Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2-Reference-Cited by-同舟云学术

Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2

Published:2020-09-22 Issue:10 Volume:58 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Muench Peter¹,Jochum Simon¹,Wenderoth Verena¹,Ofenloch-Haehnle Beatus¹,Hombach Michael²^ORCID,Strobl Matthias¹,Sadlowski Henrik³,Sachse Christopher⁴,Torriani Giulia⁵,Eckerle Isabella⁵⁶⁷⁸⁹,Riedel Alexander¹

Affiliation:

1. Roche Diagnostics GmbH, Penzberg, Germany

2. Roche Diagnostics International Ltd, Rotkreuz, Switzerland

3. Labor Berlin–Charité Vivantes Services GmbH, Berlin, Germany

4. KRH Labor GmbH, Hannover, Germany

5. Department of Molecular Medicine and Microbiology, Faculty of Medicine, Université de Genève, Geneva, Switzerland

6. Hôpitaux Universitaires Genève, Geneva, Switzerland

7. Division of Infectious Diseases, Department of Medicine, Université de Genève, Geneva, Switzerland

8. Laboratory of Virology, Division of Laboratory Medicine, Université de Genève, Geneva, Switzerland

9. Center for Emerging Viral Diseases, Université de Genève, Geneva, Switzerland

Abstract

The Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics) was developed to provide accurate, reliable detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated sensitivity, specificity, cross-reactivity, and agreement with a vesicular stomatitis virus-based pseudoneutralization assay for the Elecsys Anti-SARS-CoV-2 immunoassay. Sensitivity and agreement between Elecsys Anti-SARS-CoV-2 immunoassay and pseudoneutralization assay measurements were evaluated using samples from patients with PCR-confirmed SARS-CoV-2 infection, a majority of whom were hospitalized.

Funder

Roche Diagnostics International Ltd

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.01694-20

Reference43 articles.

1. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus–Infected Pneumonia

2. World Health Organization. 2020. Pneumonia of unknown cause—China. Disease outbreak news 5 January 2020. https://www.who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en/.

3. Covid-19 — Navigating the Uncharted

4. Hypothesis for potential pathogenesis of SARS-CoV-2 infection–a review of immune changes in patients with viral pneumonia

5. Laboratory diagnosis of emerging human coronavirus infections – the state of the art

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