RealStar®SARS-CoV-2 RT-PCR Kit U.S.*

The RealStar ® SARS-CoV-2 RT-PCR Kit U.S.* is authorized for a workflow consisting of nucleic acid extraction using the AltoStar ® Automation System AM16 in combination with the AltoStar ® Purification Kit 1.5 and the AltoStar ® Internal Control 1.5, followed by the amplification and detection of SARS-CoV-2 specific RNA using the RealStar ® SARS-CoV-2 RT-PCR Kit U.S.*. Specifications Sample types Nasopharyngeal swabs Oropharyngeal (throat) swabs Anterior nasal swabs Mid-turbinate nasal swabs Nasal washes Nasal aspirate For use with CFX96™ Touch Real-Time PCR Detection System CFX96™ Touch Deep Well Real-Time PCR Detection System Please remark 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 declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests 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 Any adverse events should be sent to the following e-mail address: support@altona-diagnostics.com