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Report of an Expert Consultation on the Uses of Nucleic Acid
Amplification Tests for the Diagnosis of Tuberculosis
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Background
Guidelines for the use of nucleic acid amplification (NAA) tests
for the diagnosis of tuberculosis (TB) were published in 1996 (1)
and updated in 2000 (2). Since then, NAA testing has become a
routine procedure in many institutions for the diagnosis of TB,
because NAA tests can rapidly and reliably detect
Mycobacterium tuberculosis bacteria directly in a specimen
one or more weeks earlier than culture. Earlier laboratory
confirmation of TB can lead to earlier treatment initiation, better
patient care and outcomes, greater opportunities to interrupt
transmission, and improved public health interventions. Two NAA
tests are approved for use in the United States by the Food and Drug
Administration (FDA). The Enhanced Amplified Mycobacterium
Tuberculosis Direct Test (E-MTD, Gen-Probe, San Diego, California)
is approved for detection of M. tuberculosis complex bacteria in
acid-fast bacilli (AFB) smear-positive and smear-negative
respiratory specimens from patients suspected of having TB. The E-MTD
test combines isothermal transcription-mediated amplification of a
portion of the 16S rRNA with a detection method that uses a
hybridization probe specific for M. tuberculosis complex bacteria.
The MTD test displays a sensitivity of >95% for detecting M.
tuberculosis bacteria in respiratory specimens from AFB-smear
positive TB suspects and 75% to 90% for detecting M. tuberculosis
bacteria in respiratory specimens from AFB-smear negative TB
suspects. The Amplicor Mycobacterium tuberculosis Test (Amplicor,
Roche Diagnostics) is approved for the detection of M. tuberculosis
complex bacteria in AFB smear-positive respiratory specimens from
patients suspected of having TB. This test uses the polymerase chain
reaction (PCR) to amplify a portion of the 16S rRNA gene that
contains a sequence that hybridizes with an oligonucleotide probe
specific for M. tuberculosis complex bacteria. The Amplicor test
displays a sensitivity of >95% for detecting M. tuberculosis
bacteria in respiratory specimens from AFB-smear positive TB
suspects and a sensitivity of 60% to 70% for detecting M.
tuberculosis bacteria in respiratory specimens from AFB-smear
negative TB suspects.
In response to a request from the Advisory Council for the
Elimination of Tuberculosis (ACET), the Association of Public Health
Laboratories (APHL) and CDC convened an expert panel to evaluate the
evidence and propose new guidelines for the use of NAA tests for the
diagnosis of TB in the United States. The panel included TB
clinicians; TB control officials; laboratory directors or
supervisors from small, medium and large public health laboratories,
hospital laboratories, and commercial laboratories; and
representatives from the Regional Training and Medical Consultation
Centers, APHL, and CDC. Meeting on June 13, 2008, the panel reviewed
available publications and guidelines to discuss applications of NAA
testing for TB diagnosis and control and to propose recommendations.
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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