MYCOBACTERIUM TUBERCULOSIS (MTB) QUALITY ASSESSMENT PROGRAM (TBQA)

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The purpose of the Mycobacterium Tuberculosis (Mtb) Quality Assessment Program (TBQA) is to provide a new resource to assess the ability of laboratories located both in the United States (U.S.) and outside (non-U.S.) to accurately and reliably perform Mtb testing to diagnose active and latent Mtb infection, monitor disease progression, and assess treatment response and vaccine efficacy in direct support of clinical trials. As new tests/methodologies are developed, the TBQA program will facilitate their adaptation, standardization and quality assessment prior to inclusion in NIAID-supported clinical investigations. The TBQA program will serve NIAID-sponsored and collaborating clinical trials networks and cohorts as well as individual grantees conducting research in and outside the United States. Examples of NIAID-sponsored Networks include the Adult AIDS Clinical Trials Group (ACTG), the International Maternal Pediatric and Adolescent AIDS Clinical Trials Group (IMPAACT) and the HIV Vaccine Trials Network (HVTN). Examples of NIAID-sponsored cohorts include the India and Brazil Regional Prospective Observational Research for Tuberculosis (RePORT). Examples of collaborating User Groups include the CDC, the Global Alliance for TB Drug Development, and the US Military HIV Research Program. The TBQA contract will be responsible for monitoring Labs’ ability to perform accurately and reliably study-specified Mtb tests (e.g. next-generation bacterial DNA and RNA sequencing, serial sputum colony count on solid media, time to positivity in liquid culture, minimal inhibitory concentration assessment, and host-based assays). This will include preparation of proficiency testing panels (or acquisition from commercial and non-commercial sources), distribution to participating laboratories, capture and statistical analysis of test results obtained from Labs, determination of performance acceptability, and generation of Lab-specific performance reports. The TBQA will provide assistance, guidance and training in corrective action when Labs’ test performance is unacceptable.