REF:

C2105 (Cassette)

INTENDED USE:

Tuberculosis Total Antibody Test is an immunochromatographic membrane assay that uses the double-antigen sandwich method to direct detection of total antibodies that anti-Mycobacterium Tuberculosis (TB) from human serum/plasma/whole blood specimens.

Tuberculosis Total Antibody Test is intended to be used as an aid in the diagnosis of Tuberculosis infection. Performance of the test is limited to professional use. Negative results do not preclude acute Tuberculosis infection. If acute infection is suspected, consult the physician, and diagnose with cultivation, chest CT or PCR Test. For research use only.  

SUMMARY:

Tuberculosis is a chronic, infectious disease caused principally by Mycobacterium Tuberculosis hominis (Koch’s bacillus), occasionally by M.bovis. The lungs are the primary target, but any organ can be infected. BCG, streptomycin, and isoniazid once made people believe that tuberculosis could be eliminated in the 20th century. However, the recent emergence of drug-resistant strains, particularly among patients with AIDS, has reinforce the infection of tuberculosis.

The World Health Organization reports that more than 8 million new cases of active tuberculosis are diagnosed. Recently, serological detection of active TB has been popular, particularly for patients who are unable to produce adequate sputum, or smear-negative, or suspected to have extrapulmonary TB. This test can be performed by minimally trained personnel, without cumbersome laboratory equipment.