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目的:对适用于生物活性测定法替代研究的相关统计学概念和受试者工作特征(receiver operating characteristic,ROC)曲线法进行介绍。方法:以生物测定中热原检测法的替代研究为例,采用各种热原检测方法对规定样品进行检测,对所获结果进行ROC曲线分析。结果与结论:4种新的体外热原检测方法(人全血白介素6法、人全血白介素1法、人外周血单个核细胞白介素6法、MM6细胞白介素6法)及家兔热原检查法的灵敏度与特异度分别为88.9%,96.6%;72.7%,93.2%;92.5%,95%;95.5%,89.8%;57.9%,88.3%。ROC曲线表明新方法的诊断效率均优于家兔法。ROC曲线法可以更加直观、清晰地说明各种热原检测法的优劣性,是一种可用于生物测定法桥接研究或替代研究中的实用方法。
OBJECTIVE: To introduce relevant statistical concepts and receiver operating characteristic (ROC) curve methods that are applicable to alternative studies of bioactivity assays. Methods: Taking the alternative study of pyrogen detection in bioassay as an example, the samples were detected by various pyrogen detection methods, and the results were analyzed by ROC curve. RESULTS AND CONCLUSION: Four new exogenous pyrogen detection methods (human whole blood interleukin 6 method, human whole blood interleukin 1 method, human peripheral blood mononuclear cell interleukin 6 method, MM6 cell interleukin 6 method) and rabbit pyrogen test The sensitivity and specificity of the method were 88.9%, 96.6%, 72.7%, 93.2%, 92.5%, 95%, 95.5%, 89.8%, 57.9%, 88.3% respectively. The ROC curve shows that the diagnostic efficiency of the new method is better than the rabbit method. ROC curve method can be more intuitive and clearly shows the advantages and disadvantages of a variety of pyrogen detection method is a practical method for bioassays bridging research or alternative research.