Abstract
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.
Highlights
In December 2019, pneumonia of unknown etiology was reported in a cluster of patients linked to a sea food market in Wuhan City, Hubei Province of China [1]
The study population consist of voluntary participants >18 years who were recruited to participate in the research “Fourway validation of serological and rapid point-of-care testing for Severe Acute Respiratory Viral-2 Coronavirus (SARS-CoV2 or COVID-19) in South Africa”
The highest percentage positivity was reported at days 15–21 post-PCR diagnosis for IgG and days 31–40 for IgA; and the specificity was lower for IgA than IgG
Summary
In December 2019, pneumonia of unknown etiology was reported in a cluster of patients linked to a sea food market in Wuhan City, Hubei Province of China [1]. The causal agent was later identified as a new strain of coronavirus named Severe Acute Respiratory SyndromeCoronavirus 2 (SARS-CoV-2), causing the clinical syndrome of COVID -19. As of 08 February2021, over 100 million cases of SARS-CoV-2, with over 1 million deaths have been reported globally. South Africa is the current epicenter of aSARS-CoV-2 infection in Africa with over 1 million cases and more than 40, 000 deaths [2]. The majority of infected patients show mild symptoms, with approximately 10–20% of cases progressing to severe or critical disease [5]. Major risk factors for severe disease include older age and comorbidities such as hypertension, diabetes, chronic obstructive pulmonary disease (COPD), and cardiovascular disease [6, 7]
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