REF:

C2109 (Cassette)

INTENDED USE:

TB IgG/IgM Antibody Joint Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM anti-Mycobacterium Tuberculosis (M. TB) and IgG anti-M. TB in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with M. TB. Any reactive specimen with TB IgG/IgM Antibody Joint Test must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY:

Tuberculosis is a chronic, communicable disease caused principally by M. TB hominis (Koch’s bacillus), occasionally by M. TB bovis. The lungs are the primary target, but any organ may be infected. The risk of TB infection has exponentially declined in the 20th century. However, the recent emergence of drug-resistant strains, particularly among patients with AIDS, has rekindled interest in TB. The incidence of infection was reported around 8 million cases per year with a death rate of 3 million per year. The mortality exceeded 50% in some African countries with high HIV rates. The initial clinical suspicion and radiographic findings, with subsequent laboratory confirmation by sputum examination and culture are the traditional method(s) in the diagnosis of active TB. However, these methods either lack sensitivity or are time consuming, in particularly are not suitable for patients who are unable to produce adequate sputum, smear-negative, or suspected to have extra-pulmonary TB.

TB IgG/IgM Antibody Joint Test is developed to alleviate these obstacles. The test detects IgM and IgG anti-M. TB in serum, plasm, or whole blood in 15 minutes. An IgM positive result indicates for a fresh M. TB infection, while an IgG positive response suggests a previous or chronic infection.

Utilizing M. TB specific antigens, it also detects IgM anti-M. TB in patients vaccinated with BCG. In addition, the test can be performed by untrained or minimal skilled personnel without cumbersome laboratory equipment.