Validation of Roche immunoassay for severe acute respiratory coronavirus 2 in South Africa. Grove, J. S, Mayne, E. S, Burgers, W. A, Blackburn, J., Jugwanth, S., Stevens, W., Scott, L., David, A., Gededzha, M., Sanne, I. M, Maphayi, M. R, Pillay, T., & George, J. A Southern African Journal of Infectious Diseases, 36(1):a286, jul, 2021. ![Validation of Roche immunoassay for severe acute respiratory coronavirus 2 in South Africa [link]](https://bibbase.org/img/filetypes/link.svg "link")
Paper doi abstract bibtex 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 \textgreater 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.
@article{Grove2021,
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 {\textgreater} 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.},
author = {Grove, Jurette S and Mayne, Elizabeth S and Burgers, Wendy A and Blackburn, Jonathan and Jugwanth, Sarika and Stevens, Wendy and Scott, Lesley and David, Anura and Gededzha, Maemu and Sanne, Ian M and Maphayi, Mpho R and Pillay, Taryn and George, Jaya A},
doi = {10.4102/SAJID.V36I1.286},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Grove et al. - 2021 - Validation of Roche immunoassay for severe acute respiratory coronavirus 2 in South Africa.pdf:pdf},
issn = {2313-1810},
journal = {Southern African Journal of Infectious Diseases},
keywords = {19,2,COVID,CoV,Infectious diseases,OA,SARS,antibodies,bacterial,clinical,communicable,diagnosis,epidemiology,fund{\_}ack,fungal,immunoglobulin G,immunoglobulin M,laboratory,original,parasitic,serology,treatment,validation,viral},
mendeley-tags = {OA,fund{\_}ack,original},
month = {jul},
number = {1},
pages = {a286},
title = {{Validation of Roche immunoassay for severe acute respiratory coronavirus 2 in South Africa}},
url = {https://sajid.co.za/index.php/sajid/article/view/286/686 https://sajid.co.za/index.php/sajid/article/view/286/687 https://sajid.co.za/index.php/sajid/article/view/286/688 https://sajid.co.za/index.php/sajid/article/view/286},
volume = {36},
year = {2021}
}
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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 \\textgreater 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. 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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 {\\textgreater} 14 days' post-diagnosis was 72.6{\\%}, with the highest sensitivity 31–50 days' post-diagnosis at 88.6{\\%}. 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