November 21, 2022
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.
An independent evaluation by the National Institutes of Health (NIH) RADx Variant Task Force has determined that the INDICAID® test detects the Omicron variant B.1.1.529 and Omicron sub-variant BA.2 (B.1.1.529.2) 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.
Taken together, our in-house testing and the independent evaluation by the RADx VTF suggest that the N protein mutations of currently circulating Omicron sub-variants, including recently identified BQ.1 and BQ.1.1, are unlikely to impact INDICAID® test performance.
A summary of the expected impact of the various Omicron sub-lineages on the INDICAID® test performance is presented in the table below.
Omicron Sub-lineage |
Expected Impact on INDICAID® Performance |
Method of Evaluation |
|---|---|---|
| B.1.1.529 | No impact | Independent evaluation by NIH RADx |
| BA.1 (B.1.1.529.1) | No impact | In-house wet-testing with recombinant N protein |
| BA.2 (B.1.1.529.2) | No impact | Independent evaluation by NIH RADx |
| BA.2.12.1 | No impact | In-house wet-testing with recombinant N protein |
| BA.3 | No impact | In-house wet-testing with recombinant N protein |
| BA.4 | No impact | In-house wet-testing with recombinant N protein |
| BA.5 | No impact | In-house wet-testing with recombinant N protein |
| BQ.1/BQ.1.1 | No impact | In-house wet-testing with recombinant N protein |
Felix Chao
VP, US General Manager