糖化血红蛋白分析仪应用能力评价

目的 对糖化血红蛋白分析仪(HPLC-723 G7)进行方法性能监控、应用能力分析,旨在充分了解其性能以保证糖化血红蛋白(HbA1c)检测结果在糖尿病血糖控制、并发症防治中的积极作用.方法 参照美国病理医学院(College of American Pathologists,CAP)的能力对比检验要求和卫生部<临床实验室管理办法>,进行精密度、稀释线性分析、标本稀释后的稳定性、不同仪器间比对、干扰物质的影响、能力比对、质量控制过程能力指数计算.结果 显示干扰试验不受各种共存物影响;标本稀释后稳定性监测良好,稀释有效性试验良好;不同仪器间比对:与BIO-RAD VariantII型分析仪进行相关性比较,Y=0.986X 0.072,r=0.998 0;CAP的 PT回报结果:与靶值很接近,结果L:5.3%、M:8.7%、H:11.4 %;CAP结果L:5.23%、M∶ 8.61%、H:11.27%;质量控制过程能力指数(Process Capabilty Index)计算:CP=Tea/3S,CP=3.57,CP>1.33.结论 糖化血红蛋白分析仪(HPLC-723 G7)的应用能力满足临床质量要求.

Utilization Evaluation of HPLC-723 G7 for Detection of Glycosylated Hemoglobin

Objective To monitor the level of glycosylated hemoglobin tested by HPLC-723 G7 and analyse the function of the machine,so as to ensure the stability of HbA1c level during the cure course of diabetes.Method The precision,linear analysis of dilution,stability of dilution,comparability between different machines,influence of interfering substance,PT(potential test)of CAP(College of American Pathologists),process capability index of QC were studied according to comparability demand of CAP and"Clinical Laboratory Management Regulation" issued by Chinese Ministry of Health.Results The analysis shows that tests were not affected by interfering substance;the linear analysis and stability of dilution were satisfied;the correlation analysis compared with BIO-RAD shows that:Y=0.986X 0.072,r=0.998 0;PT:results in our lab(L:5.3%,M:8.7%,H:11.4);results of CAP(L:5.23%,M:8.61%,H:11.27);process capability index(CP=Tea/3S,CP=3.57,CP>1.33).Conclusion The results strongly support HPLC-723 G7 could widely be used in clinical test.