干式血细胞分析仪临床性能评价

目的通过与希思美康（SysmexXE-2100D）全自动血液分析仪的比对,分析干式血细胞计数仪（QBCRD）各项指标的临床诊断性能。方法采用双盲的方法对2台仪器检测的白细胞（white blood cell,WBC）、血红蛋白（hemoglobin,HB）、血小板（platelets,PLT）、红细胞比容（hematocrit,HCT）、粒细胞绝对值（granulocyte absolutely count,GRAN）、淋巴细胞及单核细胞绝对值（lymphocyte/monocyte absolutely count,LY/MO）等6个参数进行比对,对仪器的精密度进行检测,计算线性回归方程及配对t检验。结果 QBCRD干式血细胞计数仪6项参数指标的CV均小于5%,表明该仪器精密度良好。2台仪器相关性显示WBC、HB、PLT、HCT、GRAN及LY/MO的结果相关性较好（r2分别为0.98、0.98、0.98、0.95、0.99和0.96）,配对t检验,P值大部分均大于0.05,说明比对仪器与参考仪器6项检测结果之间差异无统计学意义。结论 QBCRD干式血细胞计数仪与SysmexXE-2100D全自动血液分析仪各参数之间测定结果一致,具有可比性。该仪器适合于部队野战医院、现场急救等情况下使用。

Evaluation on performance of dry-type blood cell analyzer

Objective A comprehensive performance evaluation was done for dry-type blood cell analyzer （ QBCRD ） based on comparison with Sysmex XE-2100D Blood cell analysis system.Methods White blood cell, hemoglobin, platelet, hematocrit, granulocyte absolute count , lymphocyte absolute count , and monocyte absolute count were tested by QBCRD and Sysmex XE-2100 D blood cell analysis system in double-blind trail.Precision of QBCRD was calculated , and also the linearity regression equation , paired T-test. Results CVs of the above 6 parameters were all less than 5%, showing a good precision .Good correlation with Sysmex XE-2100 D blood cell analysis system in the above 6 parameters（r2：0.99, 0.98, 0.98, 0.95, 0.99 and 0.96）.There was no significant difference between QBCRD and Sysmex XE-2100 D blood cell analysis system in the above 6 parameters based on P value of paired T-test are all above 0.05.Conclusion All the items evaluated in QBCRD were highly correlated with System XE-2100D automated blood cell analysis system.QBCRD dry method blood cell analyzer is suitable for field hospital of army or on-the-spot first aid.