Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection
Jimmykim Pham, Sarah Meyer, Catherine Nguyen, Analee Williams, Melissa Hunsicker, Ian McHardy, Inessa Gendlina, D. Goldstein, Amy S. Fox, Angela Hudson, Paul Darby, Paul Hovey, José María López Morales, James H. Mitchell, Karen Harrington, Mehrdad Majlessi, Joshua Moberly, Ankur Shah, Andrew Worlock, Marion Walcher, Barbara Eaton, Damon Getman, Craig B. Clark
Abstract
The COVID-19 pandemic caused by the new SARS-CoV-2 coronavirus has imposed severe challenges on laboratories in their effort to achieve sufficient diagnostic testing capability for identifying infected individuals. In this study, we report the analytical and clinical performance characteristics of a new, high-throughput, fully automated nucleic acid amplification test system for the detection of SARS-CoV-2. The assay utilizes target capture, transcription-mediated amplification, and acridinium ester-labeled probe chemistry on the automated Panther system to directly amplify and detect two separate target sequences in the open reading frame 1ab (ORF1ab) region of the SARS-CoV-2 RNA genome.