The Tuberculosis IgG/IgM Rapid Test Device is a membrane-based screening test for the rapid detection of IgG anti-Mycobacterium Tuberculosis and IgM anti-Mycobacterium Tuberculosis in human whole blood, serum or plasma. This innovative rapid screening test is based on lateral flow immunochromatography and is among the easiest point of care (POC) assay diagnostics. The results obtained should not be the sole determinant for clinical decision. All positive specimens must be confirmed with other confirmation methods.

Tuberculosis (TB) represents an infection with Mycobacterium Tuberculosis, which usually attacks the lungs but the TB bacteria can also attack different parts of the body such as kidney, spine and brain. Known since ancient Egypt, it became the scourge of 19th century Europe and North America. There has been an exponential decline in the prevalence of TB in the 20th century and the advent of anti TB drugs has further diminished the impact of the disease. However, the recent emergence of drug-resistant strains, particularly among patients with AIDS, has rekindled interest in TB. The fatality rate is estimated at 55% in untreated patients and 15% in treated patients.