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Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively.
J Clin Microbiol. 2020 Aug 24; 58(9)JC

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.

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Authors+Show Affiliations

DiaSorin, S.p.A., Saluggia, Italy fabrizio.bonelli@diasorin.it.

Molecular Virology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy.

DiaSorin, S.p.A., Saluggia, Italy.

DiaSorin, S.p.A., Saluggia, Italy.

Molecular Virology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy. Department of Clinical, Surgical Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.

Department of Laboratory Medicine, ASST Niguarda Hospital, University of Milan, Milan, Italy.

DiaSorin, S.p.A., Saluggia, Italy.

DiaSorin, S.p.A., Saluggia, Italy.

DiaSorin, S.p.A., Saluggia, Italy.

Department of Laboratory Medicine, ASST Niguarda Hospital, University of Milan, Milan, Italy.

Molecular Virology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy.

Molecular Virology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy. Department of Clinical, Surgical Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.

Department of Laboratory Medicine, ASST Niguarda Hospital, University of Milan, Milan, Italy.

Molecular Virology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy. Department of Clinical, Surgical Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.

MeSH

Antibodies, NeutralizingAntibodies, ViralAutomation, LaboratoryBetacoronavirusCOVID-19COVID-19 TestingClinical Laboratory TechniquesCoronavirus InfectionsHumansImmunoglobulin GPandemicsPneumonia, ViralReproducibility of ResultsSARS-CoV-2Sensitivity and SpecificitySerologic TestsSpike Glycoprotein, Coronavirus

Pub Type(s)

Journal Article

Observational Study

Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32580948

Citation

Bonelli, Fabrizio, et al. "Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively." Journal of Clinical Microbiology, vol. 58, no. 9, 2020.

Bonelli F, Sarasini A, Zierold C, et al. Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively. J Clin Microbiol. 2020;58(9).

Bonelli, F., Sarasini, A., Zierold, C., Calleri, M., Bonetti, A., Vismara, C., Blocki, F. A., Pallavicini, L., Chinali, A., Campisi, D., Percivalle, E., DiNapoli, A. P., Perno, C. F., & Baldanti, F. (2020). Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively. Journal of Clinical Microbiology, 58(9). https://doi.org/10.1128/JCM.01224-20

Bonelli F, et al. Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively. J Clin Microbiol. 2020 Aug 24;58(9) PubMed PMID: 32580948.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively. AU - Bonelli,Fabrizio, AU - Sarasini,Antonella, AU - Zierold,Claudia, AU - Calleri,Mariella, AU - Bonetti,Alice, AU - Vismara,Chiara, AU - Blocki,Frank A, AU - Pallavicini,Luca, AU - Chinali,Alberto, AU - Campisi,Daniela, AU - Percivalle,Elena, AU - DiNapoli,Anna Pia, AU - Perno,Carlo Federico, AU - Baldanti,Fausto, Y1 - 2020/08/24/ PY - 2020/5/21/received PY - 2020/6/22/accepted PY - 2020/6/26/pubmed PY - 2020/9/9/medline PY - 2020/6/26/entrez KW - CLIA KW - COVID-19 KW - SARS-CoV-2 KW - diagnostics KW - immunoassays KW - immunoserology KW - neutralization assay KW - neutralizing antibodies KW - spike JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 58 IS - 9 N2 - 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. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/32580948/Clinical_and_Analytical_Performance_of_an_Automated_Serological_Test_That_Identifies_S1/S2_Neutralizing_IgG_in_COVID_19_Patients_Semiquantitatively_ DB - PRIME DP - Unbound Medicine ER -