摘要
目的探讨不同血细胞分析仪检测结果的可接受性,为临床提供准确、可比的血细胞检验结果。方法参考NCCLS(美国临床实验室标准化委员会)颁布的EP9-A2文件,在5台血细胞分析仪(Sysmex XE-2100、Beckman-Coulter ACT5.diff、2台Sysmex K-4500和Coulter ACT.diff2)均处于正常状态下,双份检测新鲜抗凝全血,获取白细胞计数(WBC)、红细胞计数(RBC)、血红蛋白浓度(Hb)、血细胞比容(Hct)和血小板计数(PLT)检测数据,与参加卫生部室间质评并可溯源的血细胞分析仪(Sysmex XE-2100)比较,建立回归方程,以医学决定水平或参考值作为自变量(X)计算偏倚,以1/2CLIA′88允许误差为标准判断偏倚是否可接受。结果在WBC的医学决定水平为3.0×109/L及11.0×109/L时,其偏倚均小于或等于1/2CLIA′88允许误差范围(7.5%);在RBC参考区间下限4.0×1012/L及上限5.5×1012/L处,其偏倚均小于或等于1/2CLIA′88允许范围(3.0%);在Hb的医学决定水平为45g/L及230g/L处,除Coulter ACT.diff2分析仪(偏倚为3.7%)外,其他仪器的偏倚均小于或等于1/2CLIA′88允许范围(3.5%);在Hct参考区间下限0.40处,只有K4500-1分析仪可比(偏倚为2.80%,小于或等于1/2CLIA′88标准3.0%),在Hct参考区间上限0.50处,5台仪器Hct结果均不可比;在PLT的医学决定水平为100×109/L及600×109/L时,其偏倚均小于或等于1/2CLIA′88允许范围(12.5%)。结论 相同实验室使用不同血细胞分析仪检测血液样本时,应定期执行比对试验,以便为临床疾病的诊疗提供准确、可比的血细胞检验数据。
Objective To evaluate the acceptability of the results determined by different hematology analyzers,and apply accurate and comparable test data for the clinic.Methods By reference to EP9-A2 document issued by National Committee for Clinical Laboratory Standards（NCCLS） and under the condition that 5 hematology analyzers were normal,anticoagulant fresh whole blood samples were examined in duplicate,and the test data of WBC,RBC,Hb,Hct and PLT were compared with the results determined by traceable hematology analyzer,and regression equations were established.At the same time,medical decision levels（MDL） or reference values were introduced as independent variables in order to calculate biases,1/2 allowable errors of CLIA′88 were employed to judge whether the bias was acceptable or not.Results At MDL of 3.0×109/L and 11.0×109/L,the biases in WBC analysis were less than 1/2 allowable errors of CLIA′88;the biases in RBC analysis were less than 1/2 allowable errors of CLIA′88 when lower limit and upper limit of reference interval were 4.0×1012/L and 5.5×1012/L respectively;At MDL of 45 g/L and 230g/L,the biases in Hb analysis were acceptable except for Coulter ACT.diff2 analyzer;the only acceptable result in Hct analysis was the bias of K4500-1 analyzer when lower limit of reference interval was 0.4,all biases in Hct analysis were unacceptable when upper limit was 0.5;At MDL of 100×109/L and 600×109/L,the biases in PLT analysis were acceptable for all analyzers.Conclusion Periodic comparative test should be performed in order to obtain reliable and comparable test results when different hematology analyzers in the identical laboratory are applied to analyze blood samples.
出处
《检验医学与临床》
CAS
2011年第15期1795-1797,共3页
Laboratory Medicine and Clinic
