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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
FDA Approves Rapid Test for Smear-Positive Tuberculosis
Frankel, David H.
January 16, 1996
Lancet (01/06/96) Vol.347, No.8993, P. 48

The U.S. Food and Drug Administration (FDA) has approved a new test to detect Mycobacterium tuberculosis in untreated patients who test positive to a tuberculosis smear test. Gen- Probe of San Diego, Calif. will manufacture the test, which is based on "transcription-mediated amplification (TMA)," under the name Amplified Mycobacterium Tuberculosis Direct Test. The FDA approved the test based on evidence from 6079 sputum samples, of which 198 stained positive for acid-fast bacilli. TMA detects bacterial ribosomal RNA before amplification begins. RNA is a better target than DNA because it is more abundant. The test's estimated cost is $15-$25. The FDA has stated that the test be used only with traditional sputum examination and culture.