Positive toxicology and reactive serology in tissue donors: a retrospective study over a 3-year period

Ellen Heck,Kristel Gruslin,Valerie Corder,Jill Urban,W Matthew Petroll

doi:10.1007/s10561-020-09827-2

Abstract

Assessment of donor suitability and criteria development for tissue donation evaluation which appropriately addresses the risk factors for disease transmission, especially high risk for Hepatitis B or C, HIV or other transmissible diseases as defined by the Food and Drug Administration, FDA, is a continuing concern for tissue banks. The relationship of drug use, especially IV drugs, has been determined to be associated with an increased possibility of reactive serology (Centers for Disease Control and Prevention (USCDC) in Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. Hepatitis C questions and answers for health professionals. https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm; Centers for Disease Control and Prevention (USCDC) in infectious diseases, opioids and injection drug use, 2018. https://www.cdc.gov/pwid/opioid-use.html; HIH National Institute on Drug Abuse in Health Consequences of Drug Misuse, 2017. https://www.drugabuse.gov/related-topics/health-consequences-drug-misuse). Therefore, prior drug use determined by medical social history screening frequently results in deferral of a potential donor even when the route of drug administration has not been determined to be intravenous. Because of the association of drug use in numerous cases, which come under Medical Examiner jurisdiction, a possible rule out of a number of otherwise suitable medical examiner cases could occur. This retrospective review of medical examiner cases, tissue bank referrals and tissue donors in a 3-year period examines the relationship, if any, between reactive serology and positive toxicology results. These results would appear to indicate assessment of donor medical social history screening is effective in reducing recovery of high-risk donors.

Highlights

IntroductionA retrospective examination of records of potential tissue referrals and recovered donors for a 3-year period, 2015–2017, were examined for the use of drugs as determined by toxicology screening and the finding of reactive serologies in this large urban medical examiner tissue donor population
A retrospective examination of records of potential tissue referrals and recovered donors for a 3-year period, 2015–2017, were examined for the use of drugs as determined by toxicology screening and the finding of reactive serologies in this large urban medical examiner tissue donor population. Since these donations had proceeded prior to any toxicology results or reactive serologies, the medical social history information for these donors failed to indicate a potential for high risk for communicable disease
Routine serology testing utilizing FDA approved test kits was conducted for HIV 1/HCV/HBVNAT, HIV1/ 2 plus O antibody, HCV antibody, Hepatitis B antigen, Hepatitis Bc antibody, West Nile virus, Syphilis RPR and Hepatitis C antibody by an accredited reference laboratory

Summary

Introduction

A retrospective examination of records of potential tissue referrals and recovered donors for a 3-year period, 2015–2017, were examined for the use of drugs as determined by toxicology screening and the finding of reactive serologies in this large urban medical examiner tissue donor population. Since these donations had proceeded prior to any toxicology results or reactive serologies, the medical social history information for these donors failed to indicate a potential for high risk for communicable disease. There were 318 donors in this category of medical examiner potential donors out of 843 total donors during the time period

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Results

Conclusion