Wang Yufei, Wang Jing, Zhao Haijian, Zhang Jiangtao, Zhang Tianjiao, Zeng Jie, Zhou Weiyan, Zhang Chuanbao
Beijing Hospital and National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, No. 1 Dahua Road, Dongcheng District, Beijing 100730, China; Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dongdan Santiao Road, Beijing 100005, China.
Beijing Hospital and National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, No. 1 Dahua Road, Dongcheng District, Beijing 100730, China.
Clin Chim Acta. 2016 Oct 1;461:98-102. doi: 10.1016/j.cca.2016.07.008. Epub 2016 Jul 15.
Since 2003, the National Center for Clinical Laboratories (NCCL) has organized a network of reference laboratories and several survey programs to improve standardization in China.
We analyzed the 2015 trueness verification program to assess the status of enzyme measurement standardization. Commutable serum-based materials were prepared and sent to 10 reference laboratories to assign target values for 2 enzymes (alanine aminotransferase-pyridoxal phosphate [ALT-pp] and γ-glutamyltransferase [GGT]) using IFCC reference measurement procedures.
Analytical performance was assessed for compliance to 3 indexes: trueness (bias), imprecision (CV), and accuracy (total error). Of the 250 participating laboratories, about half (≥124) used heterogeneous systems. More laboratories met the tolerance limit of imprecision than of trueness or accuracy. Except at the lowest concentration, the CV pass rates were >90% for the 2 enzymes. The optimal performance criterion derived from biological variation yielded pass rates for total error (ALT 77%, GGT 80%) that were higher than for bias (ALT 63%, GGT 73%).
PT/EQA results for commutable samples can be used to assess trueness against reference measurement procedures. Despite global and national standardization programs, bias remains a critical limitation of current enzyme measurement procedures in China.
自2003年以来，国家临床检验中心（NCCL）组织了一个参考实验室网络和多个调查项目，以提高中国的标准化水平。
我们分析了2015年的正确度验证项目，以评估酶测量标准化的现状。制备了基于可互换血清的材料，并将其发送至10个参考实验室，使用国际临床化学和检验医学联合会（IFCC）的参考测量程序为两种酶（磷酸吡哆醛-丙氨酸氨基转移酶[ALT-pp]和γ-谷氨酰转移酶[GGT]）确定靶值。
评估分析性能是否符合三个指标：正确度（偏差）、不精密度（CV）和准确度（总误差）。在250个参与实验室中，约一半（≥124个）使用了异质系统。达到不精密度公差限的实验室比达到正确度或准确度公差限的实验室更多。除最低浓度外，这两种酶的CV通过率均>90%。根据生物学变异得出的最佳性能标准得出的总误差通过率（ALT为77%，GGT为80%）高于偏差通过率（ALT为63%，GGT为73%）。
可互换样品的PT/EQA结果可用于评估相对于参考测量程序的正确度。尽管有全球和国家标准化项目，但偏差仍然是中国当前酶测量程序的一个关键限制。
