Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay
Autoři:
Sheila M. Keating aff001; Wes Rountree aff003; Eduard Grebe aff001; Andrea L. Pappas aff003; Mars Stone aff001; Dylan Hampton aff001; Christopher A. Todd aff003; Marek S. Poniewierski aff003; Ana Sanchez aff003; Cassandra G. Porth aff003; Thomas N. Denny aff003; Michael P. Busch aff001;
Působiště autorů:
Vitalant Research Institute, San Francisco, CA, United States of America
aff001; Department of Laboratory Medicine, University of California, San Francisco, CA, United States of America
aff002; Duke Human Vaccine Institute, Duke University, Durham, NC, United States of America
aff003
Vyšlo v časopise:
PLoS ONE 14(9)
Kategorie:
Research Article
doi:
https://doi.org/10.1371/journal.pone.0222290
Souhrn
Laboratory assays for identifying recent HIV-1 infections are widely used for estimating incidence in cross-sectional population-level surveys in global HIV-1surveillance. Adequate assay and laboratory performance are required to ensure accurate incidence estimates. The NIAID-supported External Quality Assurance Program Oversight Laboratory (EQAPOL) established a proficiency testing program for the most widely-used incidence assay, the HIV-1 Limiting Antigen Avidity EIA (LAg), with US Centers for Disease Control and Prevention (CDC)-approved kits manufactured by Sedia Biosciences Corporation and Maxim Biomedical. The objective of this program is to monitor the performance of participating laboratories. Four rounds of blinded external proficiency (EP) panels were distributed to up to twenty testing sites (7 North American, 5 African, 4 Asian, 2 South American and 2 European). These panels consisted of ten plasma samples: three blinded well-characterized HIV-1-seropositive samples that were included as replicates and an HIV-negative control. The seropositive samples spanned the dynamic range of the assay and are categorized as either recent or long-term infection. Participating sites performed the assay according to manufacturers’ instructions and completed an online survey to gather information on kit manufacturer, lot of kit used, laboratory procedures and the experience of technicians. On average, fifteen sites participated in each round of testing, with an average of four sites testing with only the Maxim assay, seven testing with only the Sedia assay and five sites utilizing both assays. Overall, the Sedia and Maxim assays yielded similar infection status categorization across the laboratories; however, for most of the nine HIV+ samples tested, there were significant differences in the optical density readouts, ODn (N = 8) and OD (N = 7), between LAg kit manufacturers (p < 0.05 based on mixed effects models. The EQAPOL LAg program is important for monitoring laboratory performance as well as detecting variations between manufacturers of HIV-1incidence assays.
Klíčová slova:
Biology and life sciences – Microbiology – Medical microbiology – Microbial pathogens – Viral pathogens – Immunodeficiency viruses – HIV – HIV-1 – Retroviruses – Lentivirus – Organisms – Viruses – RNA viruses – Physiology – Antibodies – Biochemistry – Proteins – Immune system proteins – Anatomy – Body fluids – Blood – Medicine and health sciences – Pathology and laboratory medicine – Pathogens – Serology – Epidemiology – HIV epidemiology – Infectious diseases – Viral diseases – HIV infections – Immune physiology – Immunology – Engineering and technology – Systems engineering – Quality assurance
Zdroje
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