Report of an Expert Consultation on the Uses of Nucleic Acid
Amplification Tests for the Diagnosis of Tuberculosis
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Molecular Drug Susceptibility Tests (DSTs)
The expert panel also addressed available information on
molecular tests for determining drug susceptibilities of M.
tuberculosis bacteria directly from clinical specimens. Two
well-characterized, CE-marked molecular DST kits are
commercially available in Europe and elsewhere. (The CE marking,
"Conformite Européenne," certifies that a product has met
European Union requirements.) The World Health Organization has
recommended the use of these tests as screening tests for
multidrug-resistant (MDR) TB. Although several laboratories in
the U.S. offer molecular DSTs as ASR tests, none have been
approved by the FDA. The expert panel considers molecular
DSTs to be an urgent public health and diagnostic need, because
extensively drug-resistant (XDR) TB and MDR TB are becoming more
prevalent globally. Such molecular DSTs should be available to all
U.S. TB programs. The expert panel endorses the recommendations
under consideration in the proposed American Thoracic Society
‘Diagnostic Standards and Classification of Tuberculosis in Adults
and Children’ which supports the use of molecular methods for
detection of drug resistance directly in AFB-smear positive sputum
sediments for TB patients who have factors predictive of drug
resistance. Last Modified: 11/25/2008
Last Reviewed: 05/18/2008 Content Source: Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
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