TB Blood Tests Preferred for Targeted Groups
Oxford, UK [Marlborough, MA]; 25 June 2010 – Oxford Immunotec Inc, announces the release of new Centers for Disease Control and Prevention (CDC) guidelines for using interferon gamma release assays (IGRA) to detect Mycobacterium tuberculosis infection. For the first time, the CDC make specific recommendations for which an IGRA is preferred over use of the 100+ year-old tuberculin skin test (TST), including persons who have received the BCG vaccination, and for persons unlikely to return for the required reading of results needed to complete the test.
A significant percentage of the approximately 20 million individuals tested for TB infection in the U.S. each year fall into the two groups for which an IGRA is now preferred. Use of IGRA tests such as the T-SPOT.TB test are expected to reduce false positives and unnecessary treatment, as well as increase the acceptance of treatment by those truly infected with TB.
In addition, the new guidelines recommend that the T-SPOT.TB test may now be used in place of the tuberculin skin test (TST) in all situations in which the CDC recommends tuberculin skin testing. Since obtaining premarket approval from the Food and Drug Administration (FDA) in July 2008, the T-SPOT.TB test has become widely utilized in hospitals, medical practices and public health facilities throughout the United States. The T-SPOT.TB test is backed by the clinical evidence of over 200 peer-reviewed publications, and is the only IGRA with both sensitivity and specificity exceeding 95% in FDA pivotal trials.
When asked about the guidelines, Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec said, “We strongly support the new recommendations the CDC has made, and believe they will have a positive impact on TB control in the U.S. The targeted use of IGRA’s provides compelling clinical and economic benefits, and hundreds of institutions have already adopted the T-SPOT.TB test for this purpose. We’re pleased to be part of the solution in the global effort to eliminate TB.”
