title: Evaluation of rapid post-mortem test kits for bovine spongiform encephalopathy (BSE) screening in Japan: Their analytical sensitivity to atypical BSE prions.
abstract: A classical type of bovine spongiform encephalopathy (C-BSE), recognized in 1987, had a large impact on public health due to its zoonotic link to variant Creutzfeldt-Jakob disease by the human consumption of dietary products contaminated with the C-BSE prion. Thus, a number of countries implemented BSE surveillance using rapid post-mortem test kits that were approved for detection of the C-BSE prion in the cattle brain. However, as atypical BSE (L- and H-BSE) cases emerged in subsequent years, the efficacy of the kits for the detection of atypical BSE prions became a matter of concern. In response to this, laboratories in the European Union and Canada evaluated the kits used in their countries. Here, we carried out an evaluation study of NippiBL®, a kit currently used for BSE screening in Japan. By applying the kit to cattle brains of field cases of C-BSE and L-BSE, and an experimental case of H-BSE, we showed its comparable sensitivities to C, L-, and H-BSE prions, and satisfactory performance required by the European Food Safety Authority. In addition to NippiBL®, two kits (TeSeE® and FRELISA®) formerly used in Japan were effective for detection of the L-BSE prion, although the two kits were unable to be tested for the H-BSE prion due to the discontinuation of domestic sales during this study. These results indicate that BSE screening in Japan is as effective as those in other countries, and it is unlikely that cases of atypical BSE have been overlooked.
authors.affiliation: a Department of Biochemistry and Cell Biology , National Institute of Infectious Diseases , Shinjuku-ku , Tokyo , Japan.
authors.forename: Ken'ichi
authors.initials: K
authors.lastname: Hagiwara
authors.affiliation: b Prion Disease Research Unit , National Institute of Animal Health , Tsukuba City , Ibaraki , Japan.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Iwamaru
authors.affiliation: b Prion Disease Research Unit , National Institute of Animal Health , Tsukuba City , Ibaraki , Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Tabeta
authors.affiliation: b Prion Disease Research Unit , National Institute of Animal Health , Tsukuba City , Ibaraki , Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yokoyama
authors.affiliation: c Department of Pathology , National Institute of Infectious Diseases , Shinjuku-ku , Tokyo , Japan.
authors.forename: Minoru
authors.initials: M
authors.lastname: Tobiume
mesh_terms: D000818:Animals; D001921:Brain / Q000473:pathology; D002417:Cattle; D003933:Diagnosis; D016643:Encephalopathy, Bovine Spongiform / Q000175:diagnosis* / Q000453:epidemiology; D005260:Female; D007564:Japan / Q000453:epidemiology; D011328:Prions / Q000032:analysis*; D012680:Sensitivity and Specificity
chemical_list: D011328:Prions
keywords: BSE surveillance; ELISA; analytical sensitivity; atypical bovine spongiform encephalopathy; evaluation study; prion; rapid post-mortem test