NEW YORK (GenomeWeb) – Altona Diagnostics said today that the RealStar Zika Virus RT-PCR Kit received approval from the Ministry of Food and Drug Safety of South Korea.
The assay is based on real-time reverse transcriptase PCR (RT-PCR) that will identify Zika in human serum or urine.
The company initially launched the kit in January 2016 as the first commercially CE-IVD marked qPCR Test for detecting Zika. Last fall, the Korea CDC granted Emergency Use Authorization for the test kit, allowing it to be used in South Korean hospitals and commercial labs.
Founded in Hamburg, Germany in 2007, Altona develops and commercializes qPCR-based assays and molecular diagnostic tests in the field of infectious diseases.