以参考方法实验室网络赋值的人血清为校准品改善酶学结果可比性的研究

Reference laboratories network assigned fresh human serum value improves the comparability of enzymology results among laboratories

目的应用参考方法实验室网络赋值的人源新鲜冰冻血清作为校准品，改善不同检测系统间酶学检测结果的可比性。方法由国内6家实验室组成的酶学参考方法实验室网络使用国际临床化学和检验医学联合会（IFCC）推荐的磷酸肌酸激酶（cK）、乳酸脱氢酶（LDH）参考测量程序为新鲜冰冻混合人血清赋值。再用此赋值血清（BCal）校准常规检测系统。各实验室在BCal校准前、后，重复检测BCal、水平1患者样本（S1）和水平2患者样本（S2）2次，记录并收集实验数据。结果使用BCal测得各检测系统的偏移，CK项目，69家实验室的62．3％的偏移小于或等于5％；95．7％的实验室的偏移小于或等于10％。LDH项目，68家实验室的52．9％的偏移小于或等于5％；92．6％的实验室的偏移小于或等于10％。Bcal校准后，2个水平患者样本CK项目系统间cV从5．15％和5．98％下降至1．93％和1．81％；LDH项目系统间cV从5．86％和5．50％下降至3．39％和3．53％。依医院级别分别统计的数据显示：校准后，三级、二级医院CK、LDH的室间cV均有明显降低，且两者无明显差异。两组均值也较校准前更趋接近。少数封闭的检测系统BCal检测结果显示：CK、LDH各系统的偏移分别为-7．O％～8．8％和-21．9％～12．7％，系统间CV分别为5．18％和11．30％。结论应用参考方法实验室网络赋值的新鲜冰冻人源血清做校准品，可在相当程度上改善酶学检验结果的可比性，并确保结果溯源至参考方法。对于少数不适用的封闭系统，应制定相应的正确度判定标准，并敦促生产厂家予以改进。

Objective Using the frozen human-pooled serum samples assigned by the reference measurement laboratories net- work as calibrator,to improve the comparability of enzymology results. Methods References were obtained using laboratories net- work consisting of 6 domestic reference laboratories according to the International Federation of Clinical Chemistry and Laboratory Medicine （IFCC） reference measurement procedures of creatine kinase （CK） and lactate dehydrogenase （LDH）. Then assigned ser- um and two levels of patient samples were detected by laboratory＇s measurement systems before and after calibration, respectively. Results There were 62.3% laboratories biases are less than 50/6 and 95.7% less than 10% for CK. As for HDL,52.9% laborato- ries biases were less than 5 % and 92.6 % are less than 10 ~. After calibration,the interlaboratory coefficients of variation （CVs） of two patient samples were decreased from 5. 15% to 1. 93%,5. 98% to 1.81% for CK and from 5. 86% to 3. 39%,5. 50% to 3.53% for LDH. After calibration, the CVs of tertiary and secondary hospital for CK and LDH were significantly reduced, and there were no significant difference between them. Conclusion Using the frozen serum samples assigned by the reference measure- ment laboratories network as calibrator, may improve considerably the comparability of enzyme results and ensuring their traceabili- ty to reference procedures.