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Emergent SARS-CoV-2 Variants

Siemens Healthineers now offers A1 Life Sciences‘ Diagnovital kits, which 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, but will not be offered initially in the U.S.

As the SARS-CoV-2 is continuously mutating and multiple SARS-CoV-2 variants are circulating globally, Siemens Healthineers wants to assure you that we have 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. This update is based on in silico analysis of 2,423,090 complete sequences for the ORF1ab target and 2,419,688 complete sequences for the N gene target of SARS-CoV-2 from the GISAID database (www.gisaid.org).

FTD SARS-CoV-2 Assay regulatory status and reaction sizes:

The FTD SARS-CoV-2 Assay (Table 1) 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)2
11416284
FTD SARS-CoV-2 Assay EUA3 (96 reactions)2
11416302

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

Table 2 provides the details regarding the main variants and clades that have been confirmed as detected.1 As we consider this a high priority, we will continue to communicate updates for emerging variants and potential impact on the FTD SARS-CoV-2 Assay in a timely manner. 

WHO label

PANGO Lineage

GISAID clade

Nextstrain clade

Alternate name

Country/ region of origin

Variants of Concern (VOC)

Alpha

B.1.1.7

GR/501Y.V1

20I/501Y.V1

VOC-202012/01

U.K.

Beta

B.1.351

GH/501Y.V2

20H/501Y.V2

VOC-202012/02

South Africa

Gamma

P1

GR/501Y.V3

20J/501Y.V3

VOC-202101/02

Brazil

Delta

B.1.617.2

G/478K.V1

21A

/

India

Variants of interest (VOI)*

Eta

B.1.525

G/484K.V3

21D

VUI-202102/03

UK/Nigeria

Iota

B.1.526

GH/253G.V1

21F

/

New York

Kappa
B.1.617.1

G/452R.V3

21B

/

India

Lambda

C.37

GR/452Q.V1

20D

/

Peru

1

2

3