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Aims: To evaluate sensitivity and specificity of the newly developed PaxView TB/NTM MPCR-ULFA Kit.
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.
Bhargava A, Bhargava M. Tuberculosis deaths are predictable and preventable: Comprehensive assessment and clinical care is the key. J Clin Tuberc Other Mycobact Dis Actions. 2020;19:100155.
Min J, Kim JS, Kim HW, Shin AY, Koo HK, et al. Clinical profiles of early and tuberculosis-related mortality in South Korea between 2015 and 2017: A cross-sectional study. BMC Infect Dis. 2019;19: 735.
Balcha TT, Sturegard E, Winqvist N, Skogmar S, Reepalu A, et al. Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: Diagnostic yield of xpert MTB/RIF compared with smear microscopy and liquid culture. PLoS One. 2014;9:85478.
Beyanga M, Kidenya BR, Gerwing-Adima L, Ochodo E, Mshana SE, et al. Investigation of household contacts of pulmonary tuberculosis patients increases case detection in Mwanza City, Tanzania. BMC Infect Dis. 2018;18:110.
Ikuabe PO, Ebuenyi ID. Prevalence of rifampicin resistance by automated Genexpert rifampicin assay in patients with pulmonary tuberculosis in Yenagoa, Nigeria. Pan Afr Med J. 2018;29:204.
Mesfin EA, Beyene D, Tesfaye A, Admasu A, Addise D, et al. Drug-resistance patterns of Mycobacterium tuberculosis strains and associated risk factors among multi drug-resistant tuberculosis suspected patients from Ethiopia. PLoS One. 2018; 13:0197737.
Sidharta SD, Yin JD, Yoong JS, Khan MS. High use of private providers for first healthcare seeking by drug-resistant tuberculosis patients: A cross-sectional study in Yangon, Myanmar. BMC Health Serv Res. 2018;18:276.
Abdurrahman ST, Emenyonu N, Obasanya OJ, Lawson L, Dacombe R, et al. The hidden costs of installing xpert machines in a tuberculosis high-burden country: Experiences from Nigeria. Pan Afr Med J. 2014;18:277.
Puri L, Oghor C, Denkinger CM, Pai M. Xpert MTB/RIF for tuberculosis testing: access and price in highly privatized health markets. 2016;94-95. Available:www.thelancet.com/lancetgh
Cho WH, Won EJ, Choi HJ, Kee SJ, Shin JH, et al. Comparison of AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR for detection of Mycobacterium tuberculosis complex in routine clinical practice. Ann Lab Med. 2015;35: 356-361.
Lee H, Park KG, Lee G, Park J, Park YG, et al. Assessment of the quantitative ability of AdvanSure TB/NTM real-time PCR in respiratory specimens by comparison with phenotypic methods. Ann Lab Med. 2014; 34:51-55.
Park YK, Bai GH, Kim SJ. Restriction fragment length polymorphism analysis of Mycobacterium tuberculosis isolated from countries in the western pacific region. J Clin Microbiol. 2000;38:191-197.
Kathirvel M, Kommoju V, Brammacharry U, Ravibalan T, Ravishankar N, et al. Clinical evaluation of mtp40 polymerase chain reaction for the diagnosis of extra pulmonary tuberculosis. World J Microbiol Biotechnol;2013. DOI: 10.1007/s11274-013-1566-z
Parra CA, Londono LP, Portillo PD, Patarroyo ME. Isolation, characterization, and molecular cloning of a specific Mycobacterium tuberculosis antigen gene: Identification of a species-specific sequence. Infect Immun. 1991;59:3411-3417.
Weil A, Plikaytis BB, Butler WR, Woodley CL, Shinnick TM. The mtp40 gene is not present in all strains of Mycobacterium tuberculosis. J Clin Microbiol. 1996;34: 2309-2311.
Sinha P, Gupta A, Prakash P, Anupurba S, Tripathi R, et al. Differentiation of Mycobacterium tuberculosis complex from non-tubercular mycobacteria by nested multiplex PCR targeting IS6110, MTP40 and 32kD alpha antigen encoding gene fragments. BMC Infect Dis. 2016;16: 123.