国内临床实验室同型半胱氨酸室内质量控制变异系数调查与分析

Investigation and Analysis of the Coefficient of Variation of Internal Quality Control of Homocysteine

目的：统计并分析2014年3月同型半胱氨酸室内质量控制（internal quality control，IQC）数据，了解目前全国检验科开展 IQC 工作的情况。方法采用基于 Web 方式的室间质量评价（external quality control，EQA）软件系统。收集参加全国同型半胱氨酸室间质量评价292家实验室的 IQC，包括2014年3月和长期累积室内质控在控数据的变异系数。依据1／3室间质量评价限（TEa），1／4TEa 和基于生物学变异导出的最低、适当和最佳允许不精密度这5个评价标准，计算同型半胱氨酸两个批号的室内质控变异系数的通过率。统计参加实验室使用的仪器并将其分为6个仪器组，然后按照5个评价标准计算各仪器组的通过率。结果有292家实验室上报了同型半胱氨酸第一个浓度水平（批号1）的数据，其中有106家上报了第二个浓度水平（批号2）的数据。按照不同标准进行评估，变异系数通过率各不相同。按照1／3TEa 标准和按照生物学变异导出的允许不精密度中的最低标准，实验室的通过率接近，为63.36％～76.42％，按照1／4TEa 和按照生物学变异导出的允许不精密度中的适当标准，实验室的通过率接近，为34.25％～57.55％，按照生物学变异导出的允许不精密度中的最佳标准，实验室通过率仅为10.62％～16.98％。统计实验室使用的仪器，结果显示参加实验室使用的仪器主要有日立（77／292）、奥林巴斯（61／292）、罗氏（19／292）、贝克曼（14／292）、雅培（10／292）和西门子（10／292）。除了西门子仪器组，其它仪器组通过率间的差异并不大。结论目前，大多数实验室可以满足1／3TEa 标准和按照生物学变异导出的允许不精密度中的最低标准，但只有一半以下的实验室能满足1／4TEa 和按照生物学变异导出的允许不精密度中的适当标准和最佳标准，说明全国实验室在同型半胱氨酸检测的精密度性能上还需进一步提高。

Objective To carry out the current status of internal quality control by statistical analysis of the Internal Quality Control （IQC）data of homocysteine in 2014 March.Methods Web-based External Quality Assessment （EQA）system was used to collect IQC data of homocysteine from 292 EQA participant laboratories nationwide.The data include thecoefficient of variation （CV）of IQC data under control in March 2014 and long-term cumulative data.Acceptable rates of CVs of two-lot internal quality controls in homocysteine were calculated according to 5 criteria,that were 1/3TEa,1/4TEa and the speci-fications based on biological variation including the minimal,appropriate and optimal allowable imprecision.The instrument the participant laboratories used were sorted into 6 groups and the passing rate of each group were calculated by the 5 crite-ria.Results 292 laboratories reported the data of level 1 IQC for homocysteine,106 of which reported the data of level 2 IQC.The passing rate was different according to different criteria.The passing rate had few difference by the criteria of 1/3TEa and the minimal allowable imprecision based on biological variation,which were from 63.36% to 76.42%.It was also true for 1/4TEa and the appropriate allowable imprecision based on biological variation,which were from 34.25% to 57.55. The passing rate was only 10.62%~16.98% by the criteria of appropriate allowable imprecision based on biological varia-tion.Statistical results showed that instruments the participant mainly used were HITACHI （77/292）,Olympus （61/292）, Roche （19/292）,Beckman （14/292）,Abbott （10/292）and Simens （10/292）.The passing rates of all the instrument group had few difference except Simens group.Conclusion Most of the laboratories could meet the criteria of 1/3TEa and the min-imal allowable imprecision based on biological variation.But less than half of the laboratories could meet the criteria of 1/4TEa and the appropriate and optimal allowable imprecision based on biological variation.The precision performance of ho-mocysteine among laboratories needs further improvement.