Tuberculosis remains an important socio-economical and medical problem throughout he world. The incidence of TB is expected to increase from 7.5 million cases per year in 1995 to 11.9 million in 2005. The case fatality rate is estimated at 55% for untreated people and 15% for the treated patients. The commonly used diagnostic tests for tuberculosis such as sputum examination of acid fast bascilli, culture of sputum or other fluids, the tuberculin skin test and radiological investigations do not achieve the required diagnostic sensitivity.
One Step TB Test is a chromatographic immunoassay for direct qualitative detection of Tuberculosis antibody in human serum.