Infectious Disease Testing & Serology Flashcards
7 cards from real CTBS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Infectious Disease Testing & Serology flashcards as text
Which federal agency establishes the mandatory infectious disease testing requirements for tissue donors in the United States?
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).
What combination of tests does FDA require for HIV detection in tissue donors?
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.
What does nucleic acid testing (NAT) detect in tissue donor specimens?
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.
Which hepatitis viruses require mandatory serological and/or NAT testing for tissue donors per FDA regulations?
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.
When a donor's infectious disease screening test returns a reactive result, the appropriate immediate action is to:
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.
In infectious disease testing, the 'window period' refers to:
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.
Which type of test is required by FDA to screen tissue donors for Treponema pallidum (syphilis)?
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.