The FDA has approved Cellestis, Inc.'s (Carnegie, Victoria, Australia) QuantiFERON-TB Gold whole-blood diagnostic test to detect the presence of Mycobacterium tuberculosis (TB) infection. The test uses synthetic TB peptides to detect gamma interferon, a protein produced by the immune system in response to TB infection.

The approval was based on data from clinical studies showing the test has higher specificity (greater than 99%) than the tuberculin skin test. According to Cellestis, the new test provides a simple yes or no answer and is unaffected by bacillus Calmette-Guerin vaccine and nearly all nontuberculous mycobacteria. It requires only a single patient visit. Results are available within 24 hours.

Cellestis expects the test to replace the tuberculin skin test.