Evidence map›Paper›PMID 37580353›Full record

ArticleScientific reports2023

Results of German external quality assessment schemes for SARS-CoV-2 antigen detection.

Laura Vierbaum, Nathalie Wojtalewicz, Hans-Peter Grunert, Anika Zimmermann, Annemarie Scholz, Sabine Goseberg, Patricia Kaiser, Ulf Duehring, Christian Drosten, Victor Corman and 17 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Scientific reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Review
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

27 authors at 10 institutions in 4 countries.

Laura Vierbaum *INSTAND E.V., Society for Promoting Quality Assurance in Medical Laboratories, Ubierstr. 20, 40223, Düsseldorf, Germany. vierbaum@instand-ev.de.
Nathalie Wojtalewicz *INSTAND E.V., Society for Promoting Quality Assurance in Medical Laboratories, Ubierstr. 20, 40223, Düsseldorf, Germany.
Hans-Peter GrunertGBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin, Potsdamer Chaussee 80, 14129, Berlin, Germany.
Anika ZimmermannIQVD GmbH, Institut für Qualitätssicherung in der Virusdiagnostik, Berlin, Potsdamer Chaussee 80, 14129, Berlin, Germany.
Annemarie ScholzIQVD GmbH, Institut für Qualitätssicherung in der Virusdiagnostik, Berlin, Potsdamer Chaussee 80, 14129, Berlin, Germany.
Sabine GosebergINSTAND E.V., Society for Promoting Quality Assurance in Medical Laboratories, Ubierstr. 20, 40223, Düsseldorf, Germany.
Patricia KaiserINSTAND E.V., Society for Promoting Quality Assurance in Medical Laboratories, Ubierstr. 20, 40223, Düsseldorf, Germany.
Ulf DuehringGBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin, Potsdamer Chaussee 80, 14129, Berlin, Germany.
Christian DrostenInstitute of Virology, Charité - University Medicine Berlin; National Consultant Laboratory for Coronaviruses; German Centre for Infection Research, Berlin, Berlin, Germany.
Victor CormanInstitute of Virology, Charité - University Medicine Berlin; National Consultant Laboratory for Coronaviruses; German Centre for Infection Research, Berlin, Berlin, Germany.
Daniela NiemeyerInstitute of Virology, Charité - University Medicine Berlin; National Consultant Laboratory for Coronaviruses; German Centre for Infection Research, Berlin, Berlin, Germany.
Holger F RabenauInstitute of Virology, Charité - University Medicine Berlin; National Consultant Laboratory for Coronaviruses; German Centre for Infection Research, Berlin, Berlin, Germany.
Martin ObermeierInstitute for Medical Virology, University Hospital, Goethe University Frankfurt, Frankfurt, Hessen, Germany.
Andreas NitscheMedizinisches Infektiologiezentrum Berlin, Berlin, Germany.
Janine MichelRobert 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.
Jim F HuggettNational Measurement Laboratory, LGC, Teddington, Middlesex, UK.
Denise M O'SullivanNational Measurement Laboratory, LGC, Teddington, Middlesex, UK.
Eloise BusbyNational Measurement Laboratory, LGC, Teddington, Middlesex, UK.
Simon CowenNational Measurement Laboratory, LGC, Teddington, Middlesex, UK.
Peter M ValloneNIST, National Institute of Standards and Technology, Applied Genetics Group, Biomolecular Measurement Division, Materials Measurement Laboratory, Gaithersburg, MD, USA.
Megan H ClevelandNIST, National Institute of Standards and Technology, Applied Genetics Group, Biomolecular Measurement Division, Materials Measurement Laboratory, Gaithersburg, MD, USA.
Samreen FalakPhysikalisch-Technische Bundesanstalt, Berlin, Germany.
Andreas KummrowPhysikalisch-Technische Bundesanstalt, Berlin, Germany.
Ingo SchellenbergINSTAND E.V., Society for Promoting Quality Assurance in Medical Laboratories, Ubierstr. 20, 40223, Düsseldorf, Germany.
Heinz ZeichhardtINSTAND E.V., Society for Promoting Quality Assurance in Medical Laboratories, Ubierstr. 20, 40223, Düsseldorf, Germany.
Martin Kammel *INSTAND E.V., Society for Promoting Quality Assurance in Medical Laboratories, Ubierstr. 20, 40223, Düsseldorf, Germany.
Association of the Scientific Medical Societies · DENational Physical Laboratory · GBCharité - Universitätsmedizin Berlin · DEMaterial Measurement Laboratory · USPhysikalisch-Technische Bundesanstalt · DERobert Koch Institute · DEAnhalt University of Applied Sciences · DEGoethe University Frankfurt · DEInstitute of Virology of the Slovak Academy of Sciences · SKMax Planck Institute for Infection Biology · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The COVID-19 pandemic illustrated the important role of diagnostic tests, including lateral flow tests (LFTs), in identifying patients and their contacts to slow the spread of infections. INSTAND performed external quality assessments (EQA) for SARS-CoV-2 antigen detection with lyophilized and chemically inactivated cell culture supernatant of SARS-CoV-2 infected Vero cells. A pre-study demonstrated the suitability of the material. Participants reported qualitative and/or quantitative antigen results using either LFTs or automated immunoassays for five EQA samples per survey. 711 data sets were reported for LFT detection in three surveys in 2021. This evaluation focused on the analytical sensitivity of different LFTs and automated immunoassays. The inter-laboratory results showed at least 94% correct results for non-variant of concern (VOC) SARS-CoV-2 antigen detection for viral loads of ≥ 4.75 × 10

Indexed as

COVID-19SARS-CoV-2AnimalsChlorocebus aethiopsHumansImmunologic TestsPandemicsSensitivity and SpecificityVero Cells

Identifiers

PMID37580353
PMCPMC10425338
OpenAlexW4385811031

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.