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Mycobacterium tuberculosis antibody rapid diagnosis reagent kit and detecting method thereof

A technology for rapid diagnosis of Mycobacterium tuberculosis, which is applied to measurement devices, analytical materials, instruments, etc., can solve the problems of few effective antigens, low labeling efficiency, complex cleavage antigen components, etc., and achieves the effect of good specificity and easy promotion.

Inactive Publication Date: 2008-03-12
天津中新科炬生物制药股份有限公司
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Problems solved by technology

But this invention is coated and marked with the lysed antigen of the whole bacterium, because the lysed antigen composition of the whole bacterium is complex, the actual effective antigen is few, the non-specific antigen is many, and the labeling efficiency is low, the sensitivity and specificity of detection can not reach the level of clinical auxiliary diagnosis requirements, the quality needs to be further improved

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  • Mycobacterium tuberculosis antibody rapid diagnosis reagent kit and detecting method thereof

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preparation example Construction

[0031] The Mycobacterium tuberculosis (TB) antibody rapid diagnostic reagent strip of the present invention is shown in Fig. 1, uses the indirect immunochromatographic technique to realize the anti-TB antibody detection in the tested serum or plasma. The preparation method of the kit is briefly described as follows, including: test strips for detecting blood antibodies and the bottom and cover of the plastic box for placing the test strips for detecting blood antibodies. It is attached to the lower part of the NC membrane 2 to form a test line (T) line 4, and goat anti-mouse IgG is coated on the upper part of the NC membrane to form a quality control line (C). Line 3 uses anti-human IgG (mouse anti-human IgG, goat anti- Human IgG or SPA) label nano-scale chromogenic particles (colloidal gold particles or latex particles or nano-magnetic beads) to prepare marker pads 6; NC membrane, colloidal gold pads 6, sample loading pads 7 and sample suction pads 5 are pasted and assembled ...

Embodiment 1

[0043] Embodiment 1: Overview of Product Development

[0044] The selection of biological raw materials is one of the key points of product development. When designing this product, it is planned to use TB 38KD and 16KD antigens as coating antigens, and mouse anti-human IgG as labeling antibodies. During the development, the corresponding antigens and antibodies were purchased from several companies. After testing, the TB antigen and mouse anti-human IgG antibody of Jinhua (Tianjin) Trading Co., Ltd. were selected as the biological raw materials for the development of this product. NC membrane is another key material in product development. After testing the products of several companies, Germany Sartorius CN140 was selected as the solid phase carrier of this kit. Other auxiliary materials such as sample pads, absorbent paper, aluminum foil bags and plastic cards are purchased from relevant qualified companies, and corresponding quality control standards have been established ...

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Abstract

The present invention relates to a method to prepare a reagent kit to quickly diagnose mycobacterium tuberculosis antigens jointly packaged by 38KD and 16KD antigens and a test method. The blood antigen test paper of the present invention jointly packages 38 KD and 16KD of TB antigens into a lower part of a NC film to form a test line (T). Goat anti-mouse IgG is packaged into an upper part of the NC film to form a quality control line (C). In addition, anti-human IgG (mouse anti-human IgG, goat anti-human IgG or SPA) marks nanometer coloring particles (colloidal gold particles or sol particles or nanometer beads) to prepare a labeling pad. The NC film, the labeling pad, a sampling pad and a sample adsorption pad are glued and assembled onto a plastic board to form the test paper. During test, few tested sample is added onto the NC film of the test paper. And then, sample diluents are added through a sampling end. After sampling, it is necessary to observe result of immunoreaction, thus realizing quick auxiliary TB antigen diagnosis.

Description

technical field [0001] The invention relates to the technical field of biological applications, in particular to a rapid diagnosis kit for mycobacterium tuberculosis antibody coated with 38KD and 16KD antigen mixture and a detection method thereof. Background technique [0002] According to the World Health Organization, nearly 1 / 3 of the world's population has been infected with tuberculosis, with 8.7 million new cases each year and 2 million deaths from tuberculosis. There are currently 20 million tuberculosis cases in the world. The number of tuberculosis patients in my country ranks second in the world. According to the Ministry of Health's estimate in 2004, there were 4.5 million tuberculosis patients in my country. According to data from the Chinese Center for Disease Control and Prevention, the number of new tuberculosis cases in 2005 and 2006 was 1.25 million and 1.13 million respectively. 75% of tuberculosis patients in my country are aged between 15 and 54, causin...

Claims

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Application Information

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IPC IPC(8): G01N33/569G01N33/558G01N33/543
Inventor 李洲杨发青
Owner 天津中新科炬生物制药股份有限公司
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