Abstract
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Performance of a Fluorescence Immunoassay-Based Interferon-Gamma Release Assay for Latent Tuberculosis Infection
by 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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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.
DOI: 10.7754/Clin.Lab.2025.250937
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