血清尿酸13种常规检验系统正确度的评价  

Trueness evaluation of 13 routine measurements for serum uric acid

作　　者：张江涛[1] 张传宝[1] 曾洁[1] 马嵘[1] 赵海舰[1] 周伟燕[1] 张天娇[1] 闫颖[1] 胡翠华[1] 汪静[1] 王冬环[1] 陈文祥[1] 

机构地区：[1]北京医院卫生部临床检验中心,100730

出　　处：《中华检验医学杂志》2015年第9期609-612,共4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：评价血清尿酸13种常规检验系统的正确度，探讨参考方法对改进常规检验系统结果一致性的作用。方法试剂评价研究。以同位素稀释液相色谱串联质谱法（ ID－LC／MS／MS ）法为比对方法，选取和光、积水、德赛、利德曼、九强、罗氏、美康、迈克、迈瑞、中生、迪瑞、长征和科华等生产厂家的13种尿酸试剂盒（酶法）为评价方法，检测仪器为日立7170A生化分析仪。2014年8月用比对方法和评价方法分别测定从2014年1月1日至6月30日卫生部北京医院检验科检测剩余血清收集的40份新鲜冰冻血清和19种制备物，将比对方法和评价方法尿酸测定结果进行直线回归分析。用拟合的直线回归方程确定评价方法的性能并对各评价方法再校准，比较再校准前后19种制备物测定值与比对方法测定值的偏倚变化。结果各评价方法具有较好的精密度（ CV＜1．75％）；13种评价方法与比对方法测定40份新鲜冰冻血清尿酸的结果间具有良好的相关性（ R^2均＞0．998，P均＜0．01）；与比对方法比较，13种评价方法测定40份血清尿酸的百分偏倚平均0．17％（范围－3．06％-7．31％）。利用比对方法再校准后，19种制备物中4种在所有方法无基质效应的制备物测定值百分偏倚降低，符合小于4．8％的生物学变异导出质量指标。结论13种尿酸常规方法均具有良好的正确度，其溯源性得到验证。利用参考方法或标准物质再校准有助于提高不同常规方法检验结果的一致性。（中华检验医学杂志，2015，38：609－612）Objective To evaluate the trueness of 13 routine measurements for serum uric acid and the role of reference method in improving harmonization and trueness among routine measurement systems. Methods The research is related to the reagent evaluation.Usingisotope dilution liquid chromatography tandem mass spectrometry （ ID-LC/MS/MS） method as the comparison method, Wako, Sekisui, DiaSys, Maker,Dirui,Leadman,BSBE,Biosina,Mindray,MedicalSystem,LongMarch,and Kehua 13 kinds of uric acid kits were chosen as the evaluation methods with Hitachi 7170A as the analyzer.serum uric acid in 40 fresh frozen serawere collected from clinical laboratory of Beijing hospital in 2014,coveringboth physiological and pathological status （ 80 -940 μmol/L ） .19 kinds of prepared materials and the 40 fronzen sera were measuredby comparison method and evaluation methods and linear regression analysis was made for the results.The performance of evaluation methods was revealed and recalibration was performed on every evaluation methodby the linear regression equation.The variation of percent bias（%） of the uric acid values in 19 preparation materials was compared.Results All test methods demonstrated good precision （ CV〈1.75） and good correlation （R^2 〉0.998, P〈0.01） with the comparison method when measuring uric acid values in 40 fresh frozen sera The meanpercent bias was 0.17% （ -3.06% -7.31%）.After recalibration, 4 of 19 samples with no matrix effect values percent bias reduced and met the demands of quality （ 〈4.8%） induced from biological variation.Conclusion All test methods demonstrated good trueness and their calibration traceability was verified.Recalibration using reference method or standard reference materials contributes to harmonization among methods.

关 键 词：尿酸 诊断试验 常规 参考值 试剂盒  诊断 结果可重复性 偏倚(流行病学) 

分 类 号：R446.1[医药卫生—诊断学]