Highlights • COVID-19 cases are rising in the US, Brazil and India with no apparent end in sight. • The validated modified CDC assay performs well but its testing capacity is limited. • Laboratories need to acquire multiple assays to meet SARS-CoV-2 testing demand. • NeuMoDx has the highest throughput and shortest TAT than the other assays tested. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), has spread rapidly around the globe since it was first identified in December of 2019 in Wuhan, China. In a race to contain the infection, researchers and healthcare officials have developed several assays to help diagnose individuals with COVID-19. To help laboratories decide what assay to bring into testing lines, factors such as assay availability, cost, throughput, and TAT should be considered. Here we validated a modified version of the CDC assay and used it as a reference to evaluate the performance of the NeuMoDxTM SARS-CoV-2 and DiaSorin SimplexaTM Covid-19 Direct assays. In silico analysis and clinical sample testing showed that the primers/probes designed by the CDC were specific to the SARS-CoV-2 as they accurately detected all reactive samples with an assay LoD of 200 copies/mL. The performance of the three assays were analyzed using 159 nasopharyngeal swabs specimen tested within 1–5 days after routine testing. A 100 % agreement was observed between the commercial assays and the modified CDC SARS-CoV-2 assay. A deeper look at the Ct values showed no significant difference between NeuMoDx and the modified CDC SARS-CoV-2 assay, whereas DiaSorin had lower overall Ct values than the modified CDC SARS-CoV-2 assay. NeuMoDx and DiaSorin workflows were much easier to perform. NeuMoDx has the highest throughput and shortest TAT, whereas although the modified CDC SARS-CoV-2 assay has comparable throughput to DiaSorin, it has the longest hands-on time and highest TAT.
【저자키워드】 COVID-19, SARS-CoV-2, pandemic, 【초록키워드】 coronavirus disease, Brazil, coronavirus, India, Infection, virus, Laboratory, Spread, Nasopharyngeal swab, SARS-CoV-2 testing, CDC, healthcare, diagnose, Analysis, in sight, acute respiratory syndrome, Factor, no significant difference, COVID-19 case, DiaSorin, specimen, help, researcher, Direct, TAT, reactive, Wuhan, China, highest, tested, analyzed, evaluate, globe, assays, comparable, cause, rising, individuals with COVID-19, the SARS-CoV-2, 【제목키워드】 validation, CDC, automated, respiratory specimen,