Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens

Wei Zhen; Ryhana Manji; Elizabeth Smith; Gregory J Berry

In this study, we compared four different platforms for the detection of SARS-CoV-2 in patient 230 specimens collected during March and April of the 2020 COVID-19 outbreak in the United States. We were 231 able to make several observations, including LoD, overall workflow comparisons, and how each test 232 performed in a head-to-head clinical comparison. Accurate and actionable results have been at the core 233 of medical decision-making during this current outbreak, both in the inpatient and outpatient setting. Our data suggest that all four PCR methods yielded comparable results (κ ≥ 0.96); however, we 250 did observe a notable difference in the sensitivity of the methods during this large-scale evaluation of EUA 251 in vitro diagnostic assays. Our study showed that the DiaSorin Molecular and Hologic Fusion assays out-252 All rights reserved. No reuse allowed without permission. author/funder, who has granted medRxiv a license to display the preprint in perpetuity.