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altona secures Korean EUA status for RealStar Zika virus test

MDBR Staff Writer Published 06 September 2016

German firm altona Diagnostics has received emergency use authorization (EUA) status from the Korea Centers for Disease Control & Prevention (KCDC) for its RealStar Zika Virus RT-PCR Kit 1.0 in vitro diagnostic test.

Under the authorization, the real-time reverse transcriptase/polymerase chain reaction (rRT-PCR) based nucleic acid test will be used as a molecular diagnostic tool for the in vitro qualitative detection of RNA from the Zika virus in human serum or urine.

The Institute Pasteur de la Guyane, which is located in Cayenne of French Guiana, has validated the frims Zika Virus test for use with serum and urine samples.

Under the test, the nucleic acid extraction will be carried out using the Qiagen’s QIAamp viral RNA mini kit.

Later, the amplification and detection of Zika virus specific RNA will be performed using the RealStar Zika Virus RT-PCR Kit 1.0 on Stratagene’s Mx 3005P QPCR system, Siemens Versant Ersant kPCR molecular system AD and Applied Biosystems’ ABI Prism 7500 SDS/Fast SDS.

The process can also be carried out on a Bio-Rad’s CFX96 real-time PCR detection system or CFX96 deep well real-time PCR detection system, Roche’s LightCycler 480 instrument II, Corbett Research’s Rotor-Gene 6000 and Qiagens’ Rotor-Gene Q 5/6 plex platform.

According to altona, the RealStar Zika Virus test is for use under EUA in Korean hospitals and commercial labs. It will be effective for one year.

In August, the World Health Organization (WHO) has accepted altona Diagnostics’ RealStar Zika Virus RT-PCR Kit 1.0 as in vitro diagnostic test.

The test has been listed by WHO as first in vitro diagnostic test, making it available for procurement agencies and member states.