Evaluation of a semi-automated Seegene PCR workflow with MTB, MDR, and NTM detection for rapid screening of tuberculosis in a low-prevalence setting.

Autor: Luukinen BV; Department of Clinical Microbiology, Fimlab Laboratories, Tampere, Finland.; Faculty of Medicine, University of Helsinki, Helsinki, Finland., Vuento R; Department of Clinical Microbiology, Fimlab Laboratories, Tampere, Finland., Hirvonen JJ; Department of Clinical Microbiology, Fimlab Laboratories, Tampere, Finland.; Mobidiag, Espoo, Finland.
Jazyk: angličtina
Zdroj: APMIS : acta pathologica, microbiologica, et immunologica Scandinavica [APMIS] 2020 May; Vol. 128 (5), pp. 406-413. Date of Electronic Publication: 2020 Apr 27.
DOI: 10.1111/apm.13040
Abstrakt: 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.
(© 2020 The Authors. APMIS published by John Wiley & Sons Ltd on behalf of Scandinavian Societies for Medical Microbiology and Pathology.)
Databáze: MEDLINE
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