The new test, which is currently undergoing validation to enter the global market, is able to diagnose TB meningitis within two hours.
Early diagnosis is the key to improving the health outcomes of this disease, but the current diagnostic tests are not as quick or as sensitive as they need to be.
TB meningitis is a major cause of death in Southern Africa. It’s estimated that 2% of TB, which are caused by Mycobacterium tuberculosis, develop into an infection of the membranes around the central nervous system (meninges). This TB meningitis can cause death or disability, especially in children, but is easily treatable if diagnosed early.
“The accurate diagnosis of TB meningitis represents an unmet need in public health, with problems of missed diagnosis and misdiagnosis affecting health outcomes. The greatest need for the test is in populations with a high burden of TB and HIV; particularly in sub-Saharan Africa where the test will be evaluated and launched. The long-term goal of this project is to reduce global TB meningitis deaths,” said CEO of Antrum Biotech, Khilona Radia.
The new test will compete against TB meningitis tests that either take too long to detect Mycobacterium, or are not sensitive enough to find it when it is there. According to UCT, the GeneXpert DNA detection test for TB is widely used in South Africa, but studies show that it is not sensitive enough to detect TB meningitis.
“Detection under the microscope only works 5% of the time. Smear microscopy is a very poor test. Another existing test for TB meningitis involves growing the bug in the lab in a culture, and there are problems with that too,” said Director of the Centre for Lung Infection and Immunity at UCT, Professor Keertan Dheda.
The culture-based test has a sensitivity of only 60% to 70%, and it can take four to eight weeks to give a result. According to Prof Dheda, by then most people would have died, or they would have developed severe disabilities due to the disease.
“Although it is rapid in getting the answer on the same day, the problem is that it detects TB meningitis in only 50-60% of cases; we have a major unmet need for a more sensitive test. Preliminary results from our studies show a vast improvement in sensitivity when compared to GeneXpert,” said Prof Dheda.
“There will be on-going studies by different groups of people in different parts of the world to confirm the results that we find in Southern Africa,” concluded Dheda.