Invasive aspergillosis (IA) is a life-threatening infection that mainly occurs in immunocompromised patients. Here, we compared the novel Aspergillus-specific galactomannoprotein (GP) enzyme-linked immunosorbent assay (ELISA) (Euroimmun Medizinische Labordiagnostika AG) to the established Platelia Aspergillus galactomannan (GM) ELISA (Bio-Rad Laboratories) for the detection of IA. A total of 267 serum samples from 45 cases of proven and 4 episodes of probable IA (according to European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group [EORTC/MSG] criteria) and 156 sera from patients without evidence of IA were tested. Pearson's correlation statistics, as well as sensitivity and specificity, were calculated using manufacturer-recommended (GM) or optimized (GP) cutoff levels. Aspergillus fumigatus was found in 88% of culture-positive infections. When we analyzed all 423 serum samples, GM and GP tests correlated strongly (r = 0.82, P < 0.0001). Among proven IA cases using samples obtained as closely as possible to the day of proven diagnosis, the sensitivity for both tests was 40%. All cases of probable IA (defined by positive GM testing) were also GP positive. Concordant results of the two ELISAs were obtained in 43 of 49 samples (88%). Extending measurements to all sera available in the time frame of 7 days prior to 7 days after the day of proven diagnosis, 47% and 56% of the cases were detected by the GM and GP tests, respectively. Specificity was 99% for GM and 96% for GP testing. For the diagnosis of IA, sensitivity and specificity of the novel GP ELISA are similar to those of the Platelia GM ELISA. The low sensitivities of both tests underline the need for serial testing in patients at risk for IA.

中文翻译：

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一种新型曲霉菌抗原酶联免疫吸附试验的评价。

侵袭性曲霉菌病 (IA) 是一种危及生命的感染，主要发生在免疫功能低下的患者中。在这里，我们将新型曲霉特异性半乳甘露糖蛋白 (GP) 酶联免疫吸附测定 (ELISA) (Euroimmun Medizinische Labordiagnostika AG) 与已建立的 Platelia 曲霉半乳甘露聚糖 (GM) ELISA (Bio-Rad Laboratories) 进行了比较，用于检测 IA。来自 45 例已证实和 4 例疑似 IA 的总共 267 份血清样本（根据欧洲癌症研究和治疗组织/侵袭性真菌感染合作组和美国国家过敏和传染病研究所真菌病研究组 [EORTC/MSG ] 标准）和 156 份来自没有 IA 证据的患者的血清进行了测试。Pearson 的相关统计，以及敏感性和特异性，使用制造商推荐的 (GM) 或优化的 (GP) 截止水平计算。在 88% 的培养阳性感染中发现了烟曲霉。当我们分析所有 423 份血清样本时，GM 和 GP 测试具有很强的相关性（r = 0.82，P < 0.0001）。在使用尽可能接近证实诊断当天获得的样本的已证实 IA 病例中，两种测试的敏感性均为 40%。所有疑似 IA 病例（由阳性 GM 检测定义）也均为 GP 阳性。在 49 个样本中的 43 个 (88%) 中获得了两种 ELISA 的一致结果。将测量范围扩展到在证实诊断之日后 7 天之前的 7 天时间范围内可用的所有血清，GM 和 GP 测试分别检测到 47% 和 56% 的病例。GM 的特异性为 99%，GP 检测的特异性为 96%。对于 IA 的诊断，新型 GP ELISA 的灵敏度和特异性与 Platelia GM ELISA 相似。两种测试的低敏感性强调了对有 IA 风险的患者进行连续测试的必要性。