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FTD Assay Performance

FTD SARS-CoV-2 AssayProduct Focus: Inclusivity & Sensitivity

Inclusivity

Product box labeled FTD SARS-CoV-2 Assay sits on a white table in a lab setting; there are drawers in the background

The FTD SARS-CoV-2 Assay is suitable for the detection of RNA from circulating SARS-CoV-2 variants.**

The FTD SARS-CoV-2 Assay* demonstrates excellent inclusivity based on a comprehensive in silico study.**

Since SARS-CoV-2 was first identified in China in December 2019, the COVID-19 pandemic has spread across the globe. This spread has led to an accumulation of mutations in the viral genome. It is very important that RT-PCR assays are able to detect circulating strains, including any emergent variants. FTD SARS-CoV-2 targets the highly conserved ORF1ab region and the N gene to minimize the potential for not being able to detect new mutations, variants, and strains of the virus.

Read the complete Product Highlight on inclusivity here

Analytical Sensitivity 

The FTD SARS-CoV-2 Assay shows excellent analytical sensitivity by Probit analysis. A precise comparison of the analytical performance, using a US FDA SARS-CoV-2 Reference Panel, shows that the FTD SARS-CoV-2 Assay using the VERSANT kPCR Molecular System® is a top performer among a large number of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2.†

Read the FDA Assessment study on the FTD SARS-CoV-2 Assay!

Molecular diagnostics and, in particular, RT-PCR technology, continues to be the gold standard for the clinical detection of SARS-CoV-2 RNA in individuals suspected of COVID-19.†† The FTD SARS-CoV-2 Assay from Siemens Healthineers can broaden the window of detection, reduce potential false negatives, and address low viral load with sensitive detection. A highly sensitive assay is essential for early and accurate diagnosis of COVID-19. The FTD SARS-CoV-2 Assay provides the high sensitivity needed for laboratories to play a role in combating the COVID-19 pandemic.

Read the complete Product Highlight on sensitivity here 

* CE-IVD labelled for 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.

** Internal data on file from FTD R&D.

† https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data

†† IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection. https://doi.org/10.1515/cclm-2020-1412, September 18, 2020