Aspergillus Lateral Flow Assay with Digital Reader for the Diagnosis of COVID-19-Associated Pulmonary Aspergillosis (CAPA): a Multicenter Study.
Aspergillus Lateral Flow Assay with Digital Reader for the Diagnosis of COVID-19-Associated Pulmonary Aspergillosis (CAPA): a Multicenter Study.
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DOI：
10.1128/jcm.01689-21
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发表时间：
2022-01-19
影响因子：
9.4
通讯作者：
Hoenigl M
中科院分区：
文献类型：
--
作者：
Autier B;Prattes J;White PL;Valerio M;Machado M;Price J;Egger M;Gangneux JP;Hoenigl M
这项多中心研究评估了IMMY曲霉半乳甘露聚糖侧流试验（LFA）与自动阅读器用于诊断2020年3月至2021年4月期间需要重症监护室（ICU）住院的COVID-19相关急性呼吸衰竭（ARF）患者的肺曲霉菌病。回顾性纳入了来自238例患者的共196份呼吸道样本和148份血清样本（n = 344），每例患者每种样本类型最多一份。根据2020年共识标准，对病例进行了回顾性分类，以确定COVID-19相关的肺曲霉病（CAPA）状态，排除LFA结果作为真菌学标准。在1.0临界值时，LFA对CAPA（已证实/很可能/可能）的敏感性分别为52%、80%和81%，对支气管肺泡灌洗液（BALF）、非定向支气管肺泡灌洗液（NBL）和气管抽吸（TA）的特异性分别为98%、88%和67%。在0.5制造商的临界值，BALF，NBL和TA的敏感性分别为72%，90%和100%，特异性分别为79%，83%和44%。当合并所有呼吸样本时，受试者工作特征（ROC）曲线下面积（AUC）为0.823，BALF、NBL和TA分别为0.754、0.890和0.814。在0.5 ODI临界值时，血清LFA的敏感性和特异性分别为20%和93%。总体而言，当在1.0临界值下从呼吸道样本中使用时，曲霉半乳甘露聚糖LFA显示出良好的CAPA诊断性能，而血清的灵敏度有限，与CAPA期间的弱侵入性有关。由于可能会出现一些假阳性结果，因此略高于推荐临界值的孤立结果应导致进一步的真菌学调查。
This multicenter study evaluated the IMMY Aspergillus Galactomannan Lateral Flow Assay (LFA) with automated reader for diagnosis of pulmonary aspergillosis in patients with COVID-19-associated acute respiratory failure (ARF) requiring intensive care unit (ICU) admission between 03/2020 and 04/2021. A total of 196 respiratory samples and 148 serum samples (n = 344) from 238 patients were retrospectively included, with a maximum of one of each sample type per patient. Cases were retrospectively classified for COVID-19-associated pulmonary aspergillosis (CAPA) status following the 2020 consensus criteria, with the exclusion of LFA results as a mycological criterion. At the 1.0 cutoff, sensitivity of LFA for CAPA (proven/probable/possible) was 52%, 80% and 81%, and specificity was 98%, 88% and 67%, for bronchoalveolar lavage fluid (BALF), nondirected bronchoalveolar lavage (NBL), and tracheal aspiration (TA), respectively. At the 0.5 manufacturer’s cutoff, sensitivity was 72%, 90% and 100%, and specificity was 79%, 83% and 44%, for BALF, NBL and TA, respectively. When combining all respiratory samples, the receiver operating characteristic (ROC) area under the curve (AUC) was 0.823, versus 0.754, 0.890 and 0.814 for BALF, NBL and TA, respectively. Sensitivity and specificity of serum LFA were 20% and 93%, respectively, at the 0.5 ODI cutoff. Overall, the Aspergillus Galactomannan LFA showed good performances for CAPA diagnosis, when used from respiratory samples at the 1.0 cutoff, while sensitivity from serum was limited, linked to weak invasiveness during CAPA. As some false-positive results can occur, isolated results slightly above the recommended cutoff should lead to further mycological investigations.