Evidence map›Paper›PMID 34556736›Full record

ArticleScientific reports2021

Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays.

Rebeca Santano, Diana Barrios, Fàtima Crispi, Francesca Crovetto, Marta Vidal, Jordi Chi, Luis Izquierdo, Eduard Gratacós, Gemma Moncunill, Carlota Dobaño

Erratum issuedAbstract read
In one paragraph

Article in Scientific reports, 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 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Rebeca SantanoISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain. rebeca.santano@isglobal.org.ORCID http://orcid.org/0000-0002-0007-5315
Diana BarriosISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain.
Fàtima CrispiBCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine, Hospital Sant Joan de Déu and Hospital Clínic, IDIBAPS, Universitat de Barcelona, CIBER-ER, Barcelona, Spain.ORCID http://orcid.org/0000-0002-7422-5240
Francesca CrovettoBCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine, Hospital Sant Joan de Déu and Hospital Clínic, IDIBAPS, Universitat de Barcelona, CIBER-ER, Barcelona, Spain.
Marta VidalISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain.
Jordi ChiISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain.ORCID http://orcid.org/0000-0002-6633-691X
Luis IzquierdoISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain.ORCID http://orcid.org/0000-0002-3704-9874
Eduard GratacósBCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine, Hospital Sant Joan de Déu and Hospital Clínic, IDIBAPS, Universitat de Barcelona, CIBER-ER, Barcelona, Spain.
Gemma MoncunillISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain.ORCID http://orcid.org/0000-0001-5105-9836
Carlota DobañoISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain. carlota.dobano@isglobal.org.ORCID http://orcid.org/0000-0002-6751-4060

Funding

NIAID NIH HHS HHSN272201400008C
6 · The paper itself

Abstract

Serological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to assure correct diagnostics and epidemiological estimations. We evaluated the performance of the COVID-19 ELISA IgG and the COVID-19 ELISA IgM/A (Vircell, S.L.) against a highly specific and sensitive in-house Luminex immunoassay in a set of samples from pregnant women and cord blood. The agreement between both assays was moderate to high for IgG but low for IgM/A. Considering seropositivity by either IgG and/or IgM/A, the technical performance of the ELISA was highly imbalanced, with 96% sensitivity at the expense of 22% specificity. As for the clinical performance, the negative predictive value reached 87% while the positive predictive value was 51%. Our results stress the need for highly specific and sensitive assays and external validation of diagnostic tests with different sets of samples to avoid the clinical, epidemiological and personal disturbances derived from serological misdiagnosis.

Indexed as

Antibodies, ViralCOVID-19COVID-19 Serological TestingEnzyme-Linked Immunosorbent AssayFemaleFetal BloodHumansImmunoassayImmunoglobulin AImmunoglobulin GImmunoglobulin MPandemicsPregnancySARS-CoV-2Sensitivity and SpecificitySerologic TestsAntibodies, ViralImmunoglobulin AImmunoglobulin GImmunoglobulin M

Identifiers

PMID34556736
PMCPMC8460676

What OpenQuestion holds

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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.