| 摘要: |
| ［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。 |
| 关键词: 临床试验 全自动血细胞分析仪 仪器比对 |
| DOI：10.3969/j.issn.1674-3806.2011.12.17 |
| 分类号:R 446.11 |
| 基金项目: |
|
| Multicenter clinical trials on the automated hematology analyzer URIT-3010 |
|
QIN Gui-fang，QIN Xue，MO Zhi-jiang，et al.
|
|
Department of Clinical Labortories,the People′s Hospital of Guangxi Zhuang Autonomous Region,Nanning 530021,China
|
| Abstract: |
| ［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. |
| Key words: Clinical trials Automated hematology analyzer Instrument comparison |
