LDBIO Diagnostics, Lyon, France.
Aix-Marseille Université, APHM, IRD, SSA, VITROME, IHU-Méditerranée Infection, Marseille, France.
Front Cell Infect Microbiol. 2019 Jan 31;9:12. doi: 10.3389/fcimb.2019.00012. eCollection 2019.
sp. fungi cause various diseases in both immunocompetent and immunocompromised patients. The most frequent disorders include chronic pulmonary aspergillosis (CPA), a life-threatening disease that affects at least 3 million people worldwide, and allergic bronchopulmonary aspergillosis (ABPA), which affects approximately 4.8 million severe asthmatic patients globally. Diagnosis of such diseases involves IgG serological testing; however, the currently available anti- IgG detection assays are inappropriate for resource-poor laboratory settings, as they are expensive, rely on automated procedures, and require stable electrical power. Therefore, accurate CPA or ABPA diagnosis facilities are lacking in most low- and middle-income countries. We evaluated a novel anti- antibody immunochromatographic test (ICT) that requires minimal laboratory equipment. Two evaluations were performed: a single-center 4-month prospective study in a French reference laboratory (44 cases/257 patients) and a retrospective study in five French reference laboratories (262 cases and 188 controls). We estimated the ICT indices for the diagnosis of chronic aspergillosis, and the test results were compared to those of anti- IgG immunoblot (IB) assay. Of the 713 patients included in the study, 306 had chronic aspergillosis. Test sensitivity and specificity were 88.9% (95%CI[85-92]) and 96.3% (95%CI[94-98]) for the ICT and 93.1% (95%CI[90-96]) and 94.3% (95%CI[92-96]) for the IB, respectively. Agreement between the two assays was almost perfect (kappa = 0.86). As this ICT displays good diagnostic performance and complies with the ASSURED (Affordable, Sensitive, Specific, User-friendly, Equipment-free, and Delivered) criteria, we concluded that this anti- antibody ICT can be used to diagnose diseases in resource-poor settings.
真菌种属可引起免疫功能正常和免疫功能低下患者的各种疾病。最常见的疾病包括慢性肺曲霉病（CPA），这是一种危及生命的疾病，影响着全球至少 300 万人，以及变应性支气管肺曲霉病（ABPA），它影响着全球约 480 万严重哮喘患者。此类疾病的诊断涉及 IgG 血清学检测；然而，目前可用的抗 IgG 检测方法不适合资源匮乏的实验室环境，因为它们昂贵、依赖自动化程序，并且需要稳定的电力。因此，大多数中低收入国家缺乏准确的 CPA 或 ABPA 诊断设施。我们评估了一种新型的抗抗体免疫层析检测法（ICT），该方法需要最少的实验室设备。我们进行了两项评估：一项是法国参考实验室的为期 4 个月的单中心前瞻性研究（44 例/257 例患者），以及在五个法国参考实验室的回顾性研究（262 例病例和 188 例对照）。我们评估了 ICT 对慢性曲霉病的诊断指数，并将检测结果与抗 IgG 免疫印迹（IB）检测进行了比较。在纳入研究的 713 例患者中，有 306 例患有慢性曲霉病。ICT 的检测敏感性和特异性分别为 88.9%（95%CI[85-92]）和 96.3%（95%CI[94-98]），IB 的检测敏感性和特异性分别为 93.1%（95%CI[90-96]）和 94.3%（95%CI[92-96]）。两种检测方法的一致性几乎是完美的（kappa = 0.86）。由于这种 ICT 具有良好的诊断性能，并且符合 ASSURED（负担得起、敏感、特异、用户友好、无设备和交付）标准，我们得出结论，这种抗抗体 ICT 可用于在资源匮乏的环境中诊断疾病。
