Note: The tissue donor's blood was tested for relevant communicable diseases in a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or has met equivalent requirements as determined by the Centers for Medicare or Medicaid Services.
Required Donor Testing:
All results must be reported negative or non-reactive to allow release.
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HIV-1/HIV-2 + Group O Antibodies
Required
-
Cytomegalovirus Antibody (CMV Total Ab)
Required
-
Hepatitis C Virus (HCV) Antibodies
Required
-
Epstein Barr EBV Ab (IgG & IgM)
Required
-
Hepatitis B Surface Antigen (HBsAg)
Required
-
Toxoplasma gondii Ab (IgG & IgM)
Required
-
Hepatitis B Core Antibodies (HBcAb)
Required
-
Trypanosoma cruzi Ab (IgG & IgM)
Required
-
HIV/HBV/HCV-NAT2
Required
-
Creutzfeldt-Jakob (CJD)
Required
-
Treponema pallidum (Syphilis)
Required
-
Borrelia burgdorferi (Lyme)
Required
Additional Donor Testing (If Required):
-
Human T-Cell lymphotropic Virus I/II Antibodies
Conditional
-
West Nile Virus (WNV)-NAT3
Seasonal
1 The donor screening, in addition to blood analysis, may be completed via social and medical questions. A licensed health professional has reviewed the results of testing and determined the donor has met all eligibility requirements.
2 Human Immunodeficiency Virus Type 1 Nucleic Acid Test, Hepatitis B Virus Nucleic Acid Test, Hepatitis C Virus Nucleic Acid Test.
3 Required testing during WNV season per FDA guidance: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (September 2016).
Complete Instructions For Use
Review the detailed donor screening instructions and procedures
View IFU Document