Report of Expert Consultations on Rapid Molecular Testing to Detect Drug-Resistant Tuberculosis in the United States
- Conduct operational, translational, and implementation research for developing, evaluating, and selecting the most effective testing algorithms for routine use and specific scenarios.
- Evaluate the cost and benefits of molecular DR testing.
- Evaluate and compare the performance of currently available tests to facilitate the choice of test(s) to use in the molecular DR testing service.
- Develop and evaluate optimal specimen collection, transport, and processing methods.
- 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.
- Characterize the performance of molecular DR tests with AFB-smear negative, NAA positive respiratory specimens.
- Define the molecular basis of resistance to each first-line and second-line anti-TB drug.
- 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.
- Conduct regulatory quality trials for molecular DR tests aimed at obtaining FDA approval.
- Determine the value of the detection of individual mutations for predicting clinically significant drug resistance.