Immediately following donation, the plasma is deep-frozen and subjected to a series of tests to determine if the donor has been exposed to potential pathogens.1
Rigorous virus clearance testing verifies safety throughout the manufacturing operation. The manufacturing process for Talecris Biotherapeutics Albumin Products has been shown to provide a high level of clearance of both enveloped and non-enveloped viruses.2
In March 2004, Talecris Biotherapeutics became the first plasma fractionator approved by the FDA to perform in-house nucleic acid testing (NAT) of HIV in plasma donations. This testing further confirms the safety of our plasma donations. This is just another way that we at Talecris Biotherapeutics reinforce the strict standards already in place for our screening and donation process.
PCR Testing
In addition to standard antigen and antibody testing, Talecris Biotherapeutics uses state-of-the-art nucleic acid testing (NAT) technology to test the plasma units for HIV, HBV, HCV, and parvovirus B19 genetic material. These polymerase chain reaction (PCR)-based tests help reduce the "window period" during which infection is present, but detectable levels of virus antigens or antibodies have not yet developed.3
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Standard Test for Virus Markers*
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Disease of Infection
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Test
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HIV
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HIV-1/HIV-2 antibodies
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HBV
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Hepatitis B virus surface antigen
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HCV
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Hepatitis C virus antibodies
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*All tests are conducted in an FDA-licensed and approved laboratory.
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References:
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Council of Europe, Public Health Committee. Human Plasma for Fractionation.1998. Resolution AP-CSP (98) 11.
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| 2. |
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Remington KM, Petteway SR Jr. Comprehensive pathogen safety management for Plasbumin. Pediatr Crit Care Med. 2001;2(suppl):S23-S27.
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| 3. |
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Roth WK, Weber M. Seifried E. Feasibility and efficacy of routine PCR screening of blood donations for hepatitis C virus, hepatitis B virus, and HIV-1 in a blood-bank setting. Lancet. 1999;353:359-363.
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