Guidelines related serology testing for cadavers:
The following definitions and specified regulations provide guidance related to serology testing according to the Texas State Anatomical Board (SAB). These guidelines are meant to provide a framework for approved anatomical spaces and willed body programs in the State of Texas. Individual programs may choose to be more restrictive in their testing based on their activities, facilities, and staff resources.
Most Willed Body programs in the US provide cadavers to both undergraduate (UME) and graduate medical education (GME) programs. Although most UME teaching uses embalmed cadavers, most GME teaching requires fresh or lightly embalmed bodies.
For the embalmed bodies, a guideline for serology test is not clear across programs. From a historical point of view, embalmed bodies were not tested for any pathogens. It has been the general impression of many anatomists that all the pathogens are killed through the embalming process, and therefore, embalmed cadavers are safe for dissection. There has been little research done on analyzing the remaining of pathogens, namely, tuberculosis, HIV, HBV, HCV, and prion associated diseases after embalming. The results are not up-to-date and the data is not strongly convincing1. Currently, most Willed Body programs in the US do not carry out serology tests if the donated body does not have an obvious history of infectious diseases and is designated for embalming. Besides historical reasons and common practice traditions, costs could be another reason for not testing cadavers designated for embalming.
For freshly used bodies, a serology test for pathogens is necessary. There has been more research done about serology testing for organ and tissue donations than that for fresh cadaver dissection. Therefore, it is reasonable to adopt the organ and tissue donation serology testing standard for fresh cadaver dissection.
1. What to test
Through website and literature searches, the following serology screening tests are commonly used on donated organs and tissues:
A. Anti-human immunodeficiency virus (HIV) testing – antibody testing or both antibody and antigen test. Nucleic Acid Testing (NAT) is also available. (CDC) https://www.cdc.gov/hiv/pdf/testing/cdc-hiv-2019-Supplemental-Tests-for-Laboratory-Settings.pdf
B. Anti-hepatitis C virus (HCV) testing – HCV antibody test. (CDC) https://www.cdc.gov/hepatitis/hcv/pdfs/hcv_flow.pdf
C. Hepatitis B virus (HBV) surface antigen testing – HbsAg (Hepatitis B foundation) https://www.hepb.org/prevention-and-diagnosis/diagnosis/hbv-blood-tests/
D. Human T lymphotrophic virus (HTLV) that can cause leukemia or lymphoma – Antibody or molecular tests. (National organization for rare diseases) https://rarediseases.org/rare-diseases/htlv-type-i-and-type-ii/
E. Cytomegalovirus (CMV) – Antibody test. (CDC) https://www.cdc.gov/cmv/clinical/lab-tests.html
Among the five tests, HIV, HCV, and HBV are the most commonly and necessarily tested. The HTLV and CMV are less mentioned2,3,4. HIV, HCV, and HBV should be strongly recommended for testing on freshly used cadavers. HTLV and CMV could be optional recommendations.
With the pandemic of COVID-19 disease, the SARS-CoV-2 virus may be included in future tests?
2. Testing cost and justification
Testing costs may vary depending on which testing agency is used and how many tests are run. A certified testing agency or company, such as LabCorp, or Quest, is needed to ensure testing result accuracy and legal liability. If tests are done in a local hospital or a local lab facility, an inspection from SAB or an appropriate accrediting agency should be considered for its credibility. If any sample is tested positive during the first run, a second run of the same sample is required to verify the positive result.
3. How to use the test results
The director and manager of a Willed Body program should evaluate the serology test results and make decisions about the usage of the donated body. Several levels of decisions can be considered.
A. Cremate the body if there is a positive result of any category. Not to use the body anymore.
B. Embalm the body if there is a positive result of any category and still used the body for dissection after embalming.
C. Only use test-negative bodies for fresh or lightly embalmed specimen preparations.
Decision A could result in a larger number of donated bodies not being used. It may also increase the cost of operation. Based on the testing result analysis in the past 3 years at Baylor College of Medicine, there could be up to one fourth tested bodies showing a positive result on any of the tested categories.
Decision B could potentially endanger the health of the individuals who dissect the body although there is lack of evidence showing the tested pathogen is still infectious. Since the body has already tested positive, the legal liability issue must be considered.
Decision C should be recommended.
References:
1. DENIZ DEMIRYU¨REK,* ALP BAYRAMOGˇ LU, AND S¸EMSETTIN USTAC¸ ELEBI. Infective Agents in Fixed Human Cadavers: A Brief Review and Suggested Guidelines. THE ANATOMICAL RECORD (NEW ANAT.) 269:194–197, 2002
2. Victer TN, Dos Santos CS, Báo SN, Sampaio TL. Deceased tissue donor serology and molecular testing for HIV, hepatitis B and hepatitis C viruses: a lack of cadaveric validated tests. Cell Tissue Bank. 2016 Dec;17(4):543-553. Epub 2016 Jun 21.
3. Carolin Edler, Birgit Wulff, Ann-Sophie Schro der, Ina Wilkemeyer, Susanne Polywka, Thomas Meyer, Ulrich Kalus and Axel Pruss. A prospective time-course study on serological testing for human immunodeficiency virus, hepatitis B virus and hepatitis C virus with blood samples taken up to 48 h after death. Journal of Medical Microbiology (2011), 60, 920–926
4. Francis L. Delmonico. Cadaver Donor Screening for Infectious Agents in Solid Organ Transplantation. Clinical Infectious Diseases, Volume 31, Issue 3, September 2000, Pages 781–786, https://doi.org/10.1086/314000