SEROLOGY TESTING FOR DECEASED ORGAN DONORS
Serology Testing Basics
Why test donors? Donor screening for infectious diseases helps prevent unintentional disease transmission to recipients. It is also used to anticipate potential recipient infection and treat the recipient post-transplant.
What is tested? Testing kits are used to detect antigens, antibodies, or viral nucleic acid (RNA or DNA) found in the donor serum (liquid component of the blood).
Antigen: A substance that reacts with antibody molecules and antigen receptors on lymphocytes
Antibody: A blood protein produced in response to a specific antigen
Viral Nucleic Acid: Genetic material that can be detected early in the process
OPTN regulations on serology and infectious disease testing
The Organ Procurement and Transplant Network (OPTN) policy requires infectious disease testing on all deceased organ donors from non-hemodiluted blood samples, when available, using an FDA-approved hemodilution calculator. If a non-hemodilution blood sample is not available, hemodiluted blood may be used for testing. In these circumstances, the donor must also be considered PHS increased risk for disease transmission and HIV Ag/Ab or HIV NAT tested.
Minimum serology requirements for deceased organ donors
It must be taken into consideration when testing serologies that there is a period of time between a person acquiring an infection and when the serology testing will demonstrate antibodies.
Window periods are the time frame from infection to antibody production which can take a month or longer. During this time frame an antibody screening test may not detect infection even though one is present. Nucleic acid testing can detect a single strain of RNA or DNA from the serum sample and narrows the window period to days-weeks.
Best practice includes screening for HIV and HBV NAT in addition to HCV NAT.
- Centers for Disease Control and Prevention (CDC). (2013, May 5). Testing for HCV Infection: An Update of Guidance for Clinicians and Laboratorians. MMWR. Morbidity and Mortality
- Weekly Reports. Retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/ mm6218a5.htm#tab.
- Centers for Disease Control and Prevention (CDC). (2018, March 3). HIV Basics. Retrieved from https://www.cdc.gov/hiv/basics/testing.html
- Hepatitis B Foundation. (n.d.). Understanding your hepatitis B blood tests. Retrieved from http://www.hepb.org/assets/Uploads/ Understanding-Your-Hepatitis-B-Blood-Tests.pdf
- Organ Procurement and Transplantation Policies, 2.9 Required Deceased Donor Infectious Disease Testing (2018).
Special thanks to Ms. Meghan Stephenson, RN, MSN, CPTC (Director, Transplant Services, Mercy Medical Center, Des Moines, IA, formerly at Iowa Donor Network) for her contribution of this in-service content.
Content Editor: Hedi Aguiar, RN, MSN, CCRN-K, Senior Director of Programs, The Alliance (firstname.lastname@example.org)
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