Evidence map›Paper›PMID 22706797›Full record

ArticleMedical microbiology and immunology2013

Performance evaluation of a new fourth-generation HIV combination antigen-antibody assay.

A Mühlbacher, H Schennach, J van Helden, T Hebell, G Pantaleo, P Bürgisser, C Cellerai, P Permpikul, M I Rodriguez, A Eiras and 8 more

Abstract readEvaluation Study
In one paragraph

Article in Medical microbiology and immunology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–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

18 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. The evaluation of low cut-off index values of ElecsysJournal of clinical laboratory analysis · 2020
    Article
  7. Article
  8. A retrospective analysis of the application of the ElecsysJournal of clinical laboratory analysis · 2018
    Article
  9. Article
  10. Article
  11. Article
  12. Human Immunodeficiency Virus (HIV).Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2016
    Article
  13. Article
  14. Review
  15. Vaccination against infectious diseases: what is promising?Medical microbiology and immunology · 2014
    Review
  16. Article
  17. Article
  18. 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

18 authors.

A MühlbacherCentral Institute for Blood Transfusion and Immunology, Innsbruck, Austria. annelies.muehlbacher@uki.at
H Schennach
J van Helden
T Hebell
G Pantaleo
P Bürgisser
C Cellerai
P Permpikul
M I Rodriguez
A Eiras
F Alborino
P Cunningham
M Axelsson
S Andersson
O Wetlitzky
C Kaiser
P Möller
G de Sousa

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Education and diagnostic tests capable of early detection represent our most effective means of preventing transmission of human immunodeficiency virus (HIV). The importance of early detection is underlined by studies demonstrating increased life expectancy following early initiation of antiviral treatment. The Elecsys(®) HIV combi PT assay is a fourth-generation antigen-antibody combination assay developed to allow earlier detection of seroconversion, and to have increased sensitivity and improved specificity. We aimed to determine how early the assay could detect infection compared with existing assays; whether all HIV variants could be detected; and the assay's specificity using samples from blood donors, routine specimens, and patients with potential cross-reacting factors. Samples were identified as positive by the Elecsys(®) assay 4.9 days after a positive polymerase chain reaction result (as determined by the panel supplier), which was earlier than the 5.3-7.1 days observed with comparators. The analytical sensitivity of the Elecsys(®) HIV combi PT assay for the HIV-1 p24 antigen was 1.05 IU/mL, which compares favorably with the comparator assays. In addition, the Elecsys(®) assay identified all screened HIV subtypes and displayed greater sensitivity to HIV-2 homologous antigen and antibodies to HIV-1 E and O and HIV-2 than the other assays. Overall, the specificity of the Elecsys(®) assay was 99.88 % using samples from blood donors and 99.81 % when analyzing unselected samples. Potential cross-reacting factors did not interfere with assay performance. The Elecsys(®) HIV combi PT assay is a sensitive and specific assay that has been granted the CE mark according to Directive 2009/886/EC.

Indexed as

Clinical Laboratory TechniquesDiagnostic Tests, RoutineHIV-1HIV-2HIV AntibodiesHIV Core Protein p24HIV InfectionsHumansImmunoassaySensitivity and SpecificityHIV AntibodiesHIV Core Protein p24

Identifiers

PMID22706797
PMCPMC3562432

What OpenQuestion holds

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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.