Hamada C, Wada T, Sakamoto Y
System Management Department, Takeda Chemical Industries, Ltd., Osaka, Japan.
Environ Health Perspect. 1994 Jan;102 Suppl 1(Suppl 1):115-9. doi: 10.1289/ehp.94102s1115.
A statistical characterization of negative control data in the Ames Salmonella/microsome reverse mutation test was performed using data obtained at Takeda Analytical Research Laboratories during January 1989 to April 1990. The lot-to-lot variability of bacterial stock cultures and day-to-day variability of experiments were small for Salmonella typhimurium strains TA1535 and TA1537 and Escherichia coli WP2uvrA, but they were larger for S. typhimurium TA100. The number of revertant colonies for all test strains studied here followed Poisson distributions within the same day. The two-fold rule that is an empirical method to evaluate the Ames Salmonella/microsome test results has been widely used in Japan. This two-fold rule was evaluated statistically. The comparison-wise type I error rate was less than 0.05 for TA98, TA100, TA1535, TA1537, and WP2uvrA. Moreover, this rule is particularly conservative for TA100, for which the type I error rate was nearly 0.
利用武田分析研究实验室1989年1月至1990年4月期间获得的数据，对艾姆斯沙门氏菌/微粒体回复突变试验中的阴性对照数据进行了统计表征。对于鼠伤寒沙门氏菌TA1535和TA1537菌株以及大肠杆菌WP2uvrA，细菌储备培养物的批次间变异性和实验的每日变异性较小，但对于鼠伤寒沙门氏菌TA100则较大。此处研究的所有测试菌株的回复菌落数在同一天内遵循泊松分布。在日本，作为评估艾姆斯沙门氏菌/微粒体试验结果的一种经验方法的两倍规则已被广泛使用。对该两倍规则进行了统计学评估。对于TA98、TA100、TA1535、TA1537和WP2uvrA，比较型I类错误率小于0.05。此外，该规则对TA100尤为保守，其I类错误率几乎为0。
