Department of Laboratory Medicine and Pathology, Mayo Clinic Florida, Jacksonville, FL, United States.
Department of Pathology and Laboratory Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, United States.
J Appl Lab Med. 2023 Nov 2;8(6):1148-1159. doi: 10.1093/jalm/jfad009.
Many molecular gastrointestinal pathogen panels (GIPs) are Food and Drug Administration (FDA) cleared but it is still unclear how to best utilize these new diagnostic tools. GIPs are highly sensitive and specific, simultaneously detect multiple pathogens in one reaction, and can shorten the overall time of diagnosis for infectious gastroenteritis but are also expensive with relatively poor insurance reimbursement.
In this review, we take a comprehensive approach to discuss issues with utilization of GIPs from a physician perspective, and implementation from a laboratory perspective. The information presented is to assist physicians in deciding on appropriate use of GIPs in diagnostic algorithms for their patients, and to provide information to laboratories that may be considering the addition of these powerful diagnostic assays to their test menu. Some of the important topics discussed are inpatient vs outpatient use, the appropriate panel size and organisms to include, interpretation of results, laboratory validation, and reimbursement.
The information in this review provides clear guidance to both clinicians and laboratories in deciding the best use of GIPs for a specific patient population. While this technology provides many benefits over traditional methods, it can also complicate result interpretation and comes with a high cost, which necessitates the need for use recommendations.
许多分子胃肠病原体检测试剂盒（GIP）已获得美国食品和药物管理局（FDA）批准，但目前仍不清楚如何最好地利用这些新的诊断工具。GIP 具有高度的敏感性和特异性，可在一次反应中同时检测多种病原体，还可以缩短传染性肠胃炎的整体诊断时间，但价格昂贵，且保险报销相对较差。
在这篇综述中，我们从医生的角度全面探讨了利用 GIP 的问题，并从实验室的角度探讨了实施问题。提供的信息旨在帮助医生决定在其患者的诊断算法中适当使用 GIP，并为可能正在考虑将这些强大的诊断检测添加到其测试菜单中的实验室提供信息。讨论的一些重要主题包括住院患者与门诊患者的使用、适当的试剂盒大小和应包含的病原体、结果解读、实验室验证和报销。
本综述中的信息为临床医生和实验室在决定特定患者人群中 GIP 的最佳使用提供了明确的指导。虽然这项技术提供了许多优于传统方法的优势，但它也可能使结果解释复杂化，并带来高昂的成本，这就需要使用建议。
