摘要
目的调查国内临床实验室使用的6个系列进口配套γ谷氨酰转移酶（GGT）检测系统测定结果的精密度和正确度，为实验室酶学测定确定具有准确性的目标系统提供依据。方法国内两家候选酶学参考实验室使用国际临床化学和检验医学联合会（IFCC）推荐的GGT参考测量方法，为5个活性浓度水平的新鲜冰冻混合人血清确定靶值，实验人员用基于厂家配套校准品等方式校准的6个厂家配套检测系统对血清样本进行检测，每个厂家均由独立分布于5个实验室的5台仪器组成（其中1个厂家为2台），各台仪器于实验前由各厂家工程师进行了一次日常维护。收集检测数据，统计同一厂家检测系统、不同厂家检测系统间检测结果的精密度，及各厂家检测系统测定结果均值与参考方法靶值的偏倚。结果6个厂家（A、B、C、D、E、F）配套测定系统间5个水平检测结果的差异为16．1％-35．4％；不同检测系统间5个水平样本测定结果的变异系数（cv）为5．3％-8．8％；同厂家配套检测系统间5个水平样本测定结果CV分别为A：2．17％-5．07％、B：4．21％-10．98％、C：0．52％-2．38％、D：1．35％-2．59％、E：0．23％-1．54％、F：1．83％-2．38％。各厂家测定系统检测结果均值与靶值的偏倚分别为A：0．43％-8．41％、B：-1．49％- -13．04％、C：11．2％-17．73％、D：0．19％-4．62％、E：-0．30％- -2．63％、F：-0．46％-7．90％。调查显示：有2个厂家结果在本次调查的浓度范围内偏倚均小于1／4美国《临床实验室改进法案修正案》（CLIA′88）规定的允许总误差（TAE）；有2个厂家结果在特定浓度范围内偏倚可满足1／4 TAE；有2个厂家结果的偏倚在大多数情况下近于或大于1／2 TAE。调查同时显示：在高、低浓度水平，有半数以上调查厂家结果的偏倚大于1／4 TAE。结论不同厂家配套检测系统间结果的均值存在明显差异，其结果的可比性明显劣于同一厂家检测系统间的可比性；厂家应进一步保证其检测系统经参考方法校正，并应注重对检测系统测定线性的校正。
Objective To investigate the precision and trueness of results from six imported commercial systems for measurement of gamma-glutamyltransferase （GGT） in serum in order to provide reference for the clinical laboratories to verify the target accuracy. Methods Five fresh frozen human serum samples that differed in catalytic concentration were analyzed in two candidate domestic reference laboratories and the target values for GGT were assigned using IFCC reference measurement procedure. The same samples were tested by six commercial systems which were calibrated using the matched calibrator. Each system consisted of five instruments in five laboratories, which had been well maintained before measurement. The data was collected. Precision from the same manufacturer and different manufacturers and biases between target values and mean values from each system were calculated. Results The differences of the mean values for five levels of commercial systems varied from 16. 1% to 35.4%. For the five levels, the coefficients of variation （CVs） of the results from all measurement system were from 5.3% to 8.8% , and CVs from each level were A 2.17%-5.07%,B 4.21%-10.98%,C 0.52%-2.38%, D 1.35%-2.59%, E 0.23%- 1.54% -）, F 1.83% -2.38%. Biases between the mean values of each commercial systems and the target values were A 0.43%-8.41%）, B -1.49%- -13.04%）, C 11.20%-17.73%）, DO. 19%-4.62%）, E -0. 30% - -2.63% ）, F -0. 46%-7. 90%, respectively. The investigation showed that biases of two manufacturers were less than a quarter of the total allowable error （TAE） of The Clinical Laboratory Improvement Amendments of 1988 （ CLIA＇88 ） in the whole range of investigated concentrations and the other two manufacturers＇biases could meet a quarter of TAE in a relative limited range. The biases of two manufacturers were near or more than haft of TAE in most levels. It also revealed that the biases of more than haft of manufacturers were more than a quarter of TAE in the low or high level of investigated concentrations. Conclusions The mean values of each manufacturer were significantly different. The variances of commercial systems from different manufacturers were much higher than those from the same manufacturer. Some imported commercial systems for measurement GGT should be better calibrated with the reference method, especially in the whole measurement linearity.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2008年第8期942-947,共6页
Chinese Journal of Laboratory Medicine
基金
基金项目：国家科技支撑计划课题资助项目（2007BAI05B09）
首都医学发展科研基金资助项目（2007-1045）
志谢（依笔画排序）卫生部北京医院检验科、中生北控生物科技股份有限公司参考部、武装警察部队北京市总队医院检验科、解放军海军医院检验科、中国医学科学院肿瘤医院检验科、北大国际体检中心检验科、北京大学人民医院检验科、北京市回民医院检验科、北京世纪坛医院检验科、北京市体检中心检验科、北京军区总院检验科、北京华信医院检验科、北京武警总医院检验科、北京航天总医院检验科、昆泰实验室、首都医科大学附属北京同仁医院检验科、解放军第二六三医院检验科、解放军第三○四医院检验科、解放军第三○五医院检验科、解放军第三○七医院检验科、解放军总医院检验科协助本次调查.
关键词
Γ-谷氨酰转移酶
酶试剂
参考值
gamma-Glutamyltransferase
Enzymes tests
Reference values
