Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria.
Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria.
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基于临床和分析测试结果标准的实验室测试允许的不精确度。
DOI：
10.1093/clinchem/40.10.1909
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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
根据基于临床和分析检测结果的标准，估计了实验室检测的允许不精密度。所研究的分析结果标准是临床实验室改进修正案（CLIA）的能力验证标准。临床结局标准是对文献研究中检测结果的医学显著性变化的估计。允许不精密度的估计值来自质量计划模型，该模型将检测结果标准与允许的不精密度和不准确度以及确保在常规操作中达到预期结果标准所需的质量控制相关联。这些不精密度的操作规范始终比文献中最初推荐的医学上有用的CV要求更高（需要更低的CV），因为后者没有适当考虑受试者内的生物学变异。在比较允许不精密度的估计值时，CLIA结局标准比天冬氨酸转氨酶（无症状患者）、胆固醇、肌酐（无症状患者）、葡萄糖、甲状腺素、总蛋白、尿素氮、红细胞压积和凝血酶原时间的临床结局标准要求更高。临床结局标准对胆红素（急性疾病）、铁、钾、尿素氮（急性疾病）和白细胞计数要求更高。天冬氨酸转氨酶（急性疾病）、胆红素（无症状患者）、钙、肌酐（急性疾病）、钠、甘油三酯和血红蛋白的分析和临床结局标准的允许不精密度估计值重叠。
The allowable imprecision for laboratory tests has been estimated from criteria based on clinical and analytical test outcome. The analytical outcome criteria studied are the Clinical Laboratory Improvement Amendments (CLIA) criteria for proficiency testing. The clinical outcome criteria are estimates of medically significant changes in test results taken from a study in the literature. The estimates of allowable imprecision were obtained from quality-planning models that relate test outcome criteria to the allowable amount of imprecision and inaccuracy and to the quality control that is necessary to assure achievement of the desired outcome criteria in routine operation. These operating specifications for imprecision are consistently more demanding (require lower CVs) than the medically useful CVs originally recommended in the literature because the latter do not properly consider within-subject biological variation. In comparing estimates of allowable imprecision, the CLIA outcome criteria are more demanding than the clinical outcome criteria for aspartate aminotransferase (asymptomatic patients), cholesterol, creatinine (asymptomatic patients), glucose, thyroxine, total protein, urea nitrogen, hematocrit, and prothrombin time. The clinical outcome criteria are more demanding for bilirubin (acute illness), iron, potassium, urea nitrogen (acute illness), and leukocyte count. The estimates of allowable imprecision from analytical and clinical outcome criteria overlap for aspartate aminotransferase (acute illness), bilirubin (asymptomatic patients), calcium, creatinine (acute illness), sodium, triglyceride, and hemoglobin.