CTBS Infectious Disease Testing & Serology 1 — Questions and Answers
Question 1: Which federal agency establishes the mandatory infectious disease testing requirements for tissue donors in the United States?
- CDC
- FDA (Correct answer)
- OSHA
- CMS
Correct answer: FDA
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?
- HIV-1 antibody test only
- HIV-1/HIV-2 combination antibody test only
- HIV NAT only
- HIV-1/HIV-2 antibody test AND HIV NAT (Correct answer)
Correct answer: HIV-1/HIV-2 antibody test AND HIV NAT
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?
- Antibodies against viral pathogens
- Viral genetic material (RNA or DNA) (Correct answer)
- Bacterial contamination markers
- Prion proteins
Correct answer: Viral genetic material (RNA or DNA)
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?
- Hepatitis A and B only
- Hepatitis B and C only (Correct answer)
- Hepatitis A, B, and C
- Hepatitis B, C, and D
Correct answer: Hepatitis B and C only
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:
- Release the tissue if confirmatory testing is ordered
- Quarantine the tissue pending further evaluation (Correct answer)
- Automatically destroy the tissue
- Designate the tissue for research use only
Correct answer: Quarantine the tissue pending further evaluation
A reactive screening result requires immediate quarantine of associated tissue pending further evaluation, including confirmatory testing, before any release or destruction decision is made.
Question 6: In infectious disease testing, the 'window period' refers to:
- The time allowed between tissue recovery and laboratory testing
- The interval between infection and the development of a detectable immune response (Correct answer)
- The storage period before testing must be completed
- The regulatory timeframe for reporting results to the FDA
Correct answer: The interval between infection and the development of a detectable immune response
The window period is the time between initial infection and when the body produces sufficient antibodies for detection, during which a donor may be infected but test seronegative.
Question 7: Which type of test is required by FDA to screen tissue donors for Treponema pallidum (syphilis)?
- Bacterial culture and sensitivity
- Serological test such as RPR or VDRL (Correct answer)
- PCR-based nucleic acid test
- Syphilis testing is not required for tissue donors
Correct answer: Serological test such as RPR or VDRL
FDA regulations require a serological test for syphilis (Treponema pallidum), such as RPR or VDRL, as part of required donor eligibility infectious disease testing.
CTBS Infectious Disease Testing & Serology 1
Which federal agency establishes the mandatory infectious disease testing requirements for tissue donors in the United States?