侵袭性曲霉病 (IA) 是高危血液肿瘤患者的一种潜在致命感染。由于传统的诊断方法存在许多固有的挑战，聚合酶链反应（PCR）已被用于诊断 IA。这项前瞻性研究评估了商业化的 AsperGenius 多重实时 PCR 与半乳甘露聚糖检测临床疑似 IA 的血液肿瘤患者的血清样本相比，其诊断 IA 的临床效用。 2022年4月至2023年3月期间总共招募了107名患者。从这些患者中采集的血清样本（n=113）用于半乳甘露聚糖ELISA常规诊断进行PCR。根据修订版 (2020 年) 和之前 (2008 年) EORTC-MSG 标准，将患者分为可能、可能和无 IA。 PCR 和半乳甘露聚糖的性能特征是根据 EORTC 标准通过将可能病例和可能病例组合作为患病组来计算的。在 107 名招募的患者中，93 名被分为很可能/可能的 IA（患病组），14 名被分为无 IA 组。 49 名患者的 53 份样本的 PCR 呈阳性。单阳性PCR和半乳甘露聚糖的敏感性和特异性分别为51.61％（95％CI，41至62）、92.86％（66.1至9.8）和26.88％（18.2至37.1）、92.86％（66.1至99.8）。基于组合的策略（GM 和/或 PCR 阳性）表现出 62.37%（51 至 72.2）的中等敏感性和 85.71%（57.2 至 98.2）的特异性。总之，血清 GM 和/或 PCR 阳性的综合策略，以及满足 EORTC/MSG 标准的放射学检查结果，改善了临床疑似 IA 的高危血液学患者中可能 IA 的诊断。© 作者）2024 年。由牛津大学出版社代表国际人类和动物真菌学学会出版。

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 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 galactomannan ELISA were subjected to PCR. The patients were categorised into probable, possible, and no IA based on revised (2020) and previous (2008) EORTC-MSG criteria. The performance characteristics of PCR and galactomannan 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 galactomannan were 51.61% (95% CI, 41 to 62), 92.86% (66.1 to 9.8) and 26.88% (18.2 to 37.1), 92.86% (66.1 to 99.8), respectively. The combination-based strategy (GM and/or PCR positive) exhibited a moderate sensitivity of 62.37% (51 to 72.2) and a specificity of 85.71% (57.2 to 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.© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology.