The purpose of the VQA program is to provide virologic proficiency testing panels and real-time assay run controls to laboratories performing analysis on samples from NIAID-sponsored clinical studies. The VQA program is integral to the integrity of on-going and future studies concerning HIV diagnosis, disease progression, assessment of treatments, vaccine efficacy, and other preventative measures.
The goal of the VQA Qualitative HIV-1 NAT Proficiency Testing (PT) Program is to assess the proficiency of National Institute of Allergy and Infectious Diseases (NIAID) / Division of AIDS (DAIDS) -supported laboratories performing Qualitative HIV-1 NAT assays. Each participating site will be asked to perform 2 PT panels throughout the year. Each PT panel consists of 5 whole blood or 5 dried blood spot (DBS) samples from well characterized donors that are collected, processed, and characterized by the Duke VQA Team. As part of the Qualitative HIV-1 NAT program, the sites will characterize the PT panel samples as HIV positive or HIV negative, which will be used to evaluate site performance.
Laboratories are not to share information regarding the PT panels or their results with other laboratories until the study is completed and the final data have been analyzed. Laboratories should perform their PT in their own laboratory and should not subcontract out testing. Each laboratory will only receive access to its datasets and reports. Sites can only report results for their site.
HIV-1 RNA quantitation is important for monitoring the health and treatment of HIV-1 infected patients. The VQA Quantitative HIV-1 RNA Proficiency Testing (PT) Program assesses the proficiency of NIAID/DAIDS-supported laboratories performing Quantitative HIV-1 RNA assays for determination of viral load. Throughout the year, sites are asked to analyze 4 PT panels consisting of 4 spiked plasma samples and one negative control sample. All panels provided were collected, processed, and characterized by the Duke VQA team.
As part of Quantitative HIV-1 RNA testing, the sites will generate a viral load (copies/mL) and Log10 values which will be used to evaluate site performance. Site-reported viral loads from these participating labs will be summarized using specificity, accuracy, sensitivity, and precision. Statistical assessment, troubleshooting, final report, and discussion of results will occur between participating laboratories and VQA/NIAID. Laboratories should run their PT in their own laboratory and should not subcontract out testing. Each laboratory will only receive access to their datasets and reports. Sites can only report results for their site.
The Genotypic HIV-1 Drug Resistance Proficiency Testing Program assesses the proficiency of NIAID/DAIDS-supported and other interested research laboratories at sequencing virus and correctly identifying drug resistant mutations in samples collected, processed, and characterized by the Duke VQA team. Each site will be asked to perform 2 PT panels throughout the year, each consisting of 5 samples from HIV culture supernatant spiked into defibrinated human plasma.
Proficiency testing panels will include HIV-1 with known drug resistance mutations in the Protease (PR; amino acids 9-94), Reverse Transcriptase (RT; amino acids 40-237) or integrase (INT; amino acids 50-264) genes. Laboratory submitted sequences are scored against a consensus reference sequence. A nucleotide position is included in the consensus if there is at least 80% agreement for that position among all the laboratories.
Laboratories are not to share information regarding panel composition or their results with other laboratories until the study is completed and the final data have been analyzed. Laboratories should run their PT in their own laboratory and should not subcontract out testing. Each laboratory will only receive access to their datasets and reports. Sites can only report results for their site.