Emergent SARS-CoV-2 Variants
Discrimination of Omicron from Delta and other variants
Surveillance Program
As the SARS-CoV-2 virus 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 the potential of new variants to affect the performance of both the FTD™ SARS-CoV-2 Assay1 and FTD SARS-CoV-2/FluA/FluB/HRSV Assay2.
This latest update is based on previous 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). More recently, all available sequences for XBB.1.5, BF.7 and BQ.1 were downloaded from the GISAID database as of 16 January 2023. In this analysis, 76,634 sequences were analyzed for the ORF1ab target, and 76,557 sequences were analyzed for the N gene target.
The FTD SARS-CoV-2 Assay and FTD SARS-CoV-2/FluA/FluB/HRSV Assay have both been confirmed to detect the main variants and clades of SARS-CoV-2 that are currently circulating. Our recent in silico analysis showed that all the analyzed sequences were detected with a 100% detection rate by both N gene and ORF1ab assays with a maximum of three mismatches. Due to the dual target design, at least one assay can detect a sequence with no mismatch. Therefore, the subvariants detection by the FTD SARS-CoV-2 Assay and FTD SARS-CoV-2/FluA/FluB/HRSV Assay shall not be affected or result in performance issues3.
Circulating SARS-CoV-2 variants and clades* detected by the FTD SARS-CoV-2 Assay and FTD SARS-CoV-2/FluA/FluB/HRSV Assay
*The full list of previous SARS-CoV-2 variants which are no longer classified as VOC, VOI or VUM by the WHO is available on the WHO website (see https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/).
**Includes BA.1, BA.2, BA.3, BA.4, BA.5 and descendent lineages. Also includes BA.1/BA.2 circulating recombinant forms such as XE.
Real-time PCR SARS-CoV-2 assays
The FTD SARS-CoV-2 Assay and FTD SARS-CoV-2/FluA/FluB/HRSV Assay have been confirmed to detect the main variants and clades of SARS-CoV-2 that are currently circulating with a 100% detection rate.
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CE-marked for in vitro 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.