FTD SARS-CoV-2 Assay
For the specific detection of the coronavirus causing COVID-19
The FTD SARS-CoV-2 Assay1, which is intended for the initial diagnosis of the infection of the SARS-CoV-2 virus, is complemented by the portfolio of A1 Life Sciences‘ Diagnovital Research Use Only (RUO) kits. Diagnovital kits are designed to detect SARS-CoV-2 mutations and complement the Siemens Healthineers FTD SARS-CoV-2 Assay that is used as part of the initial diagnosis of COVID-19. Detection of mutations and subsequent identification of variants helps not only epidemiologists, but also helps support informed decision making about public health actions to control spread. Given the certainty that further mutations and variants will emerge, along with the uncertainty as to whether these variants will become Variants of Concern, the testing will be flexible and highly adaptable. With single-mutation formatted RUO assays, like those in the A1 Life Sciences’ Diagnovital portfolio, laboratories can select from individual assays to create their appropriate testing scheme based on mutations prevalent in their region. A1 Life Sciences’ Diagnovital portfolio, as distributed by Siemens Healthineers, will be offered for Research Use Only around the world.
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 new 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
- 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
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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.