INTENDED USE

Mycobacterium tuberculosis antibody Detection Kit is suitable for preliminary clinical screening qualitative detection of mycobacterium tuberculosis antibody in serum/plasma/whole blood sample. This reagent does not require any equipment, simple and rapid operation, and is suitable for auxiliary diagnosis of tuberculosis caused by mycobacterium tuberculosis.
For professional use only.
Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis, Mycobacterium bovis and Mycobacterium africanum in Mycobacterium tuberculosis complex, which can affect all organs of the body, especially pulmonary tuberculosis. The diagnosis of pulmonary tuberculosis is mainly based on bacteriological laboratory examinations, combined with chest imaging, epidemiological and clinical manifestations, necessary auxiliary examinations and differential diagnosis, and a comprehensive analysis is made. Coughing, expectoration for ≥2 weeks or hemoptysis are important clues for the detection and diagnosis of pulmonary tuberculosis. Sputum smear microscopy is the main method for finding patients infected with pulmonary tuberculosis, but requires equipment and skilled operators.

PRINCIPLE

Mycobacterium tuberculosis antibody detection kit adopts highly specific antibody-antigen reaction and immunochromatographic analysis technology. The reagent contains tuberculosis antigen pre-immobilized in the test area (T) on the membrane and mouse anti-human IgG monoclonal antibody colloid gold conjugates as the peridium of polyester membrane. During the test, the sample is added to the reagent injection hole, and then the buffer is added dropwise to the buffer hole. The colloidal gold and buffer are then chromatographed upwardly by capillary effect. The sample reacts with the pre-peridiumed tuberculosis antigen with the buffer chromatography to the T-line position, and the colloidal gold reacts with the mixture on the membrane. If it is positive, the tuberculosis antibody in the sample first binds to the tuberculosis antigen immobilized on the membrane during the chromatography process, and then the colloidal gold binds to the conjugate on the membrane, and a purple-red band will appear in the test area (T). This band is formed by the combination of TB antigen-TB antibody-colloidal gold complexes on the membrane. If negative, there will be no purple-red band in the test area (T). The quality control line (Line C) is with peridium of sheep anti-mouse IgG polyclonal antibody.A purple-red band appears in the control area (C) regardless of whether TB antibodies are present in the specimen. The purple-red band displayed in the quality control area (C) is the standard for judging whether there are enough samples and whether the chromatography process is normal, and also serves as the internal control standard of the reagent.