EpiFix® Donor Testing
Screening
To ensure patient safety, donor screening and testing is performed for each donor mother. Donor screening includes a review of both the donor's medical and social history to ensure that the donor has not engaged in behaviors that place her at an increased risk for the transmission of infectious disease, and to ensure that the donor has not shown signs or symptoms of illnesses.
Testing
In addition, each donor is tested for the following infectious diseases:
- HIV Type 1 antibody
- HIV Type 2 antibody
- HTLV Type 1 antibody
- HTLV Type 2 antibody
- Hepatitis C antibody
- Hepatitis B surface antigen
- Hepatitis B core total antibody
- Serological Test for Syphilis
- HIV Type 1 Nucleic Acid Test
- Hepatitis C Virus Nucleic Acid Test
- CMV Total Antibody
Quality Assurance
All screening and testing results are reviewed according to the Company's Quality Management System, which is designed to meet the requirements specified in the FDA's Good Tissue Practice regulations and in the standards of the American Association of Tissue Banks. All screening and testing records are reviewed and accepted by QA personnel before being forwarded to our Medical Director, a recognized expert in infectious disease testing. Only tissue from donors that test negative or non-reactive for the presence of infectious diseases, are accepted for transplant.
The Company is registered with the Food and Drug Administration and a licensed tissue bank in the states of California and New York. The company is compliant with the tissue bank guidelines of the American Association of Tissue Banks as well as all Federal, State and local regulations.
