INDICAID's Effectiveness to Updated Omicron Variants
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|
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Test with INDICAID® Rapid Antigen Test
- Approved for use of 2 years and up (Ages 2-14 to be administered by an adult)
- FDA EUA Authorized
- 93.4% overall accuracy
- Able to detect COVID-19 virus variants (incl. Delta & Omicron)
- HSA/FSA Eligible