Rapid Detection Test for TB Launched
The FDA recently approved a new test manufactured by Cellestis that detects the presence of tuberculosis (TB) rapidly, as detailed in a press release from Cellestis. This new test may widely replacing the tuberculin skin test (TST), which has been used for the past one hundred years to assess the presence of this condition.
The QuantiFeron-TB Gold In-Tube (QFT) allows rapid detection of the M. tuberculosis infection. The test assesses cell immune responses to proteins observed in the presence of the infection. Immune responses to peptides that encourage the M. tuberculosis proteins are measured.
Importantly, QFT test results are not influenced if patients have been vaccinated with Bacillus Calmette-Guerin (BCG). BCG can confound results with TST. Evaluation of the test is entirely objective, unlike TST results.
TST results are determined by health professionals and, as such, interpretation is subjective. In addition, TST requires at least two visits to a healthcare provider for the initial injection and then the read of skin reaction. That test antiquated test method is also prone to false-positive results.
Advantages of the QFT test include a simplified testing format with the in-tube method. This is easily integrated into any existing laboratory. Incubation of blood samples requires little work and no time to set up testing.
An additional benefit is the cost savings with a less expensive means to assess for the presence of the communicable condition. This testing approach can also be completed at remote locations secondary to the simplified logistics of testing.
October 18, 2007 Related topics: Infectious Diseases, Product Approval & Certification, New Technology & Innovation, Diagnostic