All tissue and blood samples are tested for infectious diseases by a CLIA Certified Lab, including testing for AIDS with Nucleic Acid Testing (NAT by TMA) — the newest and most reliable test to confirm the presence or absence of HIV and HCV early following exposure. As HC Biologics only works with accredited members of the American Association of Tissue Banks (AATB), all testing and processing of donated tissue meet or exceed all AATB standards and FDA regulations. All test results are evaluated by a team of specialists and physicians from the infectious disease, pathology and tissue banking fields. All required communicable disease tests listed below must be found nonreactive or negative while our comprehensive battery of testing also includes the followings:

HIV-1/2 Antibodies HIV – 1/2 – Ab
Nucleic Acid Test for HIV-1 RNA HIV – 1 NAT
Hepatitis B Virus (HBV)
HBV Surface Antigen HBsAg
HBV Core Antibody (IgG & IgM) HBcAb
Nucleic Acid Test for HBV DNA (if applicable) HBV NAT
HCV Antibody HCVAb
Nucleic Acid Test for HCV-RNA HCV NAT
Rapid Plasma Reagin Screen RPR*
T. Pallidum IgG T. pallidum IgG
Cytomegalovirus CMV Ab (IgG & IgM)
Epstein Barr Virus EBV Ab (IgG & IgM)
Toxoplasma gondii Toxoplasma Ab (IgG & IgM)
Trypanosama cruzi T. cruzi Ab (IgG & IgM)

* Tissues from 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, are cleared for transplantation use only when the result from the treponemal-specific (confirmatory) assay is nonreactive. Non-required screening tests for exposure to other viruses or parasites such as those listed below for may have been performed on the donor by other agencies involved in the donation process. A negative/nonreactive result is not required for these tests; however, all donors are evaluated on a case-by-case basis by the Medical Directors of Tissue Banks we are working with.