As the SARS-CoV-2 is continuously mutating and multiple SARS-CoV-2 variants are circulating globally, Siemens Healthineers has an active surveillance program in place. We continue to monitor the literature and the GISAID database to assess for new variants with the potential to affect the performance of the FTD SARS-CoV-2 Assay.1
This update is based on in silico analysis from January 2, 2022 of 7,071,613 complete sequences for the ORF1ab target and 7,070,040 complete sequences for the N gene target of SARS-CoV-2 from the GISAID database (www.gisaid.org).
Variants list and country of origin regarding SARS-CoV-2
Main variants and clades that have been confirmed as detected2
Country/ region of origin
Variants of Concern (VOC)
21A, 21I, 21J
B.1.1.529 + BA.x.†
21K, 21L, 21M
Variants of interest (VOI)3
Variants Under Monitoring (VUM)
†Omicron also includes all descendent Pango lineages BA.x, including BA.1, BA.1.1, BA.2 and BA.3 (reference: https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/ and https://www.epicov.org/)
Variant Testing Workflow
Omicron Positive Identification Reflex Testing Workflow
Eluates of positive SARS-CoV-2 samples are reflex-tested with Diagnovital L452R (RUO)4 and Diagnovital K417N (RUO)4 assays to help discriminate between Delta variant and Omicron variant suspected samples.
Click through the graphic below to learn more.
Collaboration with A1 Life Sciences to Track Variants
Now offering A1 Life Sciences' Diagnovital kits
Diagnovital kits are designed to detect and identify SARS-CoV-2 mutations and variants. The portfolio of A1 Life Sciences‘ Diagnovital kits will complement the FTD SARS-CoV-2 Assay, which is intended for the initial diagnosis of the infection. A1 Life Sciences’ Diagnovital portfolio, as distributed by Siemens Healthineers, will be offered for Research Use Only around the world.
SARS-CoV-2 Mutation Profiling
Since the beginning of the pandemic, SARS-CoV-2 has continued to mutate, resulting in genetic variations in the population of circulating strains of the virus. A new variant of SARS-CoV-2 may have one or more mutations that differentiate it from the predominant virus variants already circulating in the population.
This table shows the major amino acid substitutions in the Spike protein for the variants of concern (VOC), variants of interest (VOI), and other variants under monitoring.
FTD SARS-CoV-2 Assay regulatory status and reaction sizes
The FTD SARS-CoV-2 Assay has been confirmed to detect the main variants and clades of SARS-CoV-2 that are currently circulating with a 100% detection rate.
Siemens Material Number
FTD SARS-CoV-2 Assay - CE-IVD (32 reactions)
FTD SARS-CoV-2 Assay - CE-IVD (96 reactions)5
FTD SARS-CoV-2 Assay EUA1 (96 reactions)5
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CE-IVD labelled for diagnostic use in the EU. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Data on file at Fast Track Diagnostics, A Siemens Healthineers Company, Luxembourg. Data current as of May 2021.
The Epsilon, Zeta and Theta variants are no longer considered VOI by the WHO (https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/).
Research use only (RUO), not for use for clinical or diagnostics purposes.
88 reactions, when automated on the VERSANT kPCR Molecular System.