Evidence map›Paper›PMID 34190575›Full record

ArticleJournal of clinical microbiology2021

Assessing the Quality of Serological Testing in the COVID-19 Pandemic: Results of a European External Quality Assessment (EQA) Scheme for Anti-SARS-CoV-2 Antibody Detection.

Volker Ast, Victor Costina, Romy Eichner, Anna Bode, Sihem Aida, Catharina Gerhards, Margot Thiaucourt, Gerhard Dobler, Wolf-Jochen Geilenkeuser, Roman Wölfel and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical microbiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. External quality assessment of SARS-CoV-2 serology in European expert laboratories, April 2021.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2022
    Article
  6. Article
  7. 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

12 authors.

Volker AstDepartment of Clinical Chemistry, University Medical Centre Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Victor CostinaDepartment of Clinical Chemistry, University Medical Centre Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Romy EichnerDepartment of Clinical Chemistry, University Medical Centre Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Anna BodeReference-Institute for Bioanalytics, German Society for Clinical Chemistry and Laboratory Medicine (DGKL), Bonn, Germany.
Sihem AidaDepartment of Clinical Chemistry, University Medical Centre Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Catharina GerhardsDepartment of Clinical Chemistry, University Medical Centre Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Margot ThiaucourtDepartment of Clinical Chemistry, University Medical Centre Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Gerhard DoblerBundeswehr Institute of Microbiology, Munich, Germany.
Wolf-Jochen GeilenkeuserReference-Institute for Bioanalytics, German Society for Clinical Chemistry and Laboratory Medicine (DGKL), Bonn, Germany.
Roman WölfelBundeswehr Institute of Microbiology, Munich, Germany.
Michael NeumaierDepartment of Clinical Chemistry, University Medical Centre Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Verena HaselmannDepartment of Clinical Chemistry, University Medical Centre Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

External quality assessment (EQA) is a key instrument for achieving harmonization, and thus a high quality, of diagnostic procedures. As reliable test results are crucial for accurate assessment of SARS-CoV-2 infection prevalence, vaccine response, and immunity, and thus for successful management of the ongoing COVID-19 pandemic, the Reference Institute for Bioanalytics (RfB) was the first EQA provider to offer an open scheme for anti-SARS-CoV-2 antibody detection. The main objectives of this EQA were (i) to gain insights into the current diagnostic landscape and the performance of serological tests in Europe and (ii) to provide recommendations for diagnostic improvements. Within the EQA, a blinded panel of precharacterized human serum samples with variable anti-SARS-CoV-2 antibody titers was provided for detection of anti-SARS-CoV-2 IgG, IgA, and IgM antibodies. Across the three distribution rounds in 2020, 284 laboratories from 22 countries reported a total of 3,744 results for anti-SARS-CoV-2 antibody detection using more than 24 different assays for IgG. Overall, 97/3,004 results were false for anti-SARS-CoV-2 IgG, 88/248 for IgA, and 34/124 for IgM. Regarding diagnostic sensitivity and specificity, substantial differences were found between the different assays used, as well as between certified and noncertified tests. For cutoff samples, a drop in the diagnostic sensitivity to 46.3% and high interlaboratory variability were observed. In general, this EQA highlights the current variability of anti-SARS-CoV-2 antibody detection, technical limitations with respect to cutoff samples, and the lack of harmonization of testing procedures. Recommendations are provided to help laboratories and manufacturers further improve the quality of anti-SARS-CoV-2 serological diagnostics.

Indexed as

COVID-19PandemicsAntibodies, ViralHumansImmunoglobulin MSARS-CoV-2Sensitivity and SpecificitySerologic TestsAntibodies, ViralImmunoglobulin Manti-SARS-CoV-2 antibodiesCOVID-19EQAexternal quality assessment schemeimmunoassaysproficiency testingring trialSARS-CoV-2test performance

Identifiers

PMID34190575
PMCPMC8373014

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Registered trials

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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.