【摘要】 目的探讨全自动血细胞分析仪的多中心临床试验方法。方法使用试验仪器(URIT-3010)和对照仪器(XE-2100和COULTER LH750)分别检测血液样本的白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、平均红细胞体积(MCV)和血小板(PLT)项目,并计算两者相对误差的绝对值(Se)作为主要有效指标,得出Se的平均值及其95%置信区间(CI),再与国家食品药品监督管理局(SFDA)规定的容许误差进行比较。结果 WBC、RBC、HGB、MCV和PLT项目的Se平均值的95%置信区间上限均低于SFDA规定的容许误差。结论 URIT-3010等效于对照仪器XE-2100和COULTER LH750。更多还原

【Abstract】 Objective To explore the multicenter clinical trials on the automated hematology analyzer. Methods Trial instrument (URIT-3010) and control instruments(XE-2100 and COULTER LH750) were used for measuring the WBC , RBC, HGB, MCV and PLT of the blood samples respectively, calculating the absolute value of relative error (Se) as major indicators of effect to calculate the mean value of Se and 95% confidence intervals of the average. The results were compared to the admissible error regulated by state food and drug administration (SFDA). Results The upper limits of 95% confidence interval of the mean value of Se for WBC、RBC、HGB、MCV and PLT were all lower than those of the admissible error regulated by, SFDA. Conclusion URIT-3010 is equivalent to the control instruments XE-2100 and COULTER LH750.更多还原