Following WHO recommendations, high TB burden countries have commenced testing stool on GeneXpert to improve TB case finding among children and others who may not easily produce sputum. In previous wo...

The World Health Organisation (WHO) recommends rapid molecular diagnostics to improve bacteriological confirmation of tuberculosis in children. TrueNat MTB, MTB Plus and MTB-RIF Dx assays (Molbio Diag...

This trial provides strong evidence supporting the placement of low complexity molecular tuberculosis diagnostics at primary care level, to enable same-day diagnosis and treatment initiation.

Following World Health Organization recommendations, countries commenced stool testing on GeneXpert as the primary test to improve tuberculosis (TB) case finding among children who cannot produce sput...

Cost and infrastructure requirements limit access to current rapid molecular diagnostic testing for tuberculosis (TB). Recent developments in novel, swab-based assays that can be used closer to the point of care offer the potential to change the TB diagnostic landscape.MethodsWe assessed the diagnostic accuracy of 2 tests, Molbio Truenat MTB Ultima (MTB Ultima) and Pluslife MiniDock MTB Test (MiniDock MTB), among consecutively enrolled individuals aged 15 years and older, against the reference standard of culture and comparators of microscopy and Xpert MTB/RIF Ultra. Two tongue swabs, either self-collected or healthcare worker collected, and 2 sputum specimens were requested from each participant; MiniDock MTB was tested the same day and MTB Ultima was tested after storage.ResultsFrom February to June 2025, 1097 participants were enrolled in communities (382) and at health facilities (715). Sensitivities of sputum and tongue swabs on MiniDock MTB among 132 people with culture-positive TB were 86% (95% confidence interval [CI], 79–91) and 76% (95% CI, 68–82), respectively, and 67% (95% CI, 51–79) and 44% (29–59) among those with smear-negative TB. Sensitivities of sputum and tongue swabs on MTB Ultima were 84% (97/116; 95% CI, 76–89) and 74% (67/91; 95% CI, 64–82), respectively, and 58% (95% CI, 41–74) and 33% (95% CI, 18–53) among those with smear-negative TB.ConclusionsIn this population, the performance of both MiniDock MTB and MTB Ultima on tongue and sputum swabs was similar to target product profile thresholds for near point-of-care TB tests. Further studies to evaluate performance in diverse populations and settings are needed.

Goa-based Molbio Diagnostics develops point-of-care diagnostic solutions. Its flagship Truenat platform, which is patented in more than 100 countries, enables rapid molecular testing for diseases including tuberculosis (TB), COVID-19, Hepatitis B and C, Human Immunodeficiency Virus (HIV) and Human Papillomavirus (HPV).

Srinagar hospitals have received advanced diagnostic equipment, including AI-powered X-ray units and Truenat machines, to enhance the early detection and treatment of tuberculosis. The initiative is supported by CSR funding and aims to bolster public health efforts in the district.

In low-and middle-income countries, missed or delayed tuberculosis (TB) diagnoses contribute to avoidable morbidity, mortality, and transmission. Decentralized testing platforms, such as the Molbio Tr...

In low-and middle-income countries, missed or delayed tuberculosis (TB) diagnoses contribute to avoidable morbidity, mortality, and transmission. Decentralized testing platforms, such as the Molbio Tr...

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Molbio Diagnostics files DRHP to raise ₹200 crore via IPO, aiming to expand Truenat manufacturing and R&D. Discover what’s driving investor interest.

Cost and infrastructure requirements limit access to current rapid molecular diagnostic testing for tuberculosis (TB). Recent developments in novel, swab-based assays that can be used closer to the point of care offer the potential to change the TB diagnostic landscape.MethodsWe assessed the diagnostic accuracy of two tests, Molbio Truenat MTB Ultima (MTB Ultima) and Pluslife MiniDock MTB Test (MiniDock MTB), among consecutively enrolled individuals aged 15 and above, against the reference standard of culture and comparators of microscopy and Xpert MTB/RIF Ultra. Two tongue swabs, either self-collected or healthcare worker collected, and two sputum specimens were requested from each participant; MiniDock MTB was tested same day and MTB Ultima was tested after storage.ResultsFrom February to June 2025, 1,097 participants were enrolled in communities (382) and at health facilities (715). Sensitivities of sputum and tongue swabs on MiniDock MTB among 132 people with culture-positive TB were 86% (95% CI, 79-91%) and 76% (95% CI, 68-82%), respectively, and 67% (95%CI, 51-79%) and 44% (29-59%) among those with smear-negative TB. Sensitivities of sputum and tongue swabs on MTB Ultima were 84% (97/116, 95%CI, 76-89%) and 74% (67/91, 95% CI, 64-82%), respectively, and 58% (95% CI, 41-74%) and 33% (95% CI, 18-53%) among those with smear-negative TB.ConclusionsIn this population, the performance of both MiniDock MTB and MTB Ultima on tongue and sputum swabs was similar to target product profile thresholds for near point of care TB tests. Further studies to evaluate performance in diverse populations and settings are needed.

ABSTRACTThe World Health Organization (WHO) recommends testing stool with Xpert MTB/RIF Ultra (Xpert-Ultra) as an initial diagnostic test for detection of tuberculosis (TB) and rifampicin resistance in children. The option of testing stool on the Truenat platform could benefit children and their caregivers in remote areas where GeneXpert is not available. We report the results of research to validate a protocol for processing and testing stool on Truenat using an adapted Simple One Step (SOS) stool method in routine settings in Nigeria. Stool specimens from children with presumptive TB were tested with Truenat MTB Plus (Truenat) and Xpert-Ultra using a comparative cross-sectional study design. A total of 510 children were enrolled and submitted a stool specimen. Of these, 482 (94.5%) had valid results on both platforms, 28 (5.8%) with MTB detected and 454 MTB not detected. Of the 28 with MTB detected, eight were detected on both platforms, seven on Truenat only, and 13 on Xpert-Ultra only. The concordance rate between Truenat and Xpert-Ultra was high at 95.8%. Significantly more non-determinate (error/invalid) results were observed with Truenat compared to Xpert-Ultra (4.7% versus 1.2% respectively; P < 0.001). Truenat can accurately detect MTB using 100 mg of stool with an adapted SOS stool protocol. Further optimizing extraction methods could reduce the frequency of non-determinate results. These results hold promise for expansion of childhood TB diagnosis services to hard-to-reach areas with limited infrastructure that are suitable for Truenat placement. Global scale-up of these alternative testing approaches will be necessary to close the gap in childhood TB case finding.IMPORTANCEFollowing WHO recommendations, high TB burden countries have commenced testing stool on GeneXpert to improve TB case finding among children and others who may not easily produce sputum. In previous work, we adapted the Simple One Step (SOS) stool method for GeneXpert for the Truenat platform. In the present study, we validated the revised processing method under routine conditions in health care facilities in Nigeria. We tested stool from 510 children with presumptive TB on both the GeneXpert and Truenat platforms across a variety of health care settings. Concordance between Truenat and Xpert MTB detection was high at 95.8%, confirming stool can be tested on Truenat in routine services. Our study demonstrates that TB diagnostic testing for children can be provided in peripheral health facilities located in remote geographic areas with limited infrastructure where Truenat can be placed. Global scale-up will help further close the gap in childhood TB case finding.