自研糖化血红蛋白床旁检测分析仪的性能评估  

The performance evaluation of a HbA1c POCT analyzer

作　　者：李新华[1] 赵珂[1] 魏芳[2] 马凯惠 张宪党[1] LI Xinhua;ZHAO Ke;WEI Fang;MA Kaihui;ZHANG Xiandang(Shandong Institute of Endocrine ~Metabolic Diseases ,Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong 250000, China;Department of General Surgery ,Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong 250000, China)

机构地区：[1]山东省内分泌与代谢病研究所,济南250062 [2]山东中医药大学附属医院普外科,济南250000

出　　处：《检验医学与临床》2018年第10期1377-1380,共4页Laboratory Medicine and Clinic

基　　金：山东省重点研发计划项目(2015GSF118131);山东省医学科学院医药卫生科技创新工程

摘　　要：目的对自研糖化血红蛋白床旁检测分析仪进行方法学评价,为临床应用提供实验依据。方法选取该院104例健康体检者和82例糖尿病患者,采用该仪器检测糖化血红蛋白(HbA1c)水平,与Bio-Rad公司D10型糖化血红蛋白分析仪进行对比分析,确定自研仪器检测HbA1c的参考范围。依照特定顺序连续5d测定高、中、低校准品HbA1c水平,计算总不精密度,偏差、截距、斜率、非线性、漂移。结果自研检测分析系统测定HbA1c批内、批间不精密度均小于1.50%。总不精密度:低值1.298%、中值0.906%、高值1.014%,均小于美国糖尿病协会规定的5%允许误差范围。偏差:低值―0.01%、中值―0.03%、高值―0.05%,均在允许偏差范围内。斜率、漂移、非线性比较差异均无统计学意义(P>0.05),截距比较差异有统计学意义(P<0.01)。该仪器测定HbA1c参考范围为4.7%~6.3%,与Bio-Rad D10比较,具有显著的相关性(Y=1.004 9X―0.041 1,P<0.01)。标本中常见干扰物在所测水平下对HbA1c检测无明显影响。结论自研糖化血红蛋白床旁检测分析仪性能指标符合临床应用要求,可用于快速检测。Objective To provide experimental data for clinical application,the methodology was used to preliminary evaluationof the Point of Care Testing（POCT）analyzer.Methods A total of 104 controls and 82 diabetics were selected for detecting test of the concentration of HbA1c.Bio-Rad D10 HbA1c analyzer was compared with POCT analyzer through the accuracy,specificity,correlation experiments to confirm the normal reference range of HbA1c.A preliminary evaluation of the HbA1c POCT analyzer was made on calibrators at high,middle and low concentrations for a period of 5 days and the deviation of HbA1c total imprecision,the slope carrying pollution nonlinearity and drift were calculated,and t test was conducted at the same time.Results The intra and inter coefficient of variation were all less than 1.5%.The total imprecisionwere all less than the permissive 5%ranges of the American Diabetes Association,and the dates were low value 1.298%,middle value 0.906% and high value 1.014%.The low value,middle value and high value deviations within the permissive ranges,the dates were―0.01%,―0.03%,―0.05%,respectively.There were statistical significance in the intercepts,while no statistical significance in their slopes,nonlinearities and drifts.The analyzer′s normal reference range of HbA1c was 4.7%―6.3%.The data were well correlated with the results detected by Bio-Rad D10（Y=1.004 9 X-0.041 1,P〈0.01）.The common interferences had no significant interference on the HbA1c quantitative detection.Conclusion The Analyzer was satisfied with the clinical application and could be used for rapid detection of the level of HbA1c.

关 键 词：糖化血红蛋白 检测系统 方法学 性能评估 

分 类 号：R447[医药卫生—诊断学]