Validation and Integration of a New Test to Improve the Diagnosis of Tuberculous Meningitis
Tuberculosis (TB) remains a serious public health problem, particularly in sub-Saharan Africa where it is a leading cause of death. Indeed, in South Africa TB is the number one killer and ranks above HIV and trauma in this respect. Tuberculosis meningitis (TBM) where the M. tuberculosis (Mtb) bacteria infects the central nervous system is a particularly aggressive form of the disease that contributes disproportionately to the high mortality. Current microbiological and molecular tests are frequently unable to detect the bacteria in the nervous system, delaying initiation of anti-TB treatment and resulting in irreversible neuronal damage or death.
The Project Involves
- Evaluating a new rapid test developed by Antrum Biotech (commercial partner) that detects a biomarker (gamma interferon) in cerebrospinal fluid (CSF), where elevated levels suggest TB disease.
- Validation of the ìcut-offî test readout that predicts disease and investigation of the new test accuracy when used in conjunction with other rapid tests to determine the cause of meningitis.
- Generation of clinical performance data at sites in Malawi, SA and Zimbabwe, facilitating pre-market regulatory approval from national bodies and endorsement from the World Health Organisation (WHO) and access to international donor markets.
The accurate diagnosis of TBM is a public health priority and represents an unmet need. The developed in vitro diagnostic device (IVD) proposes to replace less accurate products with a rapid more sensitive test to provide improved access to life-saving treatment. The greatest need for the test is in populations with a high burden of TB and HIV (including children) i.e. in sub-Saharan Africa, which is the region in which the test will be evaluated and launched.
Professor Keertan Dheda
Unit Head, Lung Infection and Immunity Unit UCT Lung Institute - South Africa
Dr Philippa Randall
Head of Diagnostic Group, Lung Infection and Immunity Unit UCT Lung Institute - South Africa
Associate Professor Ruth McNerney
Scientific Advisor, Antrum Biotech (Pty) Ltd
Deputy Director, Lung Infection and Immunity Unit UCT Lung Institute - South Africa
Ms Khilona Radia
CEO Antrum Biotech (Pty) Ltd - South Africa
Mrs Junior Mutsvangwa
Senior Research Scientist Biomedical Research and Training Institute (BRTI) - Zimbabwe
Mr Marriott Nliwasa
PhD Fellow, College of Medicine - Malawi