CTBS Infectious Disease Testing & Serology 3

Question 1

When a cadaveric donor blood specimen is significantly hemolyzed, the tissue bank should:

Accepted Answer

Evaluate whether testing can proceed and document any potential impact on result validity

Answer

Hemolysis can interfere with certain assays; the tissue bank must assess specimen quality in consultation with the testing laboratory and document any limitations that may affect the reliability of results.

Question 2

Testing for Hepatitis B core antibody (anti-HBc) is required in tissue donors primarily because:

Accepted Answer

It detects past or present HBV exposure including donors in the window period who may be HBsAg-negative

Answer

Anti-HBc persists after infection regardless of disease resolution and can identify donors who were exposed to HBV but are in the window period before HBsAg becomes detectable, providing an additional layer of safety.

Question 3

A donor tests reactive on anti-HCV (Hepatitis C antibody) screening but non-reactive on HCV NAT. The tissue bank should:

Accepted Answer

Evaluate the discordant results according to established SOPs, considering both results

Answer

Discordant results (reactive antibody with non-reactive NAT) require evaluation per SOPs, as the reactive antibody may represent past resolved infection or a false positive, not necessarily an active transmissible infection.

Question 4

Which organization sets infectious disease testing recommendations and standards for tissue banks that often exceed minimum FDA requirements?

Accepted Answer

AATB (American Association of Tissue Banks)

Answer

The AATB sets accreditation standards for tissue banks that frequently include additional or more stringent infectious disease testing recommendations beyond the minimum mandatory FDA requirements in 21 CFR Part 1271.

Question 5

If a tissue bank uses an HIV test not specifically FDA-licensed for cadaveric specimens, what must be documented to support its use?

Accepted Answer

Validation data demonstrating the test performs acceptably on cadaveric specimens

Answer

When an assay is used outside its labeled indications (e.g., on cadaveric specimens when licensed only for antemortem blood), the tissue bank must validate and document equivalent performance to ensure reliable, defensible results.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Infectious Disease Testing & Serology 3