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Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection
BACKGROUND: Given the challenges and costs associated with implementing HIV-1 incidence assay testing, there is great interest in evaluating the use of commercial HIV diagnostic tests for determining recent HIV infection. A diagnostic test with the capability of providing reliable data for the deter...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8248699/ https://www.ncbi.nlm.nih.gov/pubmed/34197451 http://dx.doi.org/10.1371/journal.pone.0242641 |
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author | Curtis, Kelly A. Rudolph, Donna L. Pan, Yi Delaney, Kevin Anastos, Kathryn DeHovitz, Jack Kassaye, Seble G. Hanson, Carl V. French, Audrey L. Golub, Elizabeth Adimora, Adaora A. Ofotokun, Igho Bolivar, Hector Kempf, Mirjam-Colette Peters, Philip J. Switzer, William M. |
author_facet | Curtis, Kelly A. Rudolph, Donna L. Pan, Yi Delaney, Kevin Anastos, Kathryn DeHovitz, Jack Kassaye, Seble G. Hanson, Carl V. French, Audrey L. Golub, Elizabeth Adimora, Adaora A. Ofotokun, Igho Bolivar, Hector Kempf, Mirjam-Colette Peters, Philip J. Switzer, William M. |
author_sort | Curtis, Kelly A. |
collection | PubMed |
description | BACKGROUND: Given the challenges and costs associated with implementing HIV-1 incidence assay testing, there is great interest in evaluating the use of commercial HIV diagnostic tests for determining recent HIV infection. A diagnostic test with the capability of providing reliable data for the determination of recent HIV infection without substantial modifications to the test protocol would have a significant impact on HIV surveillance. The Abbott ARCHITECT HIV Ag/Ab Combo Assay is an antigen/antibody immunoassay, which meets the criteria as the first screening test in the recommended HIV laboratory diagnostic algorithm for the United States. METHODS: In this study, we evaluated the performance characteristics of the ARCHITECT HIV Ag/Ab Combo signal-to-cutoff ratio (S/Co) for determining recent infection, including estimation of the mean duration of recent infection (MDRI) and false recent rate (FRR), and selection of recency cutoffs. RESULTS: The MDRI estimates for the S/Co recency cutoff of 400 is within the 4 to 12 months range recommended for HIV incidence assays, and the FRR rate for this cutoff was 1.5%. Additionally, ARCHITECT Combo S/Co values were compared relative to diagnostic test results from two prior prospective HIV-1 diagnostic studies in order to validate the use of the S/Co for both diagnostic and recency determination. CONCLUSION: Dual-use of the ARCHITECT Combo assay data for diagnostic and incidence purposes would reduce the need for separate HIV incidence testing and allow for monitoring of recent infection for incidence estimation and other public health applications. |
format | Online Article Text |
id | pubmed-8248699 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-82486992021-07-09 Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection Curtis, Kelly A. Rudolph, Donna L. Pan, Yi Delaney, Kevin Anastos, Kathryn DeHovitz, Jack Kassaye, Seble G. Hanson, Carl V. French, Audrey L. Golub, Elizabeth Adimora, Adaora A. Ofotokun, Igho Bolivar, Hector Kempf, Mirjam-Colette Peters, Philip J. Switzer, William M. PLoS One Research Article BACKGROUND: Given the challenges and costs associated with implementing HIV-1 incidence assay testing, there is great interest in evaluating the use of commercial HIV diagnostic tests for determining recent HIV infection. A diagnostic test with the capability of providing reliable data for the determination of recent HIV infection without substantial modifications to the test protocol would have a significant impact on HIV surveillance. The Abbott ARCHITECT HIV Ag/Ab Combo Assay is an antigen/antibody immunoassay, which meets the criteria as the first screening test in the recommended HIV laboratory diagnostic algorithm for the United States. METHODS: In this study, we evaluated the performance characteristics of the ARCHITECT HIV Ag/Ab Combo signal-to-cutoff ratio (S/Co) for determining recent infection, including estimation of the mean duration of recent infection (MDRI) and false recent rate (FRR), and selection of recency cutoffs. RESULTS: The MDRI estimates for the S/Co recency cutoff of 400 is within the 4 to 12 months range recommended for HIV incidence assays, and the FRR rate for this cutoff was 1.5%. Additionally, ARCHITECT Combo S/Co values were compared relative to diagnostic test results from two prior prospective HIV-1 diagnostic studies in order to validate the use of the S/Co for both diagnostic and recency determination. CONCLUSION: Dual-use of the ARCHITECT Combo assay data for diagnostic and incidence purposes would reduce the need for separate HIV incidence testing and allow for monitoring of recent infection for incidence estimation and other public health applications. Public Library of Science 2021-07-01 /pmc/articles/PMC8248699/ /pubmed/34197451 http://dx.doi.org/10.1371/journal.pone.0242641 Text en https://creativecommons.org/publicdomain/zero/1.0/This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 (https://creativecommons.org/publicdomain/zero/1.0/) public domain dedication. |
spellingShingle | Research Article Curtis, Kelly A. Rudolph, Donna L. Pan, Yi Delaney, Kevin Anastos, Kathryn DeHovitz, Jack Kassaye, Seble G. Hanson, Carl V. French, Audrey L. Golub, Elizabeth Adimora, Adaora A. Ofotokun, Igho Bolivar, Hector Kempf, Mirjam-Colette Peters, Philip J. Switzer, William M. Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection |
title | Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection |
title_full | Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection |
title_fullStr | Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection |
title_full_unstemmed | Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection |
title_short | Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection |
title_sort | evaluation of the abbott architect hiv ag/ab combo assay for determining recent hiv-1 infection |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8248699/ https://www.ncbi.nlm.nih.gov/pubmed/34197451 http://dx.doi.org/10.1371/journal.pone.0242641 |
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