NR AWBC
AU anonym
TI WHO TSE reference materials (Importance of standardized refrence materials)
QU International Conference - Prion 2006: Strategies, advances and trends towards protection of society - 3.10.-6.10.2006, Torino, Italy, Lingotto Conference Centre - Oral sessions ORAL-46B
PT Konferenz-Vortrag
AB At several WHO TSE Consultations (1), issues related to the development of TSE Reference Materials in general and TSE Blood Reference Materials in particular have been discussed. WHO CJD brain-derived Reference Materials have been prepared (2). The preparations are maintained and distributed by the National Institute of Biological Standards (NIBSC), a WHO Collaborating Centre for Biological Standards. Several groups recently claimed to have developed promising and even partially validated bloodbased methods to identify animals infected with TSE agents during incubation period and humans with CJD. Some of those tests may be presented for regulatory review, requesting marketing authorization from national regulatory authorities. WHO has been asked to take a leading role in developing TSE Blood Reference Materials suitable to evaluate blood-based TSE diagnostic tests and screening tests for donors of blood and tissues. Materials to evaluate blood-based tests of animal TSEs important for human health would also be useful. As for other reference materials, a TSE Blood Reference Material need not be offered as a working reagent for test developers but as a calibrant to prepare in-house reference materials. Reference materials can also be suitable to assemble panels of replicate TSE-derived and control materials (in dilutions) coded and randomized. Both the original TSE Blood Reference Materials and the panels would be intended for preliminary characterization in international collaborative studies, just as the TSE Brain Reference Materials were studied previously. Any suitable biological reference material should be available in sufficient quantity to allow comparison of performance characteristics of candidate tests at a global level. If this effort proceeds, WHO would consider reconvening the WHO Working Group on TSE Reference Materials to assist in coordinating the selection of TSE materials and organizing international collaborative studies. References: (1) WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies: www.who.int/bloodproducts/tse/en (2) Proposal to establish WHO Reference Reagents for in vitro assays of CJD specimens. WHO/BS/03.1965 Rev.1: www.who.int/bloodproducts/tse/en
SP englisch
PO Italien