Evidence map›Paper›PMID 37130685›Full record

ArticleBMJ open2023

Validation of a rapid SARS-CoV-2 antibody test in general practice.

Julie Domen, Jan Yvan Jos Verbakel, Niels Adriaenssens, Beatrice Scholtes, Bart Peeters, Robin Bruyndonckx, An De Sutter, Stefan Heytens, Ann Van den Bruel, Isabelle Desombere and 5 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04779424 (Prevalence and Incidence of Antibodies Against SARS-CoV-2 Among Primary Healthcare Providers in Belgium During One Year of the COVID-19 Epidemic), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 31% 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.

NCT04779424 completednot on this map

Prevalence and Incidence of Antibodies Against SARS-CoV-2 Among Primary Healthcare Providers in Belgium During One Year of the COVID-19 Epidemic

TypeobservationalSponsorUniversiteit AntwerpenRan2020 to 2023Enrolled3,390ConditionsSARS-CoV-2, COVID-19ArmsPOCT
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

15 authors at 7 institutions in 2 countries.

Julie DomenDepartment of Family Medicine and Population Health (FAMPOP), Centre for General Practice, University of Antwerp, Antwerpen, Belgium julie.domen@uantwerpen.be.ORCID 0000-0003-3239-7834
Jan Yvan Jos VerbakelNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-7166-7211
Niels AdriaenssensDepartment of Family Medicine and Population Health (FAMPOP), Centre for General Practice, University of Antwerp, Antwerpen, Belgium.ORCID 0000-0002-7957-1177
Beatrice ScholtesGeneral Practice Department-Primary Care and Health Research Unit, Liege University, Liege, Belgium.ORCID 0000-0001-5274-822X
Bart PeetersDepartment of Laboratory Medicine, University Hospital Antwerp, Edegem, Belgium.
Robin BruyndonckxDepartment of Family Medicine and Population Health (FAMPOP), Centre for General Practice, University of Antwerp, Antwerpen, Belgium.ORCID 0000-0002-4217-2869
An De SutterDepartment of Public Health and Primary Care, University of Ghent, Gent, Belgium.ORCID 0000-0002-2540-8307
Stefan HeytensDepartment of Public Health and Primary Care, University of Ghent, Gent, Belgium.ORCID 0000-0003-1097-4987
Ann Van den BruelDepartment of Public Health and Primary Care, EPI-Centre, KU Leuven, Leuven, Belgium.ORCID 0000-0001-9012-2009
Isabelle DesombereDepartment of Infectious Diseases in Humans, Sciensano, Brussels, Belgium.ORCID 0000-0003-3521-7712
Pierre Van DammeVaccine & Infectious Disease Institute, Centre for the Evaluation of Vaccination, University of Antwerp Faculty of Medicine and Health Sciences, Antwerpen (Wilrijk, Belgium.ORCID 0000-0002-8642-1249
Herman GoossensLaboratory of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerpen, Belgium.ORCID 0000-0003-4891-4031
Laetitia BuretGeneral Practice Department-Primary Care and Health Research Unit, Liege University, Liege, Belgium.ORCID 0000-0002-5653-615X
Els DuysburghDepartment of Epidemiology and Public Health, Sciensano, Brussels, Belgium.ORCID 0000-0003-3345-7616
Samuel CoenenDepartment of Family Medicine and Population Health (FAMPOP), Centre for General Practice, University of Antwerp, Antwerpen, Belgium.ORCID 0000-0002-1238-8052
University of Antwerp · BEGhent University · BESciensano (Belgium) · BEUniversity of Liège · BEAntwerp University Hospital · BEKU Leuven · BEUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo validate a rapid serological test (RST) for SARS-CoV-2 antibodies used in seroprevalence studies in healthcare providers, including primary healthcare providers (PHCPs) in Belgium.

designA phase III validation study of the RST (OrientGene) within a prospective cohort study.

settingPrimary care in Belgium.

participantsAny general practitioner (GP) working in primary care in Belgium and any other PHCP from the same GP practice who physically manages patients were eligible in the seroprevalence study. For the validation study, all participants who tested positive (376) on the RST at the first testing timepoint (T1) and a random sample of those who tested negative (790) and unclear (24) were included.

interventionAt T2, 4 weeks later, PHCPs performed the RST with fingerprick blood (index test) immediately after providing a serum sample to be analysed for the presence of SARS-CoV-2 immunoglobulin G antibodies using a two-out-of-three assay (reference test). PRIMARY AND SECONDARY OUTCOME MEASURES: The RST accuracy was estimated using inverse probability weighting to correct for missing reference test data, and considering unclear RST results as negative for the sensitivity and positive for the specificity. Using these conservative estimates, the true seroprevalence was estimated both for T2 and RST-based prevalence values found in a cohort study with PHCPs in Belgium.

results1073 paired tests (403 positive on the reference test) were included. A sensitivity of 73% (a specificity of 92%) was found considering unclear RST results as negative (positive). For an RST-based prevalence at T1 (13.9), T2 (24.9) and T7 (70.21), the true prevalence was estimated to be 9.1%, 25.9% and 95.7%, respectively.

conclusionThe RST sensitivity (73%) and specificity (92%) make an RST-based seroprevalence below (above) 23% overestimate (underestimate) the true seroprevalence. TRIAL REGISTRATION NUMBER: NCT04779424.

Indexed as

COVID-19General PracticeAntibodies, ViralCohort StudiesCOVID-19 TestingHumansProspective StudiesSARS-CoV-2Seroepidemiologic StudiesAntibodies, ViralCOVID-19infectious diseasesprimary care

Identifiers

PMID37130685
PMCPMC10163333
OpenAlexW4367693043

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.