Mycobacterium Tuberculosis (MTB) Quality Assessment Program (TBQA)

NIH RePORTER · NIH · N01 · $1,674,843 · view on reporter.nih.gov ↗

Abstract

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).

Key facts

NIH application ID
11052750
Project number
75N93024C00002-0-9999-1
Recipient
MIDWEST RESEARCH INSTITUTE
Principal Investigator
Gene Garrard Olinger
Activity code
N01
Funding institute
NIH
Fiscal year
2024
Award amount
$1,674,843
Award type
Project period
2023-11-17 → 2024-11-16