摘要
目的评价Nordtest准则在临床实验室常规检测项目测量不确定度评估中的适用性。方法收集北京同仁医院检验科2010年7至12月共176d室内质控数据和2009至2010年卫生部临床检验中心6次室间质评结果。依据Nordtest准则评估钠、钾、氯、钙、磷、葡萄糖、尿素氮、肌酐、尿酸、总蛋白和白蛋白、总胆红素和直接胆红素、丙氨酸转氨酶、天冬氨酸转氨酶、碱性磷酸酶、谷氨酰基转移酶、肌酸激酶、乳酸脱氢酶、三酰甘油和总胆固醇共21个检测项目的合成不确定度和扩展不确定度。结果在所有检测项目中，直接胆红素的扩展不确定度最大，达到17．69％；酶类项目如丙氨酸转氨酶、天冬氨酸转氨酶、碱性磷酸酶、乳酸脱氢酶，由于受校准品不确定度的影响，扩展不确定度均〉10％；与总胆固醇（6．96％）相比，三酰甘油受校准品不确定度的影响也较大，扩展不确定度为12．70％。结论Nordtest准则适用于目前临床实验室常规检测项目测量不确定度的评估，但在评估过程中，应考虑校准品不确定度的影响。
Objective To evaluate the suitability of Nordtest guideline in estimating measurement uncertainty of routine tests in clinical laboratory. Methods Data of clinical laboratory of Beijing Tongren Hospital were collected, which came from 176 days of Internal Quality Control （IQC） from July 2010 to December 2010 and 6 times of External Quality Assesment （EQA） of NCCL from 2009 to 2010. The combined and expanded uncertainties of 21 measurements （sodium, potassium, chlorine, calcium, phosphrous, glucose, urea nitrogen, creatinine, uric acid, total protein, albumin, total bilirubin, direct bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, glutamyl transpeptidase, creatine kinase, triglyceride and total cholesterol） were evaluated according to Nordtest guideline. Results Of all the measurements, expanded uncertainty of direct bilirubin （ 17. 69% ） was the highest. For some enzymes such as ALT, AST, ALP and LDH, expanded uncertainties were all over 10% markedly influenced by the calibrator uncertainty. Expanded uncertainty of triglyceride was 12.7%, also largely influenced by calibrator uncertainty, while that of total cholesterol was 6.96%. Conclusions Nordtest guideline is suitable to evaluate the measurement uncertainty of routine assays in clinical laboratory. However, calibrator uncertainty should be taken into account in the process of evaluation.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2012年第5期457-462,共6页
Chinese Journal of Laboratory Medicine
关键词
临床化学试验
偏差
模型
统计学
Clinical chemistry tests
Uncertainty
Models, statistics
