Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively
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Open Access
- 24 August 2020
- journal article
- research article
- Published by American Society for Microbiology in Journal of Clinical Microbiology
- Vol. 58 (9)
- https://doi.org/10.1128/jcm.01224-20
Abstract
In the coronavirus (CoV) disease 2019 (COVID-19) pandemic, highly selective serological testing is essential to define exposure to severe acute respiratory syndrome CoV 2 (SARS-CoV-2). Many tests have been developed, yet with variable speeds to first results, and are of unknown quality, particularly when considering the prediction of neutralizing capacity. The LIAISON SARS-CoV-2 S1/S2 IgG assay was designed to measure antibodies against the SARS-CoV-2 native S1/S2 proteins in a standardized automated chemiluminescence assay. The clinical and analytical performances of the test were validated in an observational study using residual samples (>1,500) with a positive or negative COVID-19 diagnosis. The LIAISON SARS-CoV-2 S1/S2 IgG assay proved to be highly selective and specific and offered semiquantitative measures of serum or plasma levels of anti-S1/S2 IgG with neutralizing activity. The assay’s diagnostic sensitivities were 91.3% and 95.7% at >5 or ≥15 days from diagnosis, respectively, and 100% when assessed against a neutralizing assay. The assay’s specificity ranged between 97% and 98.5%. The average imprecision of the assay was a <5% coefficient of variation. Assay performance at 2 different cutoffs was evaluated to optimize predictive values. The automated LIAISON SARS-CoV-2 S1/S2 IgG assay brings efficient, sensitive, specific, and precise serological testing to the laboratory, with the capacity to test large amounts of samples per day; first results are available within 35 min, with a throughput of 170 tests/hour. The semiquantitative results provided by the test also associate with the presence of neutralizing antibodies and may provide a useful tool for the large-scale screening of convalescent-phase plasma for safe therapeutic use.Keywords
Funding Information
- Diasorin (no number)
This publication has 24 references indexed in Scilit:
- Non-Specific Adsorption Reduction Methods in BiosensingSensors, 2019
- A pan-coronavirus fusion inhibitor targeting the HR1 domain of human coronavirus spikeScience Advances, 2019
- Healthcare-associated infections: the hallmark of Middle East respiratory syndrome coronavirus with review of the literatureJournal of Hospital Infection, 2018
- Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interferenceInternational Journal of Pharmacokinetics, 2017
- Mechanisms of Coronavirus Cell Entry Mediated by the Viral Spike ProteinViruses, 2012
- Ready, Set, Fuse! The Coronavirus Spike Protein and Acquisition of Fusion CompetenceViruses, 2012
- Long-Term Persistence of Robust Antibody and Cytotoxic T Cell Responses in Recovered Patients Infected with SARS CoronavirusPLOS ONE, 2006
- Contributions of the structural proteins of severe acute respiratory syndrome coronavirus to protective immunityProceedings of the National Academy of Sciences of the United States of America, 2004
- A DNA vaccine induces SARS coronavirus neutralization and protective immunity in miceNature, 2004
- The Vroman Effect: A Molecular Level Description of Fibrinogen DisplacementJournal of the American Chemical Society, 2003