The last decade has seen an explosion of advanced assays for the diagnosis of infectious diseases, yet evidence-based recommendations to inform their optimal use in the care of transplant recipients are lacking. A consensus conference sponsored by the American Society of Transplantation (AST) was convened on December 7, 2021, to define the utility of novel infectious disease diagnostics in organ transplant recipients. The conference represented a collaborative effort by experts in transplant infectious diseases, diagnostic stewardship, and clinical microbiology from centers across North America to evaluate current uses, unmet needs, and future directions for assays in 5 categories including (1) multiplex molecular assays, (2) rapid antimicrobial resistance detection methods, (3) pathogen-specific T-cell reactivity assays, (4) next-generation sequencing assays, and (5) mass spectrometry-based assays. Participants reviewed and appraised available literature, determined assay advantages and limitations, developed best practice guidance largely based on expert opinion for clinical use, and identified areas of future investigation in the setting of transplantation. In addition, attendees emphasized the need for well-designed studies to generate high-quality evidence needed to guide care, identified regulatory and financial barriers, and discussed the role of regulatory agencies in facilitating research and implementation of these assays. Findings and consensus statements are presented.

中文翻译：

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定义先进传染病诊断在实体器官移植受者中的效用的共识会议

过去十年来，用于诊断传染病的先进检测方法激增，但缺乏基于证据的建议来指导其在移植受者护理中的最佳使用。由美国移植学会 (AST) 主办的共识会议于 2021 年 12 月 7 日召开，旨在定义新型传染病诊断在器官移植受者中的效用。此次会议代表了来自北美各个中心的移植传染病、诊断管理和临床微生物学专家的共同努力，以评估 5 类检测的当前用途、未满足的需求和未来方向，包括 (1) 多重分子检测、(2 ) 快速抗菌药物耐药性检测方法，(3) 病原体特异性 T 细胞反应性测定，(4) 下一代测序测定，以及 (5) 基于质谱的测定。参与者回顾和评估了现有文献，确定了检测方法的优点和局限性，主要根据临床使用的专家意见制定了最佳实践指南，并确定了移植领域未来研究的领域。此外，与会者强调需要精心设计的研究来产生指导护理所需的高质量证据，确定监管和财务障碍，并讨论监管机构在促进这些检测的研究和实施方面的作用。提出了调查结果和共识声明。