Evidence map›Paper›PMID 33574119›Full record

ArticleJournal of clinical microbiology2021

Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories.

Lene H Harritshøj, Mikkel Gybel-Brask, Shoaib Afzal, Pia R Kamstrup, Charlotte S Jørgensen, Marianne Kragh Thomsen, Linda Hilsted, Lennart Friis-Hansen, Pal B Szecsi, Lise Pedersen and 28 more

Open access · goldAbstract readComparative Study
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 85 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 3 pooled it
8.1field-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

85 citing papers in PubMed, 3 syntheses or guidelines pooled it, 137 citations in OpenAlex.

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

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

38 authors at 12 institutions in 1 country.

Lene H HarritshøjDepartment of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark Lene.holm.harritshoej@regionh.dk.ORCID 0000-0003-3100-6256
Mikkel Gybel-BraskDepartment of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-5716-5899
Shoaib AfzalDepartment of Clinical Biochemistry, Copenhagen University Hospital, Herlev and Gentofte Hospital, Herlev, Denmark.
Pia R KamstrupDepartment of Clinical Biochemistry, Copenhagen University Hospital, Herlev and Gentofte Hospital, Herlev, Denmark.
Charlotte S JørgensenDepartment of Virus & Microbiological Special Diagnostics, Statens Serum Institut, Copenhagen, Denmark.
Marianne Kragh ThomsenDepartment of Clinical Microbiology, Aarhus University Hospital, Aarhus, Denmark.
Linda HilstedDepartment of Clinical Biochemistry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Lennart Friis-HansenDepartment of Clinical Biochemistry, Copenhagen University Hospital, Bispebjerg, and Frederiksberg Hospital, Copenhagen, Denmark.
Pal B SzecsiDepartment of Clinical Biochemistry, Holbæk Hospital, Holbæk, Denmark.
Lise PedersenDepartment of Clinical Biochemistry, Holbæk Hospital, Holbæk, Denmark.
Lene NielsenDepartment of Clinical Microbiology, Copenhagen University Hospital, Herlev and Gentofte Hospital, Copenhagen, Denmark.
Cecilie B HansenLaboratory of Molecular Medicine, Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Peter GarredLaboratory of Molecular Medicine, Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Trine-Line KorsholmDepartment of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
Susan MikkelsenDepartment of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
Kirstine O NielsenDepartment of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
Bjarne K MøllerDepartment of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
Anne T HansenDepartment of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Kasper K IversenDepartment of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
Pernille B NielsenDepartment of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
Rasmus B HasselbalchDepartment of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
Kamille FoghDepartment of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
Jakob B NorskDepartment of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
Jonas Henrik KristensenDepartment of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
Kristian SchønningDepartment of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-7767-305X
Nikolai S KirkbyDepartment of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Alex C Y NielsenDepartment of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Lone H LandsyDepartment of Nonclinical and Clinical Assay Sciences in Global Discovery & Development Sciences, Novo Nordisk A/S, Måløv, Denmark.
Mette LoftagerDepartment of Nonclinical and Clinical Assay Sciences in Global Discovery & Development Sciences, Novo Nordisk A/S, Måløv, Denmark.
Dorte K HolmDepartment of Clinical Immunology, Odense University Hospital, Odense, Denmark.
Anna C NilssonDepartment of Clinical Immunology, Odense University Hospital, Odense, Denmark.
Susanne G SækmoseDepartment of Clinical Immunology, Zealand University Hospital, Næstved Hospital, Næstved, Denmark.
Birgitte Grum-SchwensenDepartment of Clinical Immunology, Zealand University Hospital, Næstved Hospital, Næstved, Denmark.
Bitten AagaardDepartment of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark.
Thøger G JensenDepartment of Clinical Microbiology, Odense University Hospital, Odense, Denmark.
Dorte M NielsenDepartment of Clinical Microbiology, Zealand University Hospital, Slagelse Hospital, Slagelse, Denmark.
Henrik UllumDepartment of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Ram B DessauDepartment of Clinical Microbiology, Zealand University Hospital, Slagelse Hospital, Slagelse, Denmark.ORCID 0000-0002-1497-6309
Copenhagen University Hospital · DKUniversity of Copenhagen · DKAarhus University Hospital · DKZealand University Hospital · DKGentofte Hospital · DKHolbæk Sygehus · DKNovo Nordisk (Denmark) · DKOdense University Hospital · DKStatens Serum Institut · DKAalborg University Hospital · DKFrederiksberg Hospital · DKUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to support clinical diagnosis and epidemiological investigations. Recently, assays for large-scale detection of total antibodies (Ab), immunoglobulin G (IgG), and IgM against SARS-CoV-2 antigens have been developed, but there are limited data on the diagnostic accuracy of these assays. This study was a Danish national collaboration and evaluated 15 commercial and one in-house anti-SARS-CoV-2 assays in 16 laboratories. Sensitivity was evaluated using 150 samples from individuals with asymptomatic, mild, or moderate COVID-19, nonhospitalized or hospitalized, confirmed by nucleic acid amplification tests (NAAT); samples were collected 13 to 73 days either from symptom onset or from positive NAAT (patients without symptoms). Specificity and cross-reactivity were evaluated in samples collected prior to the SARS-CoV-2 epidemic from >586 blood donors and patients with autoimmune diseases, cytomegalovirus or Epstein-Barr virus infections, and acute viral infections. A specificity of ≥99% was achieved by all total-Ab and IgG assays except one, DiaSorin Liaison XL IgG (97.2%). Sensitivities in descending order were Wantai ELISA total Ab (96.7%), CUH-NOVO in-house ELISA total Ab (96.0%), Ortho Vitros total Ab (95.3%), YHLO iFlash IgG (94.0%), Ortho Vitros IgG (93.3%), Siemens Atellica total Ab (93.2%), Roche Elecsys total Ab (92.7%), Abbott Architect IgG (90.0%), Abbott Alinity IgG (median 88.0%), DiaSorin Liaison XL IgG (median 84.6%), Siemens Vista total Ab (81.0%), Euroimmun/ELISA IgG (78.0%), and Snibe Maglumi IgG (median 78.0%). However, confidence intervals overlapped for several assays. The IgM results were variable, with the Wantai IgM ELISA showing the highest sensitivity (82.7%) and specificity (99%). The rate of seropositivity increased with time from symptom onset and symptom severity.

Indexed as

ImmunoassayAntibodies, ViralCOVID-19COVID-19 Serological TestingCytomegalovirus InfectionsEnzyme-Linked Immunosorbent AssayEpstein-Barr Virus InfectionsHerpesvirus 4, HumanHumansImmunoglobulin GImmunoglobulin MLaboratoriesSARS-CoV-2Sensitivity and SpecificityAntibodies, ViralImmunoglobulin GImmunoglobulin Manti-SARS-CoV-2 serology assayevaluationSARS-CoV-2 antibody test

Identifiers

PMID33574119
PMCPMC8091860
OpenAlexW3128017291

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.