LDBio曲霉免疫层析试验（ICT）IgM/IgG在社区与医院环境中诊断慢性肺曲霉病的性能

Performance of LDBio Aspergillus ICT IgM/IgG Lateral Flow Assay in Diagnosing Chronic Pulmonary Aspergillosis in Community Versus Hospital Setting.

作者信息

Sehgal Inderpaul Singh, Soundappan Kathirvel, Muthu Valliappan, Dhooria Sahajal, Prasad Kuruswamy Thurai, Rudramurthy Shivaprakash M, Aggarwal Ashutosh Nath, Raju Rajesh, Garg Mandeep, Prabhakar Nidhi, Chakrabarti Arunaloke, Agarwal Ritesh

机构信息

Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India.

Department of Community Medicine and School of Public Health, Institute of Medical Education and Research (PGIMER), Chandigarh, India.

出版信息

Mycopathologia. 2025 Jan 7;190(1):9. doi: 10.1007/s11046-024-00917-3.

DOI:10.1007/s11046-024-00917-3

PMID:39775199

Abstract

BACKGROUND

LDBio immunochromatographic lateral flow assay, a point-of care test, detects IgM/IgG antibodies against Aspergillus fumigatus (LDBio-ALFA). LDBio-ALFA has been evaluated for diagnosing chronic pulmonary aspergillosis (CPA) in hospital patients, though its efficacy in field settings remains unexamined.

OBJECTIVE

Our primary objective was to assess the diagnostic accuracy of LDBio-ALFA in diagnosing CPA in a field and a hospital cohort. The secondary objective was to compare the diagnostic performance of LDBio-ALFA and A. fumigatus-IgG measured by a commercial automated fluorescent enzyme immunoassay (FEIA) using latent class analysis (LCA).

METHODS

We prospectively enrolled adult subjects with post-tuberculosis lung abnormality (PTLA) from a tertiary care hospital (hospital cohort), and designated microscopy centers and a community health center (field cohort). We measured A. fumigatus-IgG using LDBio-ALFA and FEIA in the same serum sample.

RESULTS

We enrolled 508 subjects, of which 122 and 386 constituted field and hospital cohorts. CPA was diagnosed in 325/508 (64%) subjects. The CPA prevalence was higher in the hospital (78% [301/386]) than in the field cohort (19.7% [24/122]). The sensitivity and specificity of LDBio-ALFA in the entire cohort in diagnosing CPA was 81.2% and 85.3%. The sensitivity of LDBio-ALFA in the field cohort was 83.3% and 81.1% in the hospital population. On LCA, the sensitivity and specificity of the FEIA method (A. fumigatus-IgG ≥ 27 mgA/L) was 100% and 86.7%, while for LDBio-ALFA it was for 84.5% and 81.3% for diagnosing CPA.

CONCLUSION

LDBio-ALFA is a valuable test for diagnosing CPA in the field and in hospital patients. However, a negative test should be confirmed using an automated immunoassay.

摘要

背景

LDBio免疫层析侧向流动分析法是一种即时检测方法，可检测抗烟曲霉的IgM/IgG抗体（LDBio-ALFA）。LDBio-ALFA已在医院患者中用于诊断慢性肺曲霉病（CPA），但其在现场环境中的有效性仍未得到检验。

目的

我们的主要目的是评估LDBio-ALFA在现场和医院队列中诊断CPA的诊断准确性。次要目的是使用潜在类别分析（LCA）比较LDBio-ALFA与通过商业自动化荧光酶免疫测定法（FEIA）测量的烟曲霉-IgG的诊断性能。

方法

我们前瞻性地纳入了来自一家三级医疗医院（医院队列）、指定显微镜检查中心和社区卫生中心（现场队列）的患有肺结核后肺部异常（PTLA）的成年受试者。我们在同一血清样本中使用LDBio-ALFA和FEIA测量烟曲霉-IgG。

结果

我们纳入了508名受试者，其中122名和386名分别构成现场队列和医院队列。325/508（64%）名受试者被诊断为CPA。医院队列中的CPA患病率（78%[301/386]）高于现场队列（19.7%[24/122]）。LDBio-ALFA在整个队列中诊断CPA的敏感性和特异性分别为81.2%和85.3%。LDBio-ALFA在现场队列中的敏感性为83.3%，在医院人群中的敏感性为81.1%。根据LCA，FEIA方法（烟曲霉-IgG≥27mgA/L）诊断CPA的敏感性和特异性分别为100%和86.7%，而LDBio-ALFA的敏感性和特异性分别为84.5%和81.3%。