摘要
目的：探讨临床化学自建检测系统分析性能的确认方法。方法方法学评价研究。以血清肌酸激酶（CK）测定为例，选择在参考区间上限和下限以及医学决定水平（MDLs）浓度的6份实验样品，进行批内精密度（重复性）和日间精密度实验，计算批内CV和日间CV；使用5份能力验证试验（PT）定值样品、5份参考方法定值样品、40份新鲜冷冻血清与参考方法进行方法学比对3种方法进行正确度性能确认，计算在MDLs处的相对偏倚；基于MDLs处的CV、偏倚和允许总误差（TEa），绘制方法性能决定图、计算实验总误差和西格玛（σ）层级评价实验方法的准确度；实验结果与质量目标比较确认实验方法的精密度、正确度和准确度是否达到质量要求，并评价不同方法的有效性。结果6个实验样品的批内CV和日间CV均小于行标规定的最佳精密度要求（5.5％）。正确度初步评价结果显示，5份PT定值样品的平均偏倚为－8.96％，未达到行标规定的质量指标（允许偏倚为5.5％）；采取纠正措施后，除1个参考方法定值样品的测定偏倚（－5.8％）略高于允许偏倚外，其余9个样品的平均偏倚均小于允许偏倚；与参考方法的比对结果显示，在MDLs处的相对偏倚均小于允许偏倚。方法性能决定图显示，在MDLs处实验方法的操作性能点均位于优秀区；在接近MDL浓度处的实验总误差分别为14.2％、10.4％和7.6％，均小于行标规定的15％；在MDLs浓度处的σ层级分别为5.9、7.5和15，达到了优秀水平。结论该自建检测系统测定血清CK的精密度、正确度和准确度性能均达到了国家行标规定的最佳质量要求，且不同方法的评价结果一致，实验可根据自身实际选择合适的评价方法。
Objective To investigate the precision, trueness, and accuracy of self-developed detection system in clinical chemistry.Methods This was a methodological evaluation.Take serum creatine kinase（ CK） for instance, 6 serum sampleswith different leves （ on the upper or lower limit of the reference range or close to the medicine decide levels （ MDLs） , were collected for within-run precision（ repeatability） and within-laboratory precision （ intermediate precision ） experiments.5 proficiency testing （ PT ） samples, 5 samples assigned value by reference method, and 40 fresh-frozen serums were measured and compared with reference method for trueness verification.Drawing method evaluation decision chart, calculating total errors and sigma level evaluation experiment based on the CV, bias, and allowed total errors（TEa）were used to evaluate the accuracy performance.The precision, trueness, and accuracy were compared with the quality indicators.Results The within-run precision and within-laboratory precision were less than the highest requirement of Chinese industrial standard.The mean bias was -8.96%, didn′t reachthe required standard （5.5%）.After taking corrective actions, all samples but one （ -5.8%） met the required standard. Compared with the reference method, the mean bias on the MDLs was less than TEa.The performance points of the method evaluation decision chart indicated excellence performance.The total errors on MDLs were 14.2%, 10.4% and 7.6%, less than 15%.The sigma levels on MDLs were 5.9, 7.5 and 15, also achieved excellent level. Conclusions The precision, trueness, and accuracy performance of CK measured by self-developed detection system achieved excellent level of the Chinese industry standard, and the same results were found from different evaluation methods.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2016年第9期715-719,共5页
Chinese Journal of Laboratory Medicine
关键词
精密度
正确度
准确度
检测系统
方法学评价
Precision
Trueness
Accuracy
Measuring system
Methodological evaluation
