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Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays
INTRODUCTION: We evaluated the Roche Elecsys Anti-SARS-CoV-2 and Snibe SARS-CoV-2 S-RBD IgG spike chemiluminescent immunoassays and compared them to existing Roche/Abbott nucleocapsid and Abbott IgM spike assays. METHODS: We enrolled 184 SARS-CoV-2 RT-PCR positive samples and 215 controls (172 pre-p...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8513513/ https://www.ncbi.nlm.nih.gov/pubmed/34660869 http://dx.doi.org/10.1016/j.plabm.2021.e00257 |
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author | Lau, C.S. Wong, M.S. Hoo, S.P. Heng, P.Y. Phua, S.K. Aw, T.C. |
author_facet | Lau, C.S. Wong, M.S. Hoo, S.P. Heng, P.Y. Phua, S.K. Aw, T.C. |
author_sort | Lau, C.S. |
collection | PubMed |
description | INTRODUCTION: We evaluated the Roche Elecsys Anti-SARS-CoV-2 and Snibe SARS-CoV-2 S-RBD IgG spike chemiluminescent immunoassays and compared them to existing Roche/Abbott nucleocapsid and Abbott IgM spike assays. METHODS: We enrolled 184 SARS-CoV-2 RT-PCR positive samples and 215 controls (172 pre-pandemic, and 43 cross-reactivity) to evaluate the Roche spike antibody (anti-SARS-CoV-2-S) assay. For the Snibe evaluation, we included 119 RT-PCR positive samples and 249 controls (200 pre-pandemice, 49 cross-reactivity). 98 cases had been tested on three spike assays (Roche total antibody, Snibe IgG and Abbott IgM). RESULTS: The Roche anti-SARS-CoV-2-S assay had a CV of 0.5% (0.82U/mL) and 2.3% (8.72U/mL) and was linear from 1.16 to 240U/mL. The Snibe assay was linear from 6.43 to 77.7AU/mL, CV of 5.5% (0.43AU/mL) and 8.8% (0.18AU/mL). The Snibe spike assay was significantly more sensitive than the Abbott IgG assay at 0–6 days POS (35.2% vs 3.6%, mean difference 29.6%, 95% CI 17.5 to 41.8, p < 0.0001). Optimized LORs significantly improved the sensitivity of the Roche spike (48.1%–56.7%) and both nucleocapsid assays (Roche 43.3%–65.5%, Abbott 3.6%–18.5%) in early disease. CONCLUSION: Although both spike assays showed higher sensitivity than their nucleocapsid counterparts, lower, optimized LORs provided the most significant improvements to sensitivity. |
format | Online Article Text |
id | pubmed-8513513 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-85135132021-10-13 Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays Lau, C.S. Wong, M.S. Hoo, S.P. Heng, P.Y. Phua, S.K. Aw, T.C. Pract Lab Med Article INTRODUCTION: We evaluated the Roche Elecsys Anti-SARS-CoV-2 and Snibe SARS-CoV-2 S-RBD IgG spike chemiluminescent immunoassays and compared them to existing Roche/Abbott nucleocapsid and Abbott IgM spike assays. METHODS: We enrolled 184 SARS-CoV-2 RT-PCR positive samples and 215 controls (172 pre-pandemic, and 43 cross-reactivity) to evaluate the Roche spike antibody (anti-SARS-CoV-2-S) assay. For the Snibe evaluation, we included 119 RT-PCR positive samples and 249 controls (200 pre-pandemice, 49 cross-reactivity). 98 cases had been tested on three spike assays (Roche total antibody, Snibe IgG and Abbott IgM). RESULTS: The Roche anti-SARS-CoV-2-S assay had a CV of 0.5% (0.82U/mL) and 2.3% (8.72U/mL) and was linear from 1.16 to 240U/mL. The Snibe assay was linear from 6.43 to 77.7AU/mL, CV of 5.5% (0.43AU/mL) and 8.8% (0.18AU/mL). The Snibe spike assay was significantly more sensitive than the Abbott IgG assay at 0–6 days POS (35.2% vs 3.6%, mean difference 29.6%, 95% CI 17.5 to 41.8, p < 0.0001). Optimized LORs significantly improved the sensitivity of the Roche spike (48.1%–56.7%) and both nucleocapsid assays (Roche 43.3%–65.5%, Abbott 3.6%–18.5%) in early disease. CONCLUSION: Although both spike assays showed higher sensitivity than their nucleocapsid counterparts, lower, optimized LORs provided the most significant improvements to sensitivity. Elsevier 2021-10-13 /pmc/articles/PMC8513513/ /pubmed/34660869 http://dx.doi.org/10.1016/j.plabm.2021.e00257 Text en © 2021 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Article Lau, C.S. Wong, M.S. Hoo, S.P. Heng, P.Y. Phua, S.K. Aw, T.C. Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays |
title | Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays |
title_full | Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays |
title_fullStr | Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays |
title_full_unstemmed | Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays |
title_short | Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays |
title_sort | performance of the roche/snibe electrochemiluminescent anti-sars-cov-2 spike assays compared to the roche/abbott igg nucleocapsid and abbott igm spike assays |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8513513/ https://www.ncbi.nlm.nih.gov/pubmed/34660869 http://dx.doi.org/10.1016/j.plabm.2021.e00257 |
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