Infectious Disease Testing & Serology Flashcards

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

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

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.

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

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

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.

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

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

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.

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

Answer: AATB (American Association of Tissue Banks)

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.

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

Answer: Validation data demonstrating the test performs acceptably on cadaveric specimens

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.

The 'relevant communicable disease agents and diseases' (RCDADs) that must be tested for in tissue donors are defined in:

Answer: FDA regulations at 21 CFR Part 1271.3(r)

FDA defines RCDADs in 21 CFR Part 1271.3(r), establishing the federal standard for which communicable disease agents and diseases must be tested as part of donor eligibility determination.

A donor's specimen is repeatedly reactive on an HIV screening assay but non-reactive on an HIV supplemental (confirmatory) test. This result is most appropriately interpreted as:

Answer: A false positive on the screening assay; donor may be eligible after full evaluation

A repeatedly reactive screening result that does not confirm on a supplemental assay is generally classified as a false positive screening result, and donor eligibility is determined through the full evaluation process per SOPs.