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应用商品化定量酶免疫分析法检测尿中皮炎芽生菌抗原。

Detection of Blastomyces dermatitidis Antigen in Urine Using a Commercially Available Quantitative Enzyme Immunoassay.

机构信息

Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Rochester, Minnesota, USA.

Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

出版信息

J Clin Microbiol. 2021 Sep 20;59(10):e0144421. doi: 10.1128/JCM.01444-21. Epub 2021 Aug 4.

Abstract

Laboratory diagnosis of blastomycosis relies on a combination of methods, including antigen detection. We assessed the performance of analyte-specific reagents from Gotham Biotech (Portland, ME) for quantitative detection of Blastomyces dermatitidis galactomannan (GM) in urine using an enzyme immunoassay (EIA) compared to the quantitative EIA from MiraVista Diagnostics (Indianapolis, IN). Residual urine from 232 unique patients previously tested by the MiraVista assay was evaluated using the Gotham EIA, which showed 97.4% (74/76), 100% (156/156), and 99.1% (230/232) positive, negative, and overall agreement, respectively. Correlation between the quantitative B. dermatitidis antigen levels by the Gotham and MiraVista EIAs was low ( = 0.20). Medical records were available for 36 of the 232 patients, among whom four had confirmed blastomycosis and both the Gotham and MiraVista EIAs were positive. Nine of these patients had histoplasmosis, and the Gotham and MiraVista EIAs yielded negative results in 44.4% (4/9) and 22.2% (2/9) of cases, respectively. Both assays were negative in the remaining 23 patients. After laboratory implementation of the Gotham EIA, chart reviews were performed on the first 50 unique patients (51 samples) tested by the assay in our hospital. Among these, 3/50 (6%) samples were positive by the Gotham EIA, including two samples from a patient with culture-confirmed blastomycosis and one from a patient with histoplasmosis (also positive by the MiraVista EIA). All remaining patients were negative by the Gotham EIA and had alternative diagnoses. Our findings show comparable performance between the Gotham and MiraVista quantitative EIAs for detection of B. dermatitidis GM in urine.

摘要

芽生菌病的实验室诊断依赖于多种方法的结合,包括抗原检测。我们评估了 Gotham Biotech(波特兰,ME)的分析物特异性试剂在使用酶免疫分析(EIA)定量检测尿液中皮炎芽生菌半乳甘露聚糖(GM)方面的性能,与 MiraVista Diagnostics(印第安纳波利斯,IN)的定量 EIA 进行比较。使用 Gotham EIA 评估了之前通过 MiraVista 检测的 232 个独特患者的残留尿液,结果分别为 97.4%(74/76)、100%(156/156)和 99.1%(230/232)的阳性、阴性和总符合率。Gotham 和 MiraVista EIA 定量检测 B. dermatitidis 抗原水平之间的相关性较低( = 0.20)。232 名患者中有 36 名的病历可用,其中 4 名患有确诊的芽生菌病,且 Gotham 和 MiraVista EIA 均为阳性。这些患者中有 9 人患有组织胞浆菌病,而 Gotham 和 MiraVista EIA 分别在 44.4%(9/9)和 22.2%(2/9)的病例中产生阴性结果。其余 23 名患者的两种检测均为阴性。在 Gotham EIA 实验室实施后,对我们医院检测的前 50 名独特患者(51 个样本)进行了图表审查。在这些患者中,3/50(6%)样本的 Gotham EIA 检测结果为阳性,包括 2 例培养确诊的芽生菌病患者和 1 例组织胞浆菌病患者(也被 MiraVista EIA 检测为阳性)。所有其余患者的 Gotham EIA 检测结果均为阴性,且有其他诊断。我们的研究结果表明,Gotham 和 MiraVista 定量 EIA 在检测尿液中的皮炎芽生菌 GM 方面具有相当的性能。

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