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 summary, we have evaluated four molecular in vitro diagnostic assays for the qualitative 314 detection of SARS-CoV-2 in nasopharyngeal specimens. The data from our evaluation suggest that the 315 modified CDC, DiaSorin Molecular, Hologic and GenMark assays performed similarly (κ ≥ 0.96) and that all 316 but the CDC assay can function in a sample-to-answer capacity. The GenMark assay, however, was less 317 sensitive and had a higher LoD than both the DiaSorin Molecular and Hologic assays. When considering 318 the design of all four assays, differences that could affect assay performance could include characteristics 319 such as input volume of initial specimen, RNA purification and elution volume differences, and overall 320 differences in gene targets. The DiaSorin Molecular platform has lower testing volume capability 321 compared to the Hologic assay (8 specimens/disc run vs. 120 specimens loaded at once), but has a faster 322 TAT and less reagent/sample preparation. All of these parameters, along with patient care needs, may 323 All rights reserved. No reuse allowed without permission. author/funder, who has granted medRxiv a license to display the preprint in perpetuity.