Detection of Mycobacteria in Clinical Samples by the
Newly Developed PaxView TB/NTM MPCR-ULFA Kit
Jong-Hee Choo1, Chang-Ki Kim2 and Young-Kil Park1*
PaxGenBio, 361 Simindae-Ro, Dongan-Gu, Anyang-Si, Gyeonggi-Do 14057, Republic of Korea.
Seoul Clinical Laboratories, 13 Heungdeok 1-Ro, Giheung-Gu, Yongin-Si, Gyeonggi-Do 16954,
Republic of Korea.
This work was carried out in collaboration among all authors. Author JHC designed the clinical
experiments. Author CKK performed the clinical experiments. Author YKP performed the statistical
analysis and wrote the manuscript. All authors read and approved the final manuscript.
(1) Dr. Fernando José Cebola Lidon, Universidade Nova de Lisboa, Portugal.
(1) Mohan Khadka, Birat Medical College Teaching Hospital, Nepal.
(2) D. R. Gayathri Devi, Rajiv Gandhi University, India.
Complete Peer review History: http://www.sdiarticle4.com/review-history/62946
Received 29 August 2020
Accepted 05 November 2020
Published 12 November 2020
Aims: To evaluate sensitivity and specificity of the newly developed PaxView TB/NTM MPCR-
Study Design: Compared with the licensed AdvanSure TB/NTM real-time PCR.
Place and Duration of Study: SCL and PaxGenBio in Gyeonggi-do, Korea, between August 2018
and May 2019.
Methodology: In this study, 350 specimens including sputum, bronchial washing, body fluid,
tissue, urine, and cerebrospinal fluid were examined to evaluate the performance of the PaxView
TB/NTM MPCR-ULFA Kit compared to results of the currently licensed AdvanSure TB/NTM real-
time PCR (LG Chem, Korea).
Results: Compared to the AdvanSure TB/NTM real-time PCR, the PaxView TB/NTM MPCR-ULFA
Kit 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 also tested positive with the PaxView TB/NTM MPCR-ULFA Kit. 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 real-time PCR, 146 were
identified as MTB/NTM-negative according to the PaxView TB/NTM MPCR-ULFA Kit. 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.
Conclusion: The PaxView TB/NTM MPCR-ULFA Kit could be useful to identify MTB and NTM in
resource-limited countries, as this procedure is far more cost-effective than real-time PCR and
convenient than conventional gel electrophoresis approaches.
Keywords: Mycobacterium tuberculosis; multiplex PCR; lateral flow assay; real-time PCR; non-
Asian Journal of Biotechnology and Bioresource
6(3): 11-17, 2020; Article no.AJB2T.62946