CTBS Infectious Disease Testing & Serology 2

Question 1

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

Accepted Answer

Year-round using NAT testing

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

Combined HTLV-I/II antibody testing

Answer

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?

Accepted Answer

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

Answer

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:

Accepted Answer

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

Answer

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.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Infectious Disease Testing & Serology 2