Original Research

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

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
Southern African Journal of Infectious Diseases | Vol 36, No 1 | a286 | DOI: https://doi.org/10.4102/sajid.v36i1.286 | © 2021 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 | This work is licensed under CC Attribution 4.0
Submitted: 02 April 2021 | Published: 26 July 2021

About the author(s)

Jurette S. Grove, Department of Chemical Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and, National Health Laboratory Service, Johannesburg, South Africa
Elizabeth S. Mayne, National Health Laboratory Service, Johannesburg, South Africa; and, Department of Immunology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Wendy A. Burgers, Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; and, Department of Virology and Wellcome Centre for Infectious Diseases Research in Africa, University of Cape Town, Cape Town, South Africa
Jonathan Blackburn, Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; and, Division of Chemical and Systems Biology, Department of Integrative Biomedical Sciences, University of Cape Town, Cape Town, South Africa
Sarika Jugwanth, National Health Laboratory Service, Johannesburg, South Africa; and, Department of Immunology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Wendy Stevens, National Health Laboratory Service, Johannesburg, South Africa; and, Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Lesley Scott, National Health Laboratory Service, Johannesburg, South Africa; and, Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Anura David, National Health Laboratory Service, Johannesburg, South Africa; and, Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Maemu Gededzha, National Health Laboratory Service, Johannesburg, South Africa; and, Department of Immunology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Ian M. Sanne, HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Mpho R. Maphayi, Department of Chemical Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and, National Health Laboratory Service, Johannesburg, South Africa
Taryn Pillay, Department of Chemical Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and, National Health Laboratory Service, Johannesburg, South Africa
Jaya A. George, Department of Chemical Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and, National Health Laboratory Service, Johannesburg, South Africa


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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.


Keywords

COVID-19; SARS-CoV-2; serology; antibodies; validation; immunoglobulin G; immunoglobulin M

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