血液肿瘤患者在常规诊断环境中侵袭性曲霉病的诊断

Diagnosis of invasive aspergillosis in haemato-oncology patients in a routine diagnostic setting

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MEDICAL MYCOLOGY

影响因子:2.3

分区:医学3区 / 兽医学2区传染病学3区真菌学3区

发表日期:2024 Oct 04

作者: Dhanalakshmi Solaimalai, Rosemol Varghese, Sujith Karumathil, Uday Kulkarni, Biju George, Joy Sarojini Michael

DOI: 10.1093/mmy/myae100

摘要

侵袭性曲霉病（Invasive Aspergillosis, IA）是高危血液肿瘤患者中一种潜在致命的感染。由于传统诊断方法存在诸多固有挑战，聚合酶链反应（PCR）已被用于诊断IA。本前瞻性研究评估了一种商业化的AsperGenius多重实时PCR在临床诊断中的实用性，比较其与血清中半乳糖甘露聚糖（GM）检测在血液肿瘤患者中临床疑似IA的诊断效果。共招募107名患者，研究期间为2022年4月至2023年3月。从这些患者中采集的血清样本（n=113）用于GM酶联免疫吸附测定（ELISA）常规诊断，并进行PCR检测。根据修订版（2020）和之前（2008）欧洲肿瘤研究与治疗组织（EORTC）及美国过敏与传染病研究所真菌学组（MSG）标准，将患者分为可能、可疑和无IA组。PCR和GM的性能指标通过结合可能和可疑病例作为疾病组，依据EORTC标准进行计算。在107名入组患者中，93名被归类为可能/可疑IA（疾病组），14名为无IA组。PCR在49名患者的53个样本中呈阳性。单一阳性PCR和GM的敏感性分别为51.61%（95%置信区间，41-62）和26.88%（18.2-37.1），特异性分别为92.86%（66.1-99.8）和92.86%（66.1-99.8）。结合策略（GM和/或PCR阳性）表现出中等敏感性62.37%（51-72.2）和特异性85.71%（57.2-98.2）。总之，结合血清GM和/或PCR阳性与符合EORTC/MSG标准的影像学表现相结合的方法，显著改善了高危血液病患者中疑似IA的可能诊断。

Abstract

Invasive Aspergillosis (IA) is a potentially lethal infection in high-risk haemato-oncology patients. Since traditional diagnostic methods have many inherent challenges, Polymerase Chain Reaction (PCR) has been used to diagnose IA. This prospective study evaluated a commercial AsperGenius multiplex real-time PCR for its clinical utility in diagnosing IA compared with galactomannan (GM) testing serum samples from haemato-oncology patients with clinically suspected IA. A total of 107 patients were recruited between April 2022 and March 2023. Serum samples (n = 113) collected from those patients for the routine diagnosis by GM Enzyme Linked Immuno-Sorbent Assay (ELISA) were subjected to PCR. The patients were categorised into probable, possible, and no IA based on revised (2020) and previous (2008) European Organization for Research and Treatment of Cancer and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC-MSG) criteria. The performance characteristics of PCR and GM were calculated against the EORTC criteria by combining probable and possible cases as diseased groups. Among the 107 recruited patients, 93 were categorised into probable/possible IA (diseased group) and 14 into no IA group. The PCR was positive in 53 samples from 49 patients. The sensitivity and specificity of single positive PCR and GM were 51.61% [95% confidence interval, 41-62], 92.86% (66.1-99.8) and 26.88% (18.2-37.1), 92.86% (66.1-99.8), respectively. The combination-based strategy (GM and/or PCR positive) exhibited a moderate sensitivity of 62.37% (51-72.2) and a specificity of 85.71% (57.2-98.2). To conclude, the combined strategy of serum GM and/or PCR positivity, along with radiological findings that fulfilled the EORTC/MSG criteria, has improved the diagnosis of probable IA among high-risk haematological patients with clinically suspected IA.