ArticleTherapeutic advances in infectious disease
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.
Article in Therapeutic advances in infectious disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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 ( 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.
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