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Denge and other haemorhagic fevers

Development and comercial pro - duction of standardised PCR-assays for detection of haemorhagic fever viruses and variola virus and their implementation in the diagnostic service of EU P4 laboratories

EC contribution
: € 700 000
: 36 months
Starting date
: 01/01/2004
: CA
: viral haemorrhagic fever; variola virus; molecular diagnostics; PCR
Project Number
: SSP-CT-2003-502567


The main objective of the VHF/VARIOLA-PCR project was the development and distribution of a set of high-quality, standardised, and evaluated PCR-based detection methods for viral haemorrhagic fever (VHF) viruses and variola virus. The implementation of these assays in the diagnostic service of all existing European P4 laboratories established a laboratory infrastructure that can provide high-quality diagnostic services to all EU 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), prototypes of ready-to-use kits were developed by a small or medium-sized enterprise (SME). They will also be made available to experienced laboratories in Member States (e.g. those of the European Network of Imported Viral Diseases (ENIVD)) that do not have direct access to P4 facilities.

A different set of PCR assays was developed for confirmatory testing. These are not produced as a kit and are to be used mainly by the P4 laboratories. The development of these assays required 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. Significant attention was paid to demonstration activities and interlaboratory quality control measures to ensure that the novel technologies emerging from the project are implemented in high quality in the diagnostic service of all participating laboratories.

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