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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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Recommendations to ACET, CDC, DTBE
- ACET should discuss adopting the expert panel’s guidance
and recommendations for the use of NAA testing for the diagnosis
of TB.
- To assist in developing more sources of FDA-approved NAA
tests,
- CDC and FDA should encourage manufacturers to develop NAA
tests for TB.
- CDC should assist manufacturers with regulatory quality
trials of NAA tests.
- CDC and ACET should request that the FDA streamline or
facilitate the approval process for the new tests, perhaps by
reducing the filing requirements from the Premarket Approval (PMA)
process to the less stringent Pre-Market Notification (510K)
process.
- ACET and CDC should encourage the College of American
Pathologists (CAP) to add ‘provision of TB NAA testing’ as a
checklist question to encourage private and public health
laboratories to provide access to NAA testing for TB.
- ACET and CDC should develop recommendations on the use of
molecular tests for the detection of drug-resistant TB in the
United States.
- ACET should develop and promote a research agenda for TB
NAA testing.
- CDC should take the lead in disseminating recommendations
of the expert panel through a revision of the current
‘Guidelines for the use of nucleic acid amplification (NAA)
tests in the diagnosis of tuberculosis’ and publications in
appropriate venues.
- Because of the potential for more prompt initiation of
therapy and a reduction in TB transmission, CDC should give
priority to assisting state and local TB programs to gain access
to NAA testing for TB.
- CDC should explore validating and deploying selected Analyte Specific Reagent (ASR) tests for TB to public health
laboratories in a manner similar to that of bioterrorism-related
ASR tests. Priority should be given to rapid detection tests,
such as a real-time PCR test for TB, and tests for molecular
detection of rifampin resistance. Such tests should aim to build
on the infrastructure generated by, and the experiences of, the
Bioterrorism Preparedness and Response Program.
- CDC should consider establishing centers of excellence or
regional laboratories to provide access to molecular tests for
state and local TB public health programs. This should reduce
the cost of testing associated with reagent waste, and reduce
delays in testing due to batching of samples or to the lack of
7-day a week testing. CDC and partners should develop a clear
policy and standard operating procedure for referring specimens
to a regional laboratory for NAA testing.
- CDC should help ensure the availability of proficiency
testing programs for TB NAA testing, such as the programs of CAP
or WSLH.
- CDC should develop a broader evidence base to support
changes in recommendations and practices and investigate the
economic implications of molecular testing.
- CDC should work with partners to establish an education
program for TB control officials, laboratorians, health care
providers, and policy makers on the appropriate use of NAA tests
for the diagnosis of TB.
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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