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

Proceed with testing as normal since hemolysis does not affect assay results

Answer

Reject the specimen and cancel all testing without further evaluation

Answer

Repeat testing only if initial results are reactive

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

It is the only test that detects active, acute HBV infection

Answer

It distinguishes HBV vaccine-induced immunity from natural infection

Answer

It replaces the need for HBsAg testing in most circumstances

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

Release the tissue because the more sensitive NAT result overrides the antibody result

Answer

Automatically disqualify the donor based on the reactive antibody alone

Answer

Reserve the tissue exclusively for musculoskeletal applications

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

OSHA

Answer

CDC

Answer

The Joint Commission

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

No documentation is required if results are non-reactive

Answer

A brief notation in the donor file acknowledging the test is not FDA-licensed for this use

Answer

Prior approval from the state health department

Question 6

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

Accepted Answer

FDA regulations at 21 CFR Part 1271.3(r)

Answer

Each tissue bank's individual SOPs

Answer

CDC guidelines exclusively

Answer

State health department mandates

Question 7

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:

Accepted Answer

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

Answer

Confirmed HIV positive; the donor is disqualified

Answer

Indeterminate; tissue must be indefinitely quarantined

Answer

Inconclusive; all associated tissue must be destroyed without further testing