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.
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CE-IVD labelled for diagnostic use in the EU. Pursuing WHO emergency use listing (EUL). 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.