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测定结果回归等式为Y=－0.39+1.00×X，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测定结果回归等式为Y=－2.23+1.02×X，截距95% CI －1.16～－4.4.8，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。

Objective  To evaluate the detecting difference among three lots of ELISA kit for residual host cell protein (HCP) from same manufacturer using Passing-Bablok regression. Methods  ELISA kits from A, B, and C lots were applied to detect different sample HCP concentrations within kit labeled range. Data were analyzed with Passing-Bablok regression. Results  Correlation coefficients between measurements by lots A and B and by lots A and C were both >96% with P<0.01. The linear regression equation between A and B was Y=－0.39+1.00×X with 95% confidence interval (CI) of －0.67-－0.24 for intercept and 1.00-1.01 for slope. The linear regression equation between A and C was Y=－2.23+1.02×X, with 95% CI of －1.16-－4.48 for intercept and 1.00-1.04 for slope. Conclusions  The results by lot A are in accordance with those by lot B, but not lot C. The application of Passing-Bablok regression is feasible to assess kit lot-to-lot difference.