Dunn C D, Napier J A
Exp Hematol. 1978 Aug;6(7):577-84.
Quantitative erythropoietin determinations can only be obtained after the examination of both Standard and Test materials in a multiple dose parallel line bioassay with appropriate statistical control. The expression of results in erythropoietin units (implying quantitation) in the absence of similar dose-response relationships for Standard and Test materials can lead to errors in the estimated potency which differ markedly from the true potency. Results obtained from one-dose test systems cannot therefore be considered quantitative. Criteria which allow valid quantitation of bioassay results are discussed. Where these cannot be fulfilled, it is suggested that the results should be expressed only in terms of the measured parameter, e.g. 59Fe uptake, per constant volume of test solution.
只有在多剂量平行线生物测定中对标准品和供试品进行检测并进行适当的统计控制后,才能获得促红细胞生成素的定量测定结果。在标准品和供试品不存在相似剂量反应关系的情况下,以促红细胞生成素单位(意味着定量)表示结果,可能会导致估计效价出现误差,该误差与真实效价显著不同。因此,从单剂量测试系统获得的结果不能视为定量结果。文中讨论了能够有效定量生物测定结果的标准。如果无法满足这些标准,建议结果仅以每恒定体积测试溶液的测量参数(例如59Fe摄取量)来表示。