The role of serological testing in the SARS-CoV-2 outbreak

Mayne, Elizabeth; Scott, Lesley; Semete, B; Julsing, A; Jugwanth, Sarika; Mampeule, Nakampe; David, Anura; Gededzha, Maemu P.; Goga, Ameena; Hardie, Diana; Preiser, Wolfgang; Chetty, Kamy; Rees, Helen; Sanne, Ian; Mlisana, Koleka; George, Jaya; Stevens, Wendy

doi:10.7196/samj.2020.v110i9.15098

Cited by 13 publications

(18 citation statements)

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“…We would recommend it is best utilised for retrospective diagnosis in individuals more than 14 days' post-positive PCR who are moderately or severely symptomatic, as an ancillary diagnostic in multisystem inflammatory disorders and seroprevalence studies. 4,27…”

Section: Discussionmentioning

confidence: 99%

“…5 Immunoglobulin M antibody levels drop after about day 14 when the IgG antibody levels start to rise. There is potential for serological assays to be utilised in a variety of ways: to assist with diagnosis of the disease together with RT-PCR, 8 to identify past infections including in paediatric patients with multisystem inflammatory syndrome of COVID (MIS-C), 9 to perform seroprevalence studies, 4 to assess the immune response to a potential COVID-19 vaccine and, lastly, to identify donors for convalescent plasma. 10 Since the identification of serology methods as an ancillary diagnostic, there has been a rapid development of a wide range of different assays.…”

Section: Validation Of Roche Immunoassay For Severe Acute Respiratory Coronavirus 2 In South Africamentioning

confidence: 99%

“…10 Since the identification of serology methods as an ancillary diagnostic, there has been a rapid development of a wide range of different assays. 4 A review of 40 studies indicated that chemiluminescent immunoassays (CLIA) methodology had the highest sensitivity with a pooled sensitivity of 97.8%, compared with enzyme linked immunosorbent assay (ELISA) with 84.3% and lastly lateral flow immunoassays (LFIA) with 66.0%. 11 Roche Diagnostics (Rotkreuz, Switzerland) developed an electrochemiluminescent immunoassay (Elecsys™ Anti-SARS-CoV-2), which detects total antibodies against the SARS-CoV-2 nucleocapsid antigen, although it is most specific for IgG and IgM.…”

Section: Validation Of Roche Immunoassay For Severe Acute Respiratory Coronavirus 2 In South Africamentioning

confidence: 99%

“…The acceptable turnaround time for this test in South Africa is 24 h -48 h, but the large burden of disease and worldwide shortage of test kits have constrained availability, resulting in prolonged turnaround times worldwide. 4 Further limitations of RT-PCR include that detection relies on the presence of the viral genome in sufficient amounts for amplification. 5…”

Section: Introductionmentioning

confidence: 99%

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

Grove

Mayne

Burgers

et al. 2021

Southern African Journal of Infectious Diseases

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Validation Of Roche Immunoassay For Severe Acute Respiratory Coronavirus 2 In South Africamentioning

confidence: 99%

Section: Validation Of Roche Immunoassay For Severe Acute Respiratory Coronavirus 2 In South Africamentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Grove

Mayne

Burgers

et al. 2021

Southern African Journal of Infectious Diseases

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“…IgM is produced in response to the initial exposure to an antigen, followed by isotype switching to IgG. IgA, may be produced earlier and by more individuals than either IgM or IgG [21]. The first point of entry of SARS-CoV-2 is the mucosal surface and IgA plays an important role as part of mucosal immunity [22].…”

Section: Introductionmentioning

confidence: 99%

Performance of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies in South Africa

et al. 2021

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Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) has been identified as the causative agent for causing the clinical syndrome of COVID -19. Accurate detection of SARS-CoV-2 infection is not only important for management of infected individuals but also to break the chain of transmission. South Africa is the current epicenter of SARS-CoV-2 infection in Africa. To optimize the diagnostic algorithm for SARS-CoV-2 in the South African setting, the study aims to evaluate the diagnostic performance of the EUROIMMUN Anti-SARS-CoV-2 assays. This study reported the performance of EUROIMMUN enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgA and IgG antibodies in serum and plasma samples targeting the recombinant S1 domain of the SARS-CoV-2 spike protein as antigen. Samples were collected from 391 individuals who had tested positive for SARS-CoV-2 and 139 SARS CoV-2 negative controls. Samples were stratified by number of days’ post-PCR diagnosis and symptoms. The sensitivity of EUROIMMUN IgG was 64.1% (95% CI: 59.1–69.0%) and 74.3% (95% CI: 69.6–78.6%) for IgA and the specificity was lower for IgA [84.2% (95% CI: 77–89.2%)] than IgG [95.2% (95% CI: 90.8–98.4%)]. The EUROIMMUN Anti-SARS-CoV-2 ELISA Assay sensitivity was higher for IgA but low for IgG and improved for both assays in symptomatic individuals and at later timepoints post PCR diagnosis.

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