Chiara Della Bella, Michele Spinicci, Heba f Mustafa Alnwaisri, Filippo Bartalesi, Simona Tapinassi, Jessica Mencarini, Marisa Benagiano, Alessia Grassi, Sofia D'Elios, Arianna Troilo, Arailym Abilbayeva, Dinara Kuashova, Elmira Bitanova, Anel Tarabayeva, Eduard Arkadievich Shuralev, Alessandro Bartoloni, Mario Milco D'Elios
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.
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.
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.
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.
Alanine dehydrogenase; IGRA; Mycobacterium tuberculosis; Tuberculosis diagnosis.
Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.
- Cohort Studies
- Diagnostic Tests, Routine / methods*
- Latent Tuberculosis / diagnosis
- Latent Tuberculosis / immunology
- latent tuberculosis / microbiology
- Middle Agend
- Mycobacterium tuberculosis / genetics
- Mycobacterium tuberculosis / isolation & purification
- Mycobacterium tuberculosis / physiology
- ROC Curve
- Sensitivity and Specificity
- T-Lymphocytes / immunology