Abstract |
According to the specifications of the European Pharmacopoeia (Ph. Eur.) monograph ( Swine Erysipelas Vaccine (Inactivated), Monograph no. 64, European Pharmacopoeia, 3rd edn., 1997) on erysipelas vaccines for veterinary use, batch potency is estimated in a multi-dilution assay after immunisation and infection of mice. Recently, we described a serological assay system (ELISA) which has the potential to replace this challenge-based model (Beckmann R, Cussler K. Wirksamkeitsprüfung von Rotlaufimpfstoffen an der Labormaus. ELISA kontra Infektionsversuch. ALTEX 1994;Suppl. 1:39-45; Rosskopf-Streicher U, Johannes S, Hausleithner D, Gyra H, Cussler K. Suitability of an ELISA for the batch potency test in laboratory mice. Pharmeuropa BIO 1998;1:65-70). The humoral immune response is quantified in pooled sera of ten mice three weeks after immunisation. The results are expressed as relative potency (RP) in comparison to a reference serum. After a pre-validation study had been performed with success (Rosskopf-Streicher U, Johannes S, Wilhelm M, Gyra H, Cussler K. Potency testing of swine erysipelas vaccines by serology - results of a pre-validation study. ALTEX 1999;16:123-8), we initiated an international collaborative study with five European manufacturers and seven regulatory authorities to validate the assay and model. All participants were provided with blind-coded erysipelas vaccines of different potencies, the ELISA kit and test instructions. The participants had to immunise mice, to prepare serum samples and to perform the ELISA. Inter-laboratory reproducibility was reported by the pass/fail criteria of the vaccines under test. Intra-laboratory precision was assessed by comparing repeated measurements on three consecutive days. Day-to-day variation within the laboratories was statistically analysed by comparing pairs of RPs using Lin's concordance correlation coefficient. The results show that the ELISA is indeed a suitable alternative to replace the vaccination-challenge test. Furthermore, this new model reduces the number of animals required for the potency test by approximately 80%.
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Authors | U Rosskopf-Streicher, S Johannes, M Wilhelm, K Cussler |
Journal | Vaccine
(Vaccine)
Vol. 19
Issue 11-12
Pg. 1477-83
(Jan 08 2001)
ISSN: 0264-410X [Print] Netherlands |
PMID | 11163671
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Validation Study)
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Chemical References |
- Antibodies, Bacterial
- Bacterial Vaccines
- Vaccines, Inactivated
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Topics |
- Analysis of Variance
- Animals
- Antibodies, Bacterial
(blood)
- Bacterial Vaccines
(standards)
- Enzyme-Linked Immunosorbent Assay
(methods, standards, statistics & numerical data)
- Erysipelothrix
(immunology)
- International Cooperation
- Mice
- Quality Control
- Reference Standards
- Reproducibility of Results
- Swine
- Swine Erysipelas
(immunology, prevention & control)
- Vaccines, Inactivated
(standards)
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