CDC Issues New Guidelines for Detection of Tuberculosis; Recommends QuantiFERON-TB GOLD as Alternative to Traditional Skin Test

VALENCIA, Calif. -- The Centers for Disease Control and Prevention (CDC) has published new M. tuberculosis (TB) detection guidelines, advising that QuantiFERON-TB GOLD, a simple, one-step blood test, can be used in all circumstances under which the traditional tuberculin skin test (TST) is currently used.  The new guidelines, which note that QuantiFERON-TB GOLD offers the possibility of detecting TB with greater specificity than has been possible previously, come just days after the Centers for Medicare & Medicaid Services approved QuantiFERON-TB GOLD for reimbursement starting Jan. 1, 2006.

"QuantiFERON-TB GOLD represents a breakthrough in TB diagnosis and control and offers several important advantages, including the fact that it is more accurate than the TST and only requires one visit," said David DeBiasi RN, director of community health and tuberculosis services for the American Lung Association of Virginia.  "New diagnostics such as QuantiFERON-TB GOLD are the key to the future success of eliminating TB, which continues to ravage the globe, causing nearly 2 million deaths a year."

The guidelines, published in the CDC's Dec. 16 Morbidity and Mortality Weekly Report, affirm that QuantiFERON-TB GOLD can be administered in place of the 100-year-old TST, which despite widespread use can be unreliable because of false-positive and false-negative results.  Typical, and often mandatory, TB tests include contact investigations, evaluation of recent immigrants, and infection control surveillance programs, such as yearly testing for healthcare workers. Details of the CDC's recommendations on how to use QuantiFERON(R)-TB GOLD can be found at http://www.cdc.gov/mmwr/.

"One of the greatest problems in combating this disease has been the reliance on an antiquated detection method," said Dr. Tony Radford, managing director of Cellestis Inc., the maker of QuantiFERON-TB GOLD.  "These guidelines represent a significant advancement in the detection and potential elimination of TB in the United States."

QuantiFERON(R)-TB GOLD is also able to detect latent or non-symptomatic TB in individuals while eliminating candidates who have had BCG vaccinations for TB, a common cause for false-positive readings with the TST.  The blood test is highly specific because it measures immune responses to peptides that simulate M. tuberculosis proteins not present in the BCG vaccine.  Thus, a positive QuantiFERON-TB GOLD test result is a strong predictor of TB infection, eliminating subjective interpretations of test results.

As a blood test, QuantiFERON-TB GOLD eliminates the need for patients to visit their doctor a second time so that the results can be read. Currently, as many as 30 percent of people tested with the TST do not return for the required second screening, during which a medical professional examines a patient's skin for reactions, a possible indicator of TB infection.

Source: Cellestis Inc.