Evidence map›Paper›PMID 33310108›Full record

ArticleInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2021

Clinical evaluation of commercial automated SARS-CoV-2 immunoassays.

Maximilian Kittel, Maria Christina Muth, Ingrid Zahn, Heinz-Jürgen Roth, Margot Thiaucourt, Catharina Gerhards, Verena Haselmann, Michael Neumaier, Peter Findeisen

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Article in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Review
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  9. Harmonization of six quantitative SARS-CoV-2 serological assays using sera of vaccinated subjects.Clinica chimica acta; international journal of clinical chemistry · 2021
    Article
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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

9 authors.

Maximilian KittelInstitute for Clinical Chemistry, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany. Electronic address: maximilian.kittel@umm.de.
Maria Christina MuthMVZ Laboratory Dr. Limbach & Colleagues, Heidelberg, Germany.
Ingrid ZahnMVZ Laboratory Dr. Limbach & Colleagues, Heidelberg, Germany.
Heinz-Jürgen RothMVZ Laboratory Dr. Limbach & Colleagues, Heidelberg, Germany.
Margot ThiaucourtInstitute for Clinical Chemistry, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Catharina GerhardsInstitute for Clinical Chemistry, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Verena HaselmannInstitute for Clinical Chemistry, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Michael NeumaierInstitute for Clinical Chemistry, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Peter FindeisenMVZ Laboratory Dr. Limbach & Colleagues, Heidelberg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveNumerous immunoassays for detecting antibodies directed against SARS-CoV-2 have been rapidly developed and released. Validations of these have been performed with a limited number of samples. The lack of standardisation might lead to significantly different results. This study compared ten automated assays from six vendors in terms of sensitivity, specificity and reproducibility.

methodsThis study compared ten fully automated immunoassays from the following vendors: Diasorin, Epitope Diagnostics, Euroimmun, Roche, YHLO, and Snibe. The retrospective part of the study included patients with a laboratory-confirmed COVID-19 infection, and controls comprised patients with a suspected infection, in whom the disease was excluded. Furthermore, biobanked sera were taken as negative controls (n = 97). The retrospective part involved four groups: (1) laboratory-confirmed COVID-19 infection (n = 183); (1B) suspected COVID-19 infection (n = 167) without a qRT-PCR result but positive serological results from at least two different assays, and suspected COVID-19 infection due to a positive serological result from the Roche assay (n = 295); (2) biobanked sera obtained from patients before the emergence of SARS-CoV-2 (n = 97) as negative controls; and (2A) probably COVID-19-negative sera with negative serological results from at least two different assays (n = 152).

resultsOverall diagnostic sensitivities were: Euroimmun (IgA) 87%; Epitope Diagnostics (IgG) 83%; YHLO (IgG) 77%; Roche (IgM/IgG) 77%; Euroimmun (IgG) 75%; Diasorin (IgG) 53%; Epitope Diagnostics (IgM) 52%; Snibe (IgG) 47%; YHLO (IgM) 35%; and Snibe (IgM) 26%. Diagnostic specificities were: YHLO (IgG) 100%; Roche, 100%; Snibe (IgM/IgG) 100%; Diasorin (IgG) 97%; Euroimmun (IgG) 94%; YHLO (IgM) 94%; Euroimmun (IgA) 83%.

conclusionAssays from different vendors substantially varied in terms of their performance. These findings might facilitate selection of appropriate serological assays.

Indexed as

AdultAntibodies, ViralCOVID-19COVID-19 TestingFemaleHumansImmunoassayImmunoglobulin GMaleMiddle AgedRetrospective StudiesSARS-CoV-2Sensitivity and SpecificityAntibodies, ViralImmunoglobulin GAutomated SARS-CoV-2 antibody detectionHigh throughpu testingLongitudional monitoring of antibody developmentPandemic controlSeroconversionSerpprevalence

Identifiers

PMID33310108
PMCPMC7725057

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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.