应用Passing-Bablok回归对试剂盒批间检测差异性的评估

被引：1
|
作者：
李黎
施金荣
郭靖
杨爽
机构：
[1] 武汉生物制品研究所有限责任公司质量控制室
来源：
国际生物制品学杂志 | 2020年 / 43卷 / 04期
关键词：
回归分析; 试剂盒; 宿主细胞蛋白残留; 一致性;
D O I：
暂无
中图分类号：
TH789 [其他医疗器械];
学科分类号：
摘要：
目的用Passing-Bablok回归分析同一厂家不同批次宿主细胞蛋白(host cell protein, HCP)残留检测试剂盒测量差异性。方法用3个不同批次(A、B、C)试剂盒在检测浓度范围内测定不同浓度样品的HCP残留。应用Passing-Bablok回归分析测定结果。结果批次A与批次B、C之间测量结果相关系数均>96%(P<0.01)。批次A和B测定结果回归方程为Y=-0.39+1.00X, 截距95%置信区间(confidential interval, CI)-0.67～0.24, 斜率95% CI 1.00～1.01;批次A和C测定结果回归方程为Y=-2.23+1.02X, 截距95% CI-4.48～-1.16, 斜率95%CI 1.00～1.04。结论批次A和B测定结果一致性良好, 批次A与C测定结果存在误差。Passing-Bablok回归可用于不同批次间试剂盒检测差异性分析。
引用
收藏
页码：181 / 184
页数：4
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