seconds.

In another preferred example, after the washing liquid is added in the step (3), the step (4) is performed after the time t 2.

In another preferred example, t2 is 10-20 seconds.

In another preferred example, after the addition of the marker releasing liquid in the step (4) is completed, the step (5) is further performed after the time t3 elapses.

In another preferred example, t3 is 10-15 minutes.

In a further preferred embodiment of the method,

in the step (2), the amount of the sample to be detected is v1 volume;

in the step (3), the amount of the washing solution is v2 volume; and

in the step (4), the amount of the marker release solution is v3 volume;

and v1, v2, v3, 1, (0.8-1.2) and (10-15).

In another preferred example, v1 ═ 4 to 6 μ L, v2 ═ 4 to 8 μ L and/or v3 ═ 40 to 90 μ L.

In another preferred example, v1 ═ 5 ± 0.2 μ L, v2 ═ 5 ± 0.2 μ L and/or v3 ═ 80 ± 0.4 μ L.

It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. Not to be reiterated herein, but to the extent of space.

Drawings

FIG. 1 shows a schematic view of a detection apparatus according to one embodiment.

FIG. 2 shows a schematic top view of a reagent strip of the test device according to one embodiment.

FIG. 3 shows a schematic top view of the housing of the detection device of one embodiment.

The various designations in the figure are as follows:

1 represents a reagent strip;

11 denotes a release liner; 111 denotes a releasing liquid adding region;

12, a marker pad;

131 denotes a washing liquid addition zone; 132 denotes a sample addition zone; 133 denotes a test zone; 1331 represents a detection line, 1332 represents a quality control line;

and 14 denotes an absorbent pad.

2 denotes a housing;

21 denotes a labeled release well;

231 denotes wash addition wells; 232 denotes an addition well; and 233, a viewing aperture.

Detailed Description

As a result of extensive and intensive studies, the inventors have for the first time obtained a detection apparatus having a novel structure comprising a sample addition region and a washing solution addition region, and thus have avoided the drawback that in the case where the amount of an object to be detected in a sample is too small (e.g., the amount of an object antibody in a sample is only less than one tenth of the total amount of the antibody used), it is difficult to detect the presence (positivity) of the object antibody even if the amount of the sample is increased with a conventional detection apparatus or reagent strip. Based on this, the inventors have completed the present invention.

Term(s) for

As used herein, the terms "upstream" and "downstream" refer to upstream and downstream in the direction of chromatography (otherwise known as the direction of chromatographic flow).

As used herein, the term "detectable" refers to visible to the naked eye or readable by a machine.

As used herein, the term "detection device of the present invention" refers to a detection device as described in the first aspect.

As used herein, the term "sample" or "test sample" generally refers to a substance suspected of or likely to contain a test object (e.g., antibodies raised against a particular virus). The test sample can be used directly from the raw material or after pretreatment to change the properties of the sample. The test sample may be from any biological source, such as physiological fluids, including blood, interstitial fluid, saliva, ocular lens fluid, cerebral spinal fluid, sweat, urine, milk, ascites fluid, synovial fluid, peritoneal fluid, vaginal fluid, amniotic fluid, and the like. The test sample may be pre-treated prior to use, such as preparing plasma from blood, diluting viscous liquids, and the like. The treatment method may include filtration, precipitation, dilution, centrifugation, mixing, concentration, inactivation of interfering components and addition of reagents. In addition to physiological fluids, other fluid samples may be used, such as water, food products and the like for performing environmental or food production assays. In addition, a solid substance suspected of containing a target substance may be used as the test sample. In some cases, it may be beneficial to convert a solid sample into a liquid medium or to release the target. Preferably, in this context, when the virus is present in cells or tissues of the human or animal body and is therefore not directly detectable, and antibodies are produced during early infection of the virus, the sample or sample to be tested is made to contain the target to be tested, typically in an amount of less than 1% per microliter of sample, and/or the amount of target to be tested in the sample or sample to be tested is only less than one tenth of the amount of other substances that might interfere with the experimental results (e.g. when the target to be tested is a specific antibody produced by a particular virus, the other substances are non-specific antibodies).

Unless otherwise specified, the distance between each region of the detection device and the line structure (e.g., the release liquid addition region, the detection line, etc.) is based on the center or center line of each region or line (see, for example, fig. 2).

Detection device

In order to solve the problem of the prior art that it is difficult to obtain a correct result (e.g., a positive result cannot be obtained even if the target antibody is present) even if the amount of the sample used is increased when the content of the target antibody in the sample is small, the present invention provides a detection device having a novel structure, the detection device as shown in fig. 1, 2 and 3 comprising:

a reagent strip (1);

the reagent strip comprises a plurality of reagent strips arranged in sequence along the chromatography direction:

(a) a release pad (11); the release pad (11) is provided with a release liquid adding area (111) for adding a marker release liquid;

(b) a marker pad (12); the label pad is a label pad loaded with a label, wherein the label is a secondary antibody or an analogue-signal substance complex thereof; and the signal substance is detectable, and the secondary antibody or the analog thereof is a secondary antibody capable of binding to the target antibody or a protein similar to the secondary antibody;

(c) a fibrous membrane (13); the fiber membrane is sequentially provided with the following components in the chromatography direction:

(c1) a wash liquid addition zone (131) for adding wash liquid;

(c2) the sample adding area (132) is used for adding a sample to be detected, and the sample to be detected is a sample possibly containing a target antibody; and

(c3) a test zone (133), the test zone comprising: a detection line (1331); the detection line is a detection line (T line) coated with an antigen, and the detection line is used for indicating whether the sample to be detected contains a target antibody or not; and optionally a geological control line (1332); the quality control line is a detection line (C line) carrying a substance (such as an antibody) capable of binding with a second antibody or an analogue thereof, and the quality control line is arranged at the downstream of the detection line;

and (d) a water absorbent pad (14); the absorbent pad (14) is used for driving liquid added to the reagent strip to move along the chromatographic direction.

In another preferred example, the detection device is a detection device for detecting a target antibody in a sample to be detected.

Preferably, said detecting for detecting a target antibody in a sample comprises quantitative detection and/or qualitative detection; more preferably, it is a qualitative detection.

Preferably, the detection device is a detection device for determining whether a target antibody (e.g., a specific antibody, e.g., a specific antibody due to a virus (e.g., a new coronavirus)) is present in a sample to be tested.

Preferably, detectable means capable of emitting or presenting a signal (e.g., color, light, fluorescence, etc.) that is detectable, recognizable and/or observable by a person and/or an instrument.

Preferably, the signal substance refers to a substance that can emit a signal (such as color, light, fluorescence, etc.) by itself or under a certain condition of stimulation, which can be detected, identified or observed by a person or an instrument.

Preferably, the signal substance is colloidal gold.

Preferably, the antigen is an antigen capable of specifically binding to the target antibody.

Preferably, the secondary antibody or analog thereof refers to a secondary antibody (anti-antibody) or a protein similar to a secondary antibody capable of binding (preferably, non-specific binding) to the antibody of interest. Wherein the secondary antibody comprises: one or more secondary antibodies (anti-antibodies) of immunoglobulin m (igm), immunoglobulin g (igg); the proteins similar to the secondary antibody include: streptococcal Protein (Streptococcus Protein) G, A and L Protein (i.e. SPG, SPA and SPL).

Preferably, the fiber membrane is a nitrocellulose membrane (NC membrane).

Preferably, the reagent strip further comprises: a base (e.g. a PVC base plate) and the release liner (11), the marker pad (12), the fibrous membrane (13) and the absorbent pad (14) are disposed on the base plate.

Preferably, the marker pad is a marker pad made of glass fiber, non-woven fabric, synthetic polyester fiber, or a combination thereof.

Preferably, the absorbent pad is made of a material having strong water absorption property (such as water absorbent pad).

Preferably, the distance between the sample adding area (132) and the detection line (1331) is L4, and L4 is 5-6 mm.

Preferably, the distance between the washing solution adding region (131) and the sample adding region (132) is L3, and L3 is 2-3 mm.

Preferably, the wash liquid addition zone (131) is at a distance L2 from the downstream edge of the marker pad (12), and L2 is 0.5-1.5 mm; more preferably, L2 is 1 ± 0.1 mm.

Preferably, the distance between the release liquid adding area (111) and the upstream edge of the marker pad (12) is L1, and L1 is 1.5-2.0 mm; more preferably, L1 is 1.7 ± 0.1 mm.

Preferably, the distance between the detection line (1331) and the quality control line (1332) is L5, and L5 is 3.5-4.5 mm; more preferably, L5 is 4 ± 0.1 mm.

Preferably, the detection device further comprises: a housing (2); more preferably, the housing is provided with: a marker-releasing liquid hole (21) for adding a marker releasing liquid to the releasing liquid adding region (111); a washing liquid addition hole (231) for adding washing liquid to the washing liquid addition region (131); and an application well (232) for applying a sample to be tested to the application region (132), thereby enabling an operator to apply a corresponding reagent to a corresponding region of each zone of the reagent strip via each well of the housing.

Preferably, the housing further comprises a viewing aperture (233) for viewing the condition of the test zone.

In another embodiment, the present invention provides a test device that can be modified from the existing lateral flow assay reagents, typically further comprising a housing that covers at least the upper surface of the reagent strip, and the housing can be configured as follows:

two filling holes (such as filling holes with the diameter of 2-3 mm) are added between the shell part corresponding to the marker pad 12 (such as a gold-labeled pad) and the window hole 233 of the shell, namely, three filling holes (a marker release liquid hole 21, a washing liquid adding hole 231 and a sample adding hole 232 in sequence along the chromatographic direction) and a detection window hole (the distance from the detection line to the edge of the window is 3-4mm) are arranged on the shell. With the direction of the lateral flow assay reagent fluid flow as the front, the foremost loading hole (diameter about 2mm) is the sample loading hole 232 (sample loading hole for short), the loading hole is located 2-3mm from the rearmost edge (upstream edge) of the window hole, and the second loading hole (diameter about 2mm) is located 2-3mm behind the loading hole and 1mm in front of the marker pad (gold marker pad) (i.e. about 1mm from the downstream edge of the marker pad). The third addition hole was 4mm in size, at about 1mm behind the marker pad (i.e., about 1mm from the upstream edge of the marker pad).

Detection method

Also provided herein is a method for detecting an object to be detected in a sample, the method comprising the steps of:

(1) providing a detection device of the present application;

(2) adding a sample to be tested to a sample addition zone (132) of the detection device;

(3) adding a washing liquid to a washing liquid addition zone (131) of the detection device;

(4) adding a label-releasing liquid to a releasing liquid-adding area (111) of the detecting unit; and

(5) the test result is obtained through a test area (133) of the test device (preferably, the test result is positive or negative).

Further, after the sample to be tested is added in step (2), step (3) is performed again after t1 time (preferably, t1 is 30 to 40 seconds).

In another preferred example, after the addition of the washing solution in the step (3) is completed, the step (4) is further performed after t2 time (preferably, t2 is 10 to 20 seconds).

In another preferred example, after the addition of the marker releasing liquid in step (4) is completed, step (5) is further performed after t3 time (preferably, t3 is 10 to 15 minutes).

In another specific embodiment, in step (2), the amount of sample to be tested is v1 volume; in the step (3), the amount of the washing solution is v2 volume; in the step (4), the amount of the marker release solution is v3 volume; and v1, v2, v3, 1, (0.8-1.2) and (10-15).

In another embodiment, v1 ═ 4 to 6 μ L (e.g. 5 ± 0.2 μ L), v2 ═ 4 to 8 μ L (e.g. 5 ± 0.2 μ L) and/or v3 ═ 40 to 90 μ L (e.g. 80 ± 0.4 μ L).

It is to be understood that a person skilled in the art is able to select a suitable label supported by the label pad, an antigen supported by the detection line of the test zone, etc., according to the desired target antibody to be detected, based on the general knowledge in the art.

The detection principle of the detection device of the utility model is as follows: after a sample (such as a serum sample) is added through the sample adding hole, a target antibody (such as an antibody generated by virus) in the sample can be specifically combined with an antigen coated on a membrane, and a washing solution is added through the other liquid adding hole (namely the washing solution adding hole), so that a non-specific antibody which is not combined with the antigen on a detection line in the sample can be washed away, the combination probability of the non-specific antibody and the labeled antibody in the sample, such as labeled secondary antibody colloidal gold, is reduced when the labeled antibody chromatography passes, and the combination probability between the labeled antibody and the specific antibody combined with the antigen coated on the membrane is improved, and the detection sensitivity, specificity and the like are obviously improved compared with the original lateral chromatography detection kit.

The main advantages of the utility model include:

(a) the detection device has higher sensitivity, specificity and the like, and the sensitivity of the reagent adopting the novel detection device is improved by at least 1 order of magnitude under the condition of the same sample adding amount.

(b) The detection device of the utility model needs short detection time, and the detection time is about 5-10 minutes.

(c) The detection device of the utility model has small detection sample amount, and only needs about 2-5 microliter.

The utility model will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. The experimental procedures, in which specific conditions are not noted in the following examples, are generally carried out under conventional conditions or conditions recommended by the manufacturers. Unless otherwise indicated, percentages and parts are percentages and parts by weight.

Example 1

And (3) detecting IgG (immunoglobulin G) of the new coronavirus infection antibody:

the detection device used in this embodiment is shown in fig. 1-3, and the detection device comprises: a reagent strip 1; the reagent strip comprises a plurality of reagent strips arranged in sequence along the chromatography direction: (a) a release liner 11; (b) a marker pad 12; (c) a fibrous membrane 13; (c1) a washing solution addition part 131, (c2) a sample addition part 132; and (c3) a test zone 133, said test zone comprising: detection line 1331 and quality control line 1332; and (d) absorbent pad 14; and a housing is arranged outside the reagent strip, and the housing is provided with: a marker-releasing liquid hole 21 for adding a marker-releasing liquid to the releasing liquid adding section 111; a washing liquid adding hole 231 for adding the washing liquid to the washing liquid adding region 131; and a loading well 232 for adding a sample to be tested to the loading region 132.

In the reagent strip, the fiber membrane is a nitrocellulose membrane, a mixture (T line) coated with recombinant core antigen and S antigen and an anti-IgG coated antibody (C line) are respectively arranged on the nitrocellulose membrane, and a secondary antibody capable of capturing a specific antibody (IgM or IgG) generated by the virus is loaded on the marker pad.

Wherein the parameters on the strips are L1-1.7 mm, L2-1 mm, L3-2-3 mm, L4-5 mm, and L5-4 mm

The detection process is as follows:

1 Add 2. mu.l of sample through well 232, based on the sample flow measurement to the front 1mm of the assay T-line.

2. Add 2. mu.l of wash solution through the wash solution addition well 231. The amount of wash solution added to the well is limited to the amount that can be metered to meet the sample.

3. 80 microliters of gold label release solution was added through the label release solution addition hole 21. The amount of the gold-labeled release solution added into the hole is the minimum limit that the colloidal gold labeled with the secondary antibody on the gold-labeled pad can be dissolved and flows to the absorbent paper.

And (3) detection results:

the concentration of a detection sample is 0.05AU/ml, the sample is diluted to 0.005AU/ml, 2 microliters of 0.005AU/ml detection sample is taken, the same new crown colloidal gold reagent strip is used, the reagent strip is detected by adopting the novel detection device, the detection line can be clearly seen by naked eyes in the detection result, and the result is positive; the test strip is tested by a conventional test device (wherein the sample addition hole is arranged at the upstream of the marker pad), and when a sample to be tested is directly added into the sample addition hole, no test line appears in the test strip, and the test strip is negative.

Example 2

B, detecting the Brucella antibody:

the test device of this example was identical to that of example 1 except that the nitrocellulose membrane was coated with the Brucella LPS antigen (T line), and rabbit anti-sheep IgG (C line), and the labeled pad carried the labeled streptococcal protein A protein.

The agglutination titer of the detection sample is 1:160, the detection sample is diluted by 1000 times, 2 microliters of the detection sample is taken, the same Brucella colloidal gold reagent strip is used for detection, the reagent strip adopts the novel detection device, the detection line can be clearly seen by naked eyes in the detection result, and the result is positive; the reagent is detected by a conventional detection device (wherein the sample addition hole is located upstream of the marker pad), and when the sample to be detected is directly added into the sample addition hole, no detection line appears in the result, and the result is negative.

All documents referred to herein are incorporated by reference into this application as if each were individually incorporated by reference. Furthermore, it should be understood that various changes and modifications of the present invention can be made by those skilled in the art after reading the above teachings of the present invention, and these equivalents also fall within the scope of the present invention as defined by the appended claims.

Claims (10)

1. A novel lateral chromatography detection device is characterized in that the detection device comprises: a reagent strip (1);

the reagent strip comprises a plurality of reagent strips arranged in sequence along the chromatography direction:

(a) a release pad (11); the release pad (11) is provided with a release liquid adding area (111) for adding a marker release liquid;

(b) a marker pad (12); the label pad is a label pad loaded with a label, wherein the label is a secondary antibody or an analogue-signal substance complex thereof; and the signal substance is detectable, and the secondary antibody or the analog thereof is a secondary antibody capable of binding to the target antibody or a protein similar to the secondary antibody; wherein the protein similar to the second antibody comprises: one or more of streptococcal protein G, A and L protein;

(c) a fibrous membrane (13); the fiber membrane is sequentially provided with the following components in the chromatography direction:

(c1) a wash liquid addition zone (131) for adding wash liquid;

(c2) the sample adding area (132) is used for adding a sample to be detected, and the sample to be detected is a sample possibly containing a target antibody; and

(c3) a test zone (133), the test zone comprising: a detection line (1331); the detection line is a detection line (T line) coated with an antigen, and the detection line is used for indicating whether the sample to be detected contains a target antibody or not;

and (d) a water absorbent pad (14); the absorbent pad (14) is used for driving liquid added to the reagent strip to move along the chromatographic direction.

2. The novel lateral flow assay device of claim 1, wherein the test zone further comprises a quality control line (1332); the quality control line is a detection line carrying a substance capable of binding to the second antibody or the analog thereof, and is arranged downstream of the detection line.

3. The test device of claim 1, wherein the reagent strip further comprises: a base plate, and the release pad (11), the marker pad (12), the fibrous membrane (13), and the absorbent pad (14) are disposed on the base plate.

4. The novel lateral flow assay device of claim 1, wherein the distance between the sample application zone (132) and the detection line (1331) is L4, and L4 is 5-6 mm.

5. The detecting device according to claim 1, wherein the distance between the washing solution addition region (131) and the sample addition region (132) is L3, and L3 is 2-3 mm.

6. The novel lateral flow assay device of claim 1, wherein the wash addition zone (131) is located at a distance L2 from the downstream edge of the marker pad (12), and L2 is 0.5-1.5 mm.

7. The novel lateral flow assay device of claim 1, wherein the release solution addition zone (111) is located at a distance L1 from the upstream edge of the marker pad (12), and L1 is 1.5-2.0 mm.

8. The detection apparatus according to claim 1, wherein the distance between the detection line (1331) and the quality control line (1332) is L5, and L5 is 3.5-4.5 mm.

9. The novel lateral flow assay device of claim 1, wherein the assay device further comprises: a housing (2); and the housing is provided with:

a marker-releasing liquid hole (21) for adding a marker releasing liquid to the releasing liquid adding region (111);

a washing liquid addition hole (231) for adding washing liquid to the washing liquid addition region (131); and

a loading well (232) for adding a sample to be tested to the loading region (132).

10. The novel lateral flow assay device of claim 9, wherein the housing (2) further comprises an visualization aperture (233) for viewing the condition of the test zone.

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