Altona Zika Test Gets EUA From Korean FDA
News Sep 03, 2016
altona Diagnostics GmbH has announced that it has received Emergency Use Authorization (EUA) from the Korea Centers for Disease Control & Prevention (KCDC) for the RealStar® Zika Virus RT-PCR Kit 1.0. The real-time Reverse Transcriptase/Polymerase Chain Reaction (rRT-PCR) based nucleic acid test can be used under this authorization as a molecular diagnostic tool for the in vitro qualitative detection of RNA from the Zika virus in human serum or urine. The test performance for the use with serum and urine samples was validated by the Institute Pasteur de la Guyane, Cayenne, French Guiana.
The RealStar® Zika Virus RT-PCR Kit 1.0 is designed for a workflow consisting of nucleic acid extraction using the QIAamp® Viral RNA Mini Kit (QIAGEN) followed by the amplification and detection of Zika virus specific RNA using the RealStar® Zika Virus RT-PCR Kit 1.0 on a Mx 3005P™ QPCR System (Stratagene), VERSANT® kPCR Molecular System AD (Siemens), ABI Prism® 7500 SDS/Fast SDS (Applied Biosystems), CFX96™ Real-Time PCR Detection System or CFX96™ Deep Well Real-Time PCR Detection System (both from Bio-Rad), LightCycler® 480 Instrument II (Roche), Rotor-Gene® 6000 (Corbett Research) or Rotor-Gene® Q 5/6 plex Platform (QIAGEN).
The RealStar® Zika Virus RT-PCR Kit 1.0 is for use under KCDC Emergency Use Authorization (EUA) in Korean hospitals and commercial labs. The EUA for the RealStar® Zika Virus RT-PCR Kit 1.0 will be effective for one year.