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Altona Zika Test Gets Emergency Use Authorization From Korean CDC

This article has been updated from a previous version which incorrectly stated that Altona's test was granted EUA by the Korean Food and Drug Administration.

NEW YORK (GenomeWeb) – The Korea Centers for Disease Control & Prevention has granted Emergency Use Authorization to a Zika test from Altona Diagnostics.

The RealStar Zika Virus RT-PCR Kit is a real-time reverse transcriptase PCR assay that detects Zika virus RNA in human serum and urine. It was previously granted EUA from the US FDA and has also been given prequalification status from the World Health Organization, facilitating procurement in low- and middle-income countries.

The kit can now be used in South Korean hospitals and commercial labs, Hamburg, Germany-based Altona noted in a statement.

Testing using the RealStar kit requires extraction using the QIAamp Viral RNA Mini Kit, followed by the amplification and detection using any of the following systems: Strategene (Agilent) Mx 3005PTM QPCR, Siemens Versant kPCR, Applied Biosystems (Life Technologies) ABI Prism 7500 SDS/Fast SDS, Bio-Rad CFX96TM or CFX96TM Deep Well, Roche LightCycler 480 Instrument II, Rotor-Gene 6000 from Corbett Research (Qiagen), or a Rotor-Gene Q 5/6 plex platform from Qiagen.

To date there have been about a dozen cases of Zika in South Korea, all in people who had recently returned from traveling. In Asia, Singapore is currently experiencing an outbreak of locally-transmitted cases, with 32 new cases confirmed today bringing the total to 189, and South Korea has issued travel warnings for Singapore.