Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium
Department of Hematology, University Hospitals Leuven, Leuven, Belgium.
J Clin Microbiol. 2019 Mar 28;57(4). doi: 10.1128/JCM.01913-18. Print 2019 Apr.
Invasive pulmonary aspergillosis (IPA) is a potentially lethal infection in patients with hematological diseases or following allogeneic stem cell transplantation. Early diagnosis is essential, as delayed treatment results in increased mortality. Recently, a lateral flow device (LFD) for the diagnosis of IPA was CE marked and made commercially available by OLM Diagnostics. We retrospectively analyzed bronchoalveolar lavage fluid (BALf) collected from adult hematology patients from 4 centers in The Netherlands and Belgium. Galactomannan was retested in all samples. All samples were applied to an LFD and read out visually by two independent researchers blinded to the diagnosis of the patient. All samples were also read out using a digital reader. We included 11 patients with proven IPA, 68 patients with probable IPA, 44 patients with possible IPA, and 124 patients with no signs of IPA (controls). In cases of proven IPA versus controls, sensitivity and specificity were 0.82 and 0.86 for visual readout and 0.82 and 0.96 for digital readout, respectively. When comparing patients with proven and probable IPA as cases versus controls, sensitivity and specificity were found to be 0.71 and 0.86, respectively. When excluding serum and BALf galactomannan as mycological criteria from the 2008 European Organization for Research and Treatment of Cancer Invasive Fungal Infections Cooperative Group (EORTC)/Mycoses Study Group of the National Institute of Allergy and Infectious Diseases (MSG) consensus definitions, the LFD was less specific than galactomannan when comparing subjects with proven and probable IPA to controls (0.86 versus 0.96; = 0.005) but had similar sensitivity (0.76 versus 0.85; = 0.18). In conclusions, in this large study of the CE-marked LFD in BALf from hematology patients, the LFD had a good performance for the diagnosis of IPA.
侵袭性肺曲霉病（IPA）是血液病患者或异基因干细胞移植后潜在的致命感染。早期诊断至关重要，因为延迟治疗会导致死亡率增加。最近，一种用于 IPA 诊断的横向流动设备（LFD）获得了 CE 标志并由 OLM Diagnostics 商业化。我们回顾性分析了来自荷兰和比利时 4 个中心的成人血液病患者的支气管肺泡灌洗液（BALf）。所有样本均重新检测了半乳甘露聚糖。所有样本均应用于 LFD，并由两位独立的研究人员进行盲法观察，研究人员对患者的诊断不了解。所有样本也使用数字读取器进行读取。我们纳入了 11 例确诊 IPA 的患者、68 例疑似 IPA 的患者、44 例可能 IPA 的患者和 124 例无 IPA 迹象的患者（对照组）。在确诊 IPA 与对照组的病例比较中，目视读取的灵敏度和特异性分别为 0.82 和 0.86，数字读取的灵敏度和特异性分别为 0.82 和 0.96。当将确诊和疑似 IPA 的患者作为病例与对照组进行比较时，灵敏度和特异性分别为 0.71 和 0.86。当将血清和 BALf 半乳甘露聚糖从 2008 年欧洲癌症研究与治疗组织（EORTC）/美国国家过敏和传染病研究所（NIAID）侵袭性真菌病合作组（MSG）共识定义中的真菌学标准中排除时，与对照组相比，LFD 的特异性低于半乳甘露聚糖（0.86 与 0.96；=0.005），但灵敏度相似（0.76 与 0.85；=0.18）。总之，在这项针对血液病患者 BALf 的 CE 标记 LFD 的大型研究中，LFD 对 IPA 的诊断具有良好的性能。
