Riester, Elena and Findeisen, Peter and Hegel, J. Kolja and Kabesch, Michael and Ambrosch, Andreas and Rank, Christopher M. and Pessl, Florina and Laengin, Tina and Niederhauser, Christoph (2021) Performance evaluation of the Roche Elecsys Anti-SARS-CoV-2 S immunoassay. JOURNAL OF VIROLOGICAL METHODS, 297: 114271. ISSN 0166-0934, 1879-0984
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The Elecsys (R) 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 (SARSCoV-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 (R) SARS-CoV-2 S1/S2 IgG (99.95% [2032/2033] vs 98.82% [2009/ 2033]), ADVIA Centaur (R) 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | SPIKE; SARS-CoV-2; Spike protein; Nucleocapsid protein; Immunoassay; Antibodies |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Kinder- und Jugendmedizin |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 09 Sep 2022 10:46 |
| Last Modified: | 09 Sep 2022 10:46 |
| URI: | https://pred.uni-regensburg.de/id/eprint/46920 |
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