A donor eligibility determination based on screening and testing for relevant communicable agents and diseases is required for all donors of cells or tissue used in human cells, tissues and cellular and tissue-based products (HCT/Ps).
Infectious disease testing for donor eligibility must be performed in an FDA-registered laboratory using tests that have been licensed, approved, or cleared by the FDA specifically for use in donor screening (when available) or approved/cleared for use in low-prevalence, asymptomatic populations.
HIV-1, HIV-2, hepatitis B virus, hepatitis C virus, Treponema pallidum
HTLV I/II, cytomegalovirus (CMV)
Chlamydia trachomatis, Neisseria gonorrhoeae
West Nile Virus (WNV) NAT. Required from June 1st through October 31st for facilities within the United States (all 50 states and the District of Columbia); required year-round for facilities outside of the United States intending to import HCT/Ps into the United States.