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首页> 外文期刊>Journal of Clinical Microbiology >Prospective Evaluation of a New Aspergillus IgG Enzyme Immunoassay Kit for Diagnosis of Chronic and Allergic Pulmonary Aspergillosis
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Prospective Evaluation of a New Aspergillus IgG Enzyme Immunoassay Kit for Diagnosis of Chronic and Allergic Pulmonary Aspergillosis

机译：新型曲霉IgG酶免疫分析试剂盒对慢性和过敏性肺曲霉病诊断的前瞻性评估

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Anti-Aspergillus IgG antibodies are important biomarkers for the diagnosis of chronic pulmonary aspergillosis (CPA) and allergic bronchopulmonary aspergillosis (ABPA). We compared the performance of a new commercial enzyme immunoassay (EIA) (Bordier Affinity Products) with that of the Bio-Rad and VirionSerion EIAs. This assay is novel in its association of two recombinant antigens with somatic and metabolic antigens of Aspergillus fumigatus. In a prospective multicenter study, 436 serum samples from 147 patients diagnosed with CPA (136 samples/104 patients) or ABPA (94 samples/43 patients) and from 205 controls (206 samples) were tested. We obtained sensitivities of 97%, 91.7%, and 86.1%, and specificities of 90.3%, 91.3%, and 81.5% for the Bordier, Bio-Rad, and VirionSerion tests, respectively. The Bordier kit was more sensitive than the Bio-Rad kit (P < 0.01), which was itself more sensitive than the VirionSerion kit (P = 0.04). The Bordier and Bio-Rad kits had similar specificity (P = 0.8), both higher than that of the VirionSerion kit (P = 0.02). The area under the receiver operating characteristic (ROC) curves confirmed the superiority of the Bordier kit over the Bio-Rad and the VirionSerion kits (0.977, 0.951, and 0.897, respectively; P < 0.01 for each comparison). In a subset analysis of 279 serum samples tested with the Bordier and Bio-Rad kits and an in-house immunoprecipitin assay (IPD), the Bordier kit had the highest sensitivity (97.7%), but the IPD tended to be more specific (71.2 and 84.7%, respectively; P = 0.10). The use of recombinant, somatic, and metabolic antigens in a single EIA improved the balance of sensitivity and specificity, resulting in an assay highly suitable for use in the diagnosis of chronic and allergic aspergillosis.
机译：抗曲霉IgG抗体是诊断慢性肺曲霉病（CPA）和过敏性支气管肺曲霉病（ABPA）的重要生物标志物。我们将新型商业酶免疫分析（EIA）（Bordier Affinity产品）的性能与Bio-Rad和Virion Serion EIA的性能进行了比较。该测定法是新颖的，因为它将两种重组抗原与烟曲霉的体细胞和代谢抗原结合在一起。在一项前瞻性多中心研究中，对来自147位诊断为CPA的患者（136个样本/ 104个患者）或ABPA（94个样本/ 43个患者）和205个对照（206个样本）的436个血清样品进行了测试。对于Bordier，Bio-Rad和Virion Serion测试，我们分别获得97％，91.7％和86.1％的敏感性，以及90.3％，91.3％和81.5％的特异性。 Bordier试剂盒比Bio-Rad试剂盒（ P <0.01）敏感，后者本身比Virion Serion试剂盒（ P = 0.04）敏感。 Bordier和Bio-Rad试剂盒具有相似的特异性（ P = 0.8），均高于Virion Serion试剂盒（ P = 0.02）。接收器工作特性（ROC）曲线下方的面积证实了Bordier套件优于Bio-Rad和Virion Serion套件（分别为0.977、0.951和0.897; P <0.01）每个比较）。在用Bordier和Bio-Rad试剂盒以及内部免疫沉淀测定（IPD）测试的279个血清样品的子集分析中，Bordier试剂盒的灵敏度最高（97.7％），但IPD倾向于更特异性（71.2）和84.7％; P = 0.10）。在单个EIA中使用重组，体细胞和代谢抗原可改善敏感性和特异性之间的平衡，从而形成一种非常适合用于慢性和过敏性曲霉病诊断的检测方法。

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