Validation of Roche immunoassay for severe acute respiratory virus 2/SARS-COV-2 in South Africa
dc.contributor.author | Grove, Jurette Simone | |
dc.contributor.supervisor | George, Jaya | |
dc.contributor.supervisor | Mayne, Elizabeth | |
dc.date.accessioned | 2025-02-28T14:02:49Z | |
dc.date.issued | 2023-01 | |
dc.description | A research report submitted for graduation for the degree MMed in Chemical Pathology, to the Faculty of Health Sciences, School of Pathology, University of the Witwatersrand, Johannesburg, 2023. | |
dc.description.abstract | Background: Serology testing is an important ancillary diagnostic to the reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We aimed to evaluate the performance of the Roche Elecsys™ chemiluminescent immunoassay (Rotkreuz, Switzerland), that detects antibodies against the SARS-CoV-2 nucleocapsid antigen, at an academic laboratory in South Africa. Methods: Serum samples were collected from 312 donors with confirmed positive SARS CoV-2 RT-PCR tests, with approval from a large university’s human research ethics committee. Negative controls included samples stored prior to December 2019 and from patients who tested negative for SARS-CoV-2 on RT-PCR and were confirmed negative using multiple serology methods (n = 124). Samples were stored at –80 °C and analysed on a Roche cobas™ 602 autoanalyser. Results: Compared with RT-PCR, our evaluation revealed a specificity of 100% and overall sensitivity of 65.1%. The sensitivity in individuals > 14 days’ post-diagnosis was 72.6%, with the highest sensitivity 31–50 days’ post-diagnosis at 88.6%. Results were also compared with in-house serology tests that showed high agreement in majority of categories. Conclusions: The sensitivity at all-time points post-diagnosis was lower than reported in other studies, but sensitivity in appropriate cohorts approached 90% with a high specificity. The lower sensitivity at earlier time points or in individuals without symptomatology may indicate failure to produce antibodies, which was further supported by the comparison against in-house serology tests. | |
dc.description.submitter | MMM2025 | |
dc.faculty | Faculty of Health Sciences | |
dc.identifier | 0000-0001-9741-4418 | |
dc.identifier.citation | Grove, Jurette Simone. (2023). Validation of Roche immunoassay for severe acute respiratory virus 2/SARS-COV-2 in South Africa. [Masters dissertation, University of the Witwatersrand, Johannesburg]. WIReDSpace. https://hdl.handle.net/10539/44039 | |
dc.identifier.uri | https://hdl.handle.net/10539/44039 | |
dc.language.iso | en | |
dc.publisher | University of the Witwatersrand, Johannesburg | |
dc.rights | ©2023 University of the Witwatersrand, Johannesburg. All rights reserved. The copyright in this work vests in the University of the Witwatersrand, Johannesburg. No part of this work may be reproduced or transmitted in any form or by any means, without the prior written permission of University of the Witwatersrand, Johannesburg. | |
dc.rights.holder | University of the Witwatersrand, Johannesburg | |
dc.school | School of Pathology | |
dc.subject | COVID-19 | |
dc.subject | SARS-CoV-2 | |
dc.subject | Serology | |
dc.subject | Antibodies | |
dc.subject | Validation | |
dc.subject | Immunoglobulin G | |
dc.subject | Immunoglobulin M | |
dc.subject | UCTD | |
dc.subject.other | SDG-3: Good health and well-being | |
dc.subject.other | SDG-4: Quality education | |
dc.title | Validation of Roche immunoassay for severe acute respiratory virus 2/SARS-COV-2 in South Africa | |
dc.type | Dissertation |