Rapid PCR test detects TB from tongue swabs and sputum at point of care

Researchers led by Sally M. McFall developed a rapid automated point-of-care test for Mycobacterium tuberculosis detection that runs on the DASH® Rapid PCR System and works with both tongue swabs and sputum specimens. The work reported in the abstract describes clinical evaluations using de-identified, blinded clinical samples collected from symptomatic clinic attendees in South Africa. The testing program compared results from the new point-of-care assay to standard sputum culture and included separate sample sets for sputum and for tongue swabs. By focusing on these two sample types and by integrating the assay into the DASH® Rapid PCR System, the team aimed to create a practical, automated test that could be used outside of centralized laboratories. The abstract summarizes how the test performed on real-world clinical specimens and also reports on operational characteristics relevant to use in lower-resource settings, such as battery operation and high-temperature cartridge stability. All of these details were presented as part of the development and clinical assessment led by Sally M. McFall and collaborators.

Clinical testing included 100 de-identified, blinded sputum specimens from South African symptomatic clinic attendees, of which 49 were positive and 51 were negative by comparison to sputum culture. Against that reference, the assay achieved an overall sensitivity of 96%. Sensitivity reached 100% for smear positive samples and was 88% for smear negative samples; specificity in this sputum set was 88% when compared to sputum culture. In a separate study of 110 tongue swab specimens from South African symptomatic clinic attendees (70 positive and 40 negative by the reference), the test showed a sensitivity of 93% and a specificity of 100%. The team also demonstrated operational compatibility with peripheral low- and middle-income country (LMIC) settings by showing the system can run with external battery operation and that cartridges remained stable at 45°C for up to one year. These results, as reported in the abstract, summarize the key performance and practical characteristics of the assay on the DASH® Rapid PCR System.

The findings reported in the abstract suggest a practical pathway for decentralized detection of Mycobacterium tuberculosis because the DASH® Rapid PCR System delivered high sensitivity on sputum and strong performance on tongue swabs, while tolerating conditions expected in peripheral settings. Tongue swab testing produced 93% sensitivity and 100% specificity in the described sample set, indicating that a non-sputum specimen may be a reliable option in some clinical contexts. The sputum results—96% overall sensitivity with perfect detection of smear positive samples—show the assay can identify cases that traditional smear testing finds, while also detecting many smear negative cases. The demonstrated external battery operation and cartridge stability at 45°C for up to one year address practical barriers to use in settings without steady electricity or cold-chain storage. Taken together, the reported performance and operational features imply that this DASH® Rapid PCR System–based test could support faster, more distributed Mycobacterium tuberculosis testing, subject to further validation and implementation work beyond what is included in the abstract.