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由12家脂质研究诊所进行的胆固醇分析外部质量控制调查。

External quality-control survey of cholesterol analyses performed by 12 lipid research clinics.

作者信息

Lippel K, Ahmed S, Albers J J, Bachorik P, Muesing R, Winn C

出版信息

Clin Chem. 1978 Sep;24(9):1477-84.

PMID:688605
Abstract

We report accuracy and precision achieved in the automated analysis for cholesterol in a long-term multilaboratory study, presenting and evaluating the significance of data accumulated by 12 Lipid Research Clinics (LRC's) in the analysis of 18 unknown surveillance pools during three years. The average bias for all pools and for 13 autoAnalyzer II (Technicon Instruments Corp., Tarrytown, N.Y. 10591) instruments in the 12 clinics was -0.41% (range -1.2 to +0.3%), as compared to values established by reference methodology. The regression equation relating observed cholesterol values (y) to reference values (x) was: y = 0.35 + 0.977x. The bias varied from pool to pool (-2.3 to +5.3%), positive biases being observed for pools with cholesterol concentrations less than 1.4 g/liter, and negative biases for those pools with higher concentrations. Total standard deviations ranged between 25 and 75 mg/liter, and total CV's for most individual instruments were between 1 and 3%. Of the variability for a particular pool, less than 20% was due to differences among instruments, and within- and between-run variabilities were approximately equal. These trends were the same as those previously observed [Clin. Chem. 23, 1744 (1977)] in the analysis of bench control pools of known cholesterol concentration.

摘要

我们报告了在一项长期多实验室研究中,胆固醇自动分析所达到的准确度和精密度,展示并评估了12个脂质研究诊所(LRC)在三年间分析18个未知监测样本池时积累的数据的重要性。与参考方法确定的值相比,12个诊所中所有样本池以及13台自动分析仪II(Technicon仪器公司,纽约州塔里敦10591)的平均偏差为-0.41%(范围为-1.2%至+0.3%)。将观察到的胆固醇值(y)与参考值(x)相关联的回归方程为:y = 0.35 + 0.977x。偏差因样本池而异(-2.3%至+5.3%),胆固醇浓度低于1.4克/升的样本池观察到正偏差,而浓度较高的样本池则观察到负偏差。总标准偏差范围在25至75毫克/升之间,大多数单个仪器的总变异系数在1%至3%之间。对于特定样本池的变异性,仪器间差异导致的变异性不到20%,批内和批间变异性大致相等。这些趋势与先前在分析已知胆固醇浓度的实验台对照样本池时观察到的趋势相同[临床化学23, 1744 (1977)]。

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