血清γ-谷氨酰转移酶测定参考方法的建立及在酶校准品定值中的临床应用  

Reference method applied to assigning values for calibrators in serum gamma-glutamyltransferase assays

作　　者：李淑葵[1] 何振坤[2] 徐国宾[1] 李海霞[1] 王涛[2] 但万春[2] 

机构地区：[1]北京大学第一医院检验科,100034 [2]中生北控生物科技股份有限公司

出　　处：《中华检验医学杂志》2007年第6期679-682,共4页Chinese Journal of Laboratory Medicine

摘　　要：目的通过建立γ-谷氨酰转移酶(GGT)测定参考方法,及其对酶校准品进行定值,并将此酶校准品在常规试剂配套使用,探讨血清 GGT 测定结果的准确性与一致性。方法按照国际临床化学与检验医学联合会(IFCC)有关 GGT 活性测定的要求,建立参考方法;通过测定有证参考物质(CRM),验证参考方法的准确可靠性;并用参考方法对制备的酶校准品进行准确定值;在不同分析仪上,分别用理论 K 值和使用校准品校准的方法测定40份人血清,记录测定结果;计算测定结果与参考方法的相对偏倚及变异系数。结果采用参考方法测定 CRM,结果在 CRM 允许范围内;在HITACHI 7600、7060、7170、7180及 BECKMAN LX20、OLYMPUS AU400生化分析仪上,测定40份人血清,采用校准品校准较理论 K 值,相对偏倚≤10%的样品比例明显上升,相对偏倚≥20%的样品比例下降;测定5个浓度水平的人血清,采用理论 K 值测定结果的变异系数为11.0%～14.0%,采用校准品校准变异系数下降到5.0%以下。结论中生 GGT 试剂盒与酶校准品配套使用后,测定结果的准确性和一致性有明显提高。Objective To investigate the efficacy of using a calibrator with values assigned with the reference method for improving the comparability of serum gamma-glutamyhransferase （GGT） measurements. Methods The IFCC reference method for GGT was established and the performance was verified by testing a certified reference material （CRM）. A calibrator was prepared and its value for GGT was assigned with the reference method. Forty serum samples were measured on different （including HITACHI 7600, 7060, 7170, 7180 and BECKMAN LX20, OLYMPUS AU 400） chemistry analyzers with Zhongsheng GGT reagent kits calibrated with the calibrator. The samples were also measured on the same analyzers using a theoretical factor. Biases of results obtained with the calibration and with the theoretical factor based calculation were compared. Results The reference method results on the CRM agreed the certified value within the stated uncertainty. Serum results calculated from the theoretical factor showed various biases and inter-analyzer variations. When the analyzers were calibrated with the calibrator, the number of results with biases less than 10% became significantly higher and those with biases more than 20% significantly lower. The variation of the results on 5 serum samples was reduced from 11.0% - 14. 0% to less than 5% by using the calibrator. Conclusion Accuracy and comparability of GGT measurements with of ZhongSheng GGT kits can be improved by using a calibrator that has a value assigned with the reference method.

关 键 词：Γ-谷氨酰转移酶 参考方法 酶校准品 

分 类 号：R446.1[医药卫生—诊断学]