2021年血清肌酐检测试剂盒正确度评价研究  

Study on accuracy evaluation of national serum creatinine test kit in 2021

作　　者：张娟丽 胡泽斌[2] 于婷[2] ZHANG Juanli;HU Zebin;YU Ting(Henan Province Medical Instrument Testing Institute,Zhengzhou,Henan 450003,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]河南省医疗器械检验所,河南郑州450003 [2]中国食品药品检定研究院,北京100050

出　　处：《国际检验医学杂志》2022年第S02期48-53,共6页International Journal of Laboratory Medicine

摘　　要：目的制备具有溯源性、均匀稳定的人血清肌酐样本,对我国肌酐检测试剂盒开展正确度评价。方法收集临床新鲜血清(排除肉眼可见溶血和脂血样本),经传染病四项检测均为阴性后,多重过滤分装,制备成两水平(正常和异常)的样本。按照JJF 1343-2012《标准物质定值的通用原则及统计学原理》对样本进行均匀性和稳定性评价,并选择3家参考实验室采用基于同位素稀释液相色谱质谱法的参考方法定值,同时评估不确定度。在全国范围内开展进口或国产血清肌酐检测试剂盒的调研,并开展正确度评价。以正确度样本的标示值为指定值,要求测定值与指定值偏差均应在±10.0%内。结果建立了具有溯源性且定值准确的血清肌酐正确度样本。正确度样本水平Ⅰ、Ⅱ的F值分别为1.3350和0.8342,均小于F0.05,均匀性良好;在(20~25)℃至少稳定8 h、(2~8)℃和-20℃至少稳定30 d;定值结果分别为(82.5±1.9)μmol/L(k=2)、(308.8±4.2)μmol/L(k=2)。共有47家企业55种试剂盒参与此次正确度评价,水平Ⅰ:肌氨酸氧化酶法和苦味酸法检测试剂盒分别有5家(5/48;10.4%)和2家(2/7;28.6%)结果不满足要求;水平Ⅱ:肌氨酸氧化酶法和苦味酸法检测试剂盒分别有0家和3家(3/7;42.9%)结果不满足要求。结论国内临床应用的大部分肌酐检测试剂盒正确度良好,检测结果准确、可靠。Objective To prepare traceable,uniform and stable human serum creatinine samples,evaluate the accuracy of creatinine detection kit in China.Methods Clinical fresh serum(excluding hemolysis,lipid blood samples visible to the naked eye)was collected.Four tests of infectious diseases were detected,and the results were negative,multiple filtration and package were carried out to prepare two levels(normal and ab-normal)samples.The homogeneity and stability of samples were evaluated according to JJF 1343-2012 general principles and statistical principles for the determination of reference materials.Three reference laboratories were selected to use the reference method based on isotope dilution liquid chromatography-mass spectrome-try,and the uncertainty was evaluated at the same time.The investigation of imported or domestic serum cre-atinine test kits and the accuracy evaluation were carried out throughout the country.The marked value of the accuracy sample was assigned as the specified value,and the deviation between the measured value and the specified value should be within±10.0%.Results The serum creatinine accuracy sample with traceability and accurate value was established.the F values of accuracy sample levelsⅠandⅡwere 1.3350 and 0.8342 re-spectively,which were less than F0.05,good uniformity,stable at(20-25)℃for at least 8h,(2-8)℃and-20℃for at least 30 d.The assigned value of accuracy samples were(82.5±1.9)μmol/L(k=2)、(308.8±4.2)μmol/L(k=2)。A total of 55 kits from 47 enterprises participated in the accuracy evaluation.Level I:five(5/48;10.4%)and two(2/7;28.6%)test kits for sarcosine oxidase method and picric acid method re-spectively failed to meet the requirements;Level II:0 and 3(3/7;42.9%)test kits for sarcosine oxidase meth-od and picric acid method respectively failed to meet the requirements.Conclusion Most of the creatinine test kits used in clinical application in China have good accuracy,and the test results are accurate and reliable.

关 键 词：肌酐 正确度 肌氨酸酶法 苦味酸法 指定值 

分 类 号：R446.1[医药卫生—诊断学]