ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2021
Evaluation of sixteen ELISA SARS-CoV-2 serological tests.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Development and certification of SARS-CoV-2 S-RBD protein reference material via dual isotope dilution mass spectrometry.Analytical and bioanalytical chemistry · 2026Article
- Ultrafast and high-throughput immunoassay assay to detect anti-SARS-CoV-2 IgG antibodies in dogs and cats.Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology] · 2024Article
- Review
- Convalescent Adaptive Immunity Is Highly Heterogenous after SARS-CoV-2 Infection.Journal of clinical medicine · 2023Article
- Development of a Method for Detection of SARS-CoV-2 Nucleocapsid Antibodies on Dried Blood Spot by DELFIA Immunoassay.Diagnostics (Basel, Switzerland) · 2023Article
- Novel approach based on GQD-PHB as anchoring platform for the development of SARS-CoV-2 electrochemical immunosensor.Analytica chimica acta · 2022Article
- Pre-Pandemic Cross-Reactive Immunity against SARS-CoV-2 among Central and West African Populations.Viruses · 2022Article
- Recent Advances in CRISPR/Cas-Based Biosensors for Protein Detection.Bioengineering (Basel, Switzerland) · 2022Review
- False Positivity of Anti-SARS-CoV-2 Antibodies in Patients with Acute Tropical Diseases in Thailand.Tropical medicine and infectious disease · 2022Article
- Comparison of SARS-CoV-2 Antibodies and Six Immunoassays in Pediatric and Adult Patients 12 Weeks After COVID-19.Cureus · 2022Article
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Authors and funding
7 authors.
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Abstract
backgroundIn response to the current COVID-19 pandemic, multiple companies marketed serological tests. Rigorous, independent and comparative performances of these assays on defined clinical specimens are needed.
methodsIn a first preliminary phase, we investigated 16 IgG, IgM, IgA and pan Ig serological ELISA using a panel of 180 sera, comprising 97 sera from patients with a positive RT-PCR, and 83 negative sera sampled before November 1, 2019. In a second phase and to complete the evaluation on the full panel (100 positive and 300 negative), tests that passed pre-defined exclusion criteria of 90% sensitivity and 97% specificity were further evaluated on 220 additional sera chosen to assess possible cross-reactivity with other human viral infections.
resultsAmong the 16 tests evaluated in the preliminary phase, two were excluded due to insufficient sensitivity at 15 days post-symptom onset and one was excluded due to poor specificity. Of the 13 tests evaluated using the full panel comprised of a diverse pool of sera including those reactive against known respiratory viruses, no systematic cross-reactivity was observed. However, heterogeneities across tests were found. Consistent with kinetics of antibody expression, maximal sensitivity was found two weeks post-symptom onset.
conclusionIn this independent evaluation, we compared the performance of 16 SARS-CoV-2 serological tests using well-characterized sera and found 13 tests with more than 90% sensitivity at 15 days post-symptom onset and 97% specificity across a diverse range of negative samples.
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