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Development and commercial production of standardized PCR-assays for detection of hemorrhagic fever viruses and variola virus and their implementation in the diagnostic service of EU P4 laboratories

Objective

The main objective of the project is the development and distribution of a set of high-quality, standardized, and evaluated PCR-based detection methods for variola virus and viruses causing hemorrhagic fever (VHP; Ebola virus, Marburg virus, Lassa virus and related South American arenaviruses, and CCHF virus). The implementation of these assays in the diagnostic service of all existing European P4 laboratories will establish a laboratory infrastructure that can provide high quality diagnostic services to all Member States. Furthermore, in order to facilitate wide distribution and safe handling of PCR assays for the most relevant viruses (variola virus, Ebola and Marburg viruses, Lassa virus, and CCHF virus), the assays will be produced by a company (SME) as ready-to-use kits. These assays are intended as a rapid first-line diagnostic tool. They will also be made available to experienced laboratories in Member States, for example those of the European Network of Imported Viral Diseases (ENIVD), which do not have direct access to P4 facilities. A different set of PCR assays shall be developed for confirmatory testing. These are not produced as a kit and are to be used mainly by the P4 laboratories. The development of the PCR assays requires the concerted action of all European laboratories experienced in handling and diagnosing VHF and pox viruses as well as of a company experienced in developing and producing PCR kits for infectious agents. The project is based on pooling of the resources available in all P4 laboratories (technologies, virus strains, human and animal samples) to optimise and evaluate the PCR assays. Great attention is paid to demonstration activities and inter-laboratory quality control measures to ensure that the novel technologies arising from the project will be implemented in high-quality in the diagnostic service of all participating laboratories.

Call for proposal

FP6-2002-SSP-1
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Funding Scheme

CA - Coordination action

Coordinator

BERNHARD NOCHT INSTITUT FUER TROPENMEDIZIN
Address
Bernhard-nocht-strasse 74
Hamburg
Germany

Participants (6)

PHILIPPS UNIVERSITY MARBURG
Germany
Address
Biegenstrasse 12
Marburg
INSTITUT PASTEUR
France
Address
Rue De Docteur Roux 28
Paris
HEALTH PROTECTION AGENCY
United Kingdom
Address
61 Colindale Avenue
London
SMITTSKYDDSINSTITUTET - SWEDISH INSTITUTE FOR INFECTIOUS DISEASE CONTROL
Sweden
Address
Nobels Väg 18
Solna
INSTITUTE OF MICROBIOLOGY OF THE GERMAN ARMED FORCES
Germany
Address
Neuherbergstrasse 11
Munich
QIAGEN HAMBURG GMBH
Germany
Address
Koeningstrasse 4 A
Hamburg