id author title date pages extension mime words sentences flesch summary cache txt cord-335077-ievtvhge Hogan, Catherine A. Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens 2020-07-23 .txt text/plain 2217 115 52 The performance of the Accula test was assessed by comparing results of 100 nasopharyngeal swab samples previously characterized by the Stanford Health Care EUA laboratory-developed test (SHC-LDT), targeting the envelope (E) gene. The aim of this study was to evaluate the test performance characteristics of the Accula SARS-CoV-2 test in a clinical setting against a high-complexity reference standard. The manufacturer's instructions comprise the following steps: collection of NP swab, lysis of viral particles in SARS-CoV-2 buffer, transfer of nucleic acid solution to a test cassette that contains internal process positive and negative controls, reverse transcription of viral RNA to cDNA, nucleic acid amplification, and detection by lateral flow. We included 100 samples (50 positive, 50 negative) previously tested by the SHC-LDT and subsequently tested with the Accula SARS-CoV-2 POCT. In individuals with moderate to high pretest probability of SARS-CoV-2, reflex testing of negative samples on a separate EUA assay should be performed. ./cache/cord-335077-ievtvhge.txt ./txt/cord-335077-ievtvhge.txt