Division of Infectious Diseases and Global Public Health, University of California San Diego, San Diego, CA, USA.
Clinical and Translational Fungal-Working Group, University of California San Diego, San Diego, CA, USA.
Mycoses. 2021 Oct;64(10):1197-1202. doi: 10.1111/myc.13352. Epub 2021 Jul 24.
Detection of galactomannan (GM) from bronchoalveolar lavage fluid (BALF) or serum is broadly used for diagnosis of invasive aspergillosis (IA), although the sensitivity of GM from serum is lower in non-neutropenic patients. We evaluated the Aspergillus galactomannan Lateral Flow assay (LFA) with digital readout from serum in a mixed cohort of patients.
We performed a retrospective two-centre study evaluating the LFA from serum of patients with clinical suspicion of IA obtained between 2015 and 2021 at the University of California San Diego and the Medical University of Graz. The sensitivity and specificity was calculated for proven/probable aspergillosis versus no aspergillosis. Correlation with same-sample GM was calculated using Spearman correlation analysis and kappa statistics.
In total, 122 serum samples from 122 patients were analysed, including proven IA (n = 1), probable IA or coronavirus-associated pulmonary aspergillosis (CAPA) (n = 27), and no IA/CAPA/non-classifiable (n = 94). At a 0.5 ODI cut-off, the sensitivity and specificity of the LFA was 78.6% and 80.5%. Spearman correlation analysis showed a strong correlation between serum LFA ODI and serum GM ODI (ρ 0.459, p < .0001). Kappa was 0.611 when both LFA and GM were used with a 0.5 ODI cut-off, showing substantial agreement (p < .001).
The LFA with digital read out from serum showed good performance for the diagnosis of probable/proven aspergillosis, with substantial agreement to GM from serum. Like the LFA from BALF, the LFA from serum may serve as a more rapid test compared to conventional GM, particularly in settings where GM is not readily available.
检测支气管肺泡灌洗液（BALF）或血清中的半乳甘露聚糖（GM）广泛用于侵袭性曲霉病（IA）的诊断，尽管非中性粒细胞减少症患者血清中的 GM 敏感性较低。我们评估了来自血清的曲霉半乳甘露聚糖侧向流动检测（LFA）在混合患者队列中的表现。
我们进行了一项回顾性的双中心研究，评估了 2015 年至 2021 年期间在加利福尼亚大学圣地亚哥分校和格拉茨医科大学临床怀疑 IA 的患者的血清中的 LFA。计算了阳性/可能性 IA 与无 IA 的灵敏度和特异性。使用 Spearman 相关分析和 Kappa 统计计算与同一样本 GM 的相关性。
共分析了 122 例患者的 122 份血清样本，包括确诊 IA（n=1）、可能 IA 或冠状病毒相关肺曲霉病（CAPA）（n=27）和无 IA/CAPA/不可分类（n=94）。在 0.5 ODI 截断值下，LFA 的灵敏度和特异性分别为 78.6%和 80.5%。Spearman 相关分析显示血清 LFA ODI 与血清 GM ODI 之间存在很强的相关性（ρ0.459，p<0.0001）。当使用 0.5 ODI 截断值时，LFA 和 GM 均为阳性的 Kappa 值为 0.611，表明存在高度一致性（p<0.001）。
血清中数字读取的 LFA 对可能/确诊 IA 的诊断具有良好的性能，与血清 GM 具有实质性一致性。与 BALF 中的 LFA 一样，血清中的 LFA 可能比常规 GM 更快速，特别是在 GM 不易获得的情况下。
