FTD SARS-CoV-2 Assay
For the specific detection of the coronavirus causing COVID-19 using RT-PCR
The FTDTM SARS-CoV-2 Assay1 is a qualitative in vitro nucleic acid amplification test for the detection of severe respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in nasopharyngeal and oropharyngeal swabs of patients with signs and symptoms of SARS-CoV-2 infection in conjunction with clinical and epidemiological risk factors, who are suspected of Coronavirus Disease 2019 (COVID-19). The test is intended as an aid in the diagnosis of infections caused by the new human coronavirus SARS-CoV-2.
Clinical Use
Respiratory Testing
In late 2019, China notified the World Health Organization (WHO) of a novel strain of coronavirus. This virus, now named SARS-CoV-2, targets the epithelial cells of the respiratory tract and causes infection that can lead to Coronavirus disease 2019 (COVID-19). Siemens Healthineers automated molecular assay uses real-time PCR to detect RNA from this virus.
Emergent SARS-CoV-2 Variants
As part of our ongoing Global Surveillance Program, the FTD SARS-CoV-2 Assay1 has been shown to detect emergent SARS-CoV-2 variants.
Explore our dual-target design for the detection of SARS-CoV-2
Features & Benefits
- RT-PCR kit comprised of a single-well dual target assay for the specific detection of SARS-CoV-2 (COVID-19)
- Designed for high sensitivity, specificity, and inclusivity*
- Covers highly conserved regions within ORF1ab and N gene
- Uses the same assay setup protocol and thermal-cycling profile as all FTD respiratory disease kits
Product Focus
Product availability varies by country and is subject to local regulatory requirements.
*Data on file at Fast Track Diagnostics, A Siemens Healthineers Company, Luxembourg
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.