A profile on the Truenat assays for the detection of pulmonary tuberculosis and rifampicin resistance.

INTRODUCTION

Early diagnosis and treatment initiation are essential to prevent ongoing tuberculosis (TB) transmission and reduce the disease burden. Smear microscopy, which is widely used test for diagnosis, has limited sensitivity and does not detect rifampicin resistance. Truenat is a portable, battery-operated, chip-based test that can be placed in peripheral laboratories, serving as a point-of-care test. It also detects rifampicin resistance, which is crucial in the management of TB.

AREAS COVERED: Our review comprehensively covers the functionality and workflow of the Truenat MTB assay, in addition to its cost-effectiveness and diagnostic accuracy, based on recent evidence. We also discuss the merits and drawbacks of alternative diagnostic tests available for detecting TB and rifampicin resistance.

EXPERT OPINION: Truenat assays are rapid molecular tests that revolutionized TB diagnosis, moving toward peripheral testing. Evidence indicates that the Truenat MTB Plus performs better than the original Truenat MTB, with an approximate LOD of 30 CFU/ml. The 2025 WHO guidelines rely exclusively on data from Truenat MTB Plus. We need larger studies on the newer Truenat MTB Ultima to evaluate its performance on tongue swabs. Additionally, data on the accuracy of Truenat MTB in children remains scarce, emphasizing the importance of further research in this group. Evidence regarding its accuracy in detecting rifampicin resistance is also limited, requiring larger studies and technological advancements. Truenat MTB will remain crucial in the fight to eliminate TB in the future.