Ayse N Ceylan, Harbiye D Canat, Selda Komec, Abdurrahman Gulmez
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引用次数: 0
摘要
背景：结核病仍然是一个重大的全球健康挑战，潜伏性结核病感染（LTBI）构成了活动性疾病发展的风险。本研究旨在比较standard - standard F TB-Feron FIA测试与QuantiFERON-TB Gold Plus测试在检测LTBI方面的性能，后者是世界卫生组织（WHO）认可的测试。方法：我们纳入137名参与者，其中58.4%为健康者，41.6%为正在接受免疫抑制治疗的患者。结果：QFT-Plus与TB-Feron FIA的一致性较好，总体一致性为83.0%,Cohen’s kappa系数为0.631 （p < 0.001）。与QFT-Plus相比，TB-Feron FIA检测的敏感性为84.38%，特异性为87.10%。根据QFT Plus结果重新计算TB-Feron FIA截止值时，0.37的灵敏度和特异度最高（分别为84.37%和88.42%）。结论：我们的研究结果表明，TB-Feron FIA是诊断LTBI的可靠替代方法，其性能与QFT-Plus相当，特别是在免疫抑制患者中，其敏感性为100%。需要进一步的研究在更广泛的人群中证实这些结果。
Diagnostic Accuracy of a Novel Fluorescent Immunoassay-Based Test in Latent Tuberculosis Infection.
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.
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