We regularly investigate the impact of mutations of SARS-CoV-2 on our molecular assays and immunoassays from the start of the pandemic until now. Our latest analysis includes currently circulating variants as identified in the SARS-CoV-2 (hCOV-19) Mutation Reports. In addition to variants reported in previous analyses, the following specific variants within the Omicron BA.2.86 lineage included:
As with prior updates, these variants continue to circulate and are being tracked. No problems are anticipated at this time. We will continue to perform routine surveillance of the evolution of SARS-CoV-2 variants and remain committed to providing laboratories with high-quality molecular and serology testing solutions that aid in diagnosing affected patients.
Based on our assay design and our global surveillance team’s in-silico (computer-based) analyses, we don’t anticipate impact on the performance of Roche SARS-CoV-2 molecular assays; therefore, no false negative results with any of our molecular SARS-CoV-2 test are anticipated.
We have great confidence that our original molecular test design, incorporating two targets that focus on regions of the virus that don’t tend to change, still holds up to all currently identified variants.
| WHO Label | Pango Lineage | cobas® 6800/8800 Systems | cobas® liat Systems | cobas® ePlex System | |||||
|---|---|---|---|---|---|---|---|---|---|
| cobas® SARS-CoV-2 | cobas® SARS-CoV-2 Qualitative | cobas® SARS-CoV-2 & Influenza A/B v21,2 | cobas® SARS-CoV-2 Duo Test1,3 | cobas® SARS-CoV-2 & Influenza A/B | cobas® SARS-CoV-2 | cobas® SARS-CoV-2, Influenza A/B, & RSV1 | Respiratory Pathogen Panel 2 (RP2)1 | ||
| Omicron4 | B.1.1.529 | Detected | Detected | Detected | Detected | Detected | Detected | Detected | Detected |
1. Product is under Emergency Use Authorization.
2. The cobas® SARS-CoV-2 & Influenza A/B v2 assay is an updated version of the cobas® SARS-CoV-2 & Influenza A/B assay. The SARS-CoV-2 assay design is identical between the two products.
3. The qualitative result of cobas® SARS-CoV-2 Duo (EUA) is intended for use as an aid in the diagnosis of SARS-CoV-2. This assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; quantitative values are for informational use only.
4. Includes recently reported Omicron sub-lineages as listed above. All variants listed in previous publications are still detected by all Roche molecular tests.
As of July 15, currently identified variants of public interest are not predicted to impact our immunoassays. Our surveillance team continues to follow this closely to understand where any novel breakpoints are and if there is a chance that any of the recombinant strains would have an impact on our assays.
The rapid antigen test, Pilot COVID-19 At-Home Test, is not impacted by any current circulating strains.
We have analyzed the published sequences of the SARS-CoV-2 variants of concern and compared the variant-specific mutations to the design of the following immunoassays:
WHO Label |
Elecsys® Anti-SARS-CoV-2 Assay5 |
Elecsys® Anti-SARS-CoV-2 S Assay5 |
| Omicron | Not affected | Not affected6 |
5. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA.
6. Wet lab testing indicates that the Elecsys® Anti-SARS-CoV-2 S Assay can detect the omicron variant. Arising sub-lineages to omicron will continue to be closely monitored.
This story may be updated. If you have additional questions about the performance of our tests, please contact Roche Diagnostics Corporation’s medical and scientific affairs team at [email protected].
