Email this article An enhanced viral safety of blood preparations
- Issue: Vol 49, No 4 (2004)
- Pages: 46-48
- Section: Articles
- Submitted: 09.06.2023
- Published: 15.08.2004
- URL: https://virusjour.crie.ru/jour/article/view/11863
- ID: 11863
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Abstract
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 С virus and hepatitis В 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 С virus and to the surface antigen of hepatitis В 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 В and С viruses into monitoring the quality of donor-sera pools that are
later used in preparations' manufacturing.
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 С virus and hepatitis В 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 С virus and to the surface antigen of hepatitis В 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 В and С viruses into monitoring the quality of donor-sera pools that are
later used in preparations' manufacturing.
References
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СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).