First Diagnostic Test for Ebola Accepted by WHO

WHO has accepted the RealStar^® Filovirus Screen RT-PCR Kit 1.0 as first Ebola in vitro diagnostic test for procurement by United Nations and other partners to Ebola affected countries. It was assessed under an emergency quality assessment mechanism established by WHO to identify assays that are appropriate for use in the outbreak setting of Ebola virus disease (EVD) in West and Central Africa, and to fast-track countries’ access to reliable testing options.

The RealStar^® Filovirus Screen RT-PCR Kit 1.0 allows the qualitative detection and differention of Ebolavirus and Marburgvirus specific RNA.The assay is designed to detect all human relevant filovirus species and Restonvirus. In addition, the RealStar^® Filovirus Screen RT-PCR Kit 1.0 includes a heterologous amplification system (Internal Control) to identify possible RT-PCR inhibition and to confirm the integrity of the reagents of the kit. It was developed and validated  with the following real-time PCR instruments: Mx 3005P™ QPCR System (Stratagene),Versant^® kPCR Molecular System AD (Siemens), ABI Prism^® 7500 SDS and 7500 Fast SDS (Applied Biosystems), LightCycler^® 480 Instrument II (Roche), Rotor-Gene™ 3000/6000 (Corbett Research), Rotor-Gene Q 5/6 plex Platform (QIAGEN), CFX96 system/Dx real-time system (Bio-Rad).

A public report with additional details about the nature of the Emergency Quality Assessment Mechanism for RealStar^® Filovirus Screen RT-PCR Kit 1.0. can be found at:

http://www.who.int/diagnostics_laboratory/procurement/purchasing/en

About altona Diagnostics GmbH
altona Diagnostics, founded 2007 in Hamburg, Germany, is focused on the development, approval, manufacturing and marketing of molecular diagnostic test systems for the detection and quantification of pathogens. altona Diagnostics is a fully integrated diagnostic company. The founders and staff of altona Diagnostics have a broad experience in molecular diagnostics and corresponding technologies. Among other activities, they were among the first to make reliable molecular diagnostic kit systems commercially available in Europe during outbreak situations for SARS, avian Flu, swine Flu and EHEC. altona Diagnostics is ISO 13485 certified.

RealStar^® (altona Diagnostics GmbH); ABI Prism^® (Applied Biosystems); LightCycler^® (Roche); QIAamp^® (QIAGEN); CFX96™(Bio-Rad).Registered names, trademarks, etc. used in this document, even if not specifically marked as such, are not to beconsidered unprotected by law.