INDICAID’S Omicron Variant Update

Phase Scientific continuously monitors emerging variants of the virus that causes COVID-19 and how their mutations may impact the performance of the INDICAID COVID-19 Rapid Antigen test. A sub-variant of Omicron designated BA.2 (B.1.1529.2) was detected in the U.S. in January 2022, and the Centers For Disease Control (CDC) recently estimated that BA.2 represents more than 50% of all new COVID-19 infections in the U.S.

An independent evaluation by the National Institutes of Health (NIH) RADx Variant Task Force has determined that the INDICAID COVID-19 Rapid Antigen Test detects the Omicron variant B.1.1.529 and Omicron sub-variant BA.2 (B1.1.529.2) in live clinical samples.

Phase Scientific has also performed in-house analytical testing for the detection of Omicron sub-variant nucleocapsid (N) protein. Limiting dilution studies of recombinant N protein from the Omicron sub-variants listed in the table below demonstrated that the INDICAID test achieves a similar level of detection compared to that of the original strain of SARS-CoV-2.

Furthermore, Phase Scientific has performed in-house analytical testing for the detection of Omicron nucleocapsid (N) protein. A limiting dilution study of recombinant N protein derived from Omicron sub-variants BA.1 (B.1.152.1) and BA.2 (B.1.1.529.2) demonstrated that the INDICAID text achieves a similar level of detection for both Omicron N protein sub-variants compared to the N protein derived from the original strain of SARS-CoV-2.

Taken together, both our in-house analytical testing and the independent, evaluation by the RADx Variant Task Force suggest that the mutations identified in the Omicron variant are unlikely to impact INDICAID test performance.

Felix Chao
VP, Americas General Manager