Evaluation of Discrepant Infectious Disease Results in Deceased Organ Donors: Insights from a Retrospective Analysis of Post-Policy Testing.

Abstract

Background: In 2021, a new policy was implemented by the Organ Procurement Transplant Network requiring Organ Procurement Organizations to draw a repeat blood sample for deceased organ donors if donation had not proceeded within 96-h after the initial blood sample for screening was obtained. We performed an analysis of over 2600 deceased donor test results, comparing initial results to repeated blood draw results for human immunodeficiency virus, Hepatitis B virus, and Hepatitis C virus serology and nucleic acid test (NAT) tests. This study reviews result discrepancies and explores investigations behind peculiar results.

Methods: Infectious disease results from deceased organ donors were analyzed retrospectively for this study. Donor specimens were collected throughout the United States and tested at eleven laboratories. Food & Drug Administration-approved donor screening tests were used to determine donor eligibility.

Results: There was a 1.69% discrepancy rate comparing results from repeat blood draw specimens to original specimen results. Of these discrepancies, 0.75% of the donors had results (enzyme-linked immunoassay and/or NAT) that changed from non-reactive to reactive. 0.68% of donors had results that changed from reactive to non-reactive. 0.26% of results changed from Ultrio repeatedly reactive, non-discriminated to either non-reactive or reactive.

Conclusion: This study represents that there is more than a 1% chance that discrepant results will be obtained. Despite the low incidence of discrepancies, these rare occurrences can complicate clinical decision-making, requiring case-by-case assessments. We present several cases in which variability in results can make clinical decisions complex with limited information and the inability to perform timely confirmatory testing using tests not required by Organ Procurement Transplant Network regulations.