- Microbiologic cultures are taken from each tissue
- All donor records are reviewed by our Medical Directors to determine donor eligibility for transplantation.
- To maintain biological integrity, we process all tissue by using aseptic techniques in Class 100 environments
- Selected tissues are terminally sterilized by electron beam radiation
- All tissues undergo multiple, separate quality assurance checks prior to release to ensure utmost quality and safety
- Traceability is maintained for all tissues from recovery through testing, processing, packaging, and distribution
- HIV-1/2 Plus O Antibodies (HIV-1/2 Plus O Ab)
- Nucleic Acid Test for HIV-1 RNA (HIV-1 NAT)
- HBV Surface Antigen (HBsAg)
- HBV Core Antibody (IgG & IgM) (HBcAb)
- Nucleic Acid Test for HBV DNA (if performed) (HBV NAT)
- HCV Antibody (HCVAb)
- Nucleic Acid Test for HCV RNA (HCV NAT)
- Rapid Plasma Reagin (RPR) Screen
- T. Pallidum Ig
*A donor whose blood specimen is unsuitable for the non-treponemal screening assay, such as the RPR test, or with a reactive result from the non-treponemal screening assay, is cleared for transplantation use only when the result from the treponemal-specific (confirmatory) assay is nonreactive.
Screening tests for exposure to other viruses or parasites such as those listed below may have been completed:
- CMV Ab (IgG & IgM)
- EBV Ab (IgG & IgM)
- HTLV-I/II (Antibody HTLV-I/II-Ab)
- Toxoplasma Ab (IgG &IgM)
- T. cruzi Ab (IgG & IgM)
- Nucleic Acid Test for WNV RNA (WNV NAT)
- Zika Ab (IgM)
- Nucleic Acid Test for Zika RNA (Zika NAT)
**A donor with a reactive result for the CMV or HTLV-I/II Antibody test is suitable for use only when the result from a confirmatory assay is nonreactive.
VIVEX Biologics Canada Registration Expires 12.31.2024
VIVEX Biologics AATB Accreditation Expires 7.06.25
VIVEX Biologics FDA Registration Expires 12.31.2024
VIVEX Biologics Delaware Registration Expires 4.30.2025
VIVEX Biologics California License Expires 11.15.2025
VIVEX Biologics Maryland Permit No Expiration
VIVEX Biologics Illinois Registration Expires 5.01.2025
VIVEX Biologics New York License Expires 2.01.2025
VIVEX Biologics Oregon License Expires 3.18.2027
VIVEX Biologics Louisiana License Expires 12.31.2024
VIVEX Biologics ISO 9001:2015 Registration Expires 01.16.2025
VIVEX Biologics is committed to consistently providing products and solutions that are of the highest quality and safety to our recipients and customers. We are dedicated to serving our donors and donor families and honoring their gift. Our quality system is built on a foundation of continuous improvement to exceed regulations and standards. Our culture promotes competency, development, transparency, and collaboration to accomplish our core purpose: Your Gift, Their Life.
We adhere to strict policies and procedures in all activities. Our policies and procedures are designed, written, and revised to stay abreast of new developments and improved methods of donor examination and allograft development. All staff are trained in new procedures that affect their job responsibilities.
Quality assurance and quality control are central to all operations. Quality audits are regularly performed, and feedback is provided to staff, with the goal of providing the highest quality and safest tissue for transplantation.