应用CLSI EP5-A2文件评价ADAMSTM Alc HA-8160全自动糖化血红蛋白仪的精密度

Evaluation of the Precision Performance of ADAMS HA-8180 HbAlc Analyzer Using CLSI EPS-A2 Guidelines

目的对HA-8160全自动糖化血红蛋白仪进行精密度性能评价。方法按照CLSI EP5-A2文件要求，利用高值和正常两水平质控品对HA-8160全自动糖化血红蛋白仪测定糖化血红蛋白（HbAlc）项目的精密度进行评价。结果HA-8160全自动糖化血红蛋白仪测定糖化血红蛋白（HbAlc）项目高值和正常两水平的批内精密度变异系数分别为0．97％和1．45％；批间精密度变异系数分别为0．62％和0．34％；日间精密度变异系数分别为0．63％和0．56％；总精密度变异系数分别为1.31％和1．59％。结论HA-8160全自动糖化血红蛋白仪测定HbAlC的精密度能够满足临床检测要求。

Objective To evaluate the precision of the Automatic Glycohemoglobin Analyzer ADAMSTM Alc HA-8160. Methods Precision study was performed according to CLSI EPS-A2 guidelines,two（high and normal） levels of quality control materials were analyzed. Results For high and normal level quality control materials,the withrun CVs were 0.97% and 1.45% ,the between-run CVs were 0.62% and 0.34% ,the between-day CVs were 0.63% and 0.56% ,and the total CVs were 1.31% and 1.59%, respectively. Conclusion The ADAMSTM Alc HA-8180 HbAlc analyzer showed excellent precision,which could meet the requirements of clinical test.