Evidence map›Paper›PMID 42114928›Full record

Trial reportBMJ global health2026

User perspectives on the Molbio Truenat platform and tuberculosis assays for decentralised testing in Mozambique and Tanzania.

Maria Del Mar Castro, Celso Khosa, Grace Mhalu, Lonze Ndelwa, Simeon Mwanyonga, Thresphory Zumba, Délio Elísio, Katia Magul, Yolanda Manganhe, Antonio Machiana and 10 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ global health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04568954 (Molbio Truenat TB Platform Combined With the Truenat TB Assays for Detection of Tuberculosis and Rifampicin Resistance in Adults With Presumptive Pulmonary Tuberculosis at Primary-level Diagnostic Centres in Tanzania and Mozambique), which is not on this 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.

NCT04568954 nacompletednot on this map

Molbio Truenat TB Platform Combined With the Truenat TB Assays for Detection of Tuberculosis and Rifampicin Resistance in Adults With Presumptive Pulmonary Tuberculosis at Primary-level Diagnostic Centres in Tanzania and Mozambique: a Pragmatic, Cluster-randomized Controlled Trial

TypeinterventionalSponsorFoundation for Innovative New Diagnostics, SwitzerlandRan2022 to 2024Enrolled3,987ConditionsTuberculosis, Diagnoses DiseaseArmsTruenat TB platform/TB assays
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

20 authors.

Maria Del Mar CastroDepartment of Infectious Disease and Tropical Medicine, Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany maria.castro@uni-heidelberg.de.ORCID 0000-0002-0485-2919
Celso KhosaInstituto Nacional de Saúde, Marracuene, Mozambique.
Grace MhaluIfakara Health Institute, Ifakara, Tanzania.
Lonze NdelwaMbeya Medical Research Centre (MMRC), National Institute for Medical Research, Dar es Salaam, Tanzania.
Simeon MwanyongaMbeya Medical Research Centre (MMRC), National Institute for Medical Research, Dar es Salaam, Tanzania.
Thresphory ZumbaIfakara Health Institute, Ifakara, Tanzania.
Délio ElísioCentro de Investigação em Saúde de Manhiça, Manhica, Mozambique.
Katia MagulCentro de Investigação em Saúde de Manhiça, Manhica, Mozambique.
Yolanda ManganheInstituto Nacional de Saúde, Marracuene, Mozambique.
Antonio MachianaInstituto Nacional de Saúde, Marracuene, Mozambique.
Marta CossaCentro de Investigação em Saúde de Manhiça, Manhica, Mozambique.
Raphael EdomMbeya Medical Research Centre (MMRC), National Institute for Medical Research, Dar es Salaam, Tanzania.
Jerry HellaIfakara Health Institute, Ifakara, Tanzania.
Dinis NguenhaCentro de Investigação em Saúde de Manhiça, Manhica, Mozambique.
Morten RuhwaldFIND, Geneva, Switzerland.
Vinzeigh LeukesFIND, Geneva, Switzerland.
Adam Penn-NicholsonFIND, Geneva, Switzerland.
Katharina KranzerInstitute of Infectious Diseases and Tropical Medicine,LMU University Hospital, LMU Munich, Munich, Germany.
Claudia M DenkingerDepartment of Infectious Disease and Tropical Medicine, Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany.ORCID 0000-0002-7216-7067
TB-CAPT Consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTimely and appropriate diagnosis and treatment are key to ending tuberculosis (TB). Incorporating users' preferences when implementing decentralised strategies for diagnosis may facilitate scale-up and impact. This qualitative study embedded within a cluster randomised controlled trial explored the values and preferences of multiple stakeholders regarding a TB diagnostic strategy using the Truenat platform, mycobacterium tuberculosis (MTB) Plus and rifampicin Dx Assays in Mozambique and Tanzania.

methodsWe conducted semi-structured interviews with people with presumptive TB (n=35), professional users (laboratory technicians, nurses, clinicians, n=19) and national decision-makers (n=5). Direct observations of testing procedures and usability surveys (n=12) were also conducted. Thematic analysis was performed, informed by the Consolidated Framework for Implementation Research.

resultsFacilities varied in testing capacity, number of cases and time-to-results (from same-day to >2 weeks). Availability and supply of reagents and cartridges were described as an issue by healthcare providers and a potential cause for delayed results. The Truenat platform for detection of TB was considered easy to use (median SUS score 90/100) as well as acceptable and fit to the context where the evaluation was conducted. Truenat's advantage was appreciated in facilities with limited prior testing capacity (eg, shipping samples, using microscopy), including short time-to-results, reduced need to return to provide more samples and fewer infrastructure needs (compared with GeneXpert). People with presumptive TB preferred the same-day results and rapid initiation of treatment enabled by Truenat testing. Some viewed waiting longer time (>1 day) for the results acceptable if it were to result in increased accuracy. Regarding the diagnostic process, participants valued the support and counselling from the healthcare workers.

conclusionsThe Truenat platform and TB assays were perceived as easy to use by health providers, and as acceptable and feasible across stakeholder groups. Its implementation in decentralised settings was considered a preferred alternative to off-site Xpert testing for TB in Mozambique and Tanzania. TRIAL REGISTRATION NUMBER: NCT04568954.

Indexed as

Mycobacterium tuberculosisTuberculosisAdultFemaleHumansInterviews as TopicMaleMozambiqueQualitative ResearchRapid Diagnostic TestsRifampinTanzaniaRifampinDiagnostics and toolsPCRQualitative studyTuberculosis

Identifiers

PMID42114928
PMCPMC13182370

What OpenQuestion holds

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Registered trials

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.