Safety / Quality Services
All donor tissue is recovered, processed, and distributed according to standards established by the American Association of Tissue Banks. Donor screening exclusion criteria is performed via donor physical inspection, interview with a person who knew the donor, review of available medical records, and a review of autopsy findings (when applicable). Individuals considered to be at high risk for AIDS or hepatitis as defined by the FDA and CDC are excluded from donation.
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Details
Using FDA licensed, approved, or cleared test kits in a laboratory registered with the FDA and certified under CLIA or equivalent requirements, a serum sample from the donor has passed a hemodilution review and tested non – reactive for the following:
- Human immunodeficiency virus antibody (anti -HIV1 and anti -HIV2)
- Nucleic acid test (NAT) for HIV- 1
- Hepatitis B surface antigen (HBsAg)
- Total antibodies to Hepatitis B core antigen (anti – HBc-total, IgG/ IgM)
- Antibodies to the Hepatitis C virus (anti -HCV)
- Nucleic acid test (NAT) for HBV and HCV
- Rapid plasma reagin (RPR) or serological tests for syphilis (STS).
Based on all the screening and testing results all donated human tissues will be determined to be suitable for transplant by the Medical Director and Quality Assurance.
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