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  • Title: Optimisation and establishing of serological methods for the potency testing of immunglobulins against Clostridium tetani-toxin.
    Author: Ebert E, Abu Karim A, Kayser T, Wenig R, Weibetaer K, Wirz M, Pisani G, Schäffner G, Cubetaler K.
    Journal: ALTEX; 1998; 15(5):30-32. PubMed ID: 11178535.
    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.
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