Evidence map›Paper›PMID 27509247›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2016

Performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay in Detecting "Recent" HIV Infection and Calculating Population Incidence.

Sheila M Keating, Reshma Kassanjee, Mila Lebedeva, Shelley N Facente, Jeffrey C MacArthur, Eduard Grebe, Gary Murphy, Alex Welte, Jeffrey N Martin, Susan Little and 4 more

Open access · hybridAbstract readEvaluation Study
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 8% of its field
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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Article
  7. BioRad BioPlex® HIV Ag-Ab assay: Incidence of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2019
    Article
  8. Article
  9. Diagnosis of Human Immunodeficiency Virus Infection.Clinical microbiology reviews · 2019
    Review
  10. Article
  11. HIITE: HIV-1 incidence and infection time estimator.Bioinformatics (Oxford, England) · 2018
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. 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

14 authors at 8 institutions in 4 countries.

Sheila M Keating*Blood Systems Research Institute, San Francisco, CA; †University of California, San Francisco, San Francisco, CA; ‡The South African DST/NRF Centre of Excellence Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa; §Department of Statistical Sciences, University of Cape Town, Cape Town, South Africa; ‖Public Health England, London, United Kingdom; ¶University of California, San Diego, San Diego, CA; #Department of Medical Affairs, International AIDS Vaccine Initiative (IAVI), New York, NY; and **Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.
Reshma Kassanjee
Mila Lebedeva
Shelley N Facente
Jeffrey C MacArthur
Eduard Grebe
Gary Murphy
Alex Welte
Jeffrey N Martin
Susan Little
Matthew A Price
Esper G Kallas
Michael P Busch
Christopher D Pilcher
University of California, San Francisco · USBlood Systems Research Institute · USStellenbosch University · ZAInternational AIDS Vaccine Initiative · USPublic Health England · GBUniversidade de São Paulo · BRUniversity of California, San Diego · USUniversity of Cape Town · ZA

Funding

Unsolicited R24 for the CFAR-Network of Integrated Clinical Sciences, CNICSR24AI067039 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Michael S. Saag · 2006 to 2026
$99.4M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI PETER W HUNT · 1988 to 2026
$93.6M
Zonisamide in Patients with Neuropathic Pain Associated with Diabetic NeuropathyM01RR000046 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MARGOLIS, DAVID · 1985 to 2008
$38.5M
Transmission ProbabilityP01AI074621 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI RICHMAN, DOUGLAS D · 2008 to 2012
$23.1M
Primary Infection Resource Consortium (PIRC)R24AI106039 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LITTLE, SUSAN JANET · 2013 to 2021
$23.1M
Southern California Primary Infection ProgramU01AI043638 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI RICHMAN, DOUGLAS D · 1998 to 2010
$21.3M
Transmission and Persistence of CTL and Drug Resistance MutationsP01AI071713 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HECHT, FREDERICK M · 2007 to 2011
$14.3M
Efficacy of ART to Interrupt HIV Transmission NetworksR01MH100974 · NIMH · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LITTLE, SUSAN JANET · 2014 to 2018
$3.2M
Host Factors Influencing HIV Viral Load and Infectivity in SemenR01HD074511 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI PILCHER, CHRISTOPHER D · 2012 to 2016
$3.1M
Targeting Acute HIVR01MH068686 · NIMH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI PILCHER, CHRISTOPHER D · 2003 to 2007
$1.6M
A Pilot of Intervention to Promote Acute HIV Testing by Ambulatory Care ProvidersR34MH096606 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI PILCHER, CHRISTOPHER D · 2012 to 2014
$693k
NCRR NIH HHS M01 RR000046NIAID NIH HHS P01 AI071713NIAID NIH HHS P01 AI074621NIAID NIH HHS P30 AI027763NIAID NIH HHS R24 AI067039NIAID NIH HHS R24 AI106039NIAID NIH HHS U01 AI043638NICHD NIH HHS R01 HD074511NIMH NIH HHS L30 MH072430NIMH NIH HHS R01 MH068686NIMH NIH HHS R01 MH100974NIMH NIH HHS R34 MH096606
6 · The paper itself

Abstract

objectiveHIV seroconversion biomarkers are being used in cross-sectional studies for HIV incidence estimation. Bio-Rad Geenius HIV-1/2 Supplemental Assay is an immunochromatographic single-use assay that measures antibodies (Ab) against multiple HIV-1/2 antigens. The objective of this study was to determine whether the Geenius assay could additionally be used for recency estimation.

designThis assay was developed for HIV-1/2 confirmation; however, quantitative data acquired give information on increasing concentration and diversity of antibody responses over time during seroconversion. A quantitative threshold of recent HIV infection was proposed to determine "recent" or "nonrecent" HIV infection; performance using this cutoff was evaluated.

methodsWe tested 2500 highly characterized specimens from research subjects in the United States, Brazil, and Africa with well-defined durations of HIV infection. Regression and frequency estimation were used to estimate assay properties relevant to HIV incidence measurement: mean duration of recent infection (MDRI), false-recent rate, and assay reproducibility and robustness.

resultsUsing the manufacturer's proposed cutoff index of 1.5 to identify "recent" infection, the assay has an estimated false-recent rate of 4.1% (95% CI: 2.2 to 7.0) and MDRI of 179 days (155 to 201) in specimens from treatment-naive subjects, presenting performance challenges similar to other incidence assays. Lower index cutoffs associated with lower MDRI gave a lower rate of false-recent results.

conclusionsThese data suggest that with additional interpretive analysis of the band intensities using an algorithm and cutoff, the Geenius HIV-1/2 Supplemental Assay can be used to identify recent HIV infection in addition to confirming the presence of HIV-1 and HIV-2 antibodies.

Indexed as

AfricaAlgorithmsBrazilChromatography, AffinityDiagnostic Tests, RoutineHIV-1HIV-2HIV AntibodiesHIV InfectionsIncidenceModels, TheoreticalRetrospective StudiesUnited StatesHIV Antibodies

Identifiers

PMID27509247
PMCPMC5110377
OpenAlexW2496466453

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.