(24) The assay is the AMPLIFIED Mycobacterium tuberculosis Direct Test by Gen-Probe, Inc.
Evaluation of the enhanced Amplified Mycobacterium Tuberculosis Direct Test for the direct detection of Mycobacterium tuberculosis complex in respiratory specimens.
To date, the Food and Drug Administration (FDA) has cleared 2 NAA tests for direct detection of MTBC in respiratory specimens, the Amplified Mycobacterium Tuberculosis Direct Test
(MTD) (Gen-Probe, Inc, San Diego, Calif) and the AMPLICOR Mycobacterium tuberculosis Test (Roche Diagnostic Systems, Inc, Indianapolis, Ind).
On September 30, 1999, the Food and Drug Administration approved a reformulated Amplified Mycobacterium Tuberculosis Direct Test
[*] (MTD) (Gen-Probe(r), San Diego, California) for detection of Mycobacterium tuberculosis in acid-fast bacilli (AFB) smear-positive and smear-negative respiratory specimens from patients suspected of having tuberculosis (TB).
Evaluation of Gen-Probe amplified Mycobacterium tuberculosis direct test
and PCR for direct detection of Mycobacterium tuberculosis in clinical specimens.
Amplified mycobacterium tuberculosis direct test
for in-vitro diagnostic use: 50 test kit [Package insert].