摘要
目的探讨两种允许总误差在临床化学检测项目性能评价中的应用。方法按照Westgard等报道方法计算σ值,不精密度(CV%)为本室2008年1～6月室内质量控制的变异系数,偏倚(bias%)为本实验室参加卫生部临床检验中心2008年上半年全国常规临床化学室间质评的偏倚,允许总误差(TEa%)选用美国临床实验室改进修正案(CLIA’88)和根据生物学变异制定的允许总误差。应用计算的σ值评价临床实验室检验阶段性能,提出质量方案,指导质量改进。结果在21个测定项目中,以CLIA’88和生物学变异的临床允许误差计算的σ值小于3的测定项目分别为2个(9.5%)和5个(23.8%)。结论以CLIA’88规定的允许总误差计算的σ值评价临床实验室分析阶段性能及设计质控方案,简单易行,更适用于常规临床实验室。
Objective To study the application of two types of allowed total errors in assessing the quality performance of clinical chemical analytes. Methods According to methods reported by Westgard to calculate sigma（ σ ） values,the imprecision（CV%） and bias were collected from routine quality control and proficiency test of national center for clinical laboratory individually. Allowed total errors came from CLIA＇ 88 and biological variation.We applied sigma values to evaluate the quality performance of clinical laboratory,then designed quality control strategy and promoted quality improvement. Results The sigma values below 3 was 2（9.5%）and 5（23.8%） according to CLIA＇ 88 and biological variation in 21 analytes. Conclusion Applying the sigma values according to CLIA＇ 88 to evaluate the quality performance of clinical laboratory and designing quality control strategy were easy to do and suited for routine clinical laboratory.
出处
《中国医疗设备》
2009年第7期61-63,共3页
China Medical Devices
基金
国家科技支撑计划项目(2006BAI14B00)子项目
关键词
检验质量控制
允许总误差
生物学变异
生化分析仪
test quality control
allowed total errors
biological variation
biochemical analyzer
