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Altona Diagnostics Gets CE-IVD Mark for Coronavirus Test Kit

NEW YORK — Altona Diagnostics said on Thursday that it has received CE-IVD marking for its PCR-based SARS-CoV-2 test kit.

The RealStar SARS-CoV-2 RT-PCR Kit is designed to detect lineage B-beta coronavirus- and SARS-CoV-2-specific RNA in human respiratory swabs, according to Altona. It uses the Hamburg, Germany-based company's AltoStar Automation System AM16 for nucleic acid extraction and purification, and runs on a variety of real-time PCR instruments.

Earlier this month, Altona received Emergency Use Authorization from the US Food and Drug Administration for its RealStar SARS-CoV-2 RT-PCR Kit US, which uses components chemically identical to the ones used in the CE-IVD-marked kit. 

Altona General Manager Markus Hess said in a statement that the company has ramped up production of the SARS-CoV-2 kit and has adapted it to increase the number of reactions per kit to 384.