Assessment of the analytical sensitivity of ten lateral flow devices against the SARS-CoV-2 omicron variant

Abstract

Timely and accurate diagnostic testing is a critical component of the public health response to COVID-19. Antigen 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 SARS-CoV-2 lineages. Although antigen tests are less sensitive than 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 emergence of the SARS-CoV-2 omicron variant, it is essential to rapidly assess the performance of diagnostic assays. Here, in order to assess and compare the ability of antigen tests to detect delta and omicron variants, we performed a rapid assessment of ten commercially available antigen tests.