Current situation and some problems in research and development of biological products

In developed countries, nucleic acid detection of hepatitis C virus (HCV) and human immunodeficiency virus (HIV) has been used for screening of blood donors, which plays an important role in the elimination of infectious blood and the occurrence of TTI. In Asia, Japan is the world's first nationwide on blood HBV, HCV, 1 NAT screening countries. In Europe, from 1997 onwards has been in some countries manufacturers began to use NAT for plasma screening, in 1999 the EU promulgated regulations require direct separation and detection of HCV RNA in plasma, and then increase the HIV-1 RNA. In the ninety 's of the last century, the United States Industry and NIH, FDA, HIV - 1 and HCV - and NAT detection system. 2001, the FDA approved the first for raw plasma screening of HIV-1 NAT reagents and HCV NAT reagents (by national Genetics Institute Development). In 2004, the FDA issued guidelines and requirements of the guidelines issued 6 months enterprise of blood products and blood of NAT whole blood and blood components of HIV-1 and HCV nucleic acid screening work.