ELISA fleck diagnosis kit for tubercle bacillus infect and method for preparing specific antigen

Abstract

The invention relates to a reagent kit for diagnosing enzyme linked immune spots infected by tubercle bacillus and a method for preparing a specific antigen. The reagent kit comprises a reagent kit body and a detection reagent arranged in the kit body; the detection reagent comprises a positive standard solution, a chromogenic agent, a concentrated detergent and a diluent; the detection reagent also comprises a specific antigen of mycobacterium tuberculosis, a coated INF-gamma resistant antibody and an enzyme label secondary antibody of a vector protein conjugate; the specific antigen of mycobacterium tuberculosis is fusion protein expressed by an ESAT-6 gene and an EIS gene of the mycobacterium tuberculosis; and the INF-gamma resistant antibody is a murine IgG antibody. The method for preparing the specific antigen comprises the following steps: proper tubercle bacillus special antigen ESAT-6 and EIS are combined; and the prepared recombining fusion protein contains main antigenic determinants of two antigens. The recombining fusion protein definitely contains a T cell epitope suitable for the limitation of different HLA, and does not influence results by different groups and different HLA distribution. Clinical tests on tuberculosis patients and healthy people of different groups show that the reagent kit has more excellent specificity and sensitivity than a current similar product.

Description

Technical field: [0001] The invention relates to an enzyme-linked immunospot diagnostic kit for tuberculosis infection and a method for preparing a specific antigen, belonging to the technical field of medical immunodiagnostics. Background technique: [0002] Tuberculosis (Tuberculosis, TB) is a chronic infectious disease caused by Mycobacterium tuberculosis infection, and it is the number one killer of infectious diseases. About 1 / 3 of the world's population is infected with TB, and there are about 8 million new tuberculosis cases every year. , 1.7 million deaths. There are many reasons for the above serious epidemic situation, among which the lack of early, specific and sensitive diagnostic techniques and reagents is an important reason. At present, the diagnosis of tuberculosis and tuberculosis infection mainly includes the following techniques: 1) microbiological examination, including bacterial smear microscopy, tuberculosis culture, nucleic acid detection; 2) immunolo...

AI Technical Summary

Problems solved by technology

The main basis for determining the course of tuberculosis treatment: 1) The results of sputum bacteriological examination, the general patient will turn negative within 2 months of anti-tuberculosis treatment, and the subsequent treatment can no longer have the results of bacteriological examination as the basis for detection; 2 ) Radiological examination, based on the shadow changes of lesions to guide treatment, but most of the patients after the acute phase, the shadow changes are not obvious, and it is difficult to quantitatively analyze, and it is even more difficult to be objective

Therefore, none of these indicators can objectively and quantitatively evaluate the effect of tuberculosis anti-tuberculosis treatment

In addition to considering reasonable medical expenses, the treatment of tuberculosis has two particularities: 1) the side effects of anti-tuberculosis treatment are large, and transitional treatment increases the probability of toxic and side effects; Insufficient course of treatment is the main reason for relapse

Images