The rapid fluorescent focus inhibition test is a suitable method for batch potency testing of inactivated rabies vaccines.
The European Pharmacopoeia proposes two methods for potency determination of inactivated rabies vaccines for veterinary use: The first one is a classical mouse challenge test, which is imprecise, time-consuming, and causes severe distress to the test animals. Alternatively, the potency may be determined serologically by measuring the neutralizing antibody titers induced after vaccination of mice by using a rapid fluorescent focus inhibition test (RFFIT). Although this method is faster and less painful for the animals, it is not widely used yet, and only little data exist concerning the comparability of both methods. We have therefore performed a comparative study, in which we demonstrated a good correlation between the challenge test results and the mean titers determined by RFFIT. Furthermore, all vaccine batches failing the challenge test were also recognized as insufficient in the serological assay. This publication further describes the influence of different vaccine administration routes on the resulting antibody titers, and it proposes various modifications to the serological assay protocol which could improve its overall practicability. Finally, we recommend that the serological assay be used for the potency testing of inactivated rabies vaccines.
Krämer
B
B
Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, Langen, Germany. krabe@pei.de
Schildger
H
H
Behrensdorf-Nicol
H A
HA
Hanschmann
K M
KM
Duchow
K
K
D000818:Animals; D000917:Antibody Formation / Q000276:immunology; D002478:Cells, Cultured; D005260:Female; D005455:Fluorescent Antibody Technique / Q000379:methods; D051379:Mice; D009500:Neutralization Tests / Q000379:methods; D011818:Rabies / Q000097:blood / Q000175:diagnosis / Q000517:prevention & control; D011819:Rabies Vaccines / Q000032:analysis* / Q000276:immunology; D012698:Serologic Tests / Q000379:methods; D014611:Vaccination / Q000379:methods; D015164:Vaccines, Inactivated / Q000032:analysis
D011819:Rabies Vaccines; D015164:Vaccines, Inactivated