在常规诊断环境中，出血 - 肿瘤患者中浸润性曲霉病的诊断
Diagnosis of invasive aspergillosis in haemato-oncology patients in a routine diagnostic setting
影响因子:2.30000
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
摘要
浸润性曲霉病（IA）是高风险出血肿瘤患者的潜在致命感染。由于传统的诊断方法有许多固有的挑战，因此聚合酶链反应（PCR）已用于诊断IA。这项前瞻性研究评估了一项商业曲属多重实时PCR，用于诊断IA的临床实用性，与半乳糖量（GM）测试来自临床上怀疑IA的Haemato-Concologology患者的血清样品相比。在2022年4月至2023年3月之间，总共招募了107例患者。从这些患者中收集的血清样品（n = 113）通过GM酶连接的免疫吸收测定法（ELISA）进行常规诊断。基于修订后的（2020年）和先前（2008年）的癌症研究和治疗组织以及国家过敏和传染病研究所Mycoses Mycoses研究小组（EORTC-MSG）标准，将患者分为可能的，可能的和无IA。 PCR和GM的性能特征是根据EORTC标准将可能的情况和可能的病例组合为患病组来计算的。在107名招募患者中，有93名分为可能/可能的IA（患病组），而没有IA组为14个。来自49例患者的53个样本中的PCR为阳性。单个正PCR和GM的敏感性和特异性为51.61％[95％置信区间，41-62]，92.86％（66.1-99.8）和26.88％（18.2-37.1），92.86％（分别为66.1-1-99.8）。基于组合的策略（GM和/或PCR阳性）的灵敏度为62.37％（51-72.2），特异性为85.71％（57.2-98.2）。总而言之，血清GM和/或PCR阳性的综合策略以及满足EORTC/MSG标准的放射学发现，改善了在具有临床上怀疑IA的高风险血液学患者中可能IA的诊断。
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.