Report of an Expert Consultation on the Uses of Nucleic Acid Amplification Tests for the Diagnosis of Tuberculosis

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Research Needs

1. Conduct operational research for developing, evaluating, and selecting the most effective and efficient NAA testing algorithms for routine use and for specific scenarios.
2. Develop and evaluate tests suitable for use with non-respiratory specimens (e.g., cerebrospinal fluid, gastric aspirates, or biopsies).
3. Develop and evaluate tests that will enhance the diagnosis of TB in children.
4. Develop and evaluate optimal specimen collection, transport, and processing methods.
5. Determine the influences of specimen quality and quantity on NAA test performance.
6. Characterize the ability of NAA tests to detect M. tuberculosis bacteria in mixed infections.
7. Develop, evaluate, and deploy NAA tests with improved performance and ease-of-use and features that include
   1. point-of-care testing, turnaround times of <2 hours
   2. automatable, minimal hands-on time
   3. minimal specimen processing required
   4. closed system to minimize end-product contamination concerns
   5. internal controls for inhibitors
   6. increased sensitivity, perhaps through using target capture technologies
   7. quality-assured reagents for use in the test reactions and for use as controls
8. Conduct regulatory quality trials for any new NAA test aimed at obtaining FDA approval.