Performance of a Fluorescence Immunoassay-Based Interferon-Gamma Release Assay for Latent Tuberculosis Infection.

IF 0.7 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY

Clinical laboratory Pub Date : 2026-09-01 DOI:10.7754/Clin.Lab.2025.250937

Eungjun Yoon, Jae Joon Lee, Hyejin Ryu, Ajoy Kumar Verma, Ashish Ranjan, Lokender Kumar, Rajesh Kumar, Gavish Kumar, Ankita Dey, Tae Yeul Kim, Minjeong Nam

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引用次数: 0

Abstract

Background: Latent tuberculosis infection (LTBI) diagnosis is crucial for controlling tuberculosis (TB). Interferon-gamma release assay (IGRA) diagnoses LTBI by measuring interferon-gamma produced by TB antigen-stimulated T-cells. In this study, we evaluated the clinical performance of AFIAS IGRA-TB (Boditech Med, Inc.).

Methods: A total of 200 subjects, including those without known risk factors for TB infection, those with known TB contact, and those with active TB, were analyzed using both AFIAS IGRA-TB and QuantiFERON-TB Gold In-Tube (QFT-GIT; Qiagen) according to the manufacturers' instructions.

Results: The positive, negative, and overall percent agreements between AFIAS IGRA-TB and QFT-GIT were 88.2% (95% confidence interval [CI]: 76.6 - 94.5%), 95.4% (95% CI: 90.4 - 97.9%), and 93.4% (95% CI: 88.8 - 96.2%), respectively. Cohen's kappa coefficient was 0.84, indicating excellent agreement.

Conclusions: AFIAS IGRA-TB demonstrated equivalent clinical performance to QFT-GIT. Given its ease of use, minimal reliance on trained personnel or complex equipment, and rapid turnaround time, AFIAS IGRA-TB has the potential to serve as an alternative test for diagnosing LTBI and active TB in resource-limited settings.

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基于荧光免疫分析的干扰素γ释放法检测潜伏结核感染的性能。

背景：潜伏性结核感染（LTBI）的诊断是控制结核（TB）的关键。干扰素γ释放试验（IGRA）通过测量TB抗原刺激t细胞产生的干扰素γ来诊断LTBI。在本研究中，我们评估了AFIAS IGRA-TB （Boditech Med, Inc.）的临床表现。方法：采用AFIAS IGRA-TB和QuantiFERON-TB金管（QFT-GIT; Qiagen）对200例无已知结核感染危险因素、已知结核接触者和活动性结核患者进行分析。结果：AFIAS IGRA-TB和QFT-GIT之间的阳性、阴性和总体百分比一致性分别为88.2%（95%置信区间[CI]: 76.6 - 94.5%）、95.4% （95% CI: 90.4 - 97.9%）和93.4% （95% CI: 88.8 - 96.2%）。Cohen’s kappa系数为0.84，一致性极好。结论：AFIAS IGRA-TB的临床表现与QFT-GIT相当。由于其易于使用，对训练有素的人员或复杂设备的依赖最小，周转时间短，AFIAS IGRA-TB有可能在资源有限的环境中作为诊断LTBI和活动性结核病的替代测试。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical laboratory 医学-医学实验技术

CiteScore

1.50

自引率

0.00%

发文量

494

审稿时长

3 months

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.