Linnet K
Stat Med. 1987 Mar;6(2):147-58. doi: 10.1002/sim.4780060207.
For a quantitative laboratory test the 0.975 fractile of the distribution of reference values is commonly used as a discrimination limit, and the sensitivity of the test is the proportion of diseased subjects with values exceeding this limit. A comparison of the estimates of sensitivity between two tests without taking into account the sampling variation of the discrimination limits can increase the type I error to about seven times the nominal value of 0.05. Correct statistical procedures are considered, and the power and required sample size are studied for Gaussian and log-Gaussian distributions of diagnostic test values. The results may be useful for the planning phase of studies to evaluate quantitative diagnostic tests.
对于定量实验室检测，参考值分布的0.975分位数通常用作判别限，检测的灵敏度是值超过该限的患病受试者的比例。在不考虑判别限抽样变异的情况下比较两种检测的灵敏度估计值，可能会使I型错误增加到约为名义值0.05的七倍。文中考虑了正确的统计程序，并针对诊断检测值的高斯分布和对数高斯分布研究了检验效能和所需样本量。这些结果可能对评估定量诊断检测的研究规划阶段有用。
