Detection of Mycobacteria in Clinical Samples by the Newly Developed PaxView TB/NTM MPCR-ULFA Kit...

The aim of this study was to determine the sensitivity and specificity of the PaxView TB/NTM MPCR-ULFA Kit, which was recently created.

Study Design: AdvanSure TB/NTM real-time PCR was compared to the licenced AdvanSure TB/NTM real-time PCR.

SCL and PaxGenBio performed the research in Gyeonggi-do, Korea, between August 2018 and May 2019.

Methodology: A total of 350 specimens were tested in this sample, including sputum, bronchial washing, body fluid, tissue, urine, and cerebrospinal fluid, to compare the output of the PaxView TB/NTM MPCR-ULFA Kit to the results of the currently licenced AdvanSure TB/NTM real-time PCR kit (LG Chem, Korea).

The PaxView TB/NTM MPCR-ULFA Kit test was found to have 100 percent sensitivity as compared to the AdvanSure TB/NTM real-time PCR. In other words, the PaxView TB/NTM MPCR-ULFA Kit detected all 140 MTB and 61 non-tuberculous mycobacteria (NTM) specimens that tested positive with the AdvanSure TB/NTM real-time PCR. The specificity of the later package, on the other hand, was found to be 97.9% (146/149; 95 percent CI 95.6–100.0), which means that out of 149 MTB/NTM specimens that tested negative with the AdvanSure TB/NTM real-time PCR, 146 were marked as MTB/NTM-negative by the PaxView TB/NTM MPCR-ULFA Kit. Despite this, the average 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), indicating that the two diagnostic tools produced nearly identical results.

Conclusion: The PaxView TB/NTM MPCR-ULFA Kit may be useful in identifying MTB and NTM in resource-constrained countries because it is much less expensive than real-time PCR and far more convenient than traditional gel electrophoresis methods.

Please see the link :- https://www.journalajb2t.com/index.php/AJB2T/article/view/30082