The US Department of Health and Human Services, National Institutes of Health has a continuing requirement for NIAID Virology Quality Assurance.

The Division of AIDS (DAIDS) in the National Institute of Allergy and Infectious Diseases (NIAID) supports a global research portfolio to advance biological knowledge of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), its related co-infections, and its co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” DAIDS develops and supports the infrastructure and biomedical research needed to: 1) reduce HIV incidence through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) develop interventions to treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) foster partnerships with scientific and community stakeholders to develop and implement effective interventions. High quality test results support the safety of study participants and the reliability of study results. DAIDS employs a variety of Laboratory Quality Assurance contractual resources to monitor and enhance the ability of laboratories to accurately and reliably perform trial-specified clinical laboratory testing (https://www.niaid.nih.gov/research/daids-clinical-research-policies-standard-procedures).

The purpose of the NIAID Virology Quality Assurance (VQA) program is to provide a comprehensive quality assessment program for virologic assays for HIV and other viral pathogens (including emerging pathogens and pandemic response) performed on samples collected from participants enrolled in NIAID-sponsored and collaborative multisite clinical studies. The goal of the VQA program is to ensure the validity and inter- and intra-laboratory comparability of virologic laboratory data by providing laboratories with proficiency testing (PT) panels and real-time assay run controls, and analyzing PT panel and assay run data within each laboratory and across laboratories participating in the program. The VQA program implements standards of performance for new and existing state-of-the-art virologic assays, develops and employs biostatistical methods relating to the assays, and acquires, tests, stores and dispenses quality control materials (QCMs) and reagents. The VQA program is critical to the scientific integrity of on-going and future studies concerning HIV diagnosis, pathogenesis, drug resistance, and cure, including the assessment of vaccine and treatment efficacy, post-exposure prophylaxis (PrEP), other preventive measures, and response to emerging viral pathogens of pandemic potential.

The VQA has been in operation since 1988 and has developed and standardized quality control procedures for numerous virologic assays in support of NIAID-sponsored and collaborative clinical trials. The VQA will continue to serve current and future NIAID-sponsored clinical trial networks, cohorts, and collaborating study groups (User Groups), as well as individual grantees conducting clinical research.

The current contract is held by Duke University, Durham, North Carolina, under contract number 75N93019C00015. The period of performance of the current contract is September 21, 2019, through September 20, 2026.

• The Contractor shall provide laboratories (Labs) performing virologic testing for NIAID-sponsored and collaborative clinical trials with a comprehensive quality assessment program and real-time assay validation for virologic assays for HIV and other viral pathogens. The contract also provides for the planning and execution of single and multi-laboratory studies for the evaluation and development of new and existing virologic assays and supporting statistical methodologies. QCMs necessary for this work will be acquired, characterized, stored, catalogued, and dispensed as necessary
• The Contractor shall serve Labs associated with current and future NIAID-sponsored clinical trial networks and collaborating study groups. Currently, the contract serves approximately 110 laboratories, with 55 international laboratories in 22 countries