The problem

Recent terrorist attacks have exposed a number of security gaps in many countries. One potential problem is a general lack of preparedness against a possible bioterror attack, such as the release of number of viruses, such as the variola virus and those causing haemorrhagic fever. The clinical symptoms in the early stages of these viral infections are all very similar and resemble a flu-like illness. Early testing is, therefore, important to establish an accurate diagnosis, but existing diagnostic techniques are either not rapid enough, require high virus concentrations, or lack accuracy. 

Overview:

Polymerase Chain Reaction (PCR) assays can provide results more rapidly than existing diagnostic tests. The main objective of the VHF/Variola-PCR project is the development and distribution of PCR-based detection methods for viral haemorrhagic fever and variola viruses.

The project will:

• Develop PCR tests that can be commercially produced as ready-to-use kits intended as a first-line diagnostic tool in laboratories that do not have P4 containment facilities
• Develop a different set of PCR tests for confirmation testing by laboratories with P4 containment facilities
• Disseminate information on the availability of the PCR test kits

Contribution to policy development:

• VHF/Variola-PCR will deliver an improved laboratory detection service providing rapid diagnosis of viral agents that may be used as biological threats
• It will strengthen the laboratory infrastructure providing enhanced preparedness against potential bioterrorism
• It will provide an earlier alert to public health authorities to enable them to coordinate responses in the event of the deliberate release or accidental importation of the variola virus or haemorrhagic fever viruses

Project deliverables

• Development of first-line PCR assays – start July 2004, end March 2005
• Development of confirmatory PCR assays – start July 2004, end May 2006
• Commercial production of the PCR assays – start September 2004, end January 2006
• Production of training package – start November 2004, end February 2006

Dissemination

• Biannual meetings for strategic decisions
• Relevant results will be disseminated through the European Network of Imported Viral Diseases
• Scientific results will be published in appropriate journals
• Press releases will be used to inform the public – Ongoing

Technical information

Project acronym: VHF/VARIOLA-PCR
Project’s official full title: Development and commercial production of standardized PCR-assays for the detection of viral haemorrhagic fever viruses and variola virus and their implementation in the diagnostic service of EU P4 laboratories
Research priority: 2.7. Issues related to civil protection (including biosecurity and protection against risks arising from terrorist attacks), and crisis management
Specific webpage: Details not yet available
Proposal/contract no: 502567
Start date: 01/01/2004
Kick off meeting: 06/05/2004
Completion date: 31/12/2006
European Commission scientific officer: Paul Vossen (paul.vossen@ec.europa.eu)

Coordinator:
Name: Bernhard-Nocht-Institute for Tropical Medicine
Abbreviated Name: BNI
Address: Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany
Country: Germany
Tel: +49 (0)40/4 28 18 405
Fax: +49 (0)40/4 28 18 400
Website: http://www15.bni-hamburg.de/bni/bni2/neu2/

Partners

Name: Philipps-University of Marburg, Institute of Virology
Abbreviated Name: PUM
Country: Germany 

Name: Pasteur Institute, Unit of Biology and Emerging Viral Infections
Abbreviated Name: IP
Country: France 

Name: Health Protection Agency, Porton Down
Abbreviated Name: HPA Porton
Country: United Kingdom 

Name: Health Protection Agency, Colindale
Abbreviated Name: HPA Colindale
Country: United Kingdom 

Name: Swedish Institute of Infectious Disease Control
Abbreviated Name: SMI
Country: Sweden 

Name: Institute of Microbiology of the German Armed Forces
Abbreviated Name: InstMicro-BioBw
Country: Germany 

Name: Artus GmbH
Abbreviated Name: Artus
Country: Germany

Latest news

Project deliverables progress

• Development of first-line PCR assays – start July 2004, end March 2005
  • Assay comparison: completed
  • Assay selection for optimisation: ongoing
  • Lassa virus S gene (Demby) assay: target region sequencing ongoing
  • Ebola/Marburg L gene (A/B primer) assay: target region sequencing ongoing
  • Variola 14-kDa fusion protein gene: protocol completed
  • New World arenaviruses: protocol completed
• Development of confirmatory PCR assays – start July 2004, end May 2006
  • Lassa L gene assay: target region sequencing ongoing
  • Variola HA gene: protocol completed
• Commercial production of the PCR assays – start September 2004, end January 2006
  • Variola 14-kDa fusion protein gene: ongoing
• Production of training package – start November 2004, end February 2006
  • Variola 14-kDa fusion protein gene: planned Nov 2004, Hamburg (DE)

Dissemination progress

• Biannual meetings for strategic decisions
  • 6 May 2004 in Hamburg (DE)
  • 27 September 2004 in Lyon (FR)
  • Planned: March and September 2005, July and December 2006
• Relevant results will be disseminated through the European Network of Imported Viral Diseases
  • at ENIVD meeting 22 May 2004 in Ljubljana (SI)
• Scientific results will be published in appropriate journals
  • Olson VA, Laue T, Laker MT, Babkin IV, Drosten C, Shchelkunov SN, Niedrig M, Damon IK, Meyer H. Real-time PCR system for detection of orthopoxviruses and simultaneous identification of smallpox virus. J Clin Microbiol. 2004 May;42(5): 1940-6
  • Panning M, Asper M, Kramme S, Schmitz H, Drosten C. Rapid detection and differentiation of human pathogenic orthopox viruses by a fluorescence resonance energy transfer real-time PCR assay. Clin Chem. 2004 Apr;50(4): 702-8.
  • Niedrig M, Schmitz H, Becker S, Gunther S, ter Meulen J, Meyer H, Ellerbrok H, Nitsche A, Gelderblom HR, Drosten C. First international quality assurance study on the rapid detection of viral agents of bioterrorism. J Clin Microbiol. 2004 Apr;42(4): 1753-5.
• Press releases will be used to inform the public – Ongoing