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

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; antibodies; immunoglobulin G; immunoglobulin M; serology; validation.

FIGURE 1

Summary of samples used in validation.