ArticleClinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases2020
Validation of a commercially available SARS-CoV-2 serological immunoassay.
Article in Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 114 papers, 1 of them a synthesis that pooled it.
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114 citing papers in PubMed, 1 synthesis or guideline pooled it, 173 citations in OpenAlex.
- Testing for SARS-CoV-2 (COVID-19): a systematic review and clinical guide to molecular and serological in-vitro diagnostic assays.Reproductive biomedicine online · 2020Pooled it
- Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial.Lancet (London, England) · 2021Trial
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- Estimating the incidence of SARS-CoV-2 infections by jointly modelling seroprevalence, hospitalization and mortality data, February 2020 - January 2021, Belgium.Archives of public health = Archives belges de sante publique · 2026Article
- Multiplex pan-filovirus assay performance and reproducibility across varied geographical and resource settings.PloS one · 2026Article
- Real-world immune response to SARS-CoV-2 vaccination in Thai patients with systemic lupus erythematosus: a cross-sectional observational study.Lupus science & medicine · 2025Observational
- Symptoms Six Weeks After COVID-19 Are Reduced Among US Health Care Personnel Receiving Additional Vaccine Doses During the Omicron Period, December 2021-April 2022.Open forum infectious diseases · 2024Article
- Exploratory study of antibody titers against SARS-CoV-2 using an indirect immunoperoxidase assay in COVID-19 patients and vaccinated volunteers.Tropical medicine and health · 2024Article
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- Bayesian workflow for time-varying transmission in stratified compartmental infectious disease transmission models.PLoS computational biology · 2024Article
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- Distinct phenotype of SARS-CoV-2 Omicron BA.1 in human primary cells but no increased host range in cell lines of putative mammalian reservoir species.Virus research · 2024Article
- Research progress in methods for detecting neutralizing antibodies against SARS-CoV-2.Analytical biochemistry · 2023Review
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- Recent development of microfluidics-based platforms for respiratory virus detection.Biomicrofluidics · 2023Article
- Observational
- Relationship between Anti-SARS-CoV-2 S Abs and IFN-λ3 Levels in the Administration of Oxygen following COVID-19 Vaccination.ImmunoHorizons · 2023Article
- A comparison of 7 commercial anti-SARS-CoV-2 antibody immunoassays.Archives of medical science : AMS · 2023Article
- Early riser specific immune cell response by delayed-type hypersensitivity in a kidney transplant patient vaccinated against COVID-19.BMJ case reports · 2022Article
- SARS-CoV-2 Serology: Utility and Limits of Different Antigen-Based Tests through the Evaluation and the Comparison of Four Commercial Tests.Biomedicines · 2022Article
54 more citing papers are in PubMed but not listed here.
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Authors and funding
20 authors at 3 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo validate the diagnostic accuracy of a Euroimmun SARS-CoV-2 IgG and IgA immunoassay for COVID-19.
methodsIn this unmatched (1:2) case-control validation study, we used sera of 181 laboratory-confirmed SARS-CoV-2 cases and 326 controls collected before SARS-CoV-2 emergence. Diagnostic accuracy of the immunoassay was assessed against a whole spike protein-based recombinant immunofluorescence assay (rIFA) by receiver operating characteristic (ROC) analyses. Discrepant cases between ELISA and rIFA were further tested by pseudo-neutralization assay.
resultsCOVID-19 patients were more likely to be male and older than controls, and 50.3% were hospitalized. ROC curve analyses indicated that IgG and IgA had high diagnostic accuracies with AUCs of 0.990 (95% Confidence Interval [95%CI]: 0.983-0.996) and 0.978 (95%CI: 0.967-0.989), respectively. IgG assays outperformed IgA assays (p=0.01). Taking an assessed 15% inter-assay imprecision into account, an optimized IgG ratio cut-off > 2.5 displayed a 100% specificity (95%CI: 99-100) and a 100% positive predictive value (95%CI: 96-100). A 0.8 cut-off displayed a 94% sensitivity (95%CI: 88-97) and a 97% negative predictive value (95%CI: 95-99). Substituting the upper threshold for the manufacturer's, improved assay performance, leaving 8.9% of IgG ratios indeterminate between 0.8-2.5.
conclusionsThe Euroimmun assay displays a nearly optimal diagnostic accuracy using IgG against SARS-CoV-2 in patient samples, with no obvious gains from IgA serology. The optimized cut-offs are fit for rule-in and rule-out purposes, allowing determination of whether individuals in our study population have been exposed to SARS-CoV-2 or not. IgG serology should however not be considered as a surrogate of protection at this stage.
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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.