CTBS Infectious Disease Testing & Serology

Question 1

Which federal agency establishes the mandatory infectious disease testing requirements for tissue donors in the United States?

Accepted Answer

FDA

Answer

The FDA establishes mandatory infectious disease testing requirements for tissue donors through 21 CFR Part 1271, which governs human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Question 2

What combination of tests does FDA require for HIV detection in tissue donors?

Accepted Answer

HIV-1/HIV-2 antibody test AND HIV NAT

Answer

FDA requires both serological testing (HIV-1/HIV-2 antibody) and nucleic acid testing (NAT) for HIV to reduce the risk of false-negative results during the window period.

Question 3

What does nucleic acid testing (NAT) detect in tissue donor specimens?

Accepted Answer

Viral genetic material (RNA or DNA)

Answer

NAT directly detects viral nucleic acids (RNA or DNA), allowing identification of infection earlier than antibody-based tests by eliminating the reliance on the host immune response.

Question 4

Which hepatitis viruses require mandatory serological and/or NAT testing for tissue donors per FDA regulations?

Accepted Answer

Hepatitis B and C only

Answer

FDA mandates testing for HBsAg, anti-HBc, and anti-HCV along with HCV NAT; Hepatitis A and D are not required under 21 CFR Part 1271 donor eligibility testing.

Question 5

When a donor's infectious disease screening test returns a reactive result, the appropriate immediate action is to:

Accepted Answer

Quarantine the tissue pending further evaluation

Answer

A reactive screening result requires immediate quarantine of associated tissue pending further evaluation, including confirmatory testing, before any release or destruction decision is made.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Infectious Disease Testing & Serology