Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands.
Radboud University Medical Center-Canisius Wilhelmina Hospital, Center of Expertise for Mycology, Nijmegen, The Netherlands.
J Clin Microbiol. 2023 May 23;61(5):e0004423. doi: 10.1128/jcm.00044-23. Epub 2023 Apr 25.
Galactomannan (GM) testing of bronchoalveolar lavage (BAL) fluid samples has become an essential tool to diagnose invasive pulmonary aspergillosis (IPA) and is part of diagnostic guidelines. Enzyme-linked immunosorbent assays (ELISAs) (enzyme immunoassays [EIAs]) are commonly used, but they have a long turnaround time. In this study, we evaluated the performance of an automated chemiluminescence immunoassay (CLIA) with BAL fluid samples. This was a multicenter retrospective study in the Netherlands and Belgium. BAL fluid samples were collected from patients with underlying hematological diseases with a suspected invasive fungal infection. Diagnosis of IPA was based on the 2020 European Organisation for Research and Treatment of Cancer (EORTC)/Mycoses Study Group Education and Research Consortium (MSGERC) consensus definitions. GM results were reported as optical density index (ODI) values. ODI cutoff values for positive results that were evaluated were 0.5, 0.8, and 1.0 for the EIA and 0.16, 0.18, and 0.20 for the CLIA. Probable IPA cases were compared with two control groups, one with no evidence of IPA and another with no IPA or possible IPA. Qualitative agreement was analyzed using Cohen's κ, and quantitative agreement was analyzed by Spearman's correlation. We analyzed 141 BAL fluid samples from 141 patients; 66 patients (47%) had probable IPA, and 56 cases remained probable IPA when the EIA GM result was excluded as a criterion, because they also had positive culture and/or duplicate positive PCR results. Sixty-three patients (45%) had possible IPA and 12 (8%) had no IPA. The sensitivity and specificity of the two tests were quite comparable, and the overall qualitative agreement between EIA and CLIA results was 81 to 89%. The correlation of the actual CLIA and EIA values was strong at 0.72 (95% confidence interval, 0.63 to 0.80). CLIA has similar performance, compared to the gold-standard EIA, with the benefits of faster turnaround because batching is not required. Therefore, CLIA can be used as an alternative GM assay for BAL fluid samples.
半乳甘露聚糖（GM）检测支气管肺泡灌洗液（BAL）样本已成为诊断侵袭性肺曲霉病（IPA）的重要工具，也是诊断指南的一部分。酶联免疫吸附测定（ELISA）（酶免疫测定[EIA]）常用于检测 GM，但检测时间较长。在这项研究中，我们评估了一种自动化化学发光免疫分析（CLIA）在 BAL 液样本中的性能。这是一项在荷兰和比利时进行的多中心回顾性研究。从患有疑似侵袭性真菌感染的基础血液病患者中收集 BAL 液样本。IPA 的诊断基于 2020 年欧洲癌症研究与治疗组织（EORTC）/霉菌学研究组教育与研究联合会（MSGERC）共识定义。GM 结果以光密度指数（ODI）值报告。评估的阳性结果的 ODI 截断值为 EIA 的 0.5、0.8 和 1.0，CLIA 的 0.16、0.18 和 0.20。将可能的 IPA 病例与两个对照组进行比较，一个对照组无 IPA 证据，另一个对照组无 IPA 或可能 IPA。使用 Cohen's κ 分析定性一致性，使用 Spearman 相关系数分析定量一致性。我们分析了 141 例 141 例患者的 BAL 液样本；66 例患者（47%）患有可能的 IPA，当排除 EIA GM 结果作为标准时，56 例患者仍为可能 IPA，因为他们也有阳性培养和/或重复阳性 PCR 结果。63 例患者（45%）患有可能 IPA，12 例患者（8%）无 IPA。两种检测方法的敏感性和特异性相当，EIA 和 CLIA 结果的总体定性一致性为 81%至 89%。实际 CLIA 和 EIA 值之间的相关性很强，为 0.72（95%置信区间，0.63 至 0.80）。CLIA 与金标准 EIA 相比具有相似的性能，由于不需要分批处理，因此具有更快的周转时间优势。因此，CLIA 可作为 BAL 液样本 GM 检测的替代方法。
