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