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