The Challenge

Current diagnostics are sputum dependent.
Obtaining sputum from the lungs is hazardous and slow.
Sputum-based testing is inherently unreliable
in HIV-burdened populations.

Obtaining sputum samples is difficult in:

  • Children
  • ICU patients
  • Trauma unit admissions
  • Patients with weak immune systems
  • HIV patients

Extrapulmonary TB accounts for 15 to 20% of all TB cases, posing diagnostic and therapeutic challenges due to its diverse clinical presentations and is common among immuno-compromised individuals (Zeb et al., 2023).

Globally, the gap between the estimated 10.8 million people newly infected with TB and 8.2 million newly diagnosed cases reported in 2023, was estimated at about 2.7 million (WHO, 2024).

Early detection at the first patient consultation would enable early diagnosis and treatment decisions (Pai et al., 2023).

Molecular testing is often restricted by high costs and infrastructural requirements not feasible in many regions burdened by TB (Beri, 2024).

TB treatment can take months, and monitoring efficacy could identify those at risk of poor outcomes. Sputum and Nucleic acid-based assays are not suitable for monitoring the response to TB treatment due to the persistence of nucleic acids in nonviable TB bacilli, even beyond successful TB treatment (WHO, 2023).