title: [Optimisation and establishing of serological methods for the potency testing of immunglobulins against Clostridium tetani-toxin]
abstract: The quality control of human tetanus immunglobulin requires animal experiments according to European Pharmacopoeia monograph 398. The potency estimation has to be done in a toxin neutralisation test in mice (MNT) or guinea pigs. Immunoassays could also be used if they show a suitable sensitivity and specificity. The first results of our study verify that an indirect enzyme linked immunosorbent assay (ELISA), a rocket immunelectrophoresis (RIE) and a toxin binding inhibition test (ToBI) could be used as serological alternativ methods to the MNT. Studies on the reproducibility of the in vitro methods resulted inter-assay coefficients of variation between 2 and 27%. The ELISA is more sensitive (limit of detectability: 0,005 IE/ml) than the ToBI (0,04 IE/ml) and the RIE (5 IE/ml). The transferability of the ELISA to other labs is proofed. The transferability of the RIE and the ToBI will be tested in the near future.
authors.affiliation: Paul-Ehrlich-Institut, D-Langen.
authors.forename: Elvira
authors.initials: E
authors.lastname: Ebert
authors.forename: Annett
authors.initials: A
authors.lastname: Abu Karim
authors.forename: Tanja
authors.initials: T
authors.lastname: Kayser
authors.forename: Renate
authors.initials: R
authors.lastname: Wenig
authors.forename: Karin
authors.initials: K
authors.lastname: Weibetaer
authors.forename: Maria
authors.initials: M
authors.lastname: Wirz
authors.forename: Giulio
authors.initials: G
authors.lastname: Pisani
authors.forename: Gabriele
authors.initials: G
authors.lastname: Schäffner
authors.forename: Klaus
authors.initials: K
authors.lastname: Cubetaler