Contribution

The consortium has expertise in diagnostic assay validation, including validation of CSF diagnostic assays. Two partners (P1 and P9) participated in a previous FAIR project (“Control of classical swine fever by molecular diagnosis and epidemiology”, FAIR-CT95-707) where series of ring tests were performed in six European laboratories as reported by Paton et al. (2000a, b). Five partners (P1, P2, P3, P5, P6) work together in project “Development, standardisation and harmonisation of novel multiplex nucleic acid tests for the detection of economically important viruses of farm animals”, QLK2-CT-2000-00486. This project aims the multiplex PCR detection of eight viruses of swine (www.multiplex-eu.org), including OIE List A viruses FMDV, CSFV, ASFV, VSV, SVDV. The project, which was finished in February 2004, yielded a number of articles on new PCR diagnostic methods, published in peer-reviewed international journals. Further papers on standardisation and validation, including ring tests are in preparation.

Partners have reached OIE Stages 1, 2 and 5 during their diagnostic developments (Belák and Thorén, 2001) and this development will be continued in this project. To assure the reliability of the diagnostic PCR assays, other nucleic-acid-based diagnostic techniques, ELISA methods, as well as the pen-side tests developed in this project, the consortium is planning to standardise the assays by following the EU standards outlined in: General requirements for the competence of testing and calibration laboratories (EN ISO/IEC 17025:2000). The validation process, routines employed and test results will be documented and finally a statement will be made by describing the suitability of the tests for direct and/or indirect virus detection. Special attention will be focused on the following parameters: a) LoD (Level of Detection); b) Linearity of the method; c) Reproducibility; d) Repeatability; e) Robustness. During this process we have to be aware that until quite recently proper schemes for the validation of diagnostic PCR assays have neither been formulated nor used in veterinary virology. The OIE has modified and adapted this general standard to the special conditions that apply in the veterinary field.