Detecting Coronavirus Variants with Roche Assays

Variants of the virus that causes COVID-19 continue to make news. Here's what to know about our tests.

November 14, 2023


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 and XBB sublineages were recently evaluated:

  • BA.2.86 ("Pirola")
  • BA.2.75 lineages

CH.1.1 [Sublineages: CH.1.1.1, CH.1.1.2, CH.1.1.3, CH.1.1.4, CH.1.1.5, ...]

  • XBB.X lineages

XBB.1.16 [Sublineages: FU.1, FU.2, XBB.1.16.1, XBB.1.16.2, XBB.1.16.3, ...]

XBB.1.5 . X [Sublineages: EK.1, EK.2, EK.2.1, EK.3, EK.4, EL.1, EM.1, ...EU.1,…XBB.1.5.29 , ...]

XBB.1.9 [Sublineages: EG.1, EG.1.1, EG.1.2, EG.1.3, EG.1.4, EG.5.1 (“Eris”), HV.1 ,…]

XBB.2.3 [Sublineages: GE.1, GJ.1, GJ.1.1, GJ.2, GM.1, ...]

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.

Molecular assays

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:

  • cobas® SARS-CoV-2 and cobas® SARS-CoV-2 & Influenza A/B for use on cobas® 6800/8800 systems 
  • cobas SARS-CoV-2 and cobas SARS-CoV-2 & Influenza A/B for use on cobas® liat systems
  • GenMarkDx® ePlex Respiratory Pathogen Panel (RP2 Panel)

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 September 9, 2023

View Full Table

Predicted Impacts of Variants of Public Interest as of September 9, 2023


WHO Label
Pango Lineage
cobas® 6800/8800 Systems
cobas® liat systems
GenMark® ePlex System
    cobas® SARS-CoV-21 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 Respiratory Pathogen (RP2) Panel 21
Omicron4 B.1.1.529 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 September 9, 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:

  • Elecsys® Anti-SARS-CoV-2 assay
  • Elecsys® Anti-SARS-CoV-2 S assay

Impact of variants on antibody assays run on Elecsys® e analyzers

View Full Table

Impact of variants on 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 affected4

4. 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].

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