LIOFeron® TB/LTBI

Assay Principle

The LIOFeron® TB/LTBI test is based on the detection of cellular cytokine responses to tuberculosis-specific antigens in whole blood samples. Upon incubation of samples in stimulation tubes, antigen-specific immune cells release interferon-gamma which then is quantified via enzyme-linked immunosorbent assay (ELISA). The system includes antigen stimulation tubes as well as positive and negative controls for reliable performance.

Intended Use

The kit is intended for professional use in clinical laboratories. Results should be interpreted in the context of clinical assessment and other available diagnostic data.

Pack sizes and formats

• LIOFeron® TB/LTBI Human Blood Stimulation Tubes (IVD) (PC, NC, TB antigen A, TB antigen B): 22 tests
• LIOFeron® TB/LTBI Human interferon-gamma ELISA (IVD) (MTP, standard, detection antibody, conjugate, substrate, stop, wash buffer, incubation buffer): 22 tests
• LIOFeron® TB/LTBI Human interferon-gamma ELISA (IVD) (2× MTP, standard, detection antibody, conjugate, substrate, stop, wash buffer, incubation buffer): 44 tests

Technical Specifications

• Sample material: Whole blood
• Technology: interferon-gamma release assay (IGRA)
• Detection method: ELISA-based interferon-gamma detection

System Components

• Antigen-coated blood collection tubes
• Positive and negative control tubes
• ELISA reagents for interferon-gamma detection

Citations

1. Della Bella C, Spinicci M, Alnwaisri HFM, et al. LIOFeron® TB/LTBI: A novel and reliable test for LTBI and tuberculosis. Int J Infect Dis. 2020;91(2):177-181. PMID: 31877486 Full text (PDF)
2. Gong W, Wu X. Differential Diagnosis of Latent Tuberculosis Infection and Active Tuberculosis: A Key to a Successful Tuberculosis Control Strategy. Front Microbiol. 2021;12:745592. PMID: 34745048 Full text (PDF)
3. Bayaa R. Development and clinical evaluation of new blood-based tests for improving the diagnosis of pulmonary tuberculosis and identification of candidate biomarkers for treatment monitoring: a multicenter study in moderate and high incidence settings [doctoral thesis]. Lyon: Université de Lyon; 2022. HAL record Full text (PDF)
4. Della Bella C, Motisi MA, Venturini E, et al. Performance evaluation of the LIOFeron® TB/LTBI IGRA for screening of paediatric LTBI and tuberculosis. Eur J Pediatr. 2025;184(2):147. PMID: 39831989 Full text (PDF)