Materials for the development and certification of a standard sample for anti-D antibody contents in human immunoglobulin drugs are presented. Preparation of the negative component of the standard sample from blood plasma of Rh-positive group IV(AB) donors without anti-D antibodies; the positive component, from blood plasma of Rh-negative group IV(AB) donors is justified. The immunoglobulin should be concentrated to produce a solution with protein contents in the range 48 – 51 mg/mL and anti-D antibody titer 1:8. Flow cytofluorimetry is shown to allow standardization of the preparation of the standard sample positive component.

中文翻译：

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用于测定人免疫球蛋白制剂中抗 D 抗体含量的标准样品的开发和认证

介绍了用于开发和认证人免疫球蛋白药物中抗 D 抗体含量标准样品的材料。无抗D抗体的Rh阳性IV(AB)组供者血浆标准样品阴性成分的制备；来自 Rh 阴性 IV(AB) 组供者血浆的阳性成分是合理的。应浓缩免疫球蛋白以产生蛋白质含量范围为 48 – 51 mg/mL 且抗 D 抗体效价为 1:8 的溶液。流式细胞荧光法显示允许标准样品阳性成分的制备标准化。