Search

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.

April 11, 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.

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.

 

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 March 15, 2023

View Full Table
close

Predicted 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
  1. These variants had sequences deposited in the GISAID database in the past week. They reflect sequences in circulation. Strains out of circulation have been removed for clarity but have been described in prior memos. All variants have been assessed by in-silico analysis and all molecular tests are predicted to detect them. 
  2. Products are under Emergency Use Authorization.
  3. The latest XBB.1.5 variants contain mutations in the N gene which could have an impact on the performance of the ePlex RP2 Panel. The likelihood of an impact is small, but investigations are ongoing to determine the risk of a false negative detection.
  4. Includes the following currently circulating variants and sublineages: B.1.1.529 [Sublineages: BA.1, BA.1.1, BA.1.1.1, BA.1.1.2, BA.1.1.3,...XBB.1.16, XBB 1.9.1, XBB 1.9.2; this includes analysis of the T28297C mutation], XBB.1.5 [Sublineages: EK.1, EK.2, EL.1, EM.1, XBB.1.5.1,...], CH.1.1 [Sublineages: CH.1.1.1, CH.1.1.2, CH.1.1.3, CH.1.1.4, CH.1.1.5,...], BA.2.75 [Sublineages: BA.2.75.1, BA.2.75.2, BA.2.75.3, BA.2.75.4, BA.2.75.5,...], BA.5 [Sublineages: BA.5.1, BA.5.1.1, BA.5.1.2, BA.5.1.3, BA.5.1.4,...], BQ.1 [Sublineages: BQ.1.1, BQ.1.1.1, BQ.1.1.2, BQ.1.1.3, BQ.1.1.4,...], BQ.1.1, XBB.1.

Immunoassays

 

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:

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

Serological Antibody Assays Run on Elecsys® e Analyzers

View Full Table
close

Serological 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].