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Tuberculosis special antigen rapid diagnosis kit

A technology for rapid diagnosis of tuberculosis, applied in the field of immunodiagnosis, which can solve the problems of diagnosis uncertainty and the inability to distinguish between live and dead infectious bacteria

Inactive Publication Date: 2008-11-12
AUTOBIO DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, PCR has the advantages of high sensitivity, strong specificity, and rapidity, but it cannot distinguish the life and death of infectious bacteria, and at the same time, it is easy to be contaminated and produce false positive results, which brings uncertainty to the diagnosis.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0007] Example 1. Detection of tuberculosis-specific antigens by enzyme-linked immunoassay (ELISA).

[0008] Express and purify desA protein by genetic engineering and make desA monoclonal antibody coated enzyme-linked plate, use another monoclonal antibody or polyclonal antibody to label horseradish peroxidase, form a kit with other reagents, and use double antibody sandwich method to detect human Tuberculosis-specific antigens in serum or plasma are used for screening of infection in clinical tuberculosis patients.

[0009] 【Kit components】

[0010] (1) 1 tuberculosis-specific antigen enzyme-linked plate (96 wells)

[0011] (2) 1 bottle of sample diluent (7ml)

[0012] (3) 1 bottle (13ml) for detection of tuberculosis-specific antigen enzyme-labeled antibody

[0013] (4) Positive control (inactivated) 1 bottle (1ml)

[0014] (5) Negative control (inactivated) 1 bottle (1ml)

[0015] (6) 1 bottle of 20× washing solution (50ml)

[0016] (7) Chromogen A 1 bottle (7ml)

...

Embodiment 2

[0047] Embodiment 2, chemiluminescence detection test tuberculosis specific antigen

[0048] Principle and application: express and purify desA protein by genetic engineering and make desA monoclonal antibody coated opaque chemiluminescent microwell plate, use another monoclonal antibody or polyclonal antibody to label horseradish peroxidase, and use double antibody sandwich method to detect human Tuberculosis-specific antigens in serum or plasma, and finally the enzymatic chemiluminescent substrate amplifies the detection signal, and the content of the tested antigen is proportional to the strength of the luminescent signal, so as to achieve the purpose of quantitative detection. Screening for infection in clinical tuberculosis patients.

[0049] Kit composition:

[0050] Numbering

name

quantity

illustrate

1

2

3

4

5

6

7

8

coated board

enzyme conjugate

Standard

Luminescent Substrate ...

Embodiment 3

[0079] Embodiment 3, immunocolloidal gold method detects tuberculosis specific antigen

[0080] Principle and application: The diagnostic methods for tuberculosis include checking for acid-fast bacilli in sputum, culture of sputum (or body fluid), tuberculin test and radiographic examination. However, these methods do not achieve the required diagnostic sensitivity. The best indicators for diagnosing tuberculosis clinically and in rheumatology are serological tests, such as hemagglutination, complement fixation, immunofluorescence and radioimmunodiffusion techniques. However, these methods require expensive equipment and materials, which are severely restricted in non-developed countries.

[0081] The present invention uses the double-antibody sandwich method to detect tuberculosis-specific antigens in human serum or plasma, uses genetic engineering to express and purify the desA protein, makes desA monoclonal antibody coated with nitrocellulose membrane, and uses colloidal g...

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Abstract

The invention utilizes a genetic engineering method to express in vitro the desA protein of mycobacterium tuberculosis and produces monoclonal antibodies by using the protein. A tuberculosis specific antigen rapid diagnosis reagent kit is produced by utilizing enzyme linked immunization, chemiluminescence, colloidal gold test strip method and other diagnostics methods so as to detect MTB quickly with low cost. The technique has wide application value in clinical diagnosis.

Description

technical field [0001] The invention belongs to the field of immunodiagnosis, and in particular relates to a tuberculosis specific antigen rapid diagnosis kit. Background technique [0002] Tuberculosis is an important economic and medical problem worldwide. In 1995, tuberculosis killed more people than any infectious disease in the world. The case fatality rate is estimated to be 55% in the untreated population and 15% in treated patients. As an ancient infectious disease, tuberculosis is on the rise globally. According to WTO estimates, about 2 billion people in the world are infected with Mycobacterium tuberculosis, with 8 million new cases and 3 million deaths every year [1]. In my country, according to the fourth national tuberculosis survey in 2000, there were about 550 million tuberculosis cases in the country, nearly half of the country's population [2]. The current situation of tuberculosis in my country is severe. It is an urgent task to establish advanced dia...

Claims

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Application Information

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IPC IPC(8): G01N33/577G01N33/569G01N33/549G01N33/543
Inventor 付光宇顾军李桂林屈长江张跃锋马建军翟维金陆莹秦耘杨增利吴学炜
Owner AUTOBIO DIAGNOSTICS CO LTD
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