Evaluation of loop mediated isothermal amplification and lateral flow based POC analysis for detection of mycobacterium tuberculosis and nontuberculous mycobacterium infections

초록

Mycobacterium tuberculosis (MTB) remains a significant public health problem, requiring the development of rapid and sensitive diagnostic tools. LAMP (loop-mediated isothermal amplification)–Lateral flow assay is an isothermal nucleic acid amplify technique combined with immunochromatographic assays (LFA) matched such requirement. Here we evaluated a LAMP-LFA (BZ TB/NTM NALF Assay, Biozentech, Korea) for detection of M. Tuberculous in clinical specimens. The BZ TB/NTM NALF Assay uses LAMP technology with primers targeting the IS6110 gene of MTB and the rpoB gene of NTM. The process of BZ TB/NTM NALF assay is composed of two steps: LAMP amplification and visual detection of the amplification products by an immunochromatographic strip. A total of 324 sputum samples, including 81 MTB-positive, 162 MTB-negative, and 81 NTM-positive samples, were confirmed by TB real-time PCR (RT-PCR) using the LG AdvanSureTM TB/NTM RT-PCR Kit (LG Chem, Korea). The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the BZ TB/NTM NALF assay were evaluated and compared to those of the LG AdvanSureTM TB/NTM RT-PCR Kit. The BZ TB/NTM NALF assay demonstrated high sensitivity (100%) and specificity (99.38%) with a concordance rate of 99.59% compared to the AdvanSureTM TB/NTM RT-PCR Kit. for MTB, NTM and negative clinical samples. Our findings suggest that the TB/NTM LAMP-NALF kit is a highly sensitive and specific diagnostic tool for rapid and accurate detection of TB and NTM infections, especially in settings where traditional laboratory methods may not be practical or available.