应用NCCLS EP5-A2文件对AU5811全自动生化仪进行精密度性能评价  

Evaluation on Precision Performance of AU5811 Fully Automatic Biochemical Analyzer According to NCCLS EP5-A2 Standards

作　　者：邓常春 

机构地区：[1]韶关市第一人民医院检验科,广东韶关512000

出　　处：《中国医疗设备》2016年第6期121-122,131,共3页China Medical Devices

摘　　要：目的对AU5811全自动生化仪进行精密度性能评价,以确定其是否满足临床需要。方法利用配套试剂的校准品和质控品,根据NCCLS EP5-A2文件的要求对AU5811全自动生化仪测定糖化血红蛋白的项目进行精密度性能评价。结果 AU5811全自动生化仪测定糖化血红蛋白的项目的高值和正常水平校准品的批内精密度CV%分别是0.83%、1.1%;批间精密度CV%分别是1.25%、2.19%;日间精密度CV%分别是1.5%、2.74%;总精密度CV%分别是1.66%、3.29%。结论所有精密度CV%均在可接受范围内,AU5811全自动生化仪精密度性能可满足临床需要。Objective To evaluate the precision performance of the AU5811 fully automatic biochemical analyzer so as to meet the requirements of clinical trials. Methods With the usage of corollary reagent calibrators and quality control materials, the precision performance of the AU5811 fully automatic biochemical analyzer in measurement of glycosylated hemoglobin was examined in line with NCCLS EP5-A2 standards. Results The within-run precision CV%, the between-run precision CV%, betweenday precision CV% and the total precision CV% of Hb Ac1-high and Hb Ac1-normal measured by AU5811 fully automatic biochemical analyzer were 0.83% versus 1.1%; 1.25% versus 2.19%; 1.5% versus 2.74%; 1.66% versus 3.29% respectively. Conclusion All precision CV% results were in acceptable range, AU5811 fully automatic biochemical analyzer could meet the requirements of clinical trials.

关 键 词：NCCLS EP5-A2文件 全自动生化仪 糖化血红蛋白 变异系数 精密度 

分 类 号：R44[医药卫生—诊断学]