定值冰冻人血清校准前后γ-谷氨酰转移酶室间测定结果调查  

Biases and interlaboratory variations of gamma-glutamyltransferase measurements before and after calibration with a common human serum calibrator

作　　者：贾慧敏[1] 徐国宾[2] 童清[3] 王清涛[3] 李淑葵[2] 何振坤[4] 王涛[4] 但万春[4] 

机构地区：[1]首都医科大学附属北京朝阳医院检验科,100020 [2]北京大学第一医院检验科 [3]北京市临检中心 [4]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687-691,共5页Chinese Journal of Laboratory Medicine

摘　　要：目的观察采用参考方法赋值的冰冻人血清样本作为校准品,校准不同检测系统后,测定冰冻人血清样本γ-谷氨酰转移酶(γ-GT)活性,可否改善测定的准确性和可比性。同时观察统一校准前后,不同质控品测定结果的离散度。方法由北京市临床检验中心向参加调查的15家实验室发放标定值为59.5 U/L 的γ-GT 校准品1支,不同浓度冰冻人血清样本5支,不同厂家冰冻质控样本10支。比较统一校准前、后,不同检测系统间γ-GT 测定结果的变异和不同检测系统测定结果与参考方法测定结果间的偏差。结果对于血清样本,统一校准前、后,各检测系统测定结果与参考方法测定结果间的偏差从-9.0%～-14.2%下降到-0.8%～-7.9%。各检测系统间的变异从6.9%～11.6%下降到2.8%～4.4%。对于质控样本,统一校准前、后,各检测系统测定结果与参考方法测定结果的偏差有增加趋势,各系统间变异无明显变化。结论采用定值冰冻人血清样本作为校准品可以改善不同检测系统测定结果的准确性和可比性,但不能改善实验室质控品测定结果的可比性。Objective To investigate the accuracy and comparability of γ-glutamyhransferase （ γ- GT） measurement results on human serum samples and control materials before and after calibration with a common human serum calibrator. Methods A human serum calibrator was prepared by pooling fresh serum aliquots and assigning a value for γ-GT with the IFCC reference method. The calibrator together with 5 human serum samples and 10 control samples were sent to 15 clinical laboratories and the serum and control samples were measured with different analytical systems before and after a calibration with the calibrator. The results were analyzed for biases and interlaberatory variations. Results For the serum samples, the calibration resulted in reductions in biases from - 9. 0% - - 14. 2% to - 0. 8% - - 7.9%, and in interlaboratory variations from 6. 9% - 11.6% to 2. 8% - 4. 4%. No improvement was observed on the control samples. Conclusions Accuracy and comparability of serum γ-GT measurements can be improved by using a common human serum calibrator. Some control materials may not be commutable for human serum in γ-GT measurements.

关 键 词：Γ-谷氨酰转移酶 偏差 校准品 

分 类 号：R446.1[医药卫生—诊断学]