Mycobacterium Tuberculosis (MTB) Quality Assessment Program (TBQA)

The primary purpose of the Mycobacterium tuberculosis Quality Assessment (TBQA) contract is to support and promote access to quality-assured Mycobacterium tuberculosis (MTB) laboratory diagnosis and testing across laboratories participating in NIAID Division of AIDS (DAIDS)-supported clinical studies. MTB laboratories play a critical role in generating data that determine primary and secondary endpoints for TB clinical trials. The harmonization of methodologies among the various testing laboratories (Labs) ensures comparability of test results across multiple trial-supporting labs and comparability of data between trials. The use of appropriate methodologies and reliable test results ensures the safety of study participants and supports product advancement and approval by U.S. and non-U.S. regulatory entities. The TBQA will serve NIAID-sponsored and collaborating clinical trial networks and cohorts as well as individual grantees conducting research in and outside the U.S. 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 TB cohorts include the India and Brazil Regional Prospective Observational Research for Tuberculosis (RePORT).