First diagnostic test for zika virus accepted by WHO

23-Aug-2016 - Germany

WHO has accepted the first Zika virus Diagnostic test eligible for procurement agencies and Member States. The RealStar® Zika virus RT-PCR Kit 1.0 manufactured by altona Diagnostics was assessed under the Emergency Use Assessment and Listing Procedure (EUAL) opened to candidate in vitro diagnostics (IVDs) intended for Zika virus diagnosis in February 2016.

A public report with additional details about the WHO Emergency Use Assessment and Listing for RealStar® Zika Virus RT-PCR Kit 1.0. can be obtained via the link on the right side.

The EUAL procedure is an emergency quality assessment mechanism established by WHO during the 2014 Ebola Virus Disease outbreak. It was developed to expedite the availability of IVDs needed in public health emergency situations, based on a minimum set of available quality, safety, and performance data and an agreed plan for further evaluation.

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Topic world Diagnostics

Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.

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Topic world Diagnostics

Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.

10+ products
4 whitepaper
10+ brochures