The assays were validated using serum samples from: i) SARS-CoV-2 PCR-positive patients with a documented first day of disease ii) archived sera obtained from healthy individuals before the emergence of SARS-CoV-2 in China iii) sera from patients with acute viral respiratory tract infections caused by other coronaviruses or non-coronaviruses and iv) sera from patients positive for dengue virus, cytomegalovirus and Epstein Barr virus. These included three enzyme-linked immunosorbent assays (ELISAs) and six point-of-care (POC) lateral flow tests. This study evaluated the sensitivity and specificity of nine commercially available serological tests. Thorough validation of serological tests are required to facilitate their use in the accurate diagnosis of SARS-CoV-2 infection, confirmation of molecular results, contact tracing, and epidemiological studies. Due to urgency and demand, numerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassays are rapidly being developed and placed on the market with limited validation on clinical samples.
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