Performance evaluation of the Roche Elecsys Anti-SARS-CoV-2 S immunoassay

•The Elecsys® Anti-SARS-CoV-2 S assay detects antibodies to the SARS-CoV-2 S protein.•This assay demonstrated an overall specificity of 99.95% (7876/7880 samples).•Overall sensitivity for this assay was 97.92% (235/240 samples).•Performance was comparable to or greater than that of other commercial...

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Published in:Journal of virological methods Vol. 297; p. 114271
Main Authors: Riester, Elena, Findeisen, Peter, Hegel, J. Kolja, Kabesch, Michael, Ambrosch, Andreas, Rank, Christopher M., Pessl, Florina, Laengin, Tina, Niederhauser, Christoph
Format: Journal Article
Language:English
Published: Netherlands Elsevier B.V 01.11.2021
The Authors. Published by Elsevier B.V
Subjects:
Antibodies
Antibodies, Viral
Austria
confidence interval
COVID-19
Germany
Humans
Immunoassay
immunoassays
Nucleocapsid protein
SARS-CoV-2
Sensitivity and Specificity
Severe acute respiratory syndrome coronavirus 2
Spike protein
Switzerland
Switzerland
Austria
Germany
Antibodies
Immunoassay
SARS-CoV-2
Spike protein
Nucleocapsid protein
ISSN:0166-0934, 1879-0984, 1879-0984
Online Access:Get full text
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Summary:•The Elecsys® Anti-SARS-CoV-2 S assay detects antibodies to the SARS-CoV-2 S protein.•This assay demonstrated an overall specificity of 99.95% (7876/7880 samples).•Overall sensitivity for this assay was 97.92% (235/240 samples).•Performance was comparable to or greater than that of other commercial assays.•This assay can reliably identify past exposure to SARS-CoV-2 in various populations. The Elecsys® Anti-SARS-CoV-2 S immunoassay (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) has been developed for the detection of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein. We evaluated the assay performance using samples from seven sites in Germany, Austria, and Switzerland. For specificity and sensitivity analyses, 7880 presumed negative pre-pandemic samples and 827 SARS-CoV-2 PCR-confirmed single or sequential samples from 272 different patients were tested, respectively. The overall specificity and sensitivity (≥14 days post-PCR) for the Elecsys Anti-SARS-CoV-2 S immunoassay were 99.95% (95% confidence interval [CI]: 99.87–99.99; 7876/7880) and 97.92% (95% CI: 95.21–99.32; 235/240), respectively. The Elecsys Anti-SARS-CoV-2 S immunoassay had significantly higher specificity compared with the LIAISON® SARS-CoV-2 S1/S2 IgG (99.95% [2032/2033] vs 98.82% [2009/2033]), ADVIA Centaur® SARS-CoV-2 Total (100% [928/928] vs 86.96% [807/928]), ARCHITECT SARS-CoV-2 IgG (99.97% [2931/2932] vs 99.69% [2923/2932]), iFlash-SARS-CoV-2 IgM (100.00% [928/928] vs 99.57% [924/928]), and EUROIMMUN Anti-SARS-CoV-2 IgG (100.00% [903/903] vs 97.45% [880/903]) and IgA (100.00% [895/895] vs 95.75% [857/895]) assays. The Elecsys Anti-SARS-CoV-2 S immunoassay had significantly higher sensitivity (≥14 days post-PCR) compared with the ARCHITECT SARS-CoV-2 IgG (98.70% [76/77] vs 87.01% [67/77]), iFlash-SARS-CoV-2 IgG (100.00% [76/76] vs 93.42% [71/76]) and IgM (100.00% [76/76] vs 35.53% [27/76]), and EUROIMMUN Anti-SARS-CoV-2 IgG (98.26% [113/115] vs 93.91% [108/115]) assays. Therefore, the Elecsys Anti-SARS-CoV-2 S assay demonstrated a reliable performance across various sample populations for the detection of anti-S antibodies.
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ISSN:0166-0934
1879-0984
1879-0984
DOI:10.1016/j.jviromet.2021.114271