Validation and Integration of a New Test to Improve the Diagnosis of Tuberculous Meningitis

Validation and Integration of a New Test to Improve the Diagnosis of Tuberculous Meningitis

 

Background

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.

 

Impact

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.

 

Project Team

Professor Keertan Dheda

Principle Investigator

Unit Head, Lung Infection and Immunity Unit UCT Lung Institute - South Africa  

keertan.dheda@uct.ac.za

 

Dr Philippa Randall

Project Manager

Head of Diagnostic Group, Lung Infection and Immunity Unit UCT Lung Institute - South Africa

rndphi004@myuct.ac.za

 

Associate Professor Ruth McNerney

Scientific Advisor, Antrum Biotech (Pty) Ltd

Deputy Director, Lung Infection and Immunity Unit UCT Lung Institute - South Africa

ruth.mcnerney@uct.ac.za

 

Ms Khilona Radia

Commercial Partner

CEO Antrum Biotech (Pty) Ltd - South Africa

khilona.radia@uct.ac.za

 

Mrs Junior Mutsvangwa

Project Coordinator

Senior Research Scientist Biomedical Research and Training Institute (BRTI) - Zimbabwe 

jnr.mutsvangwa@gmail.com

 

Mr Marriott Nliwasa

Project Coordinator 

PhD Fellow, College of Medicine - Malawi 

mnliwasa@gmail.com

Project Type

Flagship project

Countries involved

Status

Ongoing