Ehrmeyer S S, Laessig R H, Leinweber J E, Oryall J J
Department of Pathology and Laboratory Medicine, University of Wisconsin, Madison 53706.
Clin Chem. 1990 Oct;36(10):1736-40.
On March 14, 1990, the Centers for Disease Control and the Health Care Financing Administration published criteria for defining minimum performance in proficiency testing (PT). Using our previously described computer modeling technique, we determined the likelihood of passing PT under the new rules. The model relates combinations of intralaboratory CV and bias to PT performance criteria. For example, a laboratory with a bias of zero and an internal CV of 5% will pass a 10% fixed-limit PT criterion (i.e., the criterion for glucose analyses) 98% of the time when five samples are used. The model provides similar analyses for all PT criteria and all relevant combinations of CV and bias. The probability of passing PT decreases as the number of analytes tested increases, i.e., from 98% to 37% as the number of analytes increases from 1 to 20. A laboratory's internal CV has a greater effect on the outcome of PT than do the corresponding bias values. We conclude that a laboratory that operates with methods that have internal CVs less than or equal to 33% and biases less than or equal to 20% of the PT criteria will have a greater than 99% chance of passing PT.
1990年3月14日，疾病控制中心和医疗保健财务管理局发布了能力验证（PT）中最低表现的定义标准。运用我们之前描述的计算机建模技术，我们确定了在新规则下通过PT的可能性。该模型将实验室内变异系数（CV）和偏差的组合与PT表现标准联系起来。例如，一个偏差为零且内部CV为5%的实验室，在使用五个样本时，98%的情况下会通过10%固定限的PT标准（即葡萄糖分析的标准）。该模型针对所有PT标准以及CV和偏差的所有相关组合提供类似分析。随着检测分析物数量的增加，通过PT的概率会降低，即当分析物数量从1增加到20时，通过概率从98%降至37%。实验室的内部CV对PT结果的影响比相应的偏差值更大。我们得出结论，一个采用内部CV小于或等于33%且偏差小于或等于PT标准20%的方法进行操作的实验室，通过PT的概率将大于99%。
