Donor Screening & Eligibility Flashcards

Which of the following serological testing results would render a tissue donor ineligible under FDA regulations regardless of other findings?

Answer: Repeatedly reactive HIV-1 NAT

A repeatedly reactive HIV-1 NAT result confirms viral nucleic acid presence and is an absolute contraindication for tissue donation.

For tissue donors who die from drowning, which of the following is a primary concern related to blood specimen integrity?

Answer: Hemodilution may compromise serological test accuracy

Hemodilution from fluid resuscitation or drowning can dilute antibody concentrations below assay detection thresholds, potentially yielding false-negative serology.

A tissue donor received 2 units of packed red blood cells 24 hours before death. Which step is required before determining serological test validity?

Answer: Apply a hemodilution algorithm to assess specimen dilution

AATB standards require applying an FDA-accepted hemodilution algorithm to determine whether transfusion compromised specimen integrity before accepting serological results.

Cytomegalovirus (CMV) serology is routinely tested in tissue donors primarily to:

Answer: Provide CMV status information to guide recipient selection by transplant physicians

CMV serology is used to inform transplant physicians about donor CMV status so they can match donors and recipients appropriately, especially for immunocompromised patients.

Under AATB standards, a tissue bank receives a donor specimen with a repeatedly reactive HBsAg result. The neutralization confirmatory test is negative. The donor should be:

Answer: Considered ineligible because HBsAg was repeatedly reactive regardless of confirmatory result

Per FDA and AATB standards, a repeatedly reactive HBsAg screening test result renders the donor ineligible, even if a supplemental test is negative.

Nucleic acid testing (NAT) for tissue donors offers the primary advantage of:

Answer: Detecting HIV and HCV during the window period before antibody development

NAT shortens the window period by detecting viral genetic material before the immune system produces detectable antibodies, reducing the risk of false-negative results.

A tissue bank procuring a donor who died outside the US must ensure that infectious disease testing is performed using:

Answer: FDA-licensed or -approved test kits, or tests approved by an equivalent regulatory authority

FDA regulations require that testing be performed with FDA-licensed, -cleared, or -approved assays, or their equivalents from recognized regulatory authorities for international donors.