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《Chinese Journal of Blood Transfusion》 2003-05
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Establishment of the method of nucleic acids amplification test for HCV/HZV-1 ofpooled source plasma

Bai Jianshi,Wang Wei,Zhu Wensi.National Institute for the Control of Pharmaceutical and Biological Products,Beijing,100850,China  
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
【Fund】: 国家发展计划委员会国家高技术应用部门发展项目 ( 2 0 0 1 5 64 )
【CateGory Index】: TQ464
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