Validation of Roche immunoassay for severe acute respiratory coronavirus 2 in South Africa

Autor: Jurette S. Grove, Elizabeth S. Mayne, Wendy A. Burgers, Jonathan Blackburn, Sarika Jugwanth, Wendy Stevens, Lesley Scott, Anura David, Maemu Gededzha, Ian M. Sanne, Mpho R. Maphayi, Taryn Pillay, Jaya A. George
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Southern African Journal of Infectious Diseases, Vol 36, Iss 1, Pp e1-e6 (2021)
Druh dokumentu: article
ISSN: 2312-0053
2313-1810
DOI: 10.4102/sajid.v36i1.286
Popis: 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.
Databáze: Directory of Open Access Journals
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