ArticleInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2021
Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients.
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 14 papers, 3 of them syntheses that pooled it.
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Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- An Indirect Comparison of Diagnostic Accuracy for Seven Different SARS-CoV-2 Serological Assays: A Meta-Analysis and Adjusted Indirect Comparison of Diagnostic Test Accuracy.Influenza and other respiratory viruses · 2025Pooled it
- Diagnostic Efficacy of 11 SARS-CoV-2 Serological Assays for COVID-19: A Meta-Analysis and Adjusted Indirect Comparison of Diagnostic Test Accuracy.Immunity, inflammation and disease · 2024Pooled it
- Antibody tests for identification of current and past infection with SARS-CoV-2.The Cochrane database of systematic reviews · 2022Pooled it
- A Multi-Center Prospective Study on Post-Vaccination Humoral Response to SARS-CoV-2 in Polish Long-Term Care Facility Residents: Associations with COVID-19 Clinical Course and Comorbidities.Infectious disease reports · 2025Article
- Pilot Study Results on Antibodies to the S- and N-Proteins of SARS-CoV-2 in Paired Sera from COVID-19 Patients with Varying Severity.Antibodies (Basel, Switzerland) · 2023Article
- Improving immunoassay detection accuracy of anti-SARS-CoV-2 antibodies through dual modality validation.Biosensors & bioelectronics: X · 2022Article
- Article
- Diagnostic accuracy of antibody-based rapid diagnostic tests in detecting coronavirus disease 2019: systematic review.Archives of medical science : AMS · 2022Review
- Article
- COVID-19 associated Multisystem Inflammatory Syndrome in Children (MIS-C) guidelines; revisiting the Western New York approach as the pandemic evolves.Progress in pediatric cardiology · 2021Article
- COVID-19 Antibody Detecting Rapid Diagnostic Tests Show High Cross-Reactivity When Challenged with Pre-Pandemic Malaria, Schistosomiasis and Dengue Samples.Diagnostics (Basel, Switzerland) · 2021Article
- The Three Pillars of COVID-19 Convalescent Plasma Therapy.Life (Basel, Switzerland) · 2021Review
- Evaluation of Antibody Response in Symptomatic and Asymptomatic COVID-19 Patients and Diagnostic Assessment of New IgM/IgG ELISA Kits.Pathogens (Basel, Switzerland) · 2021Article
- Long-Term Persistence and Relevant Therapeutic Impact of High-Titer Viral-Neutralizing Antibody in a Convalescent COVID-19 Plasma Super-Donor: A Case Report.Frontiers in immunology · 2021Article
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Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCommercial availability of serological tests to evaluate immunoglobulins (Ig) targeting severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has grown exponentially since the start of the coronavirus disease 2019 (COVID-19) outbreak. Thorough validation of these tests is important before use as epidemiological tools to infer seroprevalence in specific populations and as diagnostic tools to complement molecular approaches (e.g., quantitative reverse transcription-polymerase chain reaction).
methodsCommercial serological tests from 11 suppliers were assayed side-by-side using 126 samples from SARS-CoV-2-infected inpatients and 36 from healthy and HIV-infected individuals.
resultsThe majority of the tests assayed have >95% specificity. For the sensitivity calculation, samples were stratified by days since symptoms onset; sensitivity peaks at 16-21 days for IgM and IgA (maximum 91.2%, Euroimmun) and, dependant on the test, at 16-21 or >21 days for IgG (maximum 94.1%, Snibe). Data from semiquantitative tests show that patients with a severe clinical presentation have lower levels of Ig targeting SARS-CoV-2 at <10 days since symptoms onset and higher levels at >21 days, compared to patients with a non-severe presentation.
conclusionsThis study highlights the heterogeneity of sensitivity and generally high specificity of the serological tests and establishes a basis for their usefulness to complement diagnostic techniques and population seroprevalence studies.
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