Evaluation of the Abbott ARCHITECT HIV Ag/ Ab combo assay for determining recent HIV-1 infection

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  • Curtis, K.A.
    • Other Affiliation: Centers for Disease Control and Prevention
  • Rudolph, D.L.
    • Other Affiliation: Centers for Disease Control and Prevention
  • Pan, Y.
    • Other Affiliation: Centers for Disease Control and Prevention
  • Delaney, K.
    • Other Affiliation: Centers for Disease Control and Prevention
  • Anastos, K.
    • Other Affiliation: Montefiore Medical Center
  • DeHovitz, J.
    • Other Affiliation: State University of New York, Downstate Health Sciences University
  • Kassaye, S.G.
    • Other Affiliation: Georgetown University
  • Hanson, C.V.
    • Other Affiliation: California State Department of Health
  • French, A.L.
    • Other Affiliation: Stroger Hospital of Cook County
  • Golub, E.
    • Other Affiliation: Johns Hopkins Bloomberg School of Public Health
  • Adimora, A.A.
    • Affiliation: School of Medicine, Department of Medicine
  • Ofotokun, I.
    • Other Affiliation: Emory University
  • Bolivar, H.
    • Other Affiliation: University of Miami
  • Kempf, M.-C.
    • Other Affiliation: University of Alabama at Birmingham
  • Peters, P.J.
    • Other Affiliation: Centers for Disease Control and Prevention
  • Switzer, W.M.
    • Other Affiliation: Centers for Disease Control and Prevention
Abstract
  • 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. © 2021 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.
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Resource type
  • Article
Rights statement
  • In Copyright
License
  • CC0 1.0 Universal
Journal title
  • PLoS ONE
Journal volume
  • 16
Journal issue
  • 7-Jul
Language
  • English
Version
  • Publisher
Funder
  • National Institute of Child Health and Human Development, NICHD: U01HD032632
  • National Heart, Lung, and Blood Institute, NHLBI: U01HL146202
  • National Institute of Allergy and Infectious Diseases, NIAID: U01AI031834, U01AI034989, U01AI034993, U01AI034994, U01AI035004, U01AI042590, U01AI103390, U01AI103397, U01AI103401, U01AI103408
ISSN
  • 1932-6203
Publisher
  • Public Library of Science

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