[An enhanced viral safety of blood preparations]

Inactivation or elimination of (possibly) contaminated viruses from a pool of prepared several hundreds or thousands of donor-blood samples are an obligatory stage in the donor-blood preparation process. Virus-inactivation is verified through contaminating the basic material with viruses. The quality control of blood preparations, according to the Russian compulsory regulations, must include the testing of ready blood-based drugs for a lack of antibodies to HIV, hepatitis C virus and hepatitis B virus by using the test systems, which could not be exactly designed for the above purpose. Therefore, the below tasks are vital for the Russian Blood Service: 1) cancellation of the norm (belonging to the regulations of the quality control of blood preparations) to test the blood preparations for a lack of antibodies to HIV, hepatitis C virus and to the surface antigen of hepatitis B virus because it is biologically inexpedient and has no analogues in the world practice; 2) introduction of the virus-inactivation methods into the practice of plasma processing; 3) establishment of a special center that would evaluate the efficiency of the virus-inactivation methods used by producers of blood-based preparations; and 4) introduction of the methods of genetic testing of HIV, hepatitis B and C viruses into monitoring the quality of donor-sera pools that are later used in preparations' manufacturing.