Evidence map›Paper›PMID 24714441›Full record

ArticlePloS one2014

Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population.

Damian P Conway, Martin Holt, Anna McNulty, Deborah L Couldwell, Don E Smith, Stephen C Davies, Philip Cunningham, Phillip Keen, Rebecca Guy, Sydney Rapid HIV Test Study

Erratum issuedOpen access · goldAbstract readEvaluation StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
4.7field-weighted citation impact, top 4% 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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Observational
  10. Article
  11. Review
  12. Article
  13. 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
  14. Article
  15. Article
  16. Performance of Determine Combo and other point-of-care HIV tests among Seattle MSM.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2016
    Article
  17. Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Damian P ConwayThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Martin HoltCentre for Social Research in Health, University of New South Wales, Sydney, New South Wales, Australia.
Anna McNultySydney Sexual Health Centre, Sydney Hospital, Sydney, New South Wales, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Deborah L CouldwellWestern Sydney Sexual Health Centre, Western Sydney Local Health District, Sydney, New South Wales, Australia; Sydney Emerging Infections and Biosecurity Institute, University of Sydney, Sydney, New South Wales, Australia.
Don E SmithSchool of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia; Albion Centre, Surry Hills, Sydney, New South Wales, Australia.
Stephen C DaviesNorth Shore Sexual Health Service, Royal North Shore Hospital, St Leonards, Sydney, New South Wales, Australia.
Philip CunninghamSt Vincent's Centre for Applied Medical Research, University of New South Wales, Sydney, New South Wales, Australia; NSW State Reference Laboratory for HIV, St Vincent's Hospital, Darlinghurst, Sydney, New South Wales, Australia.
Phillip KeenThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Rebecca GuyThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Sydney Rapid HIV Test Study
UNSW Sydney · AURoyal North Shore Hospital · AUUniversity of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDetermine HIV Combo (DHC) is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics.

methodsWe compared DHC performance (overall, by test component and in early infection) with conventional laboratory HIV serology (fourth generation screening immunoassay, supplementary HIV antibody, p24 antigen and Western blot tests) when testing gay and bisexual men attending four clinic sites. Early infection was defined as either acute or recent HIV infection acquired within the last six months.

resultsOf 3,190 evaluation specimens, 39 were confirmed as HIV-positive (12 with early infection) and 3,133 were HIV-negative by reference testing. DHC sensitivity was 87.2% overall and 94.4% and 0% for the antibody and antigen components, respectively. Sensitivity in early infection was 66.7% (all DHC antibody reactive) and the DHC antigen component detected none of nine HIV p24 antigen positive specimens. Median HIV RNA was higher in false negative than true positive cases (238,025 vs. 37,591 copies/ml; p = 0.022). Specificity overall was 99.4% with the antigen component contributing to 33% of false positives.

conclusionsThe DHC antibody component detected two thirds of those with early infection, while the DHC antigen component did not enhance performance during point of care HIV testing in a high risk clinic-based population.

Indexed as

AdultAmbulatory Care FacilitiesHIV AntibodiesHIV InfectionsHIV SeropositivityHumansMaleMass ScreeningReagent Kits, DiagnosticSensitivity and SpecificityHIV AntibodiesReagent Kits, Diagnostic

Identifiers

PMID24714441
PMCPMC3979750
OpenAlexW2066060141

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.