A importância da finalização humanitária no teste de potência do soro antidiftérico

Abstract

Diphtheria is an acute infectious disease caused by Corynebacterium diphtheria, producer of the diphtheric toxin. The aim of this paper is to demonstrate the importance of establishing the humanitarian end point in the potency test of antidiphtheric serum. The protective capacity of diphtheria serum is established under the lethal effect of a fixed dose of diphtheric toxin through potency testing in albino guinea pigs (Cavia porcellus), English strain. The potency test is routinely performed in the Biological Quality Control - In Vivo for the purpose of releasing batches of antidiphtheric sera by the Butantan Institute. In the potency test, some guinea pigs show signs of disease and after the onset of symptoms it is impossible to observe any reversal in the effects caused by the disease, therefore, with the introduction of humane endpoint, the guinea pigs are removed from the test, already in the second stage of disease progression, without harming the final result, but reducing the suffering and stress of animals being tested, promoting comfort to the animals. The Biological Quality Control - In Vivo introduced the humanitarian end point in the potency test of antidiphtheria serum, promoting a refinement of the potency test, using one of the pillars of the 3R's, adding quality to the tests.