研究动态
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对含有血液系统疾病患者支气管肺泡灌洗液样本进行的VirClia伽拉克托曼聚糖抗原检测的回顾性多中心评估,用于诊断肺曲霉病。

Retrospective Multicenter Evaluation of the VirClia Galactomannan Antigen Assay for the Diagnosis of Pulmonary Aspergillosis with Bronchoalveolar Lavage Fluid Samples from Patients with Hematological Disease.

发表日期:2023 Apr 25
作者: Jochem B Buil, Sammy Huygens, Albert Dunbar, Alexander Schauwvlieghe, Marijke Reynders, Diana Langerak, Karin van Dijk, Anke Bruns, Pieter-Jan Haas, Douwe F Postma, Bart Biemond, Fatima Zohra Delma, Elizabeth de Kort, Willem J G Melchers, Paul E Verweij, Bart Rijnders
来源: JOURNAL OF CLINICAL MICROBIOLOGY

摘要:

Galactomannan (GM)测试支气管肺泡灌洗(BAL)液样本已经成为诊断侵袭性肺曲霉病(IPA)的重要工具,并成为诊断准则的一部分。酶联免疫吸附测定(ELISA)(酶免疫测定[EIA])是常用的方法,但它们有很长的运转时间。在本研究中,我们评估了自动化化学发光免疫测定(CLIA)与BAL液样本的表现。这是一项在荷兰和比利时的多中心回顾性研究。收集了患有潜在侵袭性真菌感染的血液系统疾病底层疾病患者的BAL液样本。以2020年欧洲研究和治疗癌症机构(EORTC)/真菌研究组织(MSGERC)共识定义为基础的IPA诊断。GM结果报告为光密度指数(ODI)值。评估的EIA的ODI截断值为阳性结果0.5、0.8和1.0; CLIA为0.16、0.18和0.20。患有可能IPA的病例与两个对照组进行了比较,一个组没有IPA的证据,另一个组没有IPA或可能IPA。应用Cohen系数分析定性协议,应用Spearman's系数分析定量协议。分析了141名患者的141个BAL液样本。66名患者(47%)患有可能IPA,当排除EIA GM结果作为标准时,56例病例仍然是可能IPA,因为他们也有阳性培养和/或复制阳性PCR结果。63名患者(45%)患有可能IPA,12名(8%)没有IPA。两个测试的敏感性和特异性相当,EIA和CLIA结果的整体定性一致性为81-89%。实际CLIA和EIA值之间的相关性强,为0.72(95%置信区间,0.63至0.80)。与金标准EIA相比,CLIA具有更快的周期时间,因此可以用作BAL液样本的另一种选择GM测定。
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.