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.

December 9, 2022

From delta to omicron to the next variant of the virus that causes COVID-19, Roche Diagnostics regularly investigates the impact of mutations of SARS-CoV-2. As new variant strains emerge, we are committed to ensuring our tests perform as expected. 

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.

The Pilot COVID-19 At-home Test is not expected to be impacted by BA.275. Further testing for analytical sensitivity is currently planned by our partner and manufacturer using heat-inactivated virus samples of BA.4 & BA.5. 

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 cobas® 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.

Variants of Public Interest as of November 15, 2022 (including Omicron BA.4 & BA.5)

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Variants of Public Interest as of November 15, 2022 (including Omicron BA.4 & BA.5)

World Health Organization (WHO) labeled*
Country First Detected
Pango Lineage
Nextsrain Clade
cobas® SARS CoV-2 for use on the cobas® 5800/6800/8800 Systems
cobas® SARS  CoV-2 & Influenza A/B Tests for use on the cobas® 5800/6800/880 0 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
GenMarkDxePlex® Respiratory Pathogen (RP2) Panel 2
Alpha
UK B.1.1.7 20I detected detected detected detected detected
Beta South Africa B.1.351 20H detected detected detected detected detected
Gamma

Japan/Brazil

P.1 20J detected detected detected detected detected
Delta India B.1.617.2 21A,I,J detected detected detected detected detected
Eta Africa B.1.525 21D detected detected detected detected detected
Iota USA B.1.526 21F detected detected detected detected detected
Lambda Peru C.37 21G detected detected detected detected detected
Mu Colombia B.1.621 21H detected detected detected detected detected
Omicron (BA.1 - BA.5)**

South Africa

B.1.1.529

21K,L,M

22A, B, C

detected detected detected detected detected

* 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. 
 

**Includes recently reported Omicron sub-lineages BA.2.75.2, BQ.1 (alias of BA.5.3.1.1.1.1.1, or BE.1.1.1.1), BQ.1.1, XBB (a recombinant between BJ.1 and BA.2.75), BM.1.1.1 (alias of BA.2.75.3.1.1.1 ), BA.4.4, BF.7 (BA.5.2.1.7) and BJ.1 (alias of BA.2.10.1.1). No problems are anticipated. Additional sequences of BA.2.12.1, BA.2.75, BA.4, BA.4.6 and BA.5 were also analyzed with no new concerns.

These recombinants don't impact our assay targets, and we haven't identified any issues with detection. 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. 

Roche has analyzed the published sequences of the SARS-CoV-2 variants of concerns 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

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Serological Antibody Assays Run on Elecsys® e Analyzers

World Health Organization (WHO) labeled*
Country First Detected
Elecsys Anti-SARS-CoV-2 assay
Elecsys Anti-SARS-CoV-2 S assay
Alpha UK not affected not affected
Beta South Africa not affected not affected
Gamma

Japan/Brazil

not affected not affected
Delta India not affected not affected
Eta Africa not affected not affected
Iota USA not affected not affected
Lambda Peru not affected not affected
Mu Colombia not affected not affected
Omicron

South Africa

not affected under investigation***

*** At this time, Roche cannot provide an estimation on how the Elecsys Anti-SARS-CoV-2 S assay will perform with the SARS-CoV-2 omicron variant. As soon as experimental evidence regarding the effect of the omicron variant on assay performance has been generated, these results will be shared. 

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].