Chiara Della Bella1, Michele Spinicci2, Heba F Mustafa Alnwaisri1, Filippo Bartalesi2, Simona Tapinassi1, Jessica Mencarini2, Marisa Benagiano1, Alessia Grassi1, Sofia D'Elios3, Arianna Troilo1, Arailym Abilbayeva4, Dinara Kuashova4, Elmira Bitanova4, Anel Tarabayeva4, Eduard Arkadievich Shuralev5, Alessandro Bartoloni6, Mario Milco D'Elios7. 1. Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. 2. Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Infectious and Tropical Diseases Unit, Florence Careggi University Hospital, Florence, Italy. 3. Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. 4. Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan. 5. Institute of Environmental Sciences, Kazan Federal University, and Russian Medical Academy of Continuous Professional Education, (Kazan State Medical Academy branch), and Federal Center for Toxicological, Radiation and Biological Safety, Kazan, Tatarstan, Russian Federation. 6. Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Infectious and Tropical Diseases Unit, Florence Careggi University Hospital, Florence, Italy. Electronic address: alessandro.bartoloni@unifi.it. 7. Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. Electronic address: mariomilco.delios@unifi.it.
Abstract
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.
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 LTBIpersons. 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 TBpatients and 85% and 94% in diagnosing LTBI subjects. LIOFeron®TB/LTBI assay showed sensitivity and specificity respectively of 90% and 98% in diagnosing active TBpatients 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.
Authors: V Dirix; N Dauby; M Hites; E Watelet; A Van Praet; A Godefroid; E Petit; M Singh; C Locht; F Mascart; V Corbière Journal: J Clin Microbiol Date: 2022-04-18 Impact factor: 11.677