Dionne Sara, Akana Hillary, Curran Chris, Van Slyck Sean
Eurofins Donor & Product Testing, LLC, Centennial, Colorado, USA.
New England Donor Services, Waltham, Massachusetts, USA.
Transpl Infect Dis. 2025 Jul-Aug;27(4):e70055. doi: 10.1111/tid.70055. Epub 2025 May 19.
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.
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.
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.
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.
2021年，器官获取与移植网络实施了一项新政策，要求器官获取组织在为已故器官捐献者采集用于筛查的初始血样后96小时内若未进行捐献，则需再次采集血样。我们对2600多名已故捐献者的检测结果进行了分析，比较了人类免疫缺陷病毒、乙型肝炎病毒和丙型肝炎病毒血清学及核酸检测（NAT）的初始结果与再次采血结果。本研究回顾了结果差异，并探讨了特殊结果背后的调查情况。
本研究对已故器官捐献者的传染病检测结果进行了回顾性分析。捐献者标本在美国各地采集，并在11个实验室进行检测。使用美国食品药品监督管理局批准的捐献者筛查检测来确定捐献者是否符合条件。
将再次采血标本的结果与原始标本结果进行比较，差异率为1.69%。在这些差异中，0.75%的捐献者结果（酶联免疫吸附测定和/或NAT）从非反应性变为反应性。0.68%的捐献者结果从反应性变为非反应性。0.26%的结果从Ultrio反复反应性、未区分变为非反应性或反应性。
本研究表明，获得不一致结果的可能性超过1%。尽管差异发生率较低，但这些罕见情况会使临床决策复杂化，需要逐案评估。我们介绍了几个案例，其中结果的变异性会使临床决策在信息有限且无法使用器官获取与移植网络规定以外的检测进行及时确证检测的情况下变得复杂。
