Open AccessEvaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection
Author(s) -
Kelly A. Curtis,
Donna L. Rudolph,
Yi Pan,
Kevin P. Delaney,
Kathryn Anastos,
Jack DeHovitz,
Seble Kassaye,
Carl V. Hanson,
Audrey L. French,
Elizabeth T. Golub,
Adaora A. Adimora,
Igho Ofotokun,
Héctor Bolívar,
Mirjam Colette Kempf,
Philip J. Peters,
William M. Switzer
Publication year - 2021
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0242641
Subject(s) - human immunodeficiency virus (hiv) , incidence (geometry) , cutoff , medicine , hiv diagnosis , diagnostic test , protocol (science) , immunoassay , virology , immunology , antibody , antiretroviral therapy , viral load , emergency medicine , pathology , mathematics , physics , geometry , alternative medicine , quantum mechanics
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.