Report of Expert Consultations on Rapid Molecular Testing to Detect Drug-Resistant Tuberculosis in the United States

Research Needs

1. Conduct operational, translational, and implementation research for developing, evaluating, and selecting the most effective testing algorithms for routine use and specific scenarios.
2. Evaluate the cost and benefits of molecular DR testing.
3. Evaluate and compare the performance of currently available tests to facilitate the choice of test(s) to use in the molecular DR testing service.
4. Develop and evaluate optimal specimen collection, transport, and processing methods.
5. Characterize the performance of molecular DR tests with mixtures of M. tuberculosis and NTM, mixtures of resistant and susceptible bacteria, different types of specimens, and cultures.
6. Characterize the performance of molecular DR tests with AFB-smear negative, NAA positive respiratory specimens.
7. Define the molecular basis of resistance to each first-line and second-line anti-TB drug.
8. Develop and evaluate molecular DR tests for first-line and second line anti-TB drugs. Tests are needed for drugs for which conventional testing is problematic (e.g., ethambutol, pyrazinamide) and the XDR TB defining drugs particularly the fluoroquinolones.
9. Conduct regulatory quality trials for molecular DR tests aimed at obtaining FDA approval.
10. Determine the value of the detection of individual mutations for predicting clinically significant drug resistance.