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

Only during summer months in endemic states

Answer

Only for living donors

Answer

Only for donors from tropical or subtropical regions

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 mandatory for all tissue donors per FDA regulations

Answer

CMV-reactive donors are automatically disqualified from donation

Answer

CMV testing is required only for bone marrow and hematopoietic donors

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

HTLV-I antibody testing only

Answer

HTLV-II antibody testing only

Answer

HTLV NAT testing only

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

It is mandatory for all tissue donors under 21 CFR Part 1271

Answer

It is required only for donors from Latin American endemic regions

Answer

It is required only for cardiovascular tissue donations

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

At any time within 30 days before or after tissue recovery

Answer

Within 7 days before death only

Answer

Only from arterial blood samples before cardiac arrest

Question 6

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

Accepted Answer

Not acceptable for required infectious disease testing

Answer

Acceptable if all infectious disease results are non-reactive

Answer

Acceptable depending on tissue type and volume of fluids received

Answer

Acceptable only for NAT testing but not serology

Question 7

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

Accepted Answer

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

Answer

Increase the concentration of antibodies above assay detection limits

Answer

Only affect NAT testing but not serological assays

Answer

Be corrected by using a larger specimen volume