评估 Aspergillus IgG/IgM 侧向流动检测法在乌干达真菌性哮喘血清诊断中的应用。
Evaluation of an Aspergillus IgG/IgM lateral flow assay for serodiagnosis of fungal asthma in Uganda.
机构信息
Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.
Makerere University Lung Institute, College of Health Sciences, Makerere University, Kampala, Uganda.
出版信息
PLoS One. 2021 May 28;16(5):e0252553. doi: 10.1371/journal.pone.0252553. eCollection 2021.
BACKGROUND
Diagnosis of fungal allergies in asthma remains problematic in low-and middle-income countries due to non-availability of point-of-care testing. In this study, we aimed to evaluate the performance of an Aspergillus immunochromatographic technology (ICT) IgG/M lateral flow device (LFD) for the serological diagnosis of allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitisation (SAFS) among Ugandan adult asthmatics.
METHODS
374 adult (aged ≥18years) asthmatics in the African Severe Asthma Program study, Ugandan site constituted the study population. ABPA and SAFS were diagnosed according to standard criteria. Asthmatics who did not meet the above criteria constituted a control group. The LFD tests were performed and read according to manufacturer's instructions.
RESULTS
ABPA was found in 12/374 (3.2%) and SAFS in 60/374 (16%) participants. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the Aspergillus ICT for the diagnosis of ABPA were 0.0%, 96.4%, 0.0% and 96.7% respectively, and for SAFS 6.7%, 97.1%, 30.8% and 84.5% respectively. False positive and negative rates were 3.5% and 3.2% for ABPA and 2.4% and 14.9% for SAFS, respectively. Patients with a positive LFD significantly had higher median Aspergillus fumigatus-specific IgE levels compared to those with negative LFD (median: 0.06 kUA/l VS 0.03 kUA/L, P = 0.011).
CONCLUSION
The Aspergillus ICT IgG/M LFD had a poor diagnostic performance for the diagnosis of both ABPA and SAFS. Its greatest value may be in distinguishing chronic and allergic aspergillosis in Africa.
背景
由于缺乏即时检测手段，在中低收入国家，真菌过敏的诊断在哮喘患者中仍然存在问题。本研究旨在评估曲霉免疫层析技术（ICT）IgG/M 侧向流动装置（LFD）在乌干达成年哮喘患者中用于血清学诊断变应性支气管肺曲霉病（ABPA）和真菌致敏性严重哮喘（SAFS）的性能。
方法
非洲严重哮喘计划研究乌干达站点的 374 名成年（年龄≥18 岁）哮喘患者构成了研究人群。根据标准标准诊断 ABPA 和 SAFS。不符合上述标准的哮喘患者构成对照组。根据制造商的说明进行 LFD 测试和读取。
结果
374 名患者中发现 12 例 ABPA（3.2%）和 60 例 SAFS（16%）。曲霉 ICT 诊断 ABPA 的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）分别为 0.0%、96.4%、0.0%和 96.7%，SAFS 分别为 6.7%、97.1%、30.8%和 84.5%。ABPA 的假阳性和假阴性率分别为 3.5%和 3.2%，SAFS 分别为 2.4%和 14.9%。LFD 阳性患者的烟曲霉特异性 IgE 水平中位数明显高于 LFD 阴性患者（中位数：0.06 kUA/l VS 0.03 kUA/L，P = 0.011）。
结论
曲霉 ICT IgG/M LFD 对 ABPA 和 SAFS 的诊断性能较差。它最大的价值可能在于区分非洲的慢性和变应性曲霉病。
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