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
Bibliographic Data
| ID | 22067625 |
|---|---|
| Authors | Manju Purohit (0000-0001-5385-7305, Karolinska Institutet, corresponding author), Willy Ssengooba (0000-0002-1643-110X, Makerere University), Helen Cox (0000-0001-8949-9335, University of Cape Town), César Ugarte‐Gil (0000-0002-2833-9087, Universidad Peruana Cayetano Heredia), Cesar Ugarte-Gil, James Sserubiri (Makerere University), Hafsah Tootla (0000-0002-7322-8060, University of Cape Town), Kavindhran Velen (0000-0001-8577-3915, FIND), Rita Székely (FIND), Adam Penn-Nicholson (0000-0002-1883-0059, FIND, corresponding author) |
| Year | 2025 |
| Volume | 13 |
| Pages | 1620210-1620210 |
| Publication date | 2025-06-27 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Frontiers in Public Health (JOURNAL) |
| Journal identifiers | ISSN: 2296-2565 • E-ISSN: 2296-2565 |
| Publisher | Frontiers Media SA (PUBLISHER • CH) |
| DOI | 10.3389/fpubh.2025.1620210 |
| PMID | 40655205 |
| OpenAlex | W4411706463 |
| Language | EN |
| Citations received | 1 |
| References cited | 19 |
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
Bioinformatics · Disease · Multiplex · Pandemic · Pathology · Sputum · Tuberculosis · COVID-19 diagnosis using AI · Medicine · SARS-CoV-2 detection and testing · Tuberculosis Research and Epidemiology · Internal Medicine · Pediatrics
| Citations per year | 1 |
|---|---|
| Citation span | 2026 - 2026 (1) |
| Highly cited | No |