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.
We continue to monitor 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. This includes:
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.
Predicted Impacts of Variants of Public Interest as of March 15, 2023
View Full TablePredicted Impacts of Variants of Public Interest as of March 15, 2023
WHO Label1 |
Pango Lineage |
cobas® SARS-CoV-2 for use on the cobas® 6800/ 8800 Systems |
cobas® SARS-CoV-2 Qualitative for use on the cobas® 6800/ 8800 Systems |
cobas® SARS-CoV-2 & Influenza A/B Tests for use on the cobas® 6800/ 8800 Systems |
cobas® SARS-CoV-2 Duo Test on the cobas® 6800/8800 Systems |
cobas® SARS-CoV-2 & Influenza A/B Test for use on the cobas® Liat® System |
cobas® SARS-CoV-2 Test for use on the cobas® Liat® System |
GenMarkDx ePlex® Respiratory Pathogen (RP2) Panel 2 |
Omicron4 | B.1.1.529 | Detected2 | Detected | Detected2 | Detected2 | Detected2 | Detected2 | Detected2,3 |
As of March 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:
Serological Antibody Assays Run on Elecsys® e Analyzers
View Full TableSerological Antibody Assays Run on Elecsys® e Analyzers
WHO Label |
Elecsys® Anti-SARS-CoV-2 Assay |
Elecsys® Anti-SARS-CoV-2 S Assay |
Omicron | Not affected | Not affected5 |
5. 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.
For additional insights on variants and how Roche vigilantly monitors to protect patients, read this article by two of our medical diagnostics experts.
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].