Evidence map›Paper›PMID 34186490›Full record

ArticleEBioMedicine2021

Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR.

Isabell Wagenhäuser, Kerstin Knies, Vera Rauschenberger, Michael Eisenmann, Miriam McDonogh, Nils Petri, Oliver Andres, Sven Flemming, Micha Gawlik, Michael Papsdorf and 10 more

Open access · goldAbstract readComparative StudyEvaluation Study
In one paragraph

Article in EBioMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 4 pooled it
5.5field-weighted citation impact, top 3% 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

55 citing papers in PubMed, 4 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2022
    Pooled it
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  15. The Sensitivity of Rapid Tests for SARS-CoV-2 Antigen.Deutsches Arzteblatt international · 2023
    Article
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  17. [The Diagnostic Test: Goodness, Characteristics, and Interpretation: Under the Impact of the Corona Pandemic and Different SARS-CoV-2 Tests].Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)) · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 2 institutions in 1 country.

Isabell WagenhäuserInstitute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany.
Kerstin KniesInstitute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
Vera RauschenbergerInfection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
Michael EisenmannInfection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
Miriam McDonoghDepartment of Orthopaedic Trauma, Hand, Plastic and Reconstructive Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Nils PetriDepartment of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany.
Oliver AndresDepartment of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany.
Sven FlemmingDepartment of General, Visceral, Transplantation, Vascular and Paediatric Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Micha GawlikDepartment of Psychiatry and Psychotherapy, University Hospital Wuerzburg, Wuerzburg, Germany.
Michael PapsdorfDepartment of Obstetrics and Gynaecology, University Hospital Wuerzburg, Wuerzburg, Germany.
Regina TaurinesDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wuerzburg, Wuerzburg, Germany.
Hartmut BöhmDepartment of Oral and Maxillofacial Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Johannes ForsterInstitute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany.
Dirk WeismannDepartment of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany.
Benedikt WeißbrichInstitute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
Lars DölkenInstitute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
Johannes LieseDepartment of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany.
Oliver KurzaiInstitute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany; Leibniz Institute for Natural Product Research and Infection Biology - Hans-Knoell-Institute, Jena, Germany.
Ulrich VogelInstitute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany; Infection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
Manuel KroneInstitute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany; Infection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany; Department of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany. Electronic address: krone_m@ukw.de.
Universitätsklinikum Würzburg · DEUniversity of Würzburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data from large field studies is sparse.

methodsIn a prospective performance evaluation study, RDT from three manufacturers (NADAL®, Panbio™, MEDsan®, conducted on different samples) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardised RT-qPCR Cycle threshold (C

findingsThe sensitivity of RDT compared to RT-qPCR was 42·57% (95% CI 33·38%-52·31%). The specificity was 99·68% (95% CI 99·48%-99·80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of ≥10

interpretationRDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available.

fundingGerman Federal Ministry for Education and Science (BMBF), Free State of Bavaria.

Indexed as

AdultAgedCOVID-19COVID-19 Nucleic Acid TestingCOVID-19 Serological TestingFemaleHumansMaleMiddle AgedPoint-of-Care TestingReagent Kits, DiagnosticSensitivity and SpecificitySpike Glycoprotein, CoronavirusViral LoadReagent Kits, DiagnosticSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2Antigen rapid diagnostic testClinical evaluationCOVID-19PCRPerformance evaluationSARS-CoV-2

Identifiers

PMID34186490
PMCPMC8234263
OpenAlexW3175247707

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.