摘要目的:应用ACL-TOP300全自动凝血仪建立人凝血因子Ⅷ效价测定方法并验证。方法:根据基于人凝血因子Ⅷ国家标准拟修订中国药典2020年版三部一期法要求，应用ACL-TOP300全自动凝血仪建立符合修订要求的人凝血因子Ⅷ效价测定方法，并与同类型设备比较置信区间、可信限率、误差项和平行管重复性。结果:建立的方法准确度和精密度良好；方法回收率为91.0%～96.4%，重复性和精密度的相对标准偏差均<5%；与主流检测设备相比，ACL-TOP300具有平行管差异小、误差项小和置信区间窄的特点。结论:用ACL-TOP300全自动凝血仪建立的人凝血因子Ⅷ效价测定方法的准确度、精密度、置信区间和可靠性均满足中国药典2020年版三部修订稿和国家标准要求。

abstractsObjective:To establish and validate human coagulation factor Ⅷ(FⅧ) potency measurement method using ACL-TOP300 automatic coagulation analyzer.Methods:According to new requirements of one-stage clotting method in the amended Chinese pharmacopoeia 2020 (volume Ⅲ) based on FⅧ national standard, the performances of the instrument and new established method were evaluated, including confidence interval, confidence-limit rate, random error term and repeatability between parallel tubes.Results:The established method demonstrated good accuracy and precision.The standard recoveries were between 91.0% and 96.4%. The relative standard deviations of repeatability and intermediate precision were both lower than 5%. Compared with the mainstream device, ACL-TOP300 demonstrated higher repeatability between parallel tubes, lower random error terms and narrower confidence interval.Conclusion:The accuracy, precision, confidence interval, and repeatability of the established FⅧ potency measurement method using ACL-TOP300 automatic coagulation analyzer all meet requirements in the amended Chinese pharmacopoeia 2020 (volume Ⅲ) and national standard.