Diagnostic performance of the Pluslife MiniDock MTB and Molbio MTB Ultima assays to detect tuberculosis from tongue and sputum swabs among outpatients and in active case finding in Cameroon

Background Cost and infrastructure requirements limit access to current rapid molecular diagnostic testing for tuberculosis (TB). Recent developments in novel, swab-based assays that can be used closer to the point of care offer the potential to change the TB diagnostic landscape.

We assessed the diagnostic accuracy of two tests, Molbio Truenat MTB Ultima (MTB Ultima) and Pluslife MiniDock MTB Test (MiniDock MTB), among consecutively enrolled individuals aged 15 and above in health facilities and community-based screening events in Cameroon, compared to the reference standard of TB culture. Two tongue swabs and sputum specimens were requested from each participant. Comparator tests were smear microscopy and Xpert MTB/RIF Ultra.

From February to June 2025, 1,097 participants were enrolled in communities (382) and at health facilities (715). Sensitivities of sputum and tongue swabs on MiniDock MTB among 132 people with culture-positive TB were 86% (95% CI, 79-91%) and 76% (95% CI, 68-82%), respectively, and 67% (95%CI, 51-79%) and 44% (95%CI, 29-59%) among those with smear-negative TB. Sensitivities of sputum and tongue swabs on MTB Ultima were 84% (97/116, 95%CI, 76-89%) and 74% (67/91, 95% CI, 64-82%), respectively, and 58% (95% CI, 41-74%) and 33% (95% CI, 18-53%) among those with smear-negative TB. Specificities of both tests were high (>97%).

In this population, the performance of both MiniDock MTB and MTB Ultima on tongue and sputum swabs was similar to target product profile thresholds for near point of care TB tests. Further studies to evaluate performance in diverse populations and settings are needed. Summary Our diagnostic accuracy study of new swab-based MiniDock MTB and MTB Ultima assays in Cameroon demonstrated accuracies similar to the tuberculosis detection target product profiles overall for near point of care tongue and sputum swabs. Competing Interest Statement JC and TG are members of the TB REACH Secretariat but were not involved in the grant proposal or the decision to fund the project. Clinical Trial PACTR202502473140037 Funding Statement TB REACH - an initiative of Stop TB Partnership - supported this intervention through funding from FCDO funding, and Global Affairs Canada grant number CA-3-D000920001. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by the National Ethics Committee for Research on Human Health and by the Institutional Review Board of the Cameroon Baptist Convention Health Board. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes ↵** RAPID TB consortium team members are listed in the Acknowledgments Data Availability All data produced in the present work are contained in the manuscript