Tissue Processing & Safety
All donor tissue that arrives at AlloSource has unique characteristics. Tissue processing is therefore individualized by design and starts with intense, dedicated visual and physical inspection of each tissue. Our specialized, highly trained technicians closely inspect the tissue in preparation for our proprietary cleansing process, AlloTrue™, and ensure the tissue is treated with the highest quality processes from start to finish. Also, in order to ensure the AlloSource staff stay current on surgical procedures and special surgical needs, our committed technicians interact often with the surgeons who transplant the tissue.
Learn more about our AlloTrue Cleansing Process→
Pre Screening & Testing
Before tissue is processed, serological and microbial testing takes place. Tissue is subjected to microbiological testing at recovery and must be free of specific aerobic/anaerobic microorganisms and fungal contaminants whose presence would preclude tissue from processing or transplantation.
Communicable disease testing for each donor is performed by a laboratory registered with FDA and certified to perform such testing on human tissue in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493. AlloSource maintains all testing records, which include, but are not limited to:
- Antibody to Human Immunodeficiency Virus 1 & 2 (HIV 1 & 2)
- Human Immunodeficiency Virus Type 1 (HIV-1 NAT)
- Antibody to Hepatitis C (HCV)
- Hepatitis C Virus (HCV NAT)
- Hepatitis B Core IgG/IgM Antibody (HBcAb)
- Hepatitis B Surface Antigen (HBsAg)
- Rapid Plasma Reagin or Serologic Test For Syphilis (RPR or STS)
A list of additional communicable disease tests performed is provided upon request.
Post Processing Testing
After processing is complete, additional microbial verification takes place where tissue is once again tested for contamination, assessed for acceptability and packaged. Tissue must be free of specific aerobic/anaerobic microorganisms and fungal contaminants whose presence would preclude tissue from transplantation. While the exact process differs depending on the allograft produced, each piece of tissue is:
- Sampled for final microbial testing using swab cultures, destructive tests or fluid extraction
- Evaluated to a specification to ensure graft acceptability
- Packaged in a sealed, sterile pouch
- Labeled with: donor, tissue, product IDs, size, description, expiration date and storage instructions