Bio-safety
Every tissue sent to Global Sight Network undergoes rigorous screening tests by our partner eye banks to ensure patient safety. Donor Eligibility meets the strict donor screening and laboratory testing specifications of the source eye bank and the requirements of the Eye Bank Association (EBAA) and the Food and Drug Administration (FDA).
Donors eligibility is determined via screening of medical history, social/ behavioral history, whole-body physical examination, and blood tests for infectious agents.
All tissues are negative on the following tests, by regulations:
- HBsAg-Hepatitis B Surface Antigen
- HBcAB Total (IgG and IgM)-Hepatitis B Core Total Antibody
- HIV-1/2—HIV 1 & 2 Antibody
- HIV-1 NAT-HIV-1 Nucleic Acid Amplification Test
- HCV NAT- Hepatitis C Nucleic Acid Amplification Test
- HCV Ab-Hepatitis C Antibody
- RPR-Rapid Plasma Reagin
Some tissues undergo these additional tests, as partner banks require:
- HBV NAT-Hepatitis B Nucleic Acid Amplification Test
- FTA-Fluorescent Treponemal Antibody-Confirmatory Test for Syphilis
- TPHA-Treponema Pallidum Hemagglutination Assay-Confirmatory Test for Syphilis
- HTLV I/II-Human T-Lymphotropic Virus
- CMV-Cytomegalovirus
- EBV IgG and EBV IgM-Epstein-Barr Virus Test
- Toxoplasma IgG Ab-Toxoplasmosis Test
Tissues are screened by contributing partner eye banks and by GSN to certify that they are free of stromal infiltrates, radial keratotomy scarring, foreign bodies, and any penetrating injuries that would compromise biomechanical stability.
Bio-safety surveillance ongoing at GSN includes includes environmental monitoring to ensure minimal micro-organism exposure, as well as continuing safety education of certified technical staff.