Evaluation of multiplex PCR–Universal lateral flow assay for pulmonary tuberculosis diagnosis: Comparison with Xpert MTB/RIF

Background: Global initiatives to reduce the impact of pulmonary tuberculosis (TB) depend on effective laboratory methods for detecting Mycobacterium tuberculosis complex (MTBC) in patient. The Multiplex PCR combined with Universal Lateral Flow Assay (MPCR-ULFA) provides molecular-based diagnostic approach that replaces gel electrophoresis with a universal lateral flow assay. Objective: This study purposed to assess diagnostic accuracy of MPCR-ULFA in comparison to Xpert MTB/RIF for detecting TB in suspected pulmonary TB patients. Methods: We compared the performance of Xpert MTB/RIF and MPCR-ULFA in TB detection at a total of 217 sputum samples from Malang isolates. We evaluate the diagnostic accuracy parameters, such as sensitivity, specificity, likelihood ratio, positive and negative predictive value, accuracy, and Youden index. To measure the agreement between Xpert MTB/RIF and MPCR-ULFA we evaluate the Kappa index. Results: The study results showed that MPCR-ULFA had a sensitivity and specificity of 95.74% and 93.53%, respectively. The positives likelihood ratio (LR+) was 14.80 and LR- was 0.05. Positives predictive value (PPV) was 80.36%, and the negatives predictive value (NPV) was 98.80%. The test also demonstrated an accuracy of 93.54%, a Youden index of 0.89, and a Kappa index of 0.835. Conclussion: By detecting multiple target genes, specifically IS6110 and mtp40, MPCR-ULFA enhances MTBC detection in sputum samples and offers a more cost-effective technique.