INDICAID COVID-19 Rapid Antigen Test Detects Omicron Variant B.1.1.529 & Sub-Variant BA.2 (B.1.1.529.2)News
May 24, 2022
Updated May 24TH, 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 nucleocapsid (N) protein. A limiting dilution study of recombinant N protein from BA.1 (B.1.1.529.1) and BA.2 (B.1.1.529.2) demonstrated that the INDICAID test achieves a similar level of detection for both Omicron N protein sub-variants compared to that of the original strain of SARS-CoV-2.
The recent emergence of the BA.2.12.1, BA.3, and BA.5 are not expected to have an impact on the INDICAID test’s performance as these sub-lineages share the same N protein sequence as BA.2.
Taken together, our in-house testing and the independent evaluation by the RADx VTF suggest that the N protein mutations of the Omicron sub-variants B.1.1.529, BA.1, BA.2, BA.2.12.1, BA.3 and BA.5 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 HIH RADx|
|BA.2.1.12||No impact||In-house wet-testing with recombinant N protein|
|BA.3||No impact||In-house wet-testing with recombinant N protein|
|BA.4||98.1% sequence homology||In-house wet-testing on-going|
|BA.5||No impact||In-house wet-testing with recombinant N protein|
VP, US General Manager