Diagnostic accuracy of the TrueNat™ MTB plus assay for detecting pulmonary tuberculosis in adults

Sarapia P. Mallya, Peter M. Mbelele, Riziki M. Kisonga, Daphine D. Mtunga, Haroun H. Banzi, Stephen S. Mpiima, Muzafaru Twinomujuni, Joel Bazira, Kennedy Kassaza

Abstract

Tuberculosis (TB), caused by Mycobacterium tuberculosis remains a global threat, affecting 10.8 million people and causes 1.3 million deaths annually. Over 2.5 million cases go undiagnosed partly due to current diagnostic limitations.

Introduction

Tuberculosis (TB), caused by Mycobacterium tuberculosis remains a significant public health challenge globally. Over the past decade, annual TB incidence has persistently exceeded 10 million cases worldwide [1]. From 2015 to 2023, the global TB incidence rate declined by only 8.3%, falling far short of the WHO End TB Strategy milestone of a 50% reduction by 2025.

Materials and methods 

This was a prospective cross-sectional diagnostic accuracy study. Data collection was planned and conducted before the TrueNat index test, ultra, smear microscopy and isolation of M. tuberculosis in LJ culture media.

Results

Among 276 participants with features of TB, 260 were recruited. The reasons for exclusion in 16 patients are shown in Fig 1. Among the 260 participants, 165 (63.5%) were male, with a median age (IQR) of 46.0 years (35.5–57.3). The socio-demographic and clinical characteristics of the participants are presented in Table 1.

Discussion

TrueNat™ MTB Plus, a portable point-of-care molecular diagnostic platform, offers significant advantages in sensitivity and specificity. In this study, TrueNat outperformed smear microscopy, especially in patients with low bacterial loads where microscopy is less reliable. Importantly.

Conclusion 

TrueNat demonstrated comparable accuracy to Xpert® MTB/RIF Ultra and Löwenstein–Jensen culture, with the added advantages of faster turnaround time, suitability for resource-limited settings, and the ability to detect 26.8% of participants including those with HIV infection who were missed by smear microscopy.

Citation: Mallya SP, Mbelele PM, Kisonga RM, Mtunga DD, Banzi HH, Mpiima SS, et al. (2025) Diagnostic accuracy of the TrueNat™ MTB plus assay for detecting pulmonary tuberculosis in adults. PLoS One 20(12): e0327936. https://doi.org/10.1371/journal.pone.0327936

Editor: Felix Bongomin, Gulu University, UGANDA

Received: June 23, 2025; Accepted: October 12, 2025; Published: December 22, 2025

Copyright: © 2025 Mallya et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All data supporting these results were analyzed and reported in this manuscript. The datasets used and/or analyzed have been submitted as supporting information; S1 Table in S1 File Participants metadata.

Funding: The author(s) received no specific funding for this work.

Competing interests: The authors have declared that no competing intzerests exist.