{"title":"LDBio曲霉ICT IgM/IgG横向流动试验在社区与医院诊断慢性肺曲霉病中的应用","authors":"Inderpaul Singh Sehgal, Kathirvel Soundappan, Valliappan Muthu, Sahajal Dhooria, Kuruswamy Thurai Prasad, Shivaprakash M Rudramurthy, Ashutosh Nath Aggarwal, Rajesh Raju, Mandeep Garg, Nidhi Prabhakar, Arunaloke Chakrabarti, Ritesh Agarwal","doi":"10.1007/s11046-024-00917-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":19017,"journal":{"name":"Mycopathologia","volume":"190 1","pages":"9"},"PeriodicalIF":3.6000,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Performance of LDBio Aspergillus ICT IgM/IgG Lateral Flow Assay in Diagnosing Chronic Pulmonary Aspergillosis in Community Versus Hospital Setting.\",\"authors\":\"Inderpaul Singh Sehgal, Kathirvel Soundappan, Valliappan Muthu, Sahajal Dhooria, Kuruswamy Thurai Prasad, Shivaprakash M Rudramurthy, Ashutosh Nath Aggarwal, Rajesh Raju, Mandeep Garg, Nidhi Prabhakar, Arunaloke Chakrabarti, Ritesh Agarwal\",\"doi\":\"10.1007/s11046-024-00917-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":19017,\"journal\":{\"name\":\"Mycopathologia\",\"volume\":\"190 1\",\"pages\":\"9\"},\"PeriodicalIF\":3.6000,\"publicationDate\":\"2025-01-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Mycopathologia\",\"FirstCategoryId\":\"99\",\"ListUrlMain\":\"https://doi.org/10.1007/s11046-024-00917-3\",\"RegionNum\":3,\"RegionCategory\":\"生物学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MYCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Mycopathologia","FirstCategoryId":"99","ListUrlMain":"https://doi.org/10.1007/s11046-024-00917-3","RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MYCOLOGY","Score":null,"Total":0}
Performance of LDBio Aspergillus ICT IgM/IgG Lateral Flow Assay in Diagnosing Chronic Pulmonary Aspergillosis in Community Versus Hospital Setting.
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.
期刊介绍：
Mycopathologia is an official journal of the International Union of Microbiological Societies (IUMS). Mycopathologia was founded in 1938 with the mission to ‘diffuse the understanding of fungal diseases in man and animals among mycologists’. Many of the milestones discoveries in the field of medical mycology have been communicated through the pages of this journal. Mycopathologia covers a diverse, interdisciplinary range of topics that is unique in breadth and depth. The journal publishes peer-reviewed, original articles highlighting important developments concerning medically important fungi and fungal diseases. The journal highlights important developments in fungal systematics and taxonomy, laboratory diagnosis of fungal infections, antifungal drugs, clinical presentation and treatment, and epidemiology of fungal diseases globally. Timely opinion articles, mini-reviews, and other communications are usually invited at the discretion of the editorial board. Unique case reports highlighting unprecedented progress in the diagnosis and treatment of fungal infections, are published in every issue of the journal. MycopathologiaIMAGE is another regular feature for a brief clinical report of potential interest to a mixed audience of physicians and laboratory scientists. MycopathologiaGENOME is designed for the rapid publication of new genomes of human and animal pathogenic fungi using a checklist-based, standardized format.
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