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.
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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.†
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.