Omidbakhsh Navid
Virox Technologies, Research and Development, 2770 Coventry Rd, Mississauga, Ontario L6H 6R1, Canada.
J AOAC Int. 2012 Mar-Apr;95(2):406-10. doi: 10.5740/jaoacint.11-015.
Despite its very poor reproducibility, AOAC INTERNATIONAL's use-dilution method (UDM) for bactericidal activity (AOAC Methods 964.02, 955.14, and 955.15) has been required by the U.S. Environmental Protection Agency (EPA) since 1953 for regulatory purposes, while methods with better reproducibility have been adopted in Canada and Australia. This study reviews UDM from a statistical perspective. Additionally, the test's expected results were compared to those obtained from actual evaluation of several formulations. Significant gaps have been identified in the reproducibility of the test data as predicted by statistical analysis and those presented to the EPA for product registration. UDM's poor reproducibility, along with its qualitative nature, requires the concentration of the active ingredient to be high enough to ensure all or most carriers to be free of any viable organisms. This is not in accord with the current trends towards sustainability, human safety, and environmental protection. It is recommended that the use of the method for regulatory purposes be phased out as soon as possible, and methods with better design and reproducibility be adopted instead.
尽管美国公职分析化学师协会（AOAC INTERNATIONAL）的杀菌活性使用稀释法（UDM）（AOAC方法964.02、955.14和955.15）的重现性很差，但自1953年以来，出于监管目的，美国环境保护局（EPA）一直要求使用该方法，而加拿大和澳大利亚则采用了重现性更好的方法。本研究从统计学角度对UDM进行了综述。此外，还将该测试的预期结果与几种配方实际评估所得结果进行了比较。统计分析预测的测试数据重现性与提交给EPA用于产品注册的测试数据重现性之间存在显著差距。UDM重现性差，加上其定性性质，要求活性成分的浓度足够高，以确保所有或大多数载体不含任何活的生物体。这与当前可持续发展、人类安全和环境保护的趋势不符。建议尽快逐步淘汰该方法在监管目的中的使用，转而采用设计更好、重现性更高的方法。
