Tuberculosis (TB) is a major global health issue. According to the World Health Organisation (WHO), every year there are worldwide 8.8 million new active TB cases and nearly 2 million TB deaths - 5000 every day - mostly in the poorest communities of the developing world. One third of the world's population has latent TB which may later develop into an active form of the disease. TB has also become the leading cause of death among people with HIV. While most cases of TB occur in developing countries, it is also reemerging as a threat in major urban populations in Europe, due to the increase in global travel.
The early treatment of TB is currently hindered by the lack of rapid, accurate diagnostic tools, especially those that can be applied as a point-of-care device in the resource-constrained settings in developing countries. Alternatives do exists, but they either come at a high cost or lack the required sensitivity.
In the context of the recently concluded European project Pocket, a number of world-class novel technologies was integrated into a point-of-care TB test that fills the gap between current high-end, sensitive but expensive tests and low-end, cheap tests plagued by limited accuracy. The Pocket test is based on a sensor in a silicon nitride chip, where the choice of wavelength allows for the production of a low-cost readout instrument. Combined with novel diagnostic antibodies, this results in very accurate detection of the TB antigens in urine, thereby diagnosing the presence of the TB bacterium. A panel of 10 positive and 10 negative actual clinical samples collected from various countries all over the world yielded only a single false positive. All other samples were correctly identified, including those of 5 TB-positive HIV-negative patients, which previously were difficult to detect using similar methods.
The Pocket consortium is coordinated by Ghent University. The project partners are
- CIN2-CSIC Barcelona (SP, nanob2a.cin2.es): surface chemistry
- Ghent University (BE, photonics.intec.ugent.be): photonics transducer design
- Imec (BE, www.imec.be): chip fabrication
- Lionex (DE, www.lionex.de): antibody and antigen development
- microfluidic ChipShop (DE, www.microfluidic-chipshop.com): microfluidic chip development
- Trinean (BE, www.trinean.com): instrument design
Pocket (Development of a low-cost Point-Of-Care test for Tuberculosis detection) started on November 1st 2013 and ran under the Seventh framework Program (FP7) of the European Union.