Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, 200 First Street SW, SDSC 1-526, Rochester, MN 55905, USA.
Mycopathologia. 2013 Feb;175(1-2):33-41. doi: 10.1007/s11046-012-9579-y. Epub 2012 Sep 1.
The incidence of invasive fungal infections (IFI) has increased in recent years, especially among immunocompromised hosts (ICH). In 2003, the Fungitell(®) assay received FDA clearance for the presumptive diagnosis of IFI using serum and detects (1-3)-β-D-glucan, which is a major cell wall component of certain fungi (e.g., Candida, Aspergillus, and Pneumocystis). The goal of the current study was to assess the performance of the assay on bronchoalveolar lavage (BAL) fluid and serum to identify IFI in ICH. Patients were classified as having proven, probable, possible, or no IFI according to the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) guidelines. Among 109 patients for whom the results of Fungitell were compared to the EORTC/MSG criteria, Fungitell showed a low positive predictive value for the identification of IFI from both BAL (20.0%) and serum (26.7%). However, the negative predictive value of Fungitell was significantly higher for both sample types (BAL, 83.0%; serum, 84.8%). Interestingly, the results of Fungitell were positive in BAL and serum in 7/8 (87.5%) patients diagnosed with Pneumocystis pneumonia (PcP) by real-time, non-nested PCR. These data indicate that the Fungitell assay has a low positive predictive value for the diagnosis of IFI in ICH, regardless of the specimen type that is tested. However, testing of serum samples by Fungitell may permit a rapid and noninvasive initial screening approach in patients with presumed PcP.
近年来,侵袭性真菌感染(IFI)的发病率有所增加,尤其是在免疫功能低下宿主(ICH)中。2003 年,Fungitell(®)检测法获得了 FDA 的批准,可用于通过血清检测来推测 IFI,该检测法可检测到(1-3)-β-D-葡聚糖,这是某些真菌(如念珠菌、曲霉菌和卡氏肺孢子菌)细胞壁的主要成分。本研究的目的是评估该检测法在支气管肺泡灌洗液(BAL)和血清中对 ICH 中 IFI 的检测性能。根据欧洲癌症研究和治疗组织/霉菌病研究组(EORTC/MSG)的指南,患者被分为IFI 确诊、疑似、可能或无 IFI。在 109 名 Fungitell 检测结果与 EORTC/MSG 标准进行比较的患者中,Fungitell 对 BAL(20.0%)和血清(26.7%)中 IFI 的识别的阳性预测值较低。然而,Fungitell 的阴性预测值在两种样本类型上均显著较高(BAL,83.0%;血清,84.8%)。有趣的是,在通过实时非嵌套 PCR 诊断为卡氏肺孢子菌肺炎(PcP)的 8 例患者中的 7 例(87.5%),BAL 和血清中的 Fungitell 检测结果均为阳性。这些数据表明,无论检测哪种样本类型,Fungitell 检测法对 ICH 中 IFI 的诊断阳性预测值均较低。然而,Fungitell 检测血清样本可能允许对疑似 PcP 的患者进行快速且非侵入性的初始筛选。