id author title date pages extension mime words sentences flesch summary cache txt cord-319864-t6ql9hz2 Lima, Amorce Validation of a Modified CDC Assay and Performance Comparison with the NeuMoDx™ and DiaSorin® automated assays for Rapid Detection of SARS-CoV-2 in Respiratory Specimens 2020-11-11 .txt text/plain 3048 190 65 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. In this study, we sought to describe a modified CDC SARS-CoV-2 assay validation and compare its performance and workflow to that of the NeuMoDx SARS-CoV-2 and DiaSorin Simplexa Covid-19 Direct assays using respiratory specimens. The primer/probe sets used in this validation were selected from regions of the SARS-CoV-2 virus nucleocapsid (N) gene and were described in the CDC EUA protocol for COVID-19 diagnostic testing (7) . Of the 43 samples used for comparison between modified CDC SARS-CoV-2 assay and Simplexa Covid 19 Direct assay, 37 samples were run within 2 days and 6 were run within 5 days of first testing. The clinical performance comparison between NeuMoDx SARS-CoV-2 assay, Simplexa Covid-19 Direct assay, and the modified CDC SARS-CoV-2 assay showed an overall agreement of 100%. ./cache/cord-319864-t6ql9hz2.txt ./txt/cord-319864-t6ql9hz2.txt