Publication date: Nov 26, 2025
Tuberculosis (TB) infection is a driver of the global TB epidemic. Accurate, affordable, and simpler diagnostics are crucial for identifying people for preventive therapy. We evaluated the diagnostic performance of the STANDARD F TB-Feron FIA (TB-Feron), a near-point-of-care (POC) assay for detecting TB infection. From June to December 2024, we conducted a cross-sectional study at the Vietnam National Lung Hospital, enrolling 352 participants, including 345 eligible participants: 95 with microbiologically confirmed pulmonary TB (Group 1), 200 household contacts of people with pulmonary TB (Group 2), and 50 with a recent history of a negative QFT-Plus result and no known TB exposure (Group 3). Participants were tested with TB-Feron and the reference standard, QuantiFERON TB Gold Plus (QFT-Plus). Results were compared for sensitivity and specificity (primary endpoints), with inter-test agreement (Cohen’s _705) and reproducibility (Bland-Altman analysis) as secondary outcomes. Among 345 eligible participants, TB-Feron sensitivity was 88. 4% (95% confidence interval [CI] 80. 2-94. 1) in Group 1, and specificity was 70. 0% (55. 4-82. 1) in Group 3. In Group 2, positive and negative agreements with QFT-Plus were 89. 2% (79. 8-95. 2%) and 75. 4% (66. 9-82. 6), respectively, with inter-test agreement of 80. 5% (Cohen’s _705=0. 6069, P
| Concepts | Keywords |
|---|---|
| Affordable | fluorescent immunoassay |
| Driver | interferon-gamma release assays |
| Tuberculosis | point of care |
| Vietnam | QuantiFERON-TB Gold Plus |
| TB |
Semantics
| Type | Source | Name |
|---|---|---|
| disease | MESH | Tuberculosis |
| pathway | KEGG | Tuberculosis |
| disease | MESH | Infection |
| drug | DRUGBANK | Gold |
| pathway | REACTOME | Release |