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临床实验室精密度性能的评估 被引量:4

Evaluation of precision performance in clinical laboratory
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摘要 目的 评估满足操作规范和保证室间质量评价准则规定的质量要求 ,具有足够精密度性能实验室的百分比。方法 累积分布描述在室间质量评价活动中回报的 5 0 0家实验室的不精密度。允许的不精密度可从常用的单规则和多规则 (每批具有 2~ 4个质控测定值 )质控方法的操作过程规范图中的x轴截距获得。结果 导出的允许不精密度值放在累积分布可获得满足规范实验室百分比图形上的估计值。对于白蛋白 ,2 8%的实验室达到允许的不精密度 ;总胆红素为 6 4 % ,钙为 5 2 % ,氯为 35 % ,胆固醇为 4 8% ,肌酐为 84 % ,葡萄糖为 6 1% ,钾为 95 % ,总蛋白为 6 6 % ,钠为 18% ,三酰甘油为 87% ,尿素氮为 35 % ,尿酸为 81%。结论 对于许多试验 ,为了保证满足室间质量评价要求的分析质量仍需提高其精密度水平。 Objective To estimate the percent of laboratories with precision performance sufficient to satisfy the operating specifications and guarantee the quality required by the external quality assessment (EQA) criteria. Methods Cumulative distributions that describe state-of-the-art laboratory imprecision were obtained for 500 laboratories participating in the national center for clinical laboratory EQA scheme. Allowable imprecision was estimated from the x-intercepts of charts of operating specifications prepared for commonly used single and multirule quality control procedures having two to four control measurements per run. Results The derived values for allowable imprecision were imposed on the cumulative distributions to obtain graphical estimates of the percent of laboratories satisfying the operating specifications. Up to 28% of laboratories achieve the imprecision allowable for albumin,up to 64% for total bilirubin,52% for calcium,35% for chloride,48% for cholesterol, 84% for creatinine,61% for glucose,95% for potassium,66% for total protein,18% for sodium,87% for triglycerides,35% for urea nitrogen,and 81% for uric acid. Conclusions Improvements in precision are still needed for many laboratory tests to assure the analytical quality required by the EQA total error criteria.
出处 《检验医学》 CAS 北大核心 2004年第5期455-457,共3页 Laboratory Medicine
关键词 不精密度 室间质量评价 临床实验室 质控方法 操作过程规范图 三酰甘油 评估 性能实验 Clinical quality requirements Analytical quality requirements Operating processes specifications
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