Journal Article Epublish
PubMed: 42028411 DOI: 10.1177/20499361261436542
A new multiplex molecular assay based on padlock probes and rolling circle amplification for MDR-TB detection in clinical specimens: a prospective diagnostic accuracy study.
Ther Adv Infect Dis 13:20499361261436542
Authors: Andrii Dudnyk, Nadiia Tytarenko, Oksana Lytvyniuk, Olena Tolstova, Joan-Pau Millet, Israel Molina, Adrián Antuori, Nelly Ciobanu, Valeriu Crudu, José Domínguez
Affiliations
- Germans Trias i Pujol Research Institute (IGTP), Badalona, Barcelona, Spain.
- Department of Tuberculosis, Clinical Immunology and Allergy, National Pirogov Memorial Medical University, Vinnytsia, Ukraine.
- Serveis Clínics, Carrer de García Mariño, 4, Sarrià-Sant Gervasi, 08022 Barcelona, Spain.
- Germans Trias i Pujol Research Institute (IGTP); Badalona, Barcelona, Spain. Odesa I. I. Mechnikov National University, Odesa, Ukraine.
- Microbiology Laboratory, Regional Phthisiopulmonology Center, Vinnytsia, Ukraine.
- Serveis Clinics, Barcelona, Spain.
- CIBER de Epidemiología y Salud Pública, CIBEREESP, Instituto de Salud Carlos III, Madrid, Spain.
- Microbiology Department, Laboratori Clínic Metropolitana Nord (LCMN), Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.
- PMSI Institute of Pneumology "Chiril Draganiuc," Chișinău, Moldova.
- Department of Pneumology & Allergology, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova.
- Germans Trias i Pujol Research Institute (IGTP); Badalona, Barcelona, Spain. Department of Genetics and Microbiology, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain. CIBER Enfermedades Respiratorias, CIBERES, Instituto de Salud Carlos III, Madrid, Spain.
Abstract
BACKGROUND
Patients with multidrug-resistant tuberculosis (MDR-TB) receive treatment that is at least 20% less effective than drug-susceptible cases globally.
OBJECTIVES
The study evaluated the diagnostic accuracy of mfloDx MDR-TB assay (EMPE Diagnostics AB, Solna, Sweden) for simultaneous detection of resistance to isoniazid (INH) and rifampicin (RIF) compared to culture-based drug susceptibility test (DST).
DESIGN
A prospective diagnostic accuracy study.
METHODS
Clinical samples from 287 patients (mean age 45.3 (95% CI 43.3-47.2) years; 50 (17.0%) were female) from TB facilities in Ukraine (n = 82, 28.6%), Moldova (n = 37, 12.9%) and Spain (168, 58.5%) with bacteriologically confirmed TB and persons evaluated for non-tuberculous mycobacteria (NTM) were consecutively tested. The results of the mfloDx MDR-TB assay were compared with culture-based DST.
RESULTS
A total of 186 out of 287 sputum specimens (64.8%) yielded conclusive results that allowed a definitive interpretation of resistance to at least one drug. The mfloDx MDR-TB assay demonstrated sensitivity at 86.9 (95% CI 80.6-91.7) and specificity at 100 (95% CI 79.4-100) correctly differentiating mycobacterium tuberculosis complex from NTM in smear positive sputum samples. Considering only conclusive results in sputum samples, the mfloDx MDR-TB assay simultaneously predicted resistance to INH and RIF in TB patients showing high sensitivity 100 (95% CI 93.0-100) and specificity 98.7 (95% CI 92.8-100) compared to MDR-TB detection by culture-based DST.
CONCLUSION
While approximately one-third of tests yielded inconclusive results, the mfloDx™ MDR-TB assay demonstrated potential as a rapid screening tool for INH and RIF resistance, offering a time advantage over conventional culture-based DST.
MeSH
Mycobacterium, Genes, Mdr, Tuberculosis, Multidrug-Resistant, Pharmaceutical Preparations, Sputum, Tuberculosis