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.
WHO has evaluated the test under the emergency use assessment and listing procedure (EUAL), an emergency quality assessment mechanism created by WHO during the 2014 Ebola Virus Disease outbreak.
The EUAL procedure has been developed to speed up the availability of IVDs needed in public health emergency situations.
RealStar Zika Virus test enables qualitative detection of Zika virus specific RNA in human serum or urine after extraction of the viral RNA using Qiagen’s QIAamp viral RNA mini kit.
The Institute Pasteur de la Guyane, which is located in Pasteur de la Guyane of Cayenne, validated the performance of the test.
The limit of detection studies were conducted at the Bernhard-Nocht-Institute for Tropical Medicine (BNITM), a WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research.
Based in Hamburg of Germany, altona Diagnostics is engaged in the development and manufacturing molecular diagnostic test systems for the detection and quantification of pathogens related to human infectious diseases.
The company provided molecular diagnostic kits during outbreak situations of SARS, avian Flu, swine Flu, EHEC, MERS, and Ebolavirus.