Assessment of the Analytical Sensitivity of 10 Lateral Flow Devices against the SARS-CoV-2 Omicron Variant
Joshua M. Deerain, Julian Druce, Thomas Tran, Mitchell Batty, Yano Yoga, Michael Fennell, Dominic E. Dwyer, Jen Kok, Deborah A. Williamson
Abstract
Timely and accurate diagnostic testing is a critical component of the public health response to coronavirus (CoV) disease 2019 (COVID-19). Antigen (Ag) tests are used widely in many countries to provide rapid, economical, and accessible point-of-care testing (1). The vast majority of antigen tests detect nucleocapsid (N) protein, a structural protein that displays less variation than the spike (S) protein across different severe acute respiratory syndrome (SARS)-CoV-2 lineages. Although antigen tests are less sensitive than reverse transcription-PCR (RT-PCR) tests, their ability to quickly detect individuals with high viral loads provides clinical and public health utility in many countries, including Australia, where antigen tests have recently been approved for self-testing (2). As new variants arise, including the recent SARS-CoV-2 Omicron variant, it is essential to rapidly assess the performance of diagnostic assays. Here, in order to assess and compare the abilities of antigen tests to detect the Delta and Omicron variants, we performed a rapid assessment of 10 commercially available antigen tests.