As the nebulous omicron variant of COVID-19 springs up in headlines and rears its head in various locations, diagnostic companies are scrambling to discover whether the performance of their screening tests will be affected by the new mutation. Many leaders in this space, such as Qiagen, Cue Health, Co-Diagnostics, Abbott, and Thermo Fisher Scientific, have conducted internal evaluations of their screeners and indicated that existing tests will suffice for omicron detection. Conversely, Eurofins and a few other test makers have outlined plans to develop and release omicron-specific testing kits.
The rise of COVID-19 variants in the past year led the FDA to issue a warning to healthcare professionals that diagnostic accuracy might flag if mutation were to take place within the specific areas of the RNA used by a molecular test to produce a positive result. Tests can be safeguarded against this pitfall by using samples from multiple regions of the virus' genetic code concurrently.
The World Health Organization is recommending an early proxy method for tracing positive samples back to the omicron strain. This is achieved through observing the interaction of tests with one particular mutation, a deletion in the string of genes comprising the spike protein, which was identified in the alpha variant. Thermo Fisher, whose test examines three different areas of the virus' genetic makeup, said that spike protein mutations inevitably render one of the results a failure, while the remaining return positive. Though full sequencing is necessary for confirmation, this pattern implies an omicron infection.
