Comparison between the PaxView TB/NTM MPCR-ULFA Kit and Xpert MTB/RIF for Mycobacterium Tuberculosis Detection in Indonesian Clinical Isolates

Abstract

The PaxView TB/NTM MPCR-ULFA Kit, which targets the IS6110 and mtp40 genes for Mycobacterium tuberculosis (MTB) detection, is a novel tool that substitutes gel electrophoresis for universal lateral flow assays. The sensitivity and specificity of this method were compared with those of established methodologies using Indonesian clinical isolates. In this study, 317 sputum specimens isolated from tuberculosis (TB) suspects were examined to evaluate the performance of the PaxView TB/NTM MPCR-ULFA Kit compared to that of smear microscopy and the Xpert MTB/RIF assay. Out of 317 cases, the rate of TB-positive samples evaluated by different methods was 33.4% ( 106/317; 95% CI 28.2-38.6) for smear microscopy, 37.9% (120/317; 95% CI 32.5-43.2) for the Xpert MTB/RIF, and 40.7% (129/317; 95% CI 35.3-46.1) for the PaxView TB/NTM MPCR-ULFA Kit. Compared to the Xpert MTB/RIF as a standard reference, the PaxView TB/NTM MPCR-ULFA Kit was found to possess a 92.5% sensitivity (111/120; 95% CI 87.8-97.2), a 90.8% specificity (179/197; 95% CI 86.8-94.8), 86.0% PPV (111/129; 95% CI 80.0-92.0), and a NPV 95.2% (179/188; 95% CI 92.2-98.3). The PaxView TB/NTM MPCR-ULFA Kit could be a useful molecular diagnostic tool to identify MTB in clinical samples in resource-limited countries, as this procedure is more cost-effective and sensitive than the Xpert MTB/RIF, and more convenient than conventional PCR gel electrophoresis approaches.