Evidence map›Paper›PMID 34197451›Full record

ArticlePloS one2021

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

Kelly A Curtis, Donna L Rudolph, Yi Pan, Kevin Delaney, Kathryn Anastos, Jack DeHovitz, Seble G Kassaye, Carl V Hanson, Audrey L French, Elizabeth Golub and 6 more

Abstract readEvaluation Study
In one paragraph

Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Predicting hepatitis C infection via machine learning.American journal of translational research · 2025
    Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. The contemporary immunoassays for HIV diagnosis: a concise overview.Asian biomedicine : research, reviews and news · 2023
    Review
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Kelly A CurtisDivision of HIV/ AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.ORCID 0000-0002-1785-6548
Donna L RudolphDivision of HIV/ AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
Yi PanDivision of HIV/ AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
Kevin DelaneyDivision of HIV/ AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
Kathryn AnastosAlbert Einstein College of Medicine and Montefiore Medical Center, Bronx, New York, United States of America.
Jack DeHovitzDownstate Medical Center, State University of New York, Brooklyn, New York, United States of America.
Seble G KassayeDepartment of Medicine / Division of Infectious Diseases, Georgetown University, Washington, DC, United States of America.
Carl V HansonCalifornia State Department of Health, Berkeley, California, United States of America.
Audrey L FrenchDepartment of Medicine, Stroger Hospital of Cook County, Chicago, Illinois, United States of America.
Elizabeth GolubDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Adaora A AdimoraDivision of Infectious Diseases, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.
Igho OfotokunDivision of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, United States of America.
Hector BolivarDivision of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, United States of America.
Mirjam-Colette KempfSchool of Nursing, Public Health and Medicine, University of Alabama at Birmingham, Birmingham, Alabama, United States of America.
Philip J PetersDivision of HIV/ AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
William M SwitzerDivision of HIV/ AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.

Funding

Women's Interagency HIV Study (WIHS-V)U01AI035004 · NIAID · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI ANASTOS, KATHRYN M., SHARMA, ANJALI · 1993 to 2018
$65.7M
WOMEN'S INTERAGENCY HIV STUDY ORGANIZATION, MANAGEMENT AND COMMUNICATIONSU01AI034989 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI AOUIZERAT, BRADLEY E, GREENBLATT, RUTH MARTHA · 1993 to 2018
$65.6M
Women's Interagency HIV Study (WIHS) IIIU01AI031834 · NIAID · SUNY DOWNSTATE MEDICAL CENTER · PI GUSTAFSON, DEBORAH R., MINKOFF, HOWARD · 1998 to 2018
$53.5M
WOMEN'S INTERAGENCY HIV STUDY (WIHS) ORGANIZATION AND MANAGEMENTU01AI034994 · NIAID · GEORGETOWN UNIVERSITY · PI KASSAYE, SEBLE G · 1993 to 2018
$52.0M
Women's Interagency HIV Study (WIHS) IV, Chicago ConsortiumU01AI034993 · NIAID · HEKTOEN INSTITUTE FOR MEDICAL RESEARCH · PI COHEN, MARDGE H, FRENCH, AUDREY · 1994 to 2018
$51.0M
WOMENS INTERAGENCY HIV STUDY (WIHS)U01HD032632 · NICHD · UNIVERSITY OF SOUTHERN CALIFORNIA · PI MILAM, JOEL E · 1994 to 2012
$42.0M
WIHS DATA MANAGEMENT AND ANALYSIS CENTER(WDMAC)U01AI042590 · NIAID · JOHNS HOPKINS UNIVERSITY · PI GANGE, STEPHEN J, GOLUB, ELIZABETH T · 1998 to 2018
$38.4M
MWCCS: Brooklyn Clinical Research SiteU01HL146202 · NHLBI · SUNY DOWNSTATE MEDICAL CENTER · PI TRACEY ELIZABETH WILSON, Jessica Eve Yager · 2019 to 2026
$23.6M
Emory WIHS CRS - Longitudinal CohortU01AI103408 · NIAID · EMORY UNIVERSITY · PI OFOTOKUN, IGHOVWERHA, WINGOOD, GINA MARIA · 2013 to 2018
$14.1M
UAB-MISS WIHS CohortU01AI103401 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI KEMPF, MIRJAM-COLETTE, KONKLE-PARKER, DEBORAH J · 2013 to 2018
$11.2M
University of North Carolina Womens Interagency HIV Study UNC WIHSU01AI103390 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ADIMORA, ADAORA A · 2013 to 2018
$11.0M
Miami Womens Interagency HIV Study WIHSU01AI103397 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI FISCHL, MARGARET A, METSCH, LISA R · 2013 to 2018
$9.6M
CDC HHSNHLBI NIH HHS U01 HL146202NIAID NIH HHS U01 AI031834NIAID NIH HHS U01 AI034989NIAID NIH HHS U01 AI034993NIAID NIH HHS U01 AI034994NIAID NIH HHS U01 AI035004NIAID NIH HHS U01 AI042590NIAID NIH HHS U01 AI103390NIAID NIH HHS U01 AI103397NIAID NIH HHS U01 AI103401NIAID NIH HHS U01 AI103408NICHD NIH HHS U01 HD032632
6 · The paper itself

Abstract

backgroundGiven 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.

methodsIn 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.

resultsThe 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.

conclusionDual-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.

Indexed as

False Positive ReactionsHIV-1HIV AntibodiesHIV AntigensHIV InfectionsHumansImmunoassayReagent Kits, DiagnosticSignal-To-Noise RatioHIV AntibodiesHIV AntigensReagent Kits, Diagnostic

Identifiers

PMID34197451
PMCPMC8248699

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.