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.