Detection test strip and detection card for chitosanase 3-like protein 1

Abstract

The utility model discloses a chitinase 3-sample protein 1 detection test strip and a detection card, belongs to the technical field of medical detection, and particularly relates to a chitinase 3-sample protein 1 detection test strip which comprises a supporting pad and a nitrocellulose membrane attached to the middle of the supporting pad. One end of the support pad is provided with a water absorption pad, the other end is provided with a sample pad and a chemical conjugate pad, and the sample pad is located above the chemical conjugate pad; the kit is characterized in that a colloidal gold labeled antibody region is arranged on the chemical conjugate pad, a CHI3L1 monoclonal antibody region and a polypeptide antibody region are arranged on the nitrocellulose membrane, and the value of the center distance between the CHI3L1 monoclonal antibody region and the polypeptide antibody region is 1: (1.5-3) compared with the center distance between the colloidal gold labeled antibody region and the polypeptide antibody region. The chitinase 3-like protein 1 detection kit disclosed by the utility model further comprises a chitinase 3-like protein 1 detection card.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical detection, and in particular relates to a chitinase 3-like protein 1 detection test strip and a detection card. Background Art

[0002] Chitinase 3-like protein 1 is a secretory glycoprotein, abbreviated as CHI3L1, with a molecular weight of about 40kDa. Studies have found that the concentration of CHI3L1 can be significantly increased in the serum of patients with cirrhosis. It is enriched and specifically expressed in the liver, and can be used as a highly sensitive and specific serum detection marker for staging and diagnosis of liver fibrosis. Chitinase 3-like protein 1 is a marker for liver fibrosis and cirrhosis related to hepatitis B and C; a marker for liver fibrosis and cirrhosis caused by alcoholic liver disease and Schistosoma japonicum; a marker for liver fibrosis and cirrhosis caused by non-alcoholic fatty liver disease; and a study on the efficacy and prognosis of antiviral treatment. At present, the main methods for detecting chitinase 3-like protein 1 include colloidal gold method, enzyme-linked immunosorbent assay, magnetic microparticle chemiluminescence method, etc. These methods have the disadvantages of low measurement accuracy, high cost or long measurement time. Summary of the invention

[0003] The utility model aims to provide a chitinase 3-like protein 1 detection kit with flexible detection, high detection sensitivity, fast detection speed, good anti-interference, good repeatability and small batch difference.

[0004] The technical solution adopted by the utility model to achieve the above-mentioned purpose is:

[0005] A chitinase 3-like protein 1 detection test strip comprises: a support pad, a nitrocellulose membrane attached to the middle of the support pad; a water absorption pad is arranged at one end of the support pad, and a sample pad and a chemical coupling pad are arranged at the other end, and the sample pad is located on the chemical coupling pad; a colloidal gold labeled antibody area is arranged on the chemical coupling pad, and a CHI3L1 monoclonal antibody area and a polypeptide antibody area are arranged on the nitrocellulose membrane, the center distance between the CHI3L1 monoclonal antibody area and the polypeptide antibody area is 1:1.5-3 compared with the center distance between the colloidal gold labeled antibody area and the polypeptide antibody area, the water absorption pad has a thickness of 1.35-1.55 mm, and a water creeping speed of 80-110 s / 4 cm; the nitrocellulose membrane has a thickness of 190-230 µm, and an average flow rate of 70-110 s / 4 cm. The CHI3L1 monoclonal antibody area is a detection line, and the polypeptide antibody area is a quality control line. In the test result, the test line forms a red test line, indicating that the chitinase 3-like protein 1 is positive; if the test line does not develop color, a negative result is displayed. In the use of the test strip of the utility model, the test strip also includes a quality control line. Regardless of whether the test line appears, the red quality control line should appear. If the quality control line does not appear, it indicates that the test result is invalid. After the absorbent pad and the nitrocellulose membrane meet the above-mentioned specific conditions, and the center distance between the CHI3L1 monoclonal antibody area and the polypeptide antibody area is a specific ratio compared to the center distance between the colloidal gold labeled antibody area and the polypeptide antibody area, the obtained chitinase 3-like protein 1 test strip has the excellent effects of flexible detection, high detection sensitivity, fast detection speed, good anti-interference, good repeatability, and small batch variability.

[0006] Preferably, the center distance between the CHI3L1 monoclonal antibody region and the polypeptide antibody region can be 1:1.8, 1:2, 1:2.1, 1:2.4, or 1:2.8 compared to the center distance between the colloidal gold labeled antibody region and the polypeptide antibody region.

[0007] Preferably, the absorbent pad is adjacent to the polypeptide-antibody region.

[0008] Preferably, the CHI3L1 monoclonal antibody in the CHI3L1 monoclonal antibody region is a mouse anti-CHI3L1 monoclonal antibody; or, the polypeptide antibody in the polypeptide antibody region is a mouse anti-polypeptide antibody; or, the colloidal gold-labeled antibody region contains a colloidal gold-labeled sheep anti-CHI3L1 antibody and a colloidal gold-labeled polypeptide.

[0009] Preferably, the weight of the absorbent pad is 400-460 g / m 2 .

[0010] Preferably, a second CHI3L1 monoclonal antibody area is also provided on the nitrocellulose membrane.

[0011] Preferably, the chemical coupling pad is further provided with a second colloidal gold labeled antibody area.

[0012] Preferably, the sample pad contains anti-RBC antibodies, and the content of anti-RBC antibodies on the sample pad is 0.01-0.02 mg / cm 2 .

[0013] Preferably, the colloidal gold-labeled antibody region contains 0.05-1 μg of colloidal gold-labeled CHI3L1 antibody and 0.05-1 μg of colloidal gold-labeled polypeptide.

[0014] Preferably, the CHI3L1 monoclonal antibody region contains 0.05-1 μg of CHI3L1 monoclonal antibody.

[0015] Preferably, the width of the support pad is 15-25 mm.

[0016] The utility model discloses a chitinase 3-like protein 1 detection card, comprising: a detection card shell, the detection card shell is composed of a shell with holes and a shell with grooves; the above-mentioned detection test strip is arranged in the shell with grooves, the shell with holes includes a sampling hole and a display hole, the display hole corresponds to the CHI3L1 monoclonal antibody area and the polypeptide antibody area of ​​the detection test strip, and the sampling hole corresponds to the sample pad of the detection test strip.

[0017] The utility model discloses a chitinase 3-like protein 1 detection kit, comprising a chitinase 3-like protein 1 detection card composed of a chitinase 3-like protein 1 detection test paper strip and a detection card shell, a sample diluent, and a pipette. The sample diluent is a PBS buffer solution, and the PBS buffer solution contains a preservative.

[0018] The utility model adopts a support pad, a nitrocellulose membrane, a water-absorbing pad, a sample pad and a chemical coupling pad with specific physical properties, and a colloidal gold-labeled antibody area is arranged on the chemical coupling pad, and a CHI3L1 monoclonal antibody area and a polypeptide antibody area are arranged on the nitrocellulose membrane, and the center distance between the CHI3L1 monoclonal antibody area and the polypeptide antibody area is 1:1-5 compared with the center distance between the colloidal gold-labeled antibody area and the polypeptide antibody area, so it has the following beneficial effects: flexible detection of CHI3L1 protein in human blood, high detection sensitivity, fast detection speed, good anti-interference, good repeatability, and small batch difference. Therefore, the utility model is a chitinase 3-like protein 1 detection kit with flexible detection, high detection sensitivity, fast detection speed, good anti-interference, good repeatability, and small batch difference. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a schematic diagram of the chitinase 3-like protein 1 detection test strip 1.

[0020] Figure 2 This is a schematic diagram of a test strip 2 for detecting chitinase 3-like protein 1.

[0021] Figure 3Schematic diagram of the test strip 3 for detecting chitinase 3-like protein 1.

[0022] Figure 4 It is a schematic diagram of a test strip 4 for detecting chitinase 3-like protein 1.

[0023] Figure 5 Schematic diagram of the test strip 5 for detecting chitinase 3-like protein 1.

[0024] Figure 6 Schematic diagram of the test strip 6 for detecting chitinase 3-like protein 1.

[0025] Figure 7 Schematic diagram of the test strip 7 for detecting chitinase 3-like protein 1.

[0026] Figure numerals: support pad 1, nitrocellulose membrane 2; water absorbent pad 5, sample pad 4 and chemical conjugate pad 3, colloidal gold labeled antibody area 31, CHI3L1 monoclonal antibody area 21 and polypeptide antibody area 22, second CHI3L1 monoclonal antibody area 23, second colloidal gold labeled antibody area 32. DETAILED DESCRIPTION

[0027] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0028] The following first describes the concepts involved in the present application in conjunction with the accompanying drawings. It should be noted that the following description of each concept is only to make the content of the present application easier to understand, and does not limit the scope of protection of the present application; at the same time, the embodiments and features in the embodiments of the present application can be combined with each other in the absence of conflict. The present application will be described in detail with reference to the accompanying drawings and in conjunction with the embodiments.

[0029] Embodiment 1:

[0030] A chitinase 3-like protein 1 detection test strip comprises: a support pad 1, a nitrocellulose membrane 2, a chemical coupling pad 3, a sample pad 4 and a water absorbent pad 5, wherein the nitrocellulose membrane 2 is attached to the middle of the support pad 1; the water absorbent pad 5 is arranged at one end of the support pad 1, and the sample pad 4 and the chemical coupling pad 3 are arranged at the other end, and the sample pad 4 is located on the chemical coupling pad 3.

[0031] A colloidal gold labeled antibody area 31 is set on the chemical coupling pad 3, and a CHI3L1 monoclonal antibody area 21 and a polypeptide antibody area 22 are set on the nitrocellulose membrane 2. The center distance between the CHI3L1 monoclonal antibody area 21 and the polypeptide antibody area 22 is 1:1.5 compared to the center distance between the colloidal gold labeled antibody area 31 and the polypeptide antibody area 22.

[0032] The weight of the absorbent pad 5 is 400 g / m 2 , thickness is 1.5 mm, creeping speed is 100 s / 4 cm, thickness of nitrocellulose membrane 2 is 200 µm, average flow rate is 100 s / 4 cm, sample pad 4 contains anti-RBC antibodies, and the content of anti-RBC antibodies on sample pad 4 is 0.017 mg / cm 2 .

[0033] Embodiment 2:

[0034] The difference between this embodiment and embodiment 1 is that the center distance between the CHI3L1 monoclonal antibody region 21 and the polypeptide antibody region 22 is 1:2.1 compared to the center distance between the colloidal gold labeled antibody region 31 and the polypeptide antibody region 22 .

[0035] Embodiment 3:

[0036] Compared with Example 1, the present embodiment is different in that the center distance between the CHI3L1 monoclonal antibody region 21 and the polypeptide antibody region 22 is 1:2.8 compared with the center distance between the colloidal gold labeled antibody region 31 and the polypeptide antibody region 22 .

[0037] Embodiment 4:

[0038] The present embodiment is different from the embodiment 1 in that the CHI3L1 monoclonal antibody in the CHI3L1 monoclonal antibody region 21 is a mouse anti-CHI3L1 monoclonal antibody.

[0039] Embodiment 5:

[0040] The present embodiment is different from the embodiment 1 in that the polypeptide antibody in the polypeptide antibody region 22 is a mouse anti-polypeptide antibody.

[0041] Embodiment 6:

[0042] The present embodiment is different from the embodiment 1 in that the colloidal gold labeled antibody region 31 contains colloidal gold labeled sheep anti-CHI3L1 antibody and colloidal gold labeled polypeptide.

[0043] Embodiment 7:

[0044] The difference between this embodiment and embodiment 1 is that the weight of the water-absorbing pad 5 is 400 g / m 2 , thickness is 1.45mm, and water creeping speed is 100 s / 4 cm.

[0045] Embodiment 8:

[0046] The difference between this embodiment and embodiment 1 is that the thickness of the nitrocellulose membrane 2 is 190 μm and the average flow rate is 100 s / 4 cm.

[0047] Embodiment 9:

[0048] The present embodiment is different from the embodiment 1 in that the thickness of the nitrocellulose membrane 2 is 210 μm and the average flow rate is 100 s / 4 cm.

[0049] Embodiment 10:

[0050] The difference between this embodiment and embodiment 1 is that the thickness of the nitrocellulose membrane 2 is 230 μm and the average flow rate is 100 s / 4 cm.

[0051] Embodiment 11:

[0052] The present embodiment is different from the embodiment 1 in that a second CHI3L1 monoclonal antibody region 23 is further provided on the nitrocellulose membrane 2 .

[0053] Embodiment 12:

[0054] Compared with Example 1, the present embodiment is different in that the chemical coupling pad 3 is further provided with a second colloidal gold labeled antibody area 32 .

[0055] Embodiment 13:

[0056] The difference between this embodiment and embodiment 1 is that the sample pad 4 contains anti-RBC antibodies, and the content of anti-RBC antibodies on the sample pad 4 is 0.01 mg / cm 2 .

[0057] Embodiment 14:

[0058] The difference between this embodiment and embodiment 1 is that the sample pad 4 contains anti-RBC antibodies, and the content of anti-RBC antibodies on the sample pad 4 is 0.016 mg / cm 2 .

[0059] Embodiment 15:

[0060] The difference between this embodiment and embodiment 1 is that the sample pad 4 contains anti-RBC antibodies, and the content of anti-RBC antibodies on the sample pad 4 is 0.02 mg / cm 2 .

[0061] Embodiment 16:

[0062] The present embodiment is different from the embodiment 1 in that the colloidal gold-labeled antibody region 31 contains 0.05 μg of colloidal gold-labeled CHI3L1 antibody and 0.05 μg of colloidal gold-labeled polypeptide.

[0063] Embodiment 17:

[0064] The present embodiment is different from the embodiment 1 in that the colloidal gold-labeled antibody region 31 contains 0.5 μg of colloidal gold-labeled CHI3L1 antibody and 0.5 μg of colloidal gold-labeled polypeptide.

[0065] Embodiment 18:

[0066] The present embodiment is different from the embodiment 1 in that the colloidal gold-labeled antibody region 31 contains 1 μg of colloidal gold-labeled CHI3L1 antibody and 1 μg of colloidal gold-labeled polypeptide.

[0067] Embodiment 19:

[0068] The present embodiment is different from the embodiment 1 in that the CHI3L1 monoclonal antibody region 21 contains 0.05 μg of CHI3L1 monoclonal antibody.

[0069] Embodiment 20:

[0070] The present embodiment is different from the embodiment 1 in that the CHI3L1 monoclonal antibody region 21 contains 0.5 μg of CHI3L1 monoclonal antibody.

[0071] Embodiment 21:

[0072] The present embodiment is different from the embodiment 1 in that the CHI3L1 monoclonal antibody region 21 contains 1 μg of CHI3L1 monoclonal antibody.

[0073] Embodiment 22:

[0074] The difference between this embodiment and embodiment 1 is that the width of the support pad 1 is 15 mm.

[0075] Embodiment 23:

[0076] The difference between this embodiment and embodiment 1 is that the width of the support pad 1 is 20 mm.

[0077] Embodiment 24:

[0078] The difference between this embodiment and embodiment 1 is that the width of the support pad 1 is 25 mm.

[0079] The features in each embodiment of the utility model can be used in combination freely to obtain chitinase 3-like protein 1 detection test strips with different characteristics.

[0080] Figure 1 The utility model discloses a chitinase 3-like protein 1 detection test strip, comprising a support pad 1, a nitrocellulose membrane 2, a chemical coupling pad 3, a sample pad 4 and a water-absorbing pad 5. The nitrocellulose membrane 2 is attached to the middle of the support pad 1, and a CHI3L1 monoclonal antibody region 21 and a polypeptide antibody region 22 are arranged on the nitrocellulose membrane 2; the water-absorbing pad 5 is arranged at one end of the support pad 1, the water-absorbing pad 5 is close to the polypeptide antibody region 22 on the nitrocellulose membrane 2, and one end of the water-absorbing pad 5 is above the nitrocellulose membrane 2; the sample pad 4 and the chemical coupling pad 3 are arranged at the other end of the support pad 1, the sample pad 4 is located above the chemical coupling pad 3, and the chemical coupling pad 3 is located above the nitrocellulose membrane 2.

[0081] Figure 2 This is an embodiment of the chitinase 3-like protein 1 detection test strip of the utility model, comprising a support pad 1, a nitrocellulose membrane 2, a chemical coupling pad 3 and a water-absorbing pad 5. In this embodiment, the chemical coupling pad 3 also serves as a sample pad.

[0082] Figure 3 This is an embodiment of the chitinase 3-like protein 1 detection test strip of the utility model, comprising a support pad 1, a nitrocellulose membrane 2, a chemical coupling pad 3, a sample pad 4 and a water absorbent pad 5. In this embodiment, a second colloidal gold-labeled antibody area 32 is arranged on the chemical coupling pad 3.

[0083] Figure 4 This is an embodiment of the chitinase 3-like protein 1 detection test strip of the utility model, which includes a support pad 1, a nitrocellulose membrane 2, a chemical coupling pad 3 and a water-absorbing pad 5. In this embodiment, the chemical coupling pad 3 also has the function of a sample pad, and a second colloidal gold-labeled antibody area 32 is set on the chemical coupling pad 3.

[0084] Figure 5 This is an embodiment of a chitinase 3-like protein 1 detection test strip of the utility model, comprising a support pad 1, a nitrocellulose membrane 2, a chemical coupling pad 3, a sample pad 4 and a water absorbent pad 5. In this embodiment, the chemical coupling pad 3 also has the function of a sample pad, and a second colloidal gold-labeled antibody area 32 is arranged on the chemical coupling pad 3; a second CHI3L1 monoclonal antibody area 23 is arranged on the nitrocellulose membrane 2, and the second CHI3L1 monoclonal antibody area 23 is located between the CHI3L1 monoclonal antibody area 21 and the polypeptide antibody area 22.

[0085] Figure 6This is an embodiment of a chitinase 3-like protein 1 detection test strip of the utility model, comprising a support pad 1, a nitrocellulose membrane 2, a chemical coupling pad 3 and a water-absorbing pad 5. In this embodiment, the chemical coupling pad 3 also has the function of a sample pad. At the same time, a second colloidal gold-labeled antibody area 32 is arranged on the chemical coupling pad 3, and a second CHI3L1 monoclonal antibody area 23 is arranged on the nitrocellulose membrane 2. The second CHI3L1 monoclonal antibody area 23 is located between the CHI3L1 monoclonal antibody area 21 and the polypeptide antibody area 22.

[0086] Figure 7 This is an embodiment of the chitinase 3-like protein 1 detection test strip of the utility model, comprising a support pad 1, a nitrocellulose membrane 2, a chemical coupling pad 3, a sample pad 4 and a water-absorbing pad 5. In this embodiment, the entire area of ​​the chemical coupling pad 3 is a colloidal gold-labeled antibody area.

[0087] The embodiments and / or implementation methods described above are only used to illustrate the preferred embodiments and / or implementation methods for realizing the technology of the utility model, and are not intended to limit the implementation methods of the technology of the utility model in any form. Any technical personnel in this field may make slight changes or modifications to other equivalent embodiments without departing from the scope of the technical means disclosed in the content of the utility model, but they should still be regarded as technologies or embodiments that are essentially the same as the utility model.

[0088] This article uses specific examples to illustrate the principles and implementation methods of this application. The description of the above embodiments is only used to help understand the method and its core ideas of this application. The above is only the preferred implementation method of this application. It should be pointed out that due to the limitations of textual expression and the objective existence of infinite specific structures, ordinary technicians in this technical field can make several improvements, modifications or changes without departing from the principles of this application, and can also combine the above technical features in an appropriate manner; these improvements, modifications, changes or combinations, or the direct application of the concept and technical solution of the utility model to other occasions without improvement, should be regarded as the scope of protection of this application.

Claims

1. A chitinase 3-like protein 1 detection test strip, comprising: A support pad (1), and a nitrocellulose membrane (2) attached to the middle of the support pad (1); a water absorbent pad (5) is arranged at one end of the support pad (1), and a sample pad (4) and a chemical coupling pad (3) are arranged at the other end, and the sample pad (4) is located on the chemical coupling pad (3); the characteristic is that a colloidal gold labeled antibody area (31) is arranged on the chemical coupling pad (3), and a CHI3L1 monoclonal antibody area (21) and a polypeptide antibody area (22) are arranged on the nitrocellulose membrane (2), and the center distance between the CHI3L1 monoclonal antibody area (21) and the polypeptide antibody area (22) is 1:1.5-3 compared with the center distance between the colloidal gold labeled antibody area (31) and the polypeptide antibody area (22); the water absorbent pad (5) has a thickness of 1.35-1.55 mm and a water creeping speed of 80-110 s / 4 cm; the nitrocellulose membrane (2) has a thickness of 190-230 µm and an average flow rate of 70-110 s / 4 cm.

2. A chitinase 3-like protein 1 detection test strip according to claim 1, characterized in that: The CHI3L1 monoclonal antibody in the CHI3L1 monoclonal antibody region (21) is a mouse anti-CHI3L1 monoclonal antibody; or, the polypeptide antibody in the polypeptide antibody region (22) is a mouse anti-polypeptide antibody; or, the colloidal gold-labeled antibody region (31) contains a colloidal gold-labeled sheep anti-CHI3L1 antibody and a colloidal gold-labeled polypeptide.

3. A chitinase 3-like protein 1 detection test strip according to claim 1, characterized in that: The weight of the absorbent pad (5) is 400-460 g / m 2 .

4. A chitinase 3-like protein 1 detection test strip according to claim 1, characterized in that: A second CHI3L1 monoclonal antibody region (23) is also provided on the nitrocellulose membrane (2).

5. A chitinase 3-like protein 1 detection test strip according to claim 1, characterized in that: The chemical coupling pad (3) is also provided with a second colloidal gold labeled antibody area (32).

6. A chitinase 3-like protein 1 detection test strip according to claim 1, characterized in that: The sample pad (4) contains anti-RBC antibodies, and the content of the anti-RBC antibodies on the sample pad (4) is 0.01-0.02 mg / cm 2 .

7. A chitinase 3-like protein 1 detection test strip according to claim 1, characterized in that: The colloidal gold-labeled antibody region (31) contains 0.05-1 μg of colloidal gold-labeled CHI3L1 antibody and 0.05-1 μg of colloidal gold-labeled polypeptide.

8. A chitinase 3-like protein 1 detection test strip according to claim 1, characterized in that: The CHI3L1 monoclonal antibody region (21) contains 0.05-1 μg of CHI3L1 monoclonal antibody.

9. A chitinase 3-like protein 1 detection test strip according to claim 1, characterized in that: The width of the support pad (1) is 15-25 mm.

10. A chitinase 3-like protein 1 detection card, comprising: The detection card shell is composed of a shell with a hole and a shell with a groove; characterized in that the detection test strip according to claim 1 is arranged in the shell with a groove, the shell with a hole comprises a sampling hole and a display hole, the display hole corresponds to the CHI3L1 monoclonal antibody area (21) and the polypeptide antibody area (22) of the detection test strip, and the sampling hole corresponds to the sample pad (4) of the detection test strip.

Images