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Emergent SARS-CoV-2 Variants

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 615,377 complete sequences for the ORF1ab target and 614,467 complete sequences for the N gene target of SARS-CoV-2 from the GISAID database (www.gisaid.org).

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.

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. 

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
PANGO Lineage/ Variant Name
Country Where First Emerged
B.1.1.7 (20I/501Y.V1, GR/501Y.V1 or VOC-202012/01)
U.K.
B.1.351 (20H/501.V2, GH/501Y.V2 or VOC-202012/02)
South Africa
P1 (20J/501Y.V3, GR/501Y.V3 or VOC-202101/02)
Brazil
B.1.429 and B.1.427 (GH/452R.V1 or 20C/S:452R)
California
B.1.525 (G/484K.V3 or VUI-202102/03)
UK and Denmark
VOC-202102/02 B.1.1.7 with E484K
UK
VUI-202102/01 A.23.1 with E484K
UK
B.1.526 and B.1.525 (20C)
New York
P.2 (20J or VUI-202101/01)
Brazil
B.1.1.318 (VUI-202102/04)
U.K.

B.1.616 (20C)

France

B.1.617 (G/452R.V3)

India

P.3

TBC*

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2

3