Ayse N Ceylan, Harbiye D Canat, Selda Komec, Abdurrahman Gulmez
{"title":"Diagnostic Accuracy of a Novel Fluorescent Immunoassay-Based Test in Latent Tuberculosis Infection.","authors":"Ayse N Ceylan, Harbiye D Canat, Selda Komec, Abdurrahman Gulmez","doi":"10.7754/Clin.Lab.2024.241003","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Tuberculosis is still a significant global health challenge, with latent tuberculosis infection (LTBI) posing a risk for the development of active disease. This study aimed to compare the performance of the STAN-DARD F TB-Feron FIA test with the QuantiFERON-TB Gold Plus, a test endorsed by the World Health Organization (WHO), in detecting LTBI.</p><p><strong>Methods: </strong>We included 137 participants, out of which 58.4% were healthy and 41.6% were undergoing immunosuppressive treatment.</p><p><strong>Results: </strong>The agreement between QFT-Plus and TB-Feron FIA was substantial, with an overall concordance of 83.0% and a Cohen's kappa coefficient of 0.631 (p < 0.001). The TB-Feron FIA test demonstrated a sensitivity of 84.38% and a specificity of 87.10% compared to QFT-Plus. When TB-Feron FIA cutoff values were recalculated according to QFT Plus results, the value of 0.37 gave the highest sensitivity and specificity (84.37% and 88.42%).</p><p><strong>Conclusions: </strong>Our findings suggest that TB-Feron FIA is a reliable alternative for diagnosing LTBI, with performance comparable to QFT-Plus, especially in immunosuppressive patients where sensitivity was 100%. Further studies are warranted to confirm these results in broader populations.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 3","pages":""},"PeriodicalIF":0.7000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical laboratory","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.7754/Clin.Lab.2024.241003","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Tuberculosis is still a significant global health challenge, with latent tuberculosis infection (LTBI) posing a risk for the development of active disease. This study aimed to compare the performance of the STAN-DARD F TB-Feron FIA test with the QuantiFERON-TB Gold Plus, a test endorsed by the World Health Organization (WHO), in detecting LTBI.
Methods: We included 137 participants, out of which 58.4% were healthy and 41.6% were undergoing immunosuppressive treatment.
Results: The agreement between QFT-Plus and TB-Feron FIA was substantial, with an overall concordance of 83.0% and a Cohen's kappa coefficient of 0.631 (p < 0.001). The TB-Feron FIA test demonstrated a sensitivity of 84.38% and a specificity of 87.10% compared to QFT-Plus. When TB-Feron FIA cutoff values were recalculated according to QFT Plus results, the value of 0.37 gave the highest sensitivity and specificity (84.37% and 88.42%).
Conclusions: Our findings suggest that TB-Feron FIA is a reliable alternative for diagnosing LTBI, with performance comparable to QFT-Plus, especially in immunosuppressive patients where sensitivity was 100%. Further studies are warranted to confirm these results in broader populations.
期刊介绍:
Clinical Laboratory is an international fully peer-reviewed journal covering all aspects of laboratory medicine and transfusion medicine. In addition to transfusion medicine topics Clinical Laboratory represents submissions concerning tissue transplantation and hematopoietic, cellular and gene therapies. The journal publishes original articles, review articles, posters, short reports, case studies and letters to the editor dealing with 1) the scientific background, implementation and diagnostic significance of laboratory methods employed in hospitals, blood banks and physicians'' offices and with 2) scientific, administrative and clinical aspects of transfusion medicine and 3) in addition to transfusion medicine topics Clinical Laboratory represents submissions concerning tissue transplantation and hematopoietic, cellular and gene therapies.