The University of Manchester, Oxford Road, Manchester M13 9PL, UK; Manchester Academic Health Science Centre, 46 Grafton Street, Manchester M13 9NT, UK; National Aspergillosis Centre, 2nd Floor Education and Research Centre, University Hospital of South Manchester, Southmoor Road, Manchester M23 9LT, UK.
The University of Manchester, Oxford Road, Manchester M13 9PL, UK; Manchester Academic Health Science Centre, 46 Grafton Street, Manchester M13 9NT, UK; Mycology Reference Centre, Manchester and National Aspergillosis Centre, 2nd Floor Education and Research Centre, University Hospital of South Manchester, Southmoor Road, Manchester M23 9LT, UK.
J Infect. 2016 Feb;72(2):240-9. doi: 10.1016/j.jinf.2015.11.003. Epub 2015 Dec 8.
Chronic pulmonary aspergillosis (CPA) is estimated to affect 3 million persons worldwide. Aspergillus-specific IgG is a key component in CPA diagnosis. We aimed to establish the optimal diagnostic cut offs for CPA and the comparative performance of six assays in this context.
Sera from 241 patients with CPA and 100 healthy blood donors were tested using five Aspergillus-specific IgG assays plus precipitin testing using Microgen Aspergillus antigens.
Receiver operating characteristic (ROC) curve area under the curve (AUC) results were as follows: ThermoFisher Scientific ImmunoCAP 0.996 (95% confidence interval 0.992-1), Siemens Immulite 0.991 (0.982-1), Serion 0.973 (0.960-0.987), Dynamiker 0.918 (0.89-0.946) and Genesis 0.902 (0.871-0.933). Optimal CPA diagnostic cut-offs were; ImmunoCAP 20 mg/L (96% sensitivity, 98% specificity), Immulite 10 mg/L (96% sensitivity, 98% specificity), Serion 35 U/ml (90% sensitivity, 98% specificity), Dynamiker 65 AU/ml (77% sensitivity, 97% specificity) and Genesis 20 U/ml (75% sensitivity, 99% specificity). The precipitin test was 59% sensitive and 100% specific.
ImmunoCAP and Immulite were statistically significantly superior to the other assays. Precipitins testing performed poorly. The currently accepted ImmunoCAP cut-off of 40 mg/L appears sub-optimal for CPA diagnosis and may require revision in this context.
慢性肺曲霉病(CPA)估计影响全球 300 万人。曲霉特异性 IgG 是 CPA 诊断的关键组成部分。我们旨在确定 CPA 的最佳诊断截止值,并在此背景下比较六种检测方法的性能。
使用五种曲霉特异性 IgG 检测方法和 Microgen 曲霉抗原沉淀试验检测 241 例 CPA 患者和 100 例健康献血者的血清。
受试者工作特征(ROC)曲线下面积(AUC)结果如下:赛默飞世尔科技 ImmunoCAP 为 0.996(95%置信区间为 0.992-1),西门子 Immulite 为 0.991(0.982-1),Serion 为 0.973(0.960-0.987),Dynamiker 为 0.918(0.89-0.946),Genesis 为 0.902(0.871-0.933)。最佳 CPA 诊断截止值为:ImmunoCAP 20mg/L(96%敏感性,98%特异性),Immulite 10mg/L(96%敏感性,98%特异性),Serion 35U/ml(90%敏感性,98%特异性),Dynamiker 65AU/ml(77%敏感性,97%特异性)和 Genesis 20U/ml(75%敏感性,99%特异性)。沉淀试验的敏感性为 59%,特异性为 100%。
ImmunoCAP 和 Immulite 在统计学上明显优于其他检测方法。沉淀试验的性能较差。目前接受的 40mg/L ImmunoCAP 截止值似乎不太适合 CPA 诊断,在这种情况下可能需要修订。