BC-6800全自动血细胞分析仪临床性能评价

Clinical performance testing of BC-6800 automatic hematology analyzer

目的验证BC-6800全自动血细胞分析仪的性能是否适用于常规分析。方法参考卫生部的行业标准,采集236例EDTA抗凝新鲜静脉全血,分别对仪器的携带污染、精密度、结果比对、正确度、准确度、线性、参考区间、乳糜干扰、白细胞分类进行验证。结果 2种模式的携带污染率为0%-0.37%,WBC、RBC、HGB及PLT的批内精密度分别为0.75%-2.17%、0.36%-0.53%、0%-0.51%、1.08%-3.76%,批间精密度分别为0.77%-3.09%、0.62%-1.72%、0.45%-1.90%、0.62%-4.83%;校准合格后,模式间的相对偏差分别为0.56%、0.15%、0.58%、1.44%;正确度及准确度均符合标准;与XE-5000进行相关性分析,4个参数的相关系数r分别为0.9999,0.9996,0.9999,0.9995;参考区间均能符合要求;乳糜干扰实验表明,WBC、RBC、HGB在甘油三酯浓度低于13.30 mmol/L时无明显干扰,而PLT在低于10.64 mmol/L时无明显干扰;NEU%、LYM%、MON%、EOS%和BAO%的形态学符合率分别为94%、95%、96%、100%和97%。结论 BC-6800的性能达到标准要求,可用于常规检测。

Objective To evaluate the clinical performance of BC-6800 automatic hematology analyzer in regular analysis.Methods According to the medical industrial standards,236 fresh EDTA anticoagulated venous blood samples were collected to verify the trueness,accuracy,precision,contamination,linearity,reference interval,interference of chyle of BC-6800,as well as the WBC differential count.Results For background testing,contamination rates of the automatic mode and open mode ranged from 0 to 0.37%.The within-run precision of WBC,RBC,HGB and PLT of the two modes were 0.75% - 2.17%,0.36% - 0.53%,0 - 0.51%,1.08% - 3.76%,respectively,while the between-run precision were 0.77 % - 3.09%,0.62% - 1.72%,0.45% - 1.90%,0.62% - 4.83%,respectively.Relative calibration deviations of WBC,RBC,HGB and PLT for two modes were 0.56%,0.15%,0.58%,1.44%,respectively; Trueness and accuracy were all qualified.Correlation analysis of BC-6800 and XE-5000 for WBC,RBC,HGB and PLT were excellent,and r values were 0.9999,0.9996,0.9999,0.9995,respectively.Reference intervals were all in accordance with the standard.There was no significant interference for WBC,RBC,HGB when chyle concentration was below 13.30 mmol /L,and PLT was stable when chyle concentration was below 10.64 mmol /L.Consistency of NEU%,LYM%,MON%,EOS%,BAO% between BC-6800 and morphology method were 94%,95%,96%,100%,97%,respectively.Conclusion The clinical performance of BC-6800 was capable of the routine blood test.