Evidence map›Paper›PMID 26774543›Full record

ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2016

Performance of Determine Combo and other point-of-care HIV tests among Seattle MSM.

Joanne D Stekler, George Ure, Joshua D O'Neal, Aric Lane, Fred Swanson, Janine Maenza, Claire Stevens, Robert W Coombs, Joan Dragavon, Paul D Swenson and 1 more

Abstract read
In one paragraph

Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 6% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV - CDC Recommendations, United States, 2025.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2025
    Guideline
  2. Trial
  3. The fourth generation AlereJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2017
    Trial
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  6. Article
  7. Article
  8. Article
  9. Unique Needs for the Implementation of Emergency Department Human Immunodeficiency Virus Screening in Adolescents.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2020
    Article
  10. Performance evaluation of four point-of-care HIV tests using unprocessed specimens.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020
    Article
  11. Article
  12. Article
  13. Plasmonic gold chips for the diagnosis of Toxoplasma gondii, CMV, and rubella infections using saliva with serum detection precision.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2019
    Article
  14. Article
  15. Article
  16. Article
  17. Observational
  18. Article
  19. Performance evaluation of the FDA-approved Determine™ HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2017
    Article
  20. 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

11 authors at 4 institutions in 1 country.

Joanne D SteklerDepartments of Medicine, University of Washington, Seattle, WA, United States; Departments of Epidemiology, University of Washington, Seattle, WA, United States; Public Health-Seattle & King County, Seattle, WA, United States. Electronic address: jstekler@uw.edu.
George UreDepartments of Medicine, University of Washington, Seattle, WA, United States.
Joshua D O'NealSan Francisco AIDS Foundation, San Francisco, CA, United States.
Aric LanePublic Health-Seattle & King County, Seattle, WA, United States.
Fred SwansonGay City Health Project, Seattle, WA, United States.
Janine MaenzaDepartments of Medicine, University of Washington, Seattle, WA, United States.
Claire StevensDepartments of Medicine, University of Washington, Seattle, WA, United States.
Robert W CoombsDepartments of Medicine, University of Washington, Seattle, WA, United States; Departments of Laboratory Medicine, University of Washington, Seattle, WA, United States.
Joan DragavonDepartments of Laboratory Medicine, University of Washington, Seattle, WA, United States.
Paul D SwensonPublic Health-Seattle & King County, Seattle, WA, United States.
Matthew R GoldenDepartments of Medicine, University of Washington, Seattle, WA, United States; Departments of Epidemiology, University of Washington, Seattle, WA, United States; Public Health-Seattle & King County, Seattle, WA, United States.
University of Washington · USPublic Health – Seattle & King County · USGay City Health Project · USSan Francisco AIDS Foundation · US

Funding

LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Kenneth Sherr · 1988 to 2026
$104.9M
Comparisons of Public Health Screening Methods for Acute and Early HIV InfectionR01MH086360 · NIMH · UNIVERSITY OF WASHINGTON · PI STEKLER, JOANNE DONNA · 2009 to 2013
$2.5M
Mathematical models to inform effective home-use HIV testing strategies for MSMR21HD080523 · NICHD · UNIVERSITY OF CALIFORNIA SANTA BARBARA · PI CASSELS, SUSAN LYNN · 2015 to 2016
$433k
NIAID NIH HHS P30 AI027757NIAID NIH HHS P30 AI-27757NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI-38858NIAID NIH HHS UM1 AI-068618NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI106701NICHD NIH HHS R21 HD080523NIMH NIH HHS R01 MH086360NIMH NIH HHS R01 MH-83630
6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe rapid test study was a real-time comparison of point-of-care (POC) HIV tests to determine their abilities to detect early HIV infection. STUDY

designMen and transgender persons reporting sex with men in the prior year were recruited at the Public Health-Seattle & King County STD Clinic, Gay City Health Project, and University of Washington Primary Infection Clinic. Study tests included the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids and tests performed on fingerstick whole blood specimens including OraQuick, Uni-Gold Recombigen HIV test, Determine HIV-1/2 Ag/Ab Combo, and INSTI HIV-1 Rapid Antibody Test. Specimens from subjects with negative results were sent for EIA and nucleic acid amplification testing. McNemar's exact tests compared the numbers of HIV-infected subjects detected.

resultsBetween February 2010 and August 2014, there were 3438 study visits. Twenty-four subjects had discordant POC results with at least one reactive and one non-reactive test, including one subject with a reactive Determine p24 antigen. OraQuick performed on oral fluids identified fewer persons compared to all fingerstick tests. OraQuick performed on fingerstick whole blood detected fewer persons compared to the Determine Combo antibody component (p=.008) and Combo overall (p=.004), and there was a trend when compared to INSTI (p=.06). The Determine Combo specificity was 98.99%.

conclusionsAs reported by others, Determine Combo underperforms compared to laboratory-based testing, but it did detect one acute infection. If these results are validated, the specificity of Determine Combo may limit its usefulness in populations with lower HIV incidence.

Indexed as

Homosexuality, MaleAcute DiseaseAdultAIDS SerodiagnosisHIV-1HIV AntibodiesHIV InfectionsHumansIncidenceMaleMass ScreeningMiddle AgedPoint-of-Care SystemsReagent Kits, DiagnosticSalivaSensitivity and SpecificityHIV AntibodiesReagent Kits, DiagnosticBackgroundHIV testingOral fluidsRapid HIV test

Identifiers

PMID26774543
PMCPMC4762745
OpenAlexW2231513945

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.