LIOFeron®TB/LTBI: A novel and reliable test for LTBI and tuberculosis

Int J Infect Dis. 2020 Feb:91:177-181. doi: 10.1016/j.ijid.2019.12.012. Epub 2019 Dec 23.


Objectives: High accuracy diagnostic screening tests for tuberculosis (TB) are required to improve the diagnosis of both active TB and latent Mycobacterium tuberculosis (MTB) infection (LTBI). The novel IGRA LIOFeron®TB/LTBI assay was tested and its accuracy was compared to the QuantiFERON®-TB Gold Plus assay.

Methods: A total of 389 subjects were enrolled in two cohorts and classified as healthy, active TB or LTBI persons. The blood of all the patients was tested with LIOFeron®TB/LTBI assay, containing MTB alanine dehydrogenase, able to differentiate active TB from LTBI diagnosis. The results obtained with both IGRAs, performed on the same 250 samples, were finally compared.

Results: The two assays demonstrated an excellent concordance of their results with patients' diagnosis of MTB infection. ROC analysis for QuantiFERON®-TB Gold Plus showed sensitivity and specificity respectively of 98% and 97% in diagnosing active TB patients and 85% and 94% in diagnosing LTBI subjects. LIOFeron®TB/LTBI assay showed sensitivity and specificity respectively of 90% and 98% in diagnosing active TB patients and 94% and 97% in diagnosing LTBI subjects.

Conclusions: The two IGRAs displayed the same high accuracy in diagnosing MTB infection/TB disease, and LIOFeron®TB/LTBI assay demonstrated higher sensitivity than QuantiFERON®-TB Gold Plus test in LTBI detection.

Keywords: Alanine dehydrogenase; IGRA; Mycobacterium tuberculosis; Tuberculosis diagnosis.

Publication types

  • Evaluation Study

MeSH terms

  • Adult
  • Aged
  • Cohort Studies
  • Diagnostic Tests, Routine / methods*
  • Female
  • Humans
  • Latent Tuberculosis / diagnosis*
  • Latent Tuberculosis / immunology
  • Latent Tuberculosis / microbiology
  • Male
  • Middle Aged
  • Mycobacterium tuberculosis / genetics
  • Mycobacterium tuberculosis / isolation & purification
  • Mycobacterium tuberculosis / physiology
  • ROC Curve
  • Sensitivity and Specificity
  • T-Lymphocytes / immunology