Comparison between the PaxView TB/NTM MPCR ULFA and AdvanSure TB/NTM Real-Time PCR Kits for the Detection of Mycobacterium tuberculosis and Non-Tuberculous Mycobacteria in Clinical Samples
Chang-Ki Kim, Sewon Kim, Chorong Lee
Medical Device Clinical Trial Center, Seoul Clinical laboratories, Yongin, Korea
Background: Tuberculosis (TB) remains a major global health problem, with about 10 million cases annually. Rapid and correct diagnosis is crucial to control TB. Conventional tests, like smear microscopy and culture exam, have been used as the standard diagnostic method. However, molecular diagnostic tools to detect Mycobacterium tuberculosis (MTB) are highly sensitive and rapid, and therefore their utilization has expanded recently. This study aimed to evaluate the PaxView TB/NTM MPCR ULFA kit (PaxView).
Methods: A total of 350 specimens, including sputum, bronchial washing, body fluid, tissue, urine, and cerebrospinal fluid (CSF), were examined to evaluate the performance of the PaxView compared to that of the currently licensed AdvanSure TBINTM real-time PCR kit (LG Chem, Korea). PaxView has roughly two steps of the process including multiplex PCR and lateral flow assay for IS6110 and mpt40.
Results: Compared to the AdvanSure TB/NTM PCR real-time kit, the PaxView test was found to possess a 100% sensitivity. In other words, all 140 MTB and 61 non-tuberculous mycobacteria (NTM) specimens that tested positive with the AdvanSure TB/NTM real-time PCR kit also tested positive with the PaxView. However, the specificity of the later kit found to be 97.9% (146/149; 95% CI 95.6-100.0), meaning that out of 149 MTB/NTM specimens that tested negative with the AdvanSure TB/NTM rea1-time PCR kit, 146 were identified as MTB/NTM-negative according to the PaxView. Nonetheless, the overall agreement between the two diagnostic tools was 99. 1 % (347/350; 95% CI 98. 1-100.0) and the kappa value was 0.982 (350;95% CI 0.968-0.995), meaning that the two diagnostic tools rendered almost identical results.
Conclusions: Therefore, we concluded that the PaxView kit could be useful to identify MTB and NTM in resource-limited countries, as this procedure is far more cost-effective and convenient than real-time PCR or conventional gel electrophoresis approaches.
Keywords: Tuberculosis, Nontuberculous mycobacteria, NAAT, Hybridization
* source: LMCE 2020 & KSLM 61ST Annual Meeting