Advances in securing viral safety for plasma products / 军事医学

Plasma products are considered to be special medicinesderived from healthy human plasma .During 1980′s, events of transmission of human immunodeficiency virus through plasma products were frequently reported .Since then, ensuring the viral safety of plasma products has raised great concerns all over the world .So far, with decades of effort , most countries in the world have established rigorous systems with preventive measures to ensure the viral safety of plasma prod -ucts.These measures include control of source plasma , validated inactivation/removal of infectious agents , the adherence to current good manufacturing practices .Nevertheless , new infectious agents which may be threats to viral safety require continuous studies on appropriate countermeasures .

Establishment of the method of nucleic acids amplification test for HCV/HZV-1 ofpooled source plasma / 中国输血杂志

Objective To construct the method of nucleic acids amplification test(NAT) for transfusion-transmitted viruses of source plasma.Methods Domestic fluorescence PCR kits for HCV RNA and HIV1 RNA amplification were implemented to assay of sensitivity,reproducibility and robustness of WHO international standards,and then 19196 ELISA negative plasma samples collected from four manufacturers of plasma derivatived were tested for HIV RNA and HCV RNA by NAT.Results The amplification system which had been constructed could assure the detection limits for high copies (200 IU/ml) of nucleic acids from WHO international standard ,and the detection limits for lower than 100 IU/ml of nucleic acids gradually reduced.None of HCV-RNA and HIV/1-RNA was detected in these samples.Conclusion The system of nucleic acids amplification test could be used fuo screening of transfusion-transmitted viruses in source plasma