Transcription-mediated amplification test for SARS-CoV-2.

The Aptima SARS-CoV-2 assay utilizes magnetic bead-based target capture, isothermal TMA of RNA, and dual kinetic acridinium ester-labeled probe hybridization for the isolation, amplification, and detection of an internal process control RNA and two unique sequences within the ORF1ab region of the SARS-CoV-2 viral genome. The assay is performed on the automated Panther and Panther Fusion instruments (both from Hologic, Inc., San Diego, CA) and received FDA emergency use authorization (EUA) on 14 May 2020. It is intended for the qualitative detection of SARS-CoV-2 RNA isolated and purified from nasopharyngeal (NP) swab, nasal swab (NS), midturbinate and oropharyngeal (OP) swab, NP wash/aspirate, or nasal aspirate specimens obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria. The sample input volume is 0.5 ml with continuous sample and reagent loading access and automated RNA extraction, amplification, detection, and result reporting. The time to first result is 3 h and 30 min, with a capacity of approximately 1,025 results per 24 h per instrument system.