Comparison between the PaxView TB/NTM MPCR-ULFA Kit and current methods for Mycobacterium tuberculosis detection in Malang, East Java, Indonesia

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, 148 sputum specimens isolated from suspected tuberculosis (TB) carriers 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 148 cases, the rate of TB-positive samples evaluated by different methods was 18.2% (27/148; 95% CI 11.9–24.4) for smear microscopy, 20.3% (30/148; 95% CI 13.8–26.8) for the Xpert MTB/RIF, and 34.5% (51/148; 95% CI 26.8–42.1) for the PaxView TB/NTM MPCR-ULFA Kit. Twenty sputum specimens from healthy subjects were also tested, all of which rendered negative results via the three diagnostic tools examined herein. Compared to the Xpert MTB/RIF, the PaxView TB/NTM MPCR-ULFA Kit was found to possess a 96.7% sensitivity (29/30; 95% CI 90.3-100).Moreover, the PaxView TB/NTM MPCR-ULFA Kit detected 18.6% (22/118, 95% CI 11.6–25.6) of Xpert MTB/RIF MTB negative samples and 20.7% (25/121, 95% CI 13.5–27.9) of smear microscopy negative samples as MTB positive. 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.