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Altona Diagnostics Zika Test Gains WHO Prequalification Status

NEW YORK (GenomeWeb) – Altona Diagnostics said today that its RealStar Zika Virus RT-PCR Kit 1.0 has been listed by the World Health Organization as eligible for procurement agencies and member states.

The designation enables Altona's test kits to be procured in certain low- and middle-income countries with global health donations earmarked for diagnostics.

Altona's assay was assessed under the Emergency Use Assessment and Listing Procedure, an emergency quality assessment mechanism established by WHO during the 2014 Ebola virus outbreak. The mechanism was developed to expedite the availability of in vitro diagnostics for public health emergencies.

The RealStar assay is designed to qualitatively detect Zika virus-specific RNA in human serum or urine after extraction of viral RNA using Qiagen's QIAamp Viral RNA Mini Kit, and can be run on a range of real-time PCR instruments.