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:
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)
View Full TableVariants 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:
Serological Antibody Assays Run on Elecsys® e Analyzers
View Full TableSerological 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].
