血清丙氨酸氨基转移酶常用制备物的互通性研究  

The commutability study of processed materials for serum alanine aminotransferase measurements

作　　者：齐天琪 汪静[2] 张天娇[2] 曾洁[2] 胡翠华[2] 马嵘[2] 张传宝[2] 陈文祥[2] 

机构地区：[1]中国医学科学院北京协和医学院,100730 [2]北京医院国家老年医学研究中心卫生部临床检验中心北京市临床检验工程技术研究中心

出　　处：《中华检验医学杂志》2018年第3期227-231,共5页Chinese Journal of Laboratory Medicine

基　　金：国家高技术研究发展计划（2011AA02A102,2011AA02A116）

摘　　要：目的评价血清丙氨酸氨基转移酶（ALT）22份常用制备物在11种不添加磷酸吡哆醛（PLP）和2种添加PLP常规检测方法上的互通性。方法互通性研究。留取2017年5月至8月北京医院、北京朝阳医院和北京同仁医院住院患者单人血清共100人份。11种不添加PLP的待评价方法同时测定单人血清50份，冰冻混合人血清（HSPs）、室间质评（EQA）材料、商品化校准品和质控品共22份中的ALT，并评价制备物在各系统间的互通性；2种添加PLP方法为待评价方法，IFCC血清ALT参考方法为比对方法，测定单人血清另50份和上述22份制备物的ALT，考察各制备物的互通性。11种不含PLP方法两两比对用Deming回归分析，2种含PLP方法分别与参考方法比较用简单线性回归统计。结果13种常规方法的平均批内CV为1.5%～5.0%，决定性系数0.995 1～0.999 9；Deming回归分析的斜率0.879～1.064，截距－1.96～3.30；简单线性回归的斜率0.905和0.955，截距－6.71和9.53。HSPs在51/57和56/57的方法对上有良好互通性；常规化学EQA材料、采供血机构EQA材料、商品化校准品和质控品分别在8/57～47/57、17/55～45/57、38/57以上和13/57～43/57的方法对上有互通性问题。结论除不含添加物的冰冻混合人血清外，质评材料、商品化校准品和质控品等加工制备物均存在不同程度的互通性问题。（中华检验医学杂志，2018, 41：227－231）ObjectiveTo evaluate the commutability of 22 processed materials for serum alanine aminotransferase measurements which were performed in 11 routine assays without and 2 assays with pyridoxal-5′-phosphate.Methods100 serum specimens were collected in Beijing Hospital, Zhao Yang Hospital and Tong Ren Hospital from May, 2017 to August, 2017. 50 individual specimens together with fresh frozen human serum pools （HSPs）, external quality assessment （EQA） materials, commercial calibrators and controls were measured by 11 routine assays without pyridoxal-5′-phosphate. Measurement results of the 50 individual samples were pairwise analyzed by Deming regression for slopes and intercepts, and 95% prediction interval （PI） were calculated to evaluate the commutability of processed materials. Another 50 individual specimens and 22 above-mentioned materials were analyzed by 2 assays with pyridoxal-5′-phosphate as the evaluated methods and internationally recognized reference method as the comparative method. The ordinary linear regression （OLR） and 95% PI were used to identify the commutability of 22 materials.ResultsThe Deming slopes ranged from 0.879 to 1.064 and intercepts from -1.96 to 3.30; the OLR slopes were 0.905 and 0.955 while intercepts were -6.71 and 9.53. The HSPs were commutable for 51/57 and 56/57 assay pairs. The EQA materials, commercial calibrators and controls showed noncommutability from 8/57 to 47/57, 38/57 and pairs after that, and from 13/57 to 43/57 assay pairs, respectively.ConclusionThe lyophilized materials including EQA materials, commercial calibrators and controls demonstrated poor commutability in different degrees.（Chin J Lab Med, 2018, 41： 227-231）

关 键 词：丙氨酸转氨酶 参考标准 信息交流 

分 类 号：R446.1[医药卫生—诊断学]