离子交换高效液相色谱仪MQ-2000PT检测糖化血红蛋白性能评价  

Performance Evaluation of Glycosylated Hemoglobin by Ion Exchange High Performance Liquid Chromatograph MQ-2000PT

作　　者：韩静[1] 彭海林[1] 钱锦[1] 李林[1] 金梅[1] HAN Jing;PENG Hailin;QIAN Jin(Taizhou People's Hospital,Jiangsu Taizhou 225300,China)

机构地区：[1]江苏省泰州市人民医院检验科,江苏泰州225300

出　　处：《河北医学》2018年第4期689-691,共3页Hebei Medicine

基　　金：2014年泰州市科技支撑计划项目;(编号:TS027)

摘　　要：目的:评价离子交换高效液相色谱法(HPLC)全自动糖化血红蛋白分析仪MQ-2000PT性能。方法:计算MQ-2000PT测定Hb A1c的精密度、携带污染率、线性,同时通过检测41例健康体检者的Hb A1c浓度验证其参考区间的实用性。结果:色谱法测定Hb A1c批内变异系数(CV)两水平样品分别为高值0.45%、低值0.58%,批间变异系数(CV)高值0.92%、低值1.12%;在4.6%~15.95%浓度范围内线性良好(R2=0.9998,P<0.001);高值标本对低值标本的携带污染率为0.997%;41例健康体检者Hb A1c检测结果分布在4.4%~6.2%,95.1%检测结果(39/41)在厂家提供的参考区间(4.0%~6.0%)内。结论:MQ-2000PT色谱法测定Hb A1c的性能良好。Objective:To evaluate the performance of automatic glycohemoglobin analyzer MQ-2000PT for the determination of HbA1c(glycosylated hemoglobin A1c)by the method of HPLC(ion-exchange highperformance liquid chromatography).Methods:The linearity,carryover rate and precision of MQ-2000PT were calculated.Among 41 healthy subjects,the reference interval of HbA1c was also verified.Results:The within-run of both high and low levels of HbA1c were 0.45%、0.58%,and between-run coefficients of variation(CV)were 0.92%、1.12%,respectively.An perfect linearity was found for HbA1c in the range of 4.6%~15.95%(R2=0.9998,P<0.001).There was no significantly carryover rate between high and low level samples,the carryover rate was only 0.997%.The distribution range of HbA1c among the 41 healthy subjects were 4.4%-6.2%,the determination results of 39 subjects(95.1%)were in the range(4.0%-6.0%)provided by manufacturers.Conclusions:The performance of MQ-2000PT for the determination of HbA1c is good,and can be used for routine clinical determination.

关 键 词：携带污染 高效液相色谱 糖化血红蛋白 精密度 线性 

分 类 号：R446.1[医药卫生—诊断学]