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.
Siemens Material Number
FTD SARS-CoV-2 Assay - CE-IVD (32 reactions)
FTD SARS-CoV-2 Assay - CE-IVD (96 reactions)2
FTD SARS-CoV-2 Assay EUA3 (96 reactions)2
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.
Country/ region of origin
Variants of Concern (VOC)
Variants of interest (VOI)*
*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/).
Data on file at Fast Track Diagnostics, A Siemens Healthineers Company, Luxembourg. Data current as of May 2021.
88 reactions, when automated on the VERSANT kPCR Molecular System
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.