Department of Clinical Microbiology, Christian Medical College, Vellore 632002, India.
Department of Haematology, Christian Medical College, Vellore 632002, India.
Med Mycol. 2024 Oct 4;62(10). doi: 10.1093/mmy/myae100.
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.
侵袭性曲霉病（IA）是高危血液肿瘤患者潜在的致命感染。由于传统诊断方法存在许多固有挑战，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 在诊断 IA 方面的临床实用性，与血液肿瘤患者临床疑似 IA 的血清样本的半乳甘露聚糖（GM）检测进行比较。2022 年 4 月至 2023 年 3 月期间共招募了 107 名患者。对这些患者的血清样本（n=113）进行了常规 GM 酶联免疫吸附测定（ELISA）检测，同时进行了 PCR。根据修订后的（2020 年）和之前的（2008 年）欧洲癌症研究与治疗组织和美国国立过敏与传染病研究所真菌病研究组（EORTC-MSG）标准，将患者分为可能、可能和无 IA。通过将可能和可能病例合并为疾病组，计算了 PCR 和 GM 与 EORTC 标准的性能特征。在 107 名招募的患者中，93 名患者被归类为可能/可能 IA（疾病组），14 名患者归类为无 IA 组。PCR 在 49 名患者的 53 份样本中呈阳性。单次阳性 PCR 和 GM 的敏感性和特异性分别为 51.61%（95%置信区间，41-62）、92.86%（66.1-99.8）和 26.88%（18.2-37.1）、92.86%（66.1-99.8）。基于组合的策略（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，血清 GM 和/或 PCR 阳性与符合 EORTC/MSG 标准的影像学发现相结合的联合策略，提高了临床疑似 IA 的高危血液学患者中可能 IA 的诊断。
