Lakeside School and Fidalab, the medical company providing testing for our community, are closely monitoring reports about new strains of COVID-19. The Fidalab medical team is confident that the latest genetic variants are not a threat to the test that we use for detecting COVID-19.
In this article by the U.S. Food and Drug Administration (FDA), the "Impact of Genetic Variation on Diagnostic Tests" is discussed. The research indicates that molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target. The article goes on to describe the three tests that have been authorized under emergency use authorization (EUA) guidelines:
Accula SARS-CoV-2 Test
Linea COVID-19 Assay Kit
TaqPath COVID-19 Combo Kit
The important thing to note is that the Accula test detects only one of the target variant gene and the Linea test detects only two of the target variant genes. FidaLab uses the TaqPath, which detects three of the target variant genes — making it the most reliable of all the EUA tests available.
The article indicates that "The FDA continues to monitor the effects of different variants on authorized molecular tests for the detection of SARS-CoV-2 and will update clinical laboratory staff and health care providers accordingly." Should the FDA deem any test insufficient for future changes in the molecular structure of the virus, Fidalab will be notified and Lakeside testing updated accordingly.
As we move forward, Lakeside will continue to consult with Lakeside’s Medical Advisory Board, Fidalab, and Public Health – Seattle & King County.