Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance

Background: Two manufacturers, Maxim Biomedical and Sedia Biosciences Corporation, supply CDC-approved versions of the HIV-1 Limiting Antigen Avidity EIA (LAg) for detecting ‘recent’ HIV infection in cross-sectional incidence estimation. This study assesses and compares the performance of the two as...

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Autores: Sempa, Joseph B., Welte, Alex, Busch, Michael P., Hall, Jake, Hampton, Dylan, Facente, Shelley N., Keating, Sheila M., Marson, Kara, Parkin, Neil, Pilcher, Christopher D., Murphy, Gary, Grebe, Eduard, Naniche, Denise, CEPHIA (Consortium for the Evaluation and Performance of HIV Incidence Assays)
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/149240
Acceso en línea:https://hdl.handle.net/2445/149240
Access Level:acceso abierto
Palabra clave:VIH (Virus)
Marcadors bioquímics
HIV (Viruses)
Biochemical markers
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spelling Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillanceSempa, Joseph B.Welte, AlexBusch, Michael P.Hall, JakeHampton, DylanFacente, Shelley N.Keating, Sheila M.Marson, KaraParkin, NeilPilcher, Christopher D.Murphy, GaryGrebe, EduardNaniche, DeniseCEPHIA (Consortium for the Evaluation and Performance of HIV Incidence Assays)VIH (Virus)Marcadors bioquímicsHIV (Viruses)Biochemical markersBackground: Two manufacturers, Maxim Biomedical and Sedia Biosciences Corporation, supply CDC-approved versions of the HIV-1 Limiting Antigen Avidity EIA (LAg) for detecting ‘recent’ HIV infection in cross-sectional incidence estimation. This study assesses and compares the performance of the two assays for incidence surveillance. Methods: We ran both assays on a panel of 2,500 well-characterized HIV-1-infected specimens. We analysed concordance of assay results, assessed reproducibility using repeat testing and estimated mean durations of recent infection (MDRIs) and false-recent rates (FRRs) for a range of normalized optical density (ODn) thresholds, alone and in combination with viral load thresholds. We defined three hypothetical surveillance scenarios, similar to the Kenyan and South African epidemics, and a concentrated epidemic. These scenarios allowed us to evaluate the precision of incidence estimates obtained by means of various recent infection testing algorithms (RITAs) based on each of the two assays. Results: The Maxim assay produced lower ODn values than the Sedia assay on average, largely as a result of higher calibrator readings (mean OD of 0.749 vs. 0.643), with correlation of normalized readings lower (R2 = 0.908 vs. R2 = 0.938). Reproducibility on blinded control specimens was slightly better for Maxim. The MDRI of a Maxim-based algorithm at the ‘standard’ threshold (ODn ≤1.5 & VL >1,000) was 201 days (95% CI: 180,223) and for Sedia 171 (152,191). The difference Differences in MDRI were estimated at 32.7 (22.9,42.8) and 30.9 days (21.7,40.7) for the two algorithms, respectively. Commensurately, the Maxim algorithm had a higher FRR in treatment-naive subjects (1.7% vs. 1.1%). The two assays produced similar precision of incidence estimates in the three surveillance scenarios. Conclusions: Differences between the assays can be primarily attributed to the calibrators supplied by the manufacturers. Performance for surveillance was extremely similar, although different thresholds were optimal (i.e. produced the lowest variance of incidence estimates) and at any given ODn threshold, different estimates of MDRI and FRR were obtained. The two assays cannot be treated as interchangeable: assay and algorithm-specific performance characteristic estimates must be used for survey planning and incidence estimation.Public Library of Science (PLoS)2020202020192020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion17 p.application/pdfhttps://hdl.handle.net/2445/149240Articles publicats en revistes (ISGlobal)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: http://dx.doi.org/10.1371/journal.pone.0220345PLoS ONE, 2019, vol. 14, num. 7, p. e0220345http://dx.doi.org/10.1371/journal.pone.0220345cc by (c) Sempa et al., 2019http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/1492402026-05-29T05:05:01Z
dc.title.none.fl_str_mv Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance
title Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance
spellingShingle Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance
Sempa, Joseph B.
VIH (Virus)
Marcadors bioquímics
HIV (Viruses)
Biochemical markers
title_short Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance
title_full Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance
title_fullStr Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance
title_full_unstemmed Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance
title_sort Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance
dc.creator.none.fl_str_mv Sempa, Joseph B.
Welte, Alex
Busch, Michael P.
Hall, Jake
Hampton, Dylan
Facente, Shelley N.
Keating, Sheila M.
Marson, Kara
Parkin, Neil
Pilcher, Christopher D.
Murphy, Gary
Grebe, Eduard
Naniche, Denise
CEPHIA (Consortium for the Evaluation and Performance of HIV Incidence Assays)
author Sempa, Joseph B.
author_facet Sempa, Joseph B.
Welte, Alex
Busch, Michael P.
Hall, Jake
Hampton, Dylan
Facente, Shelley N.
Keating, Sheila M.
Marson, Kara
Parkin, Neil
Pilcher, Christopher D.
Murphy, Gary
Grebe, Eduard
Naniche, Denise
CEPHIA (Consortium for the Evaluation and Performance of HIV Incidence Assays)
author_role author
author2 Welte, Alex
Busch, Michael P.
Hall, Jake
Hampton, Dylan
Facente, Shelley N.
Keating, Sheila M.
Marson, Kara
Parkin, Neil
Pilcher, Christopher D.
Murphy, Gary
Grebe, Eduard
Naniche, Denise
CEPHIA (Consortium for the Evaluation and Performance of HIV Incidence Assays)
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv VIH (Virus)
Marcadors bioquímics
HIV (Viruses)
Biochemical markers
topic VIH (Virus)
Marcadors bioquímics
HIV (Viruses)
Biochemical markers
description Background: Two manufacturers, Maxim Biomedical and Sedia Biosciences Corporation, supply CDC-approved versions of the HIV-1 Limiting Antigen Avidity EIA (LAg) for detecting ‘recent’ HIV infection in cross-sectional incidence estimation. This study assesses and compares the performance of the two assays for incidence surveillance. Methods: We ran both assays on a panel of 2,500 well-characterized HIV-1-infected specimens. We analysed concordance of assay results, assessed reproducibility using repeat testing and estimated mean durations of recent infection (MDRIs) and false-recent rates (FRRs) for a range of normalized optical density (ODn) thresholds, alone and in combination with viral load thresholds. We defined three hypothetical surveillance scenarios, similar to the Kenyan and South African epidemics, and a concentrated epidemic. These scenarios allowed us to evaluate the precision of incidence estimates obtained by means of various recent infection testing algorithms (RITAs) based on each of the two assays. Results: The Maxim assay produced lower ODn values than the Sedia assay on average, largely as a result of higher calibrator readings (mean OD of 0.749 vs. 0.643), with correlation of normalized readings lower (R2 = 0.908 vs. R2 = 0.938). Reproducibility on blinded control specimens was slightly better for Maxim. The MDRI of a Maxim-based algorithm at the ‘standard’ threshold (ODn ≤1.5 & VL >1,000) was 201 days (95% CI: 180,223) and for Sedia 171 (152,191). The difference Differences in MDRI were estimated at 32.7 (22.9,42.8) and 30.9 days (21.7,40.7) for the two algorithms, respectively. Commensurately, the Maxim algorithm had a higher FRR in treatment-naive subjects (1.7% vs. 1.1%). The two assays produced similar precision of incidence estimates in the three surveillance scenarios. Conclusions: Differences between the assays can be primarily attributed to the calibrators supplied by the manufacturers. Performance for surveillance was extremely similar, although different thresholds were optimal (i.e. produced the lowest variance of incidence estimates) and at any given ODn threshold, different estimates of MDRI and FRR were obtained. The two assays cannot be treated as interchangeable: assay and algorithm-specific performance characteristic estimates must be used for survey planning and incidence estimation.
publishDate 2019
dc.date.none.fl_str_mv 2019
2020
2020
2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/149240
url https://hdl.handle.net/2445/149240
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: http://dx.doi.org/10.1371/journal.pone.0220345
PLoS ONE, 2019, vol. 14, num. 7, p. e0220345
http://dx.doi.org/10.1371/journal.pone.0220345
dc.rights.none.fl_str_mv cc by (c) Sempa et al., 2019
http://creativecommons.org/licenses/by/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by (c) Sempa et al., 2019
http://creativecommons.org/licenses/by/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 17 p.
application/pdf
dc.publisher.none.fl_str_mv Public Library of Science (PLoS)
publisher.none.fl_str_mv Public Library of Science (PLoS)
dc.source.none.fl_str_mv Articles publicats en revistes (ISGlobal)
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,811543

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