Comparison of Truenat MTB Plus/RIF-Dx/INH with Gene Xpert MTB/XDR for the Diagnosis of Tuberculosis in Ecuador.

The Mycobacterium tuberculosis (MTB) complex (MTBC), the causative agent of tuberculosis (TB), remains a significant global health challenge, with an estimated 10.7 million cases diagnosed and 1.23 million deaths in 2024, according to the WHO. In this context, enhancing TB case detection using sensitive and rapid diagnostic methods is essential. Here, we compared the performance of two automatic polymerase chain reaction-based platforms endorsed by the WHO for MTB diagnosis: Truenat® MTB Plus/RIF-Dx/INH and Gene Xpert® MTB/XDR. By analyzing 95 clinical specimens (including pulmonary and extrapulmonary samples) using Gene Xpert MTB/XDR as the gold standard, the Truenat platform showed an overall accuracy of 98.9% and excellent agreement for MTB detection (Kappa Cohen = 0.975), excellent agreement for isoniazid resistance (Kappa Cohen = 0.972), and very good agreement for rifampicin resistance (Kappa Cohen = 0.905). The values for sensitivity and specificity were 96.5% and 100% for Truenat MTB Plus, respectively; 95.8% and 100% for Truenat MTB-INH, respectively; and 91.7% and 98.8% for Truenat MTB-RIF. This study is the first bench-to-bench clinical performance evaluation of the Truenat platform for MTB diagnosis done in Ecuador, showing its potential as an alternative sensitive and specific automatic diagnostic platform for MTB diagnosis and drug resistance testing. Considering that this study was done at the National Reference Laboratory for Mycobacteria in Ecuador, the Ministry of Public Health should develop further studies with larger sample sizes to consider Truenat platforms besides Gene Xpert as reliable diagnostic tools for the national strategy for TB control.