国产与进口血细胞分析仪检测结果可比性分析

Detection Results of Domestic and Imported Blood Cell Analyzer Comparability Analysis

目的研究国产血细胞分析仪迈瑞BC5180与进口血细胞分析仪Sysmex XE-2100检测结果的可比性。方法根据美国临床化学标准化委员会(NCCLS)标准化文件EP9-A的要求,以Sysmex XE-2100为基准,分别测定40例患者当日标本不同浓度水平的白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、血小板(PLT),计算两种方法的回归方程、相关系数及在医学决定水平处的相对偏差(SE%),以美国临床实验室改进法案修正案(CLIA'88)中能力验证对检测项目的分析质量要求的可接受范围的1/2为标准,评估结果之间的可比性。结果迈瑞BC5180检测WBC、RBC、Hb、PLT的结果与Sysmex XE-2100比较具有相关性(r>0.975,SE%均在判断标准内)。结论国产仪器可代替进口仪器,以此可节约医疗成本,得到更大的社会和经济效益。

Objective To study the comparability of the test results between domestic Mindray BC5180 blood cell analyzer and imported Sysmex XE-2100 blood cell analyzer. Methods According to the standard document EP9-A of National Committee for Clinical Laboratory Standards （NCCLS）, based on Sysmex XE-2100, the specimens were measured respectively in 40 patients with different levels of white blood cells （WBC）, red blood cell （RBC）, hemoglobin （Hb） and platelets （PLT）. The two methods of regression equation to calculate the correlation coefficient and the relative deviation in the medical decision level （SE%）, to the American Clinical Laboratory Improvement Act Amendments （CLIA＇88） validation of analytical quality test items acceptable range requires 1/2 as a standard to evaluate comparability between the results. Results The datas of WBC, RBC, Hb, PLT from BC5180 analyzer and Sysmex XE-2100 analyzer showed excellent correlation （r 〉 0.975, all SE% within the judgment standard）. Conclusions Domestic blood cell analyzer can replace imported, so as to save medical cost and get more social and economic benefits.