Altona Diagnostics Receives Emergency Use Authorization from US FDA for RealStar SARS-CoV-2 RT-PCR Kit US

Altona Diagnostics GmbH (Hamburg, Germany) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its RealStar SARS-CoV-2 RT-PCR Kit US.

The real-time Reverse Transcription/Polymerase Chain Reaction (RT-PCR) based molecular diagnostic test can be used under the EUA by authorized US laboratories for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory samples from individuals, who are suspected of COVID-19

The RealStar SARS-CoV-2 RT-PCR Kit US 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 from altona,s followed by amplification and detection of SARS-CoV-2 specific RNA with the CFX96 real-time PCR instruments from Bio-Rad.