Įach kit contains microplate strips with 8 break-off reagent wells coated with recombinant structural protein of SARS-CoV-2. The EUROIMMUN Anti-SARS-CoV-2 Assay is an enzyme-linked immunosorbent assay (ELISA) that provides semi-quantitative in vitro determination of human antibodies of immunoglobulin classes IgA and IgG against SARS-CoV-2 in serum or EDTA plasma. IgA antibodies can show higher sensitivity, while IgG antibodies typically have longer duration, better specificity, and are better suited for serosurveillance studies, , ]. Of the immunoassays currently available, choice of SARS-CoV-2 target antigens include the spike protein (S) or the nucelocapsid (N). Serological testing may be useful in conjunction with other laboratory tests and clinical findings of COVID-19 infection for epidemiological monitoring and outbreak control. Multiple manufacturers are offering serological assays, but few have received EUA the EUROIMMUN IgG assay has received EUA from the FDA. For diagnostic purposes many nucleic acid amplification assays were quickly developed and received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). The virus belongs to the Betacoronavirus genus of the Coronaviridae family, which also includes Severe Acute Respiratory Syndrome Coronavirus 1 (SARS-CoV-1) and Middle East Respiratory Syndrome Coronavirus (MERS-CoV). Severe Acute Respiratory Coronavirus 2 (SARS-CoV-2) was determined to be the agent of coronavirus disease 2019 (COVID-19). In December 2019 a novel coronavirus emerged as the cause of severe respiratory disease and quickly spread causing a worldwide pandemic. This assay demonstrated good specificity for IgA and excellent specificity for IgG and demonstrated only borderline cross reaction in 2 of the 28 samples from patients with common human coronaviruses infection, types NL63 and OC43. The EUROIMMUN Anti-SARS-CoV-2 ELISA Assay demonstrated good sensitivity for detection of IgA and excellent sensitivity for detection of IgG antibodies from samples collected ≥4 days, after COVID-19 diagnosis by PCR. Of samples collected ≥4 days after positive PCR, 38 of 42 (90.5% agreement, 95% CI: 77.9–96.2) were positive for IgA, and 42 of 42 (100% agreement, 95% CI: 91.6–100) were positive for IgG, respectively. Of 82 samples from SARS-CoV-2 PCR-positive patients, 14 tested negative and 68 tested positive for IgA (82.9% agreement, 95% CI: 73.4–89.5) while 27 tested negative and 55 tested positive for IgG (67.1% agreement, 95% CI: 56.3–76.3). Of 86 samples from SARS-CoV-2 PCR-negative patients, including 28 samples positive for common human coronavirus strains, 76 tested negative and 10 tested positive for IgA (88.4% agreement, 95% CI: 79.9–93.6) while 84 tested negative and 2 tested positive for IgG (97.7% agreement, 95% CI: 91.9–99.6). Specimens from patients, with and without COVID-19 infection, were tested at the University of Chicago Clinical Microbiology and Immunology Laboratory. In this report we present the performance of the EUROIMMUN enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgA and IgG antibodies in serum and plasma samples using recombinant S1 domain of the SARS-CoV-2 spike protein as antigen. As the Coronavirus 2019 (COVID-19) pandemic evolves, the development of immunoassays to help determine exposure and potentially predict immunity has become a pressing priority.
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