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Plasma Pool Testing
Manufacturing
- Plasma Pool Testing
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Partitioning/Fractionation
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Virus Inactivation
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Virus Elimination
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Virus Validation
Prior to further processing, each plasma pool is tested for the presence of viruses. The plasma is only used if it is non-reactive for the listed serological markers and for the virus genome (NAT). We test each plasma pool for the following serological markers: anti-HIV 1, anti-HIV 2, hepatitis B surface antigens, anti-HCV antibodies. In other words, we test each plasma pool for HIV antibodies, Hepatitis B antigens and Hepatitis C antibodies. We also test each plasma pool for the following virus genomes using NAT/PCR testing: Hepatitis A virus, Hepatitis B virus, Hepatitis C virus, HIV-1, B19 virus.
Serological Markers |
Virus Genome (NAT) for DNA or RNA |
| HIV-1 antibodies |
Hepatitis A Virus* |
| HIV-2 antibodies |
Hepatitis B Virus |
| Hepatitis B antigens |
Hepatitis C Virus (mandatory in EU) |
| Hepatitis C antibodies |
HIV-1 |
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B19 Virus* |
*Some plasma pools are not NAT-tested for Hepatitis A or B19 virus.
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