A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays

Area of Science:

• Molecular diagnostics
• Infectious disease detection
• Point-of-care testing

Background:

• Accurate tuberculosis (TB) diagnosis is crucial for global TB control.
• Molbio Diagnostics developed Truenat point-of-care molecular assays for TB and rifampicin resistance detection.
• Decentralizing TB diagnostics to primary healthcare settings is a key priority.

Purpose of the Study:

• To evaluate the diagnostic accuracy of Truenat MTB, MTB Plus, and MTB-RIF Dx assays for pulmonary TB.
• To compare the performance of Truenat assays with Xpert MTB/RIF and Ultra.
• To assess the feasibility of using Truenat assays in primary healthcare centers.

Main Methods:

• Prospective multicentre diagnostic accuracy study.
• 1807 participants with TB signs/symptoms enrolled across 19 primary healthcare centers and 7 reference laboratories in Peru, India, Ethiopia, and Papua New Guinea.
• Culture and phenotypic drug susceptibility testing used as the reference standard.

Main Results:

• Pooled sensitivity for Truenat MTB and MTB Plus was 73% and 80% in microscopy centers, respectively.
• Sensitivity for smear-negative specimens was 36% and 47% for Truenat MTB and MTB Plus, respectively.
• Truenat MTB-RIF Dx sensitivity was 84%; all assays demonstrated high specificity and comparable performance to Xpert MTB/RIF.

Conclusions:

• Molbio's Truenat assays exhibit performance comparable to Xpert MTB/RIF.
• Feasible implementation of Truenat tests in primary healthcare settings with limited infrastructure.
• Study findings support WHO policy recommendations for Molbio assays.