European specifications for imprecision and inaccuracy compared with operating specifications that assure the quality required by US CLIA proficiency-testing criteria.
European specifications for imprecision and inaccuracy compared with operating specifications that assure the quality required by US CLIA proficiency-testing criteria.
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与确保美国 CLIA 能力验证标准所需质量的操作规范相比，欧洲规范存在不精确性和不准确性。
DOI：
10.1093/clinchem/40.7.1228
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发表时间：
1994
影响因子：
9.3
通讯作者：
P. L. Barry
中科院分区：
文献类型：
--
作者：
J. Westgard;J. J. Seehafer;P. L. Barry
已将不精密度和不准确度的拟定和临时欧洲质量标准与美国CLIA能力验证（PT）的总误差标准进行了比较。为了评估单独的不精密度和不准确度质量标准与总误差标准的相对要求，我们推导出了如果检测工艺能够提供达到CLIA PT标准要求的分析质量的90%保证，则允许的不精密度和不准确度。为常用的单规则和多规则质量控制程序制备操作规范图表（OPSpecs图表），每次运行2和4次控制测量。在研究的23项检测中，拟定的欧洲不精密度和不准确度质量标准比CLIA对12项检测（白蛋白、碱性磷酸酶、淀粉酶、钙、氯化物、肌酐、乳酸脱氢酶、锂、镁、总蛋白、钠和甲状腺素）的要求更高。CLIA总误差标准比9项检测（丙氨酸氨基转移酶、天冬氨酸氨基转移酶、总胆红素、胆固醇、肌酸激酶、铁、甘油三酯、尿酸和尿素氮）的拟定欧洲质量标准要求更高。两个测试（葡萄糖，钾）在不同的决策水平显示出不同的要求。制造商和实验室分析师需要在逐个测试的基础上比较这些不同的质量标准，以指导实验室测量程序的开发，选择，评估和控制。
Proposed and interim European quality specifications for imprecision and inaccuracy have been compared with the US CLIA total error criteria for proficiency testing (PT). To assess the relative demands of separate imprecision and inaccuracy specifications vs total error criteria, we derived the imprecision and inaccuracy that would be allowable if a testing process were to provide 90% assurance of achieving the analytical quality required by CLIA PT criteria. Charts of operating specifications (OPSpecs charts) were prepared for commonly used single-rule and multi-rule quality control procedures with 2 and 4 control measurements per run. Of the 23 tests studied, the proposed European specifications for imprecision and inaccuracy were more demanding than the CLIA requirements for 12 tests (albumin, alkaline phosphatase, amylase, calcium, chloride, creatinine, lactate dehydrogenase, lithium, magnesium, total protein, sodium, and thyroxine). The CLIA total error criteria were more demanding than the proposed European specifications for nine tests (alanine aminotransferase, aspartate aminotransferase, total bilirubin, cholesterol, creatine kinase, iron, triglycerides, uric acid, and urea nitrogen). Two tests (glucose, potassium) showed different requirements at different decision levels. Manufacturers and laboratory analysts need to compare these different quality specifications on a test-by-test basis to guide the development, selection, evaluation, and control of laboratory measurement procedures.