Provide Quality Assurance for Virologic Assays

The Division of AIDS (DAIDS) issued a request for proposals (RFP) to provide comprehensive services to operate the NIAID Virology Quality Assurance (VQA) program, specifically for virologic assays for HIV and other viral pathogens.  

Program Overview 

The VQA program provides comprehensive quality assessment evaluations for virologic assays for HIV and other viral pathogens performed on samples collected from participants enrolled in NIAID-sponsored and collaborative multisite clinical studies.  

The VQA program has the following goals and associated activities: 

• 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.
• Implement standards of performance for new and existing state-of-the-art virologic assays; develop and employ biostatistical methods relating to the assays; and acquire, test, store and dispense quality control materials and reagents.  

The VQA program is critical to the scientific integrity of ongoing and future studies concerning HIV diagnosis, pathogenesis, drug resistance, and cure, including the assessment of vaccine and treatment efficacy, post-exposure prophylaxis, other preventive measures, and response to emerging viral pathogens of pandemic potential. 

Currently, the contract serves approximately 110 laboratories including 55 international laboratories in 19 countries. Refer to the RFP for specific activities the selected contractor is expected to perform (Statement of Work), along with options to increase the level of effort in support of 1) unanticipated increases in demand related to support of additional laboratories, 2) performance of late-stage assay validation or testing of clinical samples in a CLIA-certified laboratory, and 3) response to emerging viral pathogens and other public health emergency needs. 

Anticipated Period of Performance 

NIAID will award one contract, which can have a performance period of up to 7 years and level of effort for 10 full-time equivalents. Options, if necessary, may require additional resources, which are described in the RFP.  

Questions