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Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay

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 Qual...

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Autores principales: Keating, Sheila M., Rountree, Wes, Grebe, Eduard, Pappas, Andrea L., Stone, Mars, Hampton, Dylan, Todd, Christopher A., Poniewierski, Marek S., Sanchez, Ana, Porth, Cassandra G., Denny, Thomas N., Busch, Michael P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6746377/
https://www.ncbi.nlm.nih.gov/pubmed/31525218
http://dx.doi.org/10.1371/journal.pone.0222290
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author Keating, Sheila M.
Rountree, Wes
Grebe, Eduard
Pappas, Andrea L.
Stone, Mars
Hampton, Dylan
Todd, Christopher A.
Poniewierski, Marek S.
Sanchez, Ana
Porth, Cassandra G.
Denny, Thomas N.
Busch, Michael P.
author_facet Keating, Sheila M.
Rountree, Wes
Grebe, Eduard
Pappas, Andrea L.
Stone, Mars
Hampton, Dylan
Todd, Christopher A.
Poniewierski, Marek S.
Sanchez, Ana
Porth, Cassandra G.
Denny, Thomas N.
Busch, Michael P.
author_sort Keating, Sheila M.
collection PubMed
description 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.
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spelling pubmed-67463772019-09-27 Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay Keating, Sheila M. Rountree, Wes Grebe, Eduard Pappas, Andrea L. Stone, Mars Hampton, Dylan Todd, Christopher A. Poniewierski, Marek S. Sanchez, Ana Porth, Cassandra G. Denny, Thomas N. Busch, Michael P. PLoS One Research Article 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. Public Library of Science 2019-09-16 /pmc/articles/PMC6746377/ /pubmed/31525218 http://dx.doi.org/10.1371/journal.pone.0222290 Text en © 2019 Keating et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Keating, Sheila M.
Rountree, Wes
Grebe, Eduard
Pappas, Andrea L.
Stone, Mars
Hampton, Dylan
Todd, Christopher A.
Poniewierski, Marek S.
Sanchez, Ana
Porth, Cassandra G.
Denny, Thomas N.
Busch, Michael P.
Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay
title Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay
title_full Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay
title_fullStr Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay
title_full_unstemmed Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay
title_short Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay
title_sort development of an international external quality assurance program for hiv-1 incidence using the limiting antigen avidity assay
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6746377/
https://www.ncbi.nlm.nih.gov/pubmed/31525218
http://dx.doi.org/10.1371/journal.pone.0222290
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