Optimum Biologics prides itself on providing only the highest quality allografts available to our customers. All donors are screened in compliance with AATB and FDA regulations and sterilized using low dose gamma irradiation (SAL 10-6).
Screening procedures are performed in accordance with standards, regulations, statutes and/or directives of the American Association of Tissue Banks (AATB), the U.S. Food and Drug Administration (FDA), State Licensing Agencies.
All donated tissue is tested in a laboratory registered with the FDA to perform donor testing and certified to perform such testing on human specimens. Tests listed below must be found nonreactive or negative:
HUMAN IMMUNODEFICIENCY VIRUS (HIV)
| 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 |
HEPATITIS C VIRUS (HCV)
| HCV Antibody |
HCVAb |
| Nucleic Acid Test for HCV-RNA |
HCV NAT |
SYPHILIS
| Rapid Plasma Reagin Screen |
RPR* |
| T. Pallidum IgG T. pallidum |
IgG |
HTLV-I/II Antibody HTLV-I/II-Ab
| 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) |
For more information on licenses, donor screening and product availability please contact your local representative or email sales@optimumbiologics.com
Optimum Biologics