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Document › Details

Altona Diagnostics GmbH. (8/19/16). "Press Release: Altona Diagnostics Test for Zika Virus Accepted by WHO".

Region Region ALL
Organisations Organisation Altona Diagnostics GmbH
  Group Altona Diagnostics (Group)
  Organisation 2 WHO (World Health Organization)
  Group UN (United Nations)
Products Product RealStar® Zika Virus RT-PCR Kit 1.0
  Product 2 real-time PCR test (clinical diagnostics)
     


First Diagnostic Test for Zika virus accepted by WHO


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 found at:

http://www.who.int/diagnostics_laboratory/eual-zika-virus/zika/en/

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.


   
Record changed: 2016-09-14

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