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目的:对ELISA法测定甲型H1N1流感病毒裂解疫苗中卵清蛋白含量不确定度进行评定分析。方法:按照卵清蛋白检测试剂盒说明书对甲型H1N1流感病毒裂解疫苗中卵清蛋白含量进行测定。根据《测量不确定度评定与表示》(JJF1059-1999)中有关规定对测量结果中带来的各个不确定度进行分析、评定和量化。结果:量化各个不确定度分量,提出了该法的合成不确定度评估结果。结论:该法测定甲型H1N1流感病毒裂解疫苗中卵清蛋白含量的扩展不确定度U=0.68 ng.mL-1(k=2)。
OBJECTIVE: To evaluate the uncertainty of the determination of ovalbumin in ELISA method for influenza A (H1N1) virus lytic vaccine. Methods: The content of ovalbumin in influenza A H1N1 influenza virus vaccine was determined according to the instructions of ovalbumin test kit. According to “Measurement Uncertainty Evaluation and Expression” (JJF1059-1999) in the relevant provisions of the measurement results of the various uncertainty analysis, assessment and quantification. Results: The components of each uncertainty were quantified and the results of the evaluation of the proposed method were proposed. Conclusion: The extended uncertainty U = 0.68 ng.mL-1 (k = 2) for the determination of ovalbumin in influenza A (H1N1) influenza virus vaccine by this method.