Background and Need

Advances in diagnostic technologies have expanded the use of saliva as a valuable testing medium. Saliva collection is simple, non-invasive and avoids many of the challenges associated with blood or sputum sampling, making it attractive for point-of-care and community-based TB screening, including in children.

Biomarker Discovery and Diagnostic Signatures

As part of a broader TB biomarker study, the Stellenbosch research team identified 26 saliva-based protein biomarkers that differentiate individuals with active TB from those with other respiratory diseases (ORD). From this panel, the researchers developed two promising diagnostic biosignatures. A five-protein signature achieved an AUC of 1.00, 100% sensitivity and 90.9% specificity, while an alternative four-protein signature correctly classified 100% of TB and ORD participants, with an overall classification accuracy of 90.9%. These proof-of-concept findings were generated from 22 symptomatic individuals who self-presented with possible TB and require validation in larger patient cohorts.

Potential Application

The technology offers a non-invasive, saliva-based alternative with potential for development into a rapid, low-cost and portable diagnostic format, including a lateral-flow test for point-of-care use. Potential users include diagnostic laboratories, hospitals and clinics, TB screening programmes, research institutions and point-of-care diagnostic developers, with potential application in clinical, community and resource-constrained settings.

Development Stage

The technology is currently at TRL 3 – Proof of Concept Created. The next stage requires validation in larger and more diverse patient cohorts, followed by further development towards a practical diagnostic format.

Commercialisation Opportunity

Stellenbosch University is seeking licensing and co-development partners to support further biomarker validation, clinical studies and development of the technology towards a practical point-of-care diagnostic test.