altona Diagnostics receives Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for RealStar® SARS-CoV-2 RT-PCR Kit U.S.
The real-time Reverse Transcription/Polymerase Chain Reaction (RT-PCR) based molecular diagnostic test can be used under the EUA by authorized U.S. laboratories for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory samples from individuals, who are suspected of COVID-19. Details are shown in the respective official authorization documents published on our Product Page.
The RealStar® SARS-CoV-2 RT-PCR Kit U.S. is authorized to be used within 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 (altona Diagnostics) followed by amplification and detection of SARS-CoV-2 specific RNA with the CFX96™ real-time PCR instruments (Bio-Rad).
Letter of Authorization (Date of EUA issuance 2020-04-22)pdf