Evidence map›Paper›PMID 34738515›Full record

ArticleEuro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin2021

Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021.

Heinrich Scheiblauer, Angela Filomena, Andreas Nitsche, Andreas Puyskens, Victor M Corman, Christian Drosten, Karin Zwirglmaier, Constanze Lange, Petra Emmerich, Michael Müller and 2 more

Erratum issuedOpen access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin, 2021. 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 81 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 2 pooled it
7.8field-weighted citation impact, top 2% 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

81 citing papers in PubMed, 2 syntheses or guidelines pooled it, 136 citations in OpenAlex.

  1. 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
  3. A multi-country phase 2 study to evaluate the suitcase lab for rapid detection of SARS-CoV-2 in seven Sub-Saharan African countries: Lessons from the field.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2023
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  12. Comparison of a Commercial SARS-CoV-2 Rapid Antigen Test with Real-Time PCR.Infectious diseases & clinical microbiology · 2024
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  19. [From the practice of monitoring SARS-CoV-2 test sites in the city of Cologne].Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)) · 2024
    Article
  20. Article

21 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Heinrich ScheiblauerTesting Laboratory for In-vitro Diagnostic Medical Devices, Paul-Ehrlich-Institute, Langen, Germany.
Angela FilomenaTesting Laboratory for In-vitro Diagnostic Medical Devices, Paul-Ehrlich-Institute, Langen, Germany.
Andreas NitscheRobert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Robert Koch Institute, Berlin, Germany.
Andreas PuyskensRobert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Robert Koch Institute, Berlin, Germany.
Victor M CormanCharité - Universitätsmedizin Berlin, Institute of Virology and German Centre for Infection Research (DZIF), Associated Partner Site, Berlin, Germany.
Christian DrostenCharité - Universitätsmedizin Berlin, Institute of Virology and German Centre for Infection Research (DZIF), Associated Partner Site, Berlin, Germany.
Karin ZwirglmaierBundeswehr Institute of Microbiology, and German Centre for Infection Research (DZIF), Partner Site, Munich, Germany.
Constanze LangeLADR Central Laboratory Dr. Kramer & Colleagues, Geesthacht, Germany.
Petra EmmerichBernhard-Nocht Institute, Department of Virology, Hamburg, and Department of Tropical Medicine and Infectious Diseases, Center of Internal Medicine II, University of Rostock, Rostock, Germany.
Michael MüllerMVZ Labor 28 GmbH, Berlin, Germany.
Olivia KnauerTesting Laboratory for In-vitro Diagnostic Medical Devices, Paul-Ehrlich-Institute, Langen, Germany.
C Micha NüblingTesting Laboratory for In-vitro Diagnostic Medical Devices, Paul-Ehrlich-Institute, Langen, Germany.
Paul Ehrlich Institut · DERobert Koch Institute · DECharité - Universitätsmedizin Berlin · DEGerman Center for Infection Research · DEMVZ Labor Ravensburg · DEUniversity of Rostock · DEVivantes Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

IntroductionNumerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims.AimWe performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany.MethodsWe addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system.ResultsThe sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30.ConclusionsThis comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.

Indexed as

COVID-19SARS-CoV-2Antigens, ViralDiagnostic Tests, RoutineGermanyHumansSensitivity and SpecificityAntigens, ViralCE markCOVID 19rapid diagnostic testSARS-CoV-2 antigensensitivity evaluation

Identifiers

PMID34738515
PMCPMC8569926
OpenAlexW3209779245

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.