Branović K, Forcis D, Kosutic-Gulija T, Santak M, Zgorelec R, Mazuran R
Institute of Immunology, Zagreb, Croatia.
J Chromatogr A. 1999 Aug 6;852(1):305-12. doi: 10.1016/s0021-9673(99)00468-9.
The viral safety of plasma-derived products with respect to hepatitis C virus (HCV) is assured by selection of donors, screening of individual donations for antibodies to HCV and the incorporation of effective viral inactivation-removal steps into manufacturing processes. As antibody screening of single donations is not sufficient to completely eliminate HCV RNA positive plasmas from plasma pools, testing for HCV RNA by gene amplification techniques may be necessary to identify positive donations. Using modern molecular biology techniques, we developed a specific, sensitive and reproducible method for routine PCR screening for HCV RNA in plasma pools.
通过供体选择、对每份捐献进行丙型肝炎病毒（HCV）抗体筛查以及在生产过程中采用有效的病毒灭活去除步骤，可确保血浆源产品在丙型肝炎病毒（HCV）方面的病毒安全性。由于对每份捐献进行抗体筛查不足以从血浆库中完全消除HCV RNA阳性血浆，因此可能需要通过基因扩增技术检测HCV RNA，以识别阳性捐献。利用现代分子生物学技术，我们开发了一种特异、灵敏且可重复的方法，用于对血浆库中的HCV RNA进行常规PCR筛查。
