Based on Canadian regulations, every unit of plasma should test negative for all transmissible disease markers before it is released for use in further manufacturing.
The regulation requires negative test results for:
- Antibody to Human Immunodeficiency Virus (HIV) 1 and 2
- HIV Nucleic Acid Testing (NAT Test)
- Antibody to Hepatitis C Virus (HCV)
- HCV NAT Test
- Antibody to Hepatitis B Virus surface antigen (HBsAg)
- Serological test for Syphilis
Although not a regulatory requirement but as an industry standard the following tests are also conducted:
- Hepatitis B Virus (HBV) nucleic acid testing - (not a regulatory requirement)
- Hepatitis A Virus (HAV) - nucleic acid testing - (not a regulatory requirement)
- Parvovirus B19 - nucleic acid testing - (not a regulatory requirement)
To learn more about the antibody and NAT testing click here
These tests are performed to ensure the pharmaceutical products derived from the plasma collected in our centres are of the highest quality.
In addition to the disease marker testing, donor’s blood is closely monitored for protein levels to maintain their health and for their safety. Total protein concentration in donor’s serum is quantified every time they donate. Also every four months the composition of their blood proteins is evaluated through serum protein electrophoresis tests.