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.
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 assays. 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 May 15, 2022 (including Omicron BA.4 & BA.5)
View Full TableVariants of Public Interest as of May 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 |
|---|---|---|---|---|---|---|---|
| Alpha |
UK | B.1.1.7 | 20I | detected | detected | detected | detected |
| Beta | South Africa | B.1.351 | 20H | detected | detected | detected | detected |
| Gamma | Japan/Brazil |
P.1 | 20J | detected | detected | detected | detected |
| Delta | India | B.1.617.2 | 21A,I,J | detected | detected | detected | detected |
| Eta | Africa | B.1.525 | 21D | detected | detected | detected | detected |
| Iota | USA | B.1.526 | 21F | detected | detected | detected | detected |
| Lambda | Peru | C.37 | 21G | detected | detected | detected | detected |
| Mu | Colombia | B.1.621 | 21H | 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 |
* 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. All variants have been assessed by in silico (computer-based) analysis, and all molecular tests are predicted to detect them.
The terms “deltacron” and “deltamicron” are used to refer to delta x omicron recombinants. The WHO formally recognized the presence of these hybrids on March 9, 2022. Recombination events between delta and omicron and within omicron sub-lineages, BA.1 and BA.2, occur at different breakpoints. Confirmed recombinants have been given the designations X-letter (XA-XS). Some reports have indicated an increase in a BA.1 x BA.2 recombinant virus, and it's been assigned a Pangolin nomenclature of XE. It's important to note that this variant hasn't been escalated to a variant of concern by the UK, U.S., European Centre for Disease Prevention and Control (ECDC) or WHO. The break point for XE is in nsp3, and it has the spike gene from BA.2. Other recombinants are in circulation, but this is the most abundant. XD and XF are delta x omicron variants. Case numbers for XD and XF are lower than XE.
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].
