COVID-19 variants

Emergent SARS-CoV-2 Variants

Discrimination of Omicron from Delta and other variants

Surveillance Program

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 of 11,428,775 complete sequences for the ORF1ab target and 11,418,035 complete sequences for the N gene target of SARS-CoV-2 from the GISAID database as of 17 July 2022 (www.gisaid.org). In addition, all available sequences for Omicron subvariants, including BF.1, BA.4.6, BA.2.3.20 and XBB, were downloaded from the GISAID database as of 13 October 2022.

Variants list and country of origin regarding SARS-CoV-2

WHO name

PANGO Lineage

GISAID clade

Nextstrain clade

Relationship to circulating
VOC lineages

Country/ region of first origin

Variants of Concern (VOCs)*

Omicron

B.1.1.529 + BA**

GR/484A

21K, 21L,
21M, 22A,
22B, 22C, 22D

N.A

Multiple Countries

VOC subvariants under monitoring***

/

BA.5

GRA

22B, 22E

BA.5 sublineages
(e.g., BF.7, BF.14, BQ.1)

South Africa

/

BA.2.75

GRA

22D

BA.2 sublineage

United States of America

/

BJ.1

GRA

21L

BA.2 sublineage
(B..2.10.1.1)

Multiple countries

/

BA.4.6

GRA

22A

BA.4 sublineage

Multiple countries

/

XBB

/

Recombinant

Recombinant of
BA.2.10.1 and BA.2.75
sublineages

/

/

BA.2.3.20

GRA

21L

BA.2 sublineage

/

Variant 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.

Diagnosis
 

SARS-CoV-2 Detection

Profiling
 

Mutation Profiling

Sequencing
(optional)

Complete Analysis of the Viral Genome

    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.

    a representation of covid-19 variants with viruses colored differently

    SARS-CoV-2 Mutation Profiling

    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.

    Product Description
    Siemens Material Number
    FTD SARS-CoV-2 Assay - CE-IVD (32 reactions)
    11416300
    FTD SARS-CoV-2 Assay - CE-IVD (96 reactions)5
    11416284
    FTD SARS-CoV-2 Assay EUA1 (96 reactions)5
    11416302
    1
    2
    4
    5