A Method for Diagnosing Tuberculosis (TB)

Background

Current methods for TB diagnosis are either expensive and requires a stable electricity supply or are slow an inaccurate. There is therefore an urgent need for user‑friendly, rapid, inexpensive yet accurate TB diagnostic tools, particularly in resource limited settings in high burden countries.

Researchers at Stellenbosch University has developed a portfolio of diagnostic markers for patients with pulmonary TB, or for children with suspected TB meningitis. The biomarkers can be readily incorporated into low‑cost lateral‑flow based tests for rapid (15‑20mins) diagnosis of the disease at the point of care (POC).

Technology Overview

The most widely used diagnostic test for TB especially in resource-poor settings (sputum smear microscopy) has poor sensitivity, whereas the gold standard test (culture) has a long turnaround time (up to 42 days), is expensive, prone to contamination and requires extensive laboratory infrastructure.

Serum proteins are generally of higher abundance than pathogen products and are amenable to existing POC technologies such as lateral flow immunoassay. The researchers initially reported a seven-protein signature that diagnosed patients with active TB disease in primary healthcare clinics in five African countries.

A subsequent validation study evaluated the biomarkers in 292 patients from Malawi and South Africa who presented predominantly to secondary care with suspected TB identified a nine protein signature that distinguished TB from other diseases. This signature had a sensitivity of 92% and specificity of 71%.

Benefits

• Differentiates between latent TB, active TB disease, and other respiratory diseases.
• Avoids the use of sputum samples.
• Suitable for testing all patient groups.
• Can be incorporated into portable LFT device that are rapid, low cost and can be used at point of care.
• Enables applications in remote settings.

Applications

• Health care facilities (private and public hospitals, and clinics)
• National TB control programmes

Opportunity

Stellenbosch is looking for a commercialization partner.