Rapid Test for Mycobacterium tuberculosis (TB)

Test Description The American Bionostica Rapid TB Test is designed for screening for active Mycobacterial infection. It does not detect latent TB. A proprietary "TB Composite Antigen" is immobilized on a membrane solid support. Active TB specific antibodies bind to a gold conjugate and then bind to the solid phase TB antigen on the membrane. This forms a visible red-purple line. PPD positive, TB negative and normal human specimens do not develop color at the test line. This test offers an effective method of preliminary screening and is particularly useful since TB diagnosis by culture can take 6-8 weeks and is very costly. The American Bionostica Rapid TB Test clearly discriminates between persons with active Tb and uninfected or BCG vaccinated persons.

Scanning Electron Micrograph of Mycobacterium tuberculosis; Tuberculosis Research Section; National Institute of Allergy and Infectious Diseases, NIH Clinical Studies 583 patient specimens from the U.S., India, Africa,and Eastern Europe were tested. Test sensitivity was 86% Test specificity was 82% Additional studies are scheduled and on-going in Africa, Brazil and Mexico.