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

CDC

Answer

OSHA

Answer

CMS

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

HIV-1 antibody test only

Answer

HIV-1/HIV-2 combination antibody test only

Answer

HIV NAT only

Question 3

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

Accepted Answer

Viral genetic material (RNA or DNA)

Answer

Antibodies against viral pathogens

Answer

Bacterial contamination markers

Answer

Prion proteins

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

Hepatitis A and B only

Answer

Hepatitis A, B, and C

Answer

Hepatitis B, C, and D

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

Release the tissue if confirmatory testing is ordered

Answer

Automatically destroy the tissue

Answer

Designate the tissue for research use only

Question 6

In infectious disease testing, the 'window period' refers to:

Accepted Answer

The interval between infection and the development of a detectable immune response

Answer

The time allowed between tissue recovery and laboratory testing

Answer

The storage period before testing must be completed

Answer

The regulatory timeframe for reporting results to the FDA

Question 7

Which type of test is required by FDA to screen tissue donors for Treponema pallidum (syphilis)?

Accepted Answer

Serological test such as RPR or VDRL

Answer

Bacterial culture and sensitivity

Answer

PCR-based nucleic acid test

Answer

Syphilis testing is not required for tissue donors