Evidence map›Paper›PMID 41175672›Full record

ArticleEBioMedicine2025

Diagnostic accuracy of swab-based molecular tests for tuberculosis using near-point-of-care platforms: a multi-country evaluation.

Amy Steadman, Kingsley Manoj Kumar, Lucy Asege, Midori Kato-Maeda, Job Mukwatamundu, Kinari Shah, Trinh Trang, Alexey Ball, Khushboo Khimani, Dao Thi Kim Dung and 8 more

2 registry-linked trialsAbstract readMulticenter Study
In one paragraph

Article in EBioMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
–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.

NCT07420881 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Start 4 All - DARE-TB

TypeinterventionalSponsorLiverpool School of Tropical MedicineRan2026 to 2027Enrolled60,000ConditionsTB - TuberculosisArmsNear point of care (NPOC) NAATs, Low-complexity nucleic acid amplification tests (LC-NAATs), LC-NAAT using pooled testing, Computer-Aided Detection (CAD) Chest X-ray (CXR-AI), Culture (reference standard)
NCT07517471 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Start4All - Start Taking Action for TB Diagnosis SCREEN-TB

TypeinterventionalSponsorLiverpool School of Tropical MedicineRan2026 to 2027Enrolled37,000ConditionsTB - TuberculosisArmsNear point of care (NPOC) NAATs, Low-complexity nucleic acid amplification tests (LC-NAATs), LC-NAAT using pooled testing, Portable Chest X-ray Image Acquisition, Computer-Aided Detection (CAD) Chest X-ray (CXR-AI)
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Predicted Preferences for Tuberculosis Point-of-Care Tests Among Tuberculosis-Affected Individuals in 5 High Burden Countries.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  6. Article
  7. Article
  8. Diagnostic Accuracy and Usability of the PluslifeDiagnostics (Basel, Switzerland) · 2026
    Article
  9. Closing gaps through innovation in the tuberculosis pathology value chain.Journal of clinical tuberculosis and other mycobacterial diseases · 2026
    Review
  10. Cost-effectiveness of community tuberculosis screening in South Africa.American journal of respiratory and critical care medicine · 2026
    Article
  11. Article
  12. Article
  13. Article
  14. Diagnostic Yield of Tongue Swab- Compared to Sputum-Based Molecular Testing for Tuberculosis in Four High-Burden Countries.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  15. Article
  16. Article
  17. Development of a Rapid Automated Point-of-Care Test formedRxiv : the preprint server for health sciences · 2026
    Article
  18. Preferences for tongue swab versus sputum collection for TB testing: a multi-country survey.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2026
    Article
  19. Article
  20. Tongue swabmedRxiv : the preprint server for health sciences · 2026
    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

18 authors.

Amy SteadmanGlobal Health Labs, Inc., Bellevue, WA, USA.
Kingsley Manoj KumarDepartment of Pulmonary Medicine, Christian Medical College, Vellore, Tamil Nadu, India.
Lucy AsegeWalimu, Kampala, Uganda.
Midori Kato-MaedaCenter for Tuberculosis, Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA; Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco, CA, USA.
Job MukwatamunduWalimu, Kampala, Uganda.
Kinari ShahCenter for Tuberculosis, Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA; Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco, CA, USA.
Trinh TrangCenter for Promotion of Advancement of Society, Hanoi, Vietnam; UCSF -VNTP Research Collaboration Unit, Hanoi, Vietnam.
Alexey BallGlobal Health Labs, Inc., Bellevue, WA, USA.
Khushboo KhimaniGlobal Health Labs, Inc., Bellevue, WA, USA.
Dao Thi Kim DungDepartment of Microbiology, Hanoi Lung Hospital, Hanoi, Vietnam.
Joy Sarojini MichaelDepartment of Clinical Microbiology, Christian Medical College, Vellore, Tamil Nadu, India.
Devasahayam J ChristopherDepartment of Pulmonary Medicine, Christian Medical College, Vellore, Tamil Nadu, India.
Ha PhanCenter for Promotion of Advancement of Society, Hanoi, Vietnam; UCSF -VNTP Research Collaboration Unit, Hanoi, Vietnam.
Seda YerlikayaDepartment of Infectious Diseases and Tropical Medicine, Heidelberg University Hospital and Faculty of Medicine, Heidelberg University, Heidelberg, Germany; German Center for Infection Research (DZIF), Partner Site Heidelberg University Hospital, Heidelberg, Germany.
Payam NahidCenter for Tuberculosis, Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA.
Claudia M DenkingerDepartment of Infectious Diseases and Tropical Medicine, Heidelberg University Hospital and Faculty of Medicine, Heidelberg University, Heidelberg, Germany; German Center for Infection Research (DZIF), Partner Site Heidelberg University Hospital, Heidelberg, Germany.
Adithya CattamanchiCenter for Tuberculosis, Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA; Division of Pulmonary Diseases and Critical Care Medicine, University of California Irvine, Irvine, CA, USA. Electronic address: adithya.cattamanchi@uci.edu.
Alfred AndamaWalimu, Kampala, Uganda; Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.

Funding

Research Mentoring and Building Capacity of underrepresented Minority Research Scientists in India.D43TW010540 · FIC · YALE UNIVERSITY · PI MICHELE BARRY, Eva Harris · 2017 to 2026
$15.5M
FIC NIH HHS D43 TW010540
6 · The paper itself

Abstract

backgroundSwab-based molecular tests are emerging as more accessible and lower-cost options for tuberculosis (TB) diagnosis. We conducted multi-country diagnostic accuracy evaluations of late prototype versions of Truenat MTB Ultima (MTB Ultima) and MiniDock MTB Test (MiniDock MTB).

methodsWe enrolled consecutive people aged ≥12 years with presumptive TB at outpatient clinics in India, Uganda, and Vietnam. We evaluated the diagnostic accuracy of MTB Ultima and MiniDock MTB when using tongue and sputum swabs against a sputum liquid culture-based microbiological reference standard. Additionally, we compared the diagnostic accuracy of the swab-based molecular tests with that of sputum Xpert MTB/RIF Ultra (Xpert) and sputum smear microscopy.

findingsFrom January to September 2024, 1050 participants were included in the tongue swab MTB Ultima evaluation, 197 in the sputum swab MTB Ultima evaluation and 322 in the MiniDock MTB evaluations. With tongue swab-based testing, sensitivity was 77.9%, 95% CI: 70.3, 84.2 for MTB Ultima and 85.7%, 95% CI: 75.3, 92.9 for MiniDock MTB. Both were more sensitive than sputum smear microscopy (p < 0.001, McNemar's test, for both comparisons). With sputum swab-based testing, sensitivity was 93.6%, 95% CI: 82.8, 97.8, for MTB Ultima and 91.1%, 95% CI: 82.1, 95.9 for MiniDock MTB. Compared to sputum Xpert, sensitivity differed by -6.4%, 95% CI: -15.5, 2.7 for MTB Ultima and -3.0%, 95% CI: -8.6, 2.6 for MiniDock MTB. Specificity exceeded 98% for all index tests.

interpretationMTB Ultima and MiniDock MTB exceed minimum World Health Organisation accuracy targets for sputum- and non-sputum-based near-point-of-care TB tests and offer strong potential to make universal molecular testing for TB a reality.

fundingNational Institutes of Health (U01AI152087), Gates Foundation, and Global Health Labs.

Indexed as

Molecular Diagnostic TechniquesMycobacterium tuberculosisPoint-of-Care SystemsSpecimen HandlingTuberculosisAdolescentAdultAgedFemaleHumansIndiaMaleMiddle AgedSensitivity and SpecificitySputumUgandaDiagnosticsMiniDockMolbioNear-point-of-carePluslifeTuberculosis

Identifiers

PMID41175672
PMCPMC12617638

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.