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

1. ACET should discuss adopting the expert panel’s guidance and recommendations for the use of NAA testing for the diagnosis of TB.
2. To assist in developing more sources of FDA-approved NAA tests,
   1. CDC and FDA should encourage manufacturers to develop NAA tests for TB.
   2. CDC should assist manufacturers with regulatory quality trials of NAA tests.
   3. 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.
3. 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.
4. ACET and CDC should develop recommendations on the use of molecular tests for the detection of drug-resistant TB in the United States.
5. ACET should develop and promote a research agenda for TB NAA testing.
6. 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.
7. 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.
8. 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.
9. 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.
10. CDC should help ensure the availability of proficiency testing programs for TB NAA testing, such as the programs of CAP or WSLH.
11. CDC should develop a broader evidence base to support changes in recommendations and practices and investigate the economic implications of molecular testing.
12. 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.