一款新型糖化血红蛋白床旁检测系统线性评价  

The Linearity Evaluation of a New Hemoglobin A1c Analyzer(HbA1c) for Point-of-Care Testing(POCT)

作　　者：王尉[1] 郑华荣[2] 周睿[3] 汤小琨 

机构地区：[1]首都医科大学附属北京地坛医院输血科,北京100015 [2]中国计量科学研究院,北京100013 [3]首都医科大学附属北京朝阳医院检验科,北京100020 [4]天津医科大学临床医学院,天津300070

出　　处：《标记免疫分析与临床》2017年第4期453-455,共3页Labeled Immunoassays and Clinical Medicine

基　　金：首都卫生发展科研专项项目(2016-1-2031);国家临床重点专科建设项目;北京医院协会研究项目

摘　　要：目的对一款新型床旁检测(point-of-care testing,POCT)糖化血红蛋白(HbA1c)分析仪的线性进行评价,从而对这仪器及试剂进行初步评价。方法根据临床和实验室标准化协会(CLSI)EP6-A文件,配制11个HbA1c浓度为等间距排列的试验样本。按随机顺序对它们进行测定,每个样本重复测定两次,对试验数据进行多项式回归分析。结果测定结果未发现离群点。试验样本的不精密度变异系数(CVr)为2.4%。二次回归多项式非线性系数b_2与0之间的差异无统计学意义(P=0.743),三次回归多项式非线性系数b_2、b_3与0之间的差异无统计学意义(P=0.869、0.847),最适多项式为一次多项式,最适方程为Y=0.971X+2.899(r=0.998)。结论该HbA1c检测系统在3.90%~13.45%范围内呈线性,该试剂盒申明的线性范围与本验证试验结果一致。Objective To evaluate the linearity of a new hemoglobin A1 c analyzer for point-of-care testing, as well as its instrument and test kit. Methods According to the EP6-A document, described by Clinical and Laboratory Standards Institute （CLSI）, 11 HbAlc concentrations of equal spaced were prepared as test samples, which were measured in duplicate in random order. Then the data were analyzed with polynomial regression analysis. Results No outlier was found in all the results. The coefficient variation of imprecision （CVr） is 2.4%. There was no statistically significant difference between zero and nonlinear coefficient b2 ~b3 in quadratic regression polynomial （P = 0. 869,0. 847 ）, and the linear equation was optimal. The regression equation of HbA1 c was Y = 0.971X ＋ 2.899 （r = 0. 998 ）. Conclusion The HbA1 c test kit was linear in the range of 3.90% - 13.45%, and the linear range stated in the kit was consistent with the results of this validation test.

关 键 词：床旁检测 糖化血红蛋白 线性 评价方法 

分 类 号：R446.1[医药卫生—诊断学]