Evaluation of a semi-automated Seegene PCR workflow with MTB, MDR, and NTM detection for rapid screening of tuberculosis in a low-prevalence setting.
In areas of low tuberculosis (TB) prevalence, laboratory diagnosis of TB may essentially cover non-tuberculous mycobacteria (NTM) in addition to Mycobacterium tuberculosis (MTB). In this study, a semi-automated PCR workflow distinguishing MTB and NTM (Anyplex™ MTB/NTMe, Seegene) and subsequently detecting MTB isoniazid/rifampicin resistance (Allplex™ MTB/MDRe, Seegene) was evaluated for replacing smear microscopy of acid-fast bacilli as the rapid screening method for TB. With 279 clinical samples, 47 cultures positive for MTB and 76 for NTM, the Anyplex™ MTB/NTMe assay and smear microscopy showed equal sensitivities (49.6% vs 50.8%, respectively) but Anyplex™ MTB/NTMe was more sensitive for MTB (63.8% vs 25.6%) than for NTM (40.8% vs 64.5%). Allplex™ MTB/MDRe showed a slightly higher sensitivity of 68.1% for MTB (32/47 positive, n = 222). Antibiotic resistance profiles were correctly identified for all MTB isolates (one MDR isolate). Specificity was 100% for both assays. Anyplex™ MTB/NTMe detected all the 18 NTM species present in the study. The analytical performance of the evaluated high-throughput workflow was relatively weak compared to culture but potentially adequate as a rapid screening method analogous to smear microscopy with additional differentiation between TB, MDR-TB, and NTM.
['Luukinen|Bruno Vincent|BV|https://orcid.org/0000-0003-3578-782X', 'Vuento|Risto|R|', 'Hirvonen|Jari Juhani|JJ|']
D057205:Automation, Laboratory D001431:Bacteriological Techniques D024901:Drug Resistance, Multiple, Bacterial D006801:Humans D025202:Molecular Diagnostic Techniques D009169:Mycobacterium tuberculosis D009170:Nontuberculous Mycobacteria D011237:Predictive Value of Tests D060888:Real-Time Polymerase Chain Reaction D012680:Sensitivity and Specificity D018088:Tuberculosis, Multidrug-Resistant
tuberculosis Anyplex Allplex clinical microbiology molecular diagnostics mycobacteriology