Evidence map›Paper›PMID 40655205›Full record

ArticleFrontiers in public health2025

Performance evaluation of the Molbio diagnostics Truenat MTB Ultima/COVID-19 multiplex assay for TB and COVID-19 case detection among people with symptoms suggestive of tuberculosis-a study protocol for clinical trials.

Manju Purohit, Willy Ssengooba, Helen Cox, Cesar Ugarte-Gil, James Sserubiri, Hafsah Tootla, Kavindhran Velen, Rita Székely, Adam Penn-Nicholson

Abstract read
In one paragraph

Article in Frontiers in public health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Manju PurohitDepartment of Pathology, R D Gardi Medical College, Ujjain, MP, India.
Willy SsengoobaDepartment of Medical Microbiology, Makerere University, Kampala, Uganda.
Helen CoxDivision of Medical Microbiology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
Cesar Ugarte-GilDepartment of Epidemiology, School of Public and Population Health, The University of Texas Medical Branch, Galveston, TX, United States.
James SserubiriDepartment of Medical Microbiology, Makerere University, Kampala, Uganda.
Hafsah TootlaDivision of Medical Microbiology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
Kavindhran VelenFIND, Geneva, Switzerland.
Rita SzékelyFIND, Geneva, Switzerland.
Adam Penn-NicholsonFIND, Geneva, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Tuberculosis (TB) remains a major public health problem globally, as reflected in persistently high morbidity and mortality rates. Current control efforts have been further complicated by the ongoing SARS-CoV-2 (COVID-19) pandemic. Rapid molecular diagnostics remain crucial to identifying the millions of people with undiagnosed TB. Objectives: The study aimed to determine the diagnostic accuracy of Truenat MTB Ultima/COVID-19 for the detection of COVID-19 and TB among presumptive TB participants, using a microbiological reference standard (MRS) and a country-approved real-time reverse transcription polymerase chain reaction (RT-PCR) COVID-19 assay. Methods: This prospective cohort study assessed the diagnostic accuracy of the Truenat MTB Ultima/COVID-19 multiplex test among adults with presumptive TB, enrolled from healthcare facilities in four countries, aiming to reach 270 confirmed TB cases. The inclusion criteria were as follows: adults who self-reported at least one symptom suggestive of pulmonary TB, were willing to return for a day 2 visit, and agreed to provide oral swab samples for bio-banking. Patients were excluded from enrolment in the study if they had started anti-TB treatment within 60 days or TB preventive therapy within 6 months prior to enrolment or if they were unable to provide 3 mL of sputum or nasopharyngeal (NP) and tongue swab samples. Expected outcome: This study expected to obtain point estimates of the sensitivity and specificity of the Truenat MTB Ultima/COVID-19 multiplex test for TB and COVID-19 detection, compared to Xpert Ultra, among presumptive TB participants using an MRS and pre-defined COVID-19 assay.

Indexed as

COVID-19COVID-19 Nucleic Acid TestingTuberculosisTuberculosis, PulmonaryAdultFemaleHumansMaleMiddle AgedProspective StudiesSARS-CoV-2Sensitivity and SpecificityCOVID-19diagnosisprotocolTruenat COMBOtuberculosis

Identifiers

PMID40655205
PMCPMC12245902

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.