Immunochromatographic test strip, and production method and application thereof

An immunochromatographic test strip and special technology, applied in analytical materials, measuring devices, instruments, etc., can solve the problems of high price, long research and development cycle, and high technical barriers, achieve high specificity and anti-interference, and avoid non-specific reactions. , the effect of strong anti-interference ability

Inactive Publication Date: 2018-04-13
NANJING VAZYME MEDICAL TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, both methods have certain disadvantages: (1) When using secondary antibodies as C-line coatings, since most of the commonly used marker antibodies are mouse antibodies, the commonly used secondary antibodies are generally anti-mouse IgG , but some blocking agents are often added in the preparation of test strips to eliminate the interference caused by heterophilic antibodies in the blood samples of the people to be tested. There are generally two types of blocking agents, one is mouse IgG, which will During the detection, it combines with the secondary antibody of the quality control line to interfere with the detection results. The other is a non-IgG blocker, but this blocker has high technical barriers and is expensive, and is not suitable for large-scale production of diagnostic reagents. Use; (2) When the substance to be tested or the recombinant protein of the substance to be tested is used as the C-line coating, the specificity and accuracy of the color development results of the quality control line are guaranteed, but it will increase the difficulty of reagent development, as we all know The research and development process of the antigen is difficult, the research and development cycle is long, and the price is expensive. If each test item needs to develop the corresponding antigen, it will not only increase the reagent development cycle but also increase the cost of reagent development, which is very important in actual production. unacceptable

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  • Immunochromatographic test strip, and production method and application thereof
  • Immunochromatographic test strip, and production method and application thereof
  • Immunochromatographic test strip, and production method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0034] The preparation of embodiment 1 lipoprotein phospholipase A2 (Lp-PLA2) quantum dot immunofluorescence detection kit

[0035] 1. Key material information used in the examples

[0036] Marker binding pad: Shanghai Jiening Biotechnology Co., Ltd.

[0037] Nitrocellulose membrane: Milipore;

[0038] Lp-PLA2 monoclonal antibody (L-1#, L-2#): Nanjing Nuoweizan Biotechnology Co., Ltd.;

[0039] DNP-labeled BSA (DNP-BSA): Nanjing Nuoweizan Biotechnology Co., Ltd.;

[0040] Anti-DNP monoclonal antibody: Nanjing Nuoweizan Biotechnology Co., Ltd.;

[0041] Carboxylated quantum dots (QDs): Nanjing Nuoweizan Biotechnology Co., Ltd.

[0042] 2. QDs coupled with L-1# antibody, DNP-BSA

[0043] (1) QDs activation: take 50 μl of QDs stock solution with a solid content of 10%, dilute to 500 μl with 50 mM boric acid-borax buffer (pH 9.0), mix well, add 5 μl of EDC solution (50 mg / ml), 5 μl of NHS solution (75 mg After mixing, stir and react at room temperature (25°C) for 30 minutes, c...

Embodiment 2

[0065] The detection of embodiment 2 lipoprotein phospholipase A2 (Lp-PLA2) quantum dot immunofluorescence detection kit

[0066] 1. Test strip calibration and calibration curve drawing

[0067] Get each 5 test strips of kit 1 and kit 2 prepared in Example 1, respectively add calibrators with 5 concentrations ( ) on the sample pad of the test strip, and repeat the test once for each concentration point, the amount of sample added 120 μl, reacted for 15 minutes and detected on the automatic immunofluorescence analyzer, with the concentration value of the calibrator as the X-axis, and the average value of the 2 signal values ​​obtained from each point test as the Y-axis, draw a standard curve, such as figure 2 , 3 .

[0068] 2. Clinical sample testing

[0069] Sera from 95 patients who had tested the Lp-PLA2 project were collected. The diagnostic methodology was an enzymatic kit, and the source was Nanjing Drum Tower Hospital;

[0070] Use the Lp-PLA2 mass method detection ...

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Abstract

The invention discloses an immunochromatographic test strip, and a production method and an application thereof. The test strip is characterized in that a labeling compound carries an inert protein connected with a special label and used for quality control, and a quality control line contains a monoclonal antibody specifically binding to the special label carried by the inert protein. The test strip has an independent quality control system, so the obtained test result has a high specificity and an anti-interference property, non-specific reactions brought by the self-bearing antibodies in human blood samples are effectively avoided, and the effectiveness of the test strip is effectively indicated.

Description

technical field [0001] The invention relates to the field of biological detection, in particular to an immunochromatographic test strip and a manufacturing method and application thereof. Background technique [0002] Immunochromatography is a rapid diagnostic technology that has emerged in the past ten years. It combines traditional immunolabeling technology with chromatography. , using the capillary action of the liquid to allow the analyte to flow forward and generate an immune reaction on the detection line to form an immune complex, and finally detect with the naked eye or corresponding instruments to achieve qualitative, semi-quantitative and quantitative analysis of the analyte. [0003] Immunochromatography technology has the advantages of fast detection and simple operation. Usually, the experimental results can be obtained within 10-20 minutes after adding the sample, and it does not require complicated detection equipment, which meets the situational requirements ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/558G01N33/532
CPCG01N33/558G01N33/532
Inventor 曹林唐波杨晨辰朱婷婷
Owner NANJING VAZYME MEDICAL TECH CO LTD
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