CTBS Infectious Disease Testing & Serology 2 — Questions and Answers
Question 1: Per FDA guidance, West Nile Virus (WNV) testing for tissue donors should be performed:
- Only during summer months in endemic states
- Year-round using NAT testing (Correct answer)
- Only for living donors
- Only for donors from tropical or subtropical regions
Correct 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.
Question 2: Which statement is TRUE regarding Cytomegalovirus (CMV) testing for tissue donors?
- CMV testing is mandatory for all tissue donors per FDA regulations
- CMV testing is clinically relevant but not a mandatory FDA requirement for most tissue types (Correct answer)
- CMV-reactive donors are automatically disqualified from donation
- CMV testing is required only for bone marrow and hematopoietic donors
Correct 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.
Question 3: Current FDA regulations require which Human T-cell Lymphotropic Virus (HTLV) testing for tissue donors?
- HTLV-I antibody testing only
- HTLV-II antibody testing only
- Combined HTLV-I/II antibody testing (Correct answer)
- HTLV NAT testing only
Correct 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.
Question 4: Regarding Chagas disease (Trypanosoma cruzi) testing for tissue donors in the U.S., which statement is most accurate?
- It is mandatory for all tissue donors under 21 CFR Part 1271
- It is required only for donors from Latin American endemic regions
- FDA has issued guidance recommending it, but it is not currently a mandatory CFR requirement for most tissue (Correct answer)
- It is required only for cardiovascular tissue donations
Correct 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.
Question 5: For cadaveric tissue donors, infectious disease testing specimens must be collected:
- At any time within 30 days before or after tissue recovery
- Within 7 days before death only
- At or proximal to the time of death within defined regulatory timeframes (Correct answer)
- Only from arterial blood samples before cardiac arrest
Correct 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.
Question 6: Donor blood specimens collected 10 days before the donor's death are generally:
- Acceptable if all infectious disease results are non-reactive
- Acceptable depending on tissue type and volume of fluids received
- Not acceptable for required infectious disease testing (Correct answer)
- Acceptable only for NAT testing but not serology
Correct 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.
Question 7: Hemodilution of a cadaveric donor's blood is a concern because it may:
- Increase the concentration of antibodies above assay detection limits
- Dilute antibody concentrations below detectable levels, causing false-negative results (Correct answer)
- Only affect NAT testing but not serological assays
- Be corrected by using a larger specimen volume
Correct 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.
CTBS Infectious Disease Testing & Serology 2
Per FDA guidance, West Nile Virus (WNV) testing for tissue donors should be performed: