Measures for minimizing the risk of transmission of bovine spongioform encephalopathy (BSE) agent via veterinary medicinal products: The present governmental guidance and a perspective on the technical progress in the test for the BSE agent
2003
Hirayama, N. (Japan. Ministry of Agriculture, Forestry and Fisheries, Kokubunji, Tokyo. National Veterinary Assay Lab.) | Noda, K.
Currently available detection techniques for the BSE-agent are not sensitive enough as a test for the contamination of veterinary medicinal products (VMP) . Therefore, trilateral governments, Japan, EU and USA, took respective measures as a precaution to minimize the risk of transmission of the BSE agent. The EU government strongly recommends the use of non-ruminant materials for VMP production. However, the government will permit the use of materials originated from non- or low-BSE outbreak states with reliable certification when there are no alternatives. The Japanese government has essentially forbidden the use of ruminant-derived ingredients with some exceptions. On the contrary, the US government, the only BSE-free federal among the trilateral, does not limit the use of ruminant materials originated from its own states. There is a substantial amount of ongoing research into the development of new tests for the BSE agent or infectious forms of the prion protein (PrP sup(Sc)). Among these, a conformation-dependent immunoassay or CDI is thought to be one of the most promising techniques for highly sensitive detection of PrP sup(Sc). A protein misfolding cyclic amplification or PMCA method that achieves the conversion of normal form of prion protein into PrP sup(Sc) in vitro, is also expected to lead to a highly sensitive detection method. In addition, an RNA aptamer method has recently been used to develop a PrP sup(Sc)-specific probe, and some promising results have been obtained. Combining some of the methods mentioned herein with those currently available, may lead to a suitable evaluation test for contamination in VMP in the future.
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