论文部分内容阅读
通过对冻干低pH静注免疫球蛋白成品的检测和临床使用观察,发现对献血者进行抗-HCV抗体筛选,可使成品抗-HCV阳性率大幅度降低。由于筛选方法的限制和HCV感染后空窗期的存在,合并后的原料血浆污染HCV在所难免;冻干低pH静注免疫球蛋白成品无论其抗-HCV是阴性还是阳性,PCR检测HCV-RNA均为阴性的实验结果提示制备工艺过程可以去除HCV。临床初步观察和回顾性调查中均未发现HCV传播的迹象。
Through the freeze-dried low pH intravenous immunoglobulin product testing and clinical observation, we found that anti-HCV antibody screening for blood donors, finished products can significantly reduce the positive rate of anti-HCV. Due to the restriction of the screening method and the presence of empty windows after HCV infection, it is unavoidable that the pooled raw plasma-contaminated HCV is ineffective; freeze-dried low pH intravenous immunoglobulin products whether negative or positive for anti-HCV, The RNA negative results suggest that the preparation process can remove HCV. No evidence of HCV transmission was found in both clinical and retrospective studies.