STUDY PROTOCOL article

Front. Public Health

Sec. Infectious Diseases: Epidemiology and Prevention

Volume 13 - 2025 | doi: 10.3389/fpubh.2025.1620210

Performance evaluation of the Molbio Diagnostics Truenat™ MTB UltimaPlus/COVID-19 multiplex assay for TB and COVID-19 case detection among people with symptoms suggestive of Tuberculosis-A Study protocol for clinical trial

Provisionally accepted
MANJU PUROHITMANJU PUROHIT1,2*Willy SsengoobaWilly Ssengooba3Helen CoxHelen Cox4Cesar Ugarte-GilCesar Ugarte-Gil5,6James SserubiriJames Sserubiri3Hafsah TootlaHafsah Tootla7,8Kavindhran VelenKavindhran Velen9Rita SzekelyRita Szekely9Adam Penn-NicholsonAdam Penn-Nicholson9*
  • 1Karolinska Institutet (KI), Solna, Sweden
  • 2Ruxmaniben Deepchand Gardi Medical College, Ujjain, Madhya Pradesh, India
  • 3Department of Medical Microbiology, Makerere, University, Kampala, Uganda, Kampala, Uganda
  • 4Department of Medical Microbiology, Makerere, University,, Kampala,, Uganda
  • 5Department of Epidemiology, School of Public and Population Health, The University of Texas Medical Branch, Galveston, Tx, USA, Texas, United States
  • 6Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru, Lima, Peru
  • 7National Health Laboratory Service, Department of Medical Microbiology, Red Cross War Memorial Children’s Hospital, Cape Town, South Africa, Cape Town, South Africa
  • 8Division of Medical Microbiology, Faculty of Health Sciences, University of Cape Town, Cape Town, Western Cape, South Africa
  • 9FIND, Geneva, Switzerland, geneva, Switzerland

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Tuberculosis (TB) remains a major public health problem globally, reflected in persistently high morbidity and mortality rates. Current control efforts have been further compounded by the ongoing SARS-CoV2 (COVID-19) pandemic. Rapid molecular diagnostics remain crucial if we are to find the millions of people with undiagnosed TB.To determine the diagnostic accuracy of Truenat™ MTB UltimaPlus/COVID-19 for COVID-19 and TB detection among presumptive TB participants using a Microbiological reference standard (MRS) and a country-approved RT-PCR (real time -polymerase chain reaction) COVID-19 assay.This prospective cohort study will assess the diagnostic accuracy of the Truenat™ MTB UltimaPlus/COVID-19 multiplex test among adults with presumptive TB enrolled from health care facilities in 4 countries to reach 270 confirmed TB cases, with inclusion criteria: Adult, self-reports at least one or more symptoms suggestive of pulmonary TB; willing to return for a day 2 visit and provide oral swab samples for bio-banking. The patients will be excluded to be enrolled in the study if having startedanti-TB treatment, on anti-TB treatment within 60 days or TB preventive therapy within 6 months prior to enrolment, unable to provide 3ml of sputum or nasopharyngeal and tongue swabs.Point estimates of sensitivity and specificity of Truenat™ MTB UltimaPlus/COVID-19 multiplex for TB and COVID-19 detection compared to Xpert Ultra among presumptive TB participants using a MRS and defined COVID-19 assay

Keywords: Truenat COMBO, Tuberculosis, COVID-19, diagnosis, protocol

Received: 29 Apr 2025; Accepted: 09 Jun 2025.

Copyright: © 2025 PUROHIT, Ssengooba, Cox, Ugarte-Gil, Sserubiri, Tootla, Velen, Szekely and Penn-Nicholson. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
MANJU PUROHIT, Karolinska Institutet (KI), Solna, Sweden
Adam Penn-Nicholson, FIND, Geneva, Switzerland, geneva, Switzerland

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Supplementary Material