Development and Clinical Evaluation of Fast Tests for Tuberculosis Diagnosis
It is widely accepted that rapid, cost-effective diagnosis of high sensitivity and specificity is a pre-requisite for the prevention and control of tuberculosis, a global disease in humans killing more than 3 million people annually. Methods and devices currently in use do not meet these requirements. The main objectives of this proposal are 1. to identify novel antigens using genomic and proteomic approach, 2. to purify sufficient quantities of antigens and raise antibodies 3. optimise immobilisation conditions for the specific antigens and antibodies on different carriers, 3. manufacture and evaluate the tests using approximately 6000 clinical specimens (sputum, saliva, serum, urine) from TB patients before and during therapy. In our opinion, such tests and devices would be a major breakthrough in the early diagnosis and prevention of tuberculosis. In this project, experts from EU member states and scientists from TB-endemic countries (India, Turkey, Nigeria) shall evaluate the clinical potential of antigen and antibody detection using the high speed, cost-effective POC tests, with which results can be obtained on site within 20 min. The main aim is to develop a non-invasive, low cost test stable at room temperature enabling its application in developing countries.
LIONEX Diagnostics & Therapeutics GmbH (DE)