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

Abstract

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. METHODS: We assessed the diagnostic accuracy of 2 tests, Molbio Truenat MTB Ultima (MTB Ultima) and Pluslife MiniDock MTB Test (MiniDock MTB), among consecutively enrolled individuals aged 15 years and older, against the reference standard of culture and comparators of microscopy and Xpert MTB/RIF Ultra. Two tongue swabs, either self-collected or healthcare worker collected, and 2 sputum specimens were requested from each participant; MiniDock MTB was tested the same day and MTB Ultima was tested after storage. RESULTS: From February to June 2025, 1097 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% confidence interval [CI], 79-91) and 76% (95% CI, 68-82), respectively, and 67% (95% CI, 51-79) and 44% (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. CONCLUSIONS: 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.