CAJ | 학술논문

目的：评价日本TOSOH HLC-723 G7糖化血红蛋白检测系统的分析性能。方法：按照临床实验室标准化协会(CLSI)指南文件,对TOSOH公司HLC-723G7糖化分析仪检测糖化血红蛋白(HBLAC)的精密度、准确度、线性范围、生物参考区间及携带污染率进行了验证,并与卫生部临检中心的质量标准进行比较。结果：CV批内<1/4Tea(CLIA’88),CV批间<1/3Tea(CLIA’88)；实验结果准确度平均偏倚(SE%)在1.114%,符合卫生部允许的偏差范围；各项目可报告范围试验测定值结果与预测值接近,重复试验各项目结果相关性好( r 2=0.9986),线性理想(斜率接近1)；生物参考区间与厂商提供的性能指标相符；携带污染率低于1%。结论：TOSOH G7糖化分析仪对于糖化血红蛋白(HBLAC)的检测,在精密度、准确度、生物参考区间、线性范围和污染携带率等五个方面均达到了临床检验的要求。
목적：평개일본TOSOH HLC-723 G7당화혈홍단백검측계통적분석성능。방법：안조림상실험실표준화협회(CLSI)지남문건,대TOSOH공사HLC-723G7당화분석의검측당화혈홍단백(HBLAC)적정밀도、준학도、선성범위、생물삼고구간급휴대오염솔진행료험증,병여위생부림검중심적질량표준진행비교。결과：CV비내<1/4Tea(CLIA’88),CV비간<1/3Tea(CLIA’88)；실험결과준학도평균편의(SE%)재1.114%,부합위생부윤허적편차범위；각항목가보고범위시험측정치결과여예측치접근,중복시험각항목결과상관성호( r 2=0.9986),선성이상(사솔접근1)；생물삼고구간여엄상제공적성능지표상부；휴대오염솔저우1%。결론：TOSOH G7당화분석의대우당화혈홍단백(HBLAC)적검측,재정밀도、준학도、생물삼고구간、선성범위화오염휴대솔등오개방면균체도료림상검험적요구。
Objective:To evaluated the analytic performance of TOSOH HLC-723 G7 for the determination of HBLAC in blood. Methods:According the the CLSI guidelines, the study included the evaluation of precison, accurancy, linearity, reference range and contamination rate. And compared the HBLAC results with the quality standard of Clinical Test Center of Ministry of Health. Results:CV within batch<1/4 tea (CLIA’88), CV between batch<1/3 tea(CLIA’88);accuracy of experimental results the average bias SE%in 1.114%, under the allowed deviation of Ministry of Health. The report test results of each determination value scope project is close to the predicted value. repeated trials results have good correlation(r2=0.9986), linear ideal (slope is close to 1);biological reference interval and the performance indicators provided by manufacturers is consistent;carry pollution rate is lower than 1%. Conclusions:The HLC-723 G7 instrument seems to be a reliable system for routine assay HBLAC, its precison, accurancy, linearity, reference range and contamination rate have reached the experiment requirements of clinical test.