Infectious Disease Testing & Serology Flashcards

Per FDA guidance, West Nile Virus (WNV) testing for tissue donors should be performed:

Answer: Year-round using NAT testing

FDA guidance recommends year-round NAT testing for WNV in tissue donors due to potential for year-round transmission in some geographic areas and the risk of asymptomatic infection.

Which statement is TRUE regarding Cytomegalovirus (CMV) testing for tissue donors?

Answer: CMV testing is clinically relevant but not a mandatory FDA requirement for most tissue types

CMV testing is not a mandatory FDA requirement under 21 CFR Part 1271 for most tissue types, though AATB standards recommend it and results are used for recipient matching rather than automatic disqualification.

Current FDA regulations require which Human T-cell Lymphotropic Virus (HTLV) testing for tissue donors?

Answer: Combined HTLV-I/II antibody testing

FDA regulations require combined serological testing for both HTLV-I and HTLV-II antibodies in tissue donors as part of the required communicable disease testing panel.

Regarding Chagas disease (Trypanosoma cruzi) testing for tissue donors in the U.S., which statement is most accurate?

Answer: FDA has issued guidance recommending it, but it is not currently a mandatory CFR requirement for most tissue

FDA issued guidance recommending Chagas testing for tissue donors, but mandatory testing for Trypanosoma cruzi is not currently codified in 21 CFR Part 1271 for most tissue types.

For cadaveric tissue donors, infectious disease testing specimens must be collected:

Answer: At or proximal to the time of death within defined regulatory timeframes

FDA regulations specify that donor specimens must be collected at or proximal to the time of death within defined timeframes to ensure test results accurately represent the donor's infectious status at recovery.

Donor blood specimens collected 10 days before the donor's death are generally:

Answer: Not acceptable for required infectious disease testing

Specimens collected more than 7 days before death fall outside acceptable collection timeframes and cannot be used for required infectious disease testing under FDA regulations.

Hemodilution of a cadaveric donor's blood is a concern because it may:

Answer: Dilute antibody concentrations below detectable levels, causing false-negative results

Large volumes of IV fluids or blood products can dilute serum antibodies below the detection threshold of serological assays, potentially causing false-negative results that require evaluation using established hemodilution algorithms.