Bio-Rad has assessed our SARS-CoV-2 Diagnostic tests against the genetic mutations of the Omicron variant (B.1.1.529) and based on that assessment, Bio-Rad COVID-19 detection kits are unlikely to be impacted by Omicron variant.
This assessment was made using the Global Initiative on Sharing All Influenza Data (GISAID) database spanning from July 1, 2021 to November 22, 2021. An alignment with the oligonucleotide primer and probe sequences was performed against temporally and geographically representative nucleic acid sequences for SARS-CoV-2 in the GISAID database to demonstrate the predicted inclusivity of the assays. An evaluation of 2,377,146 SARS-CoV-2 sequences was used. Bio-Rad continues to monitor sequences as part of a regular surveillance program.
This applies to the following COVID-19 diagnostic tests:
Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kits:
- Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kit (12015361)
- Reliance SARS-CoV-2 Flu A Flu B RT-PCR Kit (IVD) (12016027)
Results confirmed no new mutations in the SC2 assay target region are present in the Omicron variant, thus the Omicron variant should have no impact on the assay performance.
Reliance SARS-CoV-2 RT-PCR Assay Kits:
- Reliance SARS-CoV-2 RT-PCR Assay Kit (12014115)
- Reliance SARS-CoV-2 RT-PCR Assay Kit (IVD) (12015534)
Results confirmed no new mutations in the N2 assay target region are present in the Omicron variant. There is one mutation in the region with homology to the N1 probe, which may attenuate the signal in the Hex channel. The risk of this mutation is predicted to be low; the thermal cycling and assay conditions have been optimized to tolerate one mismatch without impacting assay performance. In addition, a sample is considered to be positive if either SARS-CoV-2 marker (N1 or N2) cross the threshold line within 40 cycles.
SARS-CoV-2 Droplet Digital PCR (ddPCR) Test Kits:
- 2019-nCoV CDC ddPCR Triplex Probe Assay (12008202)
- SARS-CoV-2 ddPCR Kit (12013743)
- 2019-nCoV CDC ddPCR Triplex Probe Assay (12014779)
These ddPCR assays do not target the S region of the virus, a region highly susceptible to mutation. Results confirmed that mutations in the Omicron variant do not overlap the region targeted by these assays.