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Evaluation of a semi‐automated Seegene PCR workflow with MTB, MDR, and NTM detection for rapid screening of tuberculosis in a low‐prevalence setting
Author(s) -
Luukinen Bruno Vincent,
Vuento Risto,
Hirvonen Jari Juhani
Publication year - 2020
Publication title -
apmis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 88
eISSN - 1600-0463
pISSN - 0903-4641
DOI - 10.1111/apm.13040
Subject(s) - mycobacterium tuberculosis , tuberculosis , rifampicin , isoniazid , microbiology and biotechnology , medicine , mycobacterium tuberculosis complex , antibiotics , virology , biology , pathology
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.