This project is in the development of tools to assess (therapeutic) monitoring of 3 neglected diseases, Leishmaniasis, Tuberculosis and Trachoma. The project is split into 3 workpackages, each addressing one disease.

Part 1: Diagnostic test for Leishmaniasis

Leishmaniasis is caused by a single-celled, eukaryotic parasite transmitted by the bite of an infected sand fly. In humans, a range of clinical symptoms can be observed from self-healing skin lesions in cutaneous leishmaniasis (CL), lesions of the mucosal tracts, mucosal leishmaniasis (MCL) to the fatal form, visceral leishmaniasis (VL), also known as Kala-Azar, which affects internal organs (in particular, spleen, liver, lymph nodes and bone marrow). In addition, 5-60% (depending on geographical area) of treated VL patients may develop the condition known as Post-Kala Azar Dermal Leishmaniasis (PKDL), which becomes a reservoir for ongoing transmission of VL.

Improvement of treatment outcome in leishmaniasis patients by the evaluation of novel diagnostic targets in combination with LAMP technology

Part 2: Treat to test for Tuberculosis

Antigens or TB degradation products are excreted in urine of TB patients, making these, in principle, ideal targets for a simple urinary dipstick test. As these antigens are derived directly from the pathogen there is potential for very specific tests that could accurately diagnose TB disease. Unfortunately, in reality, several decades of research by many different groups has not led to an assay that is sensitive enough to accurately diagnose TB disease in the majority of patients. This is unfortunate, as there is an enormous worldwide unmet need for a truly simple point-of-care test.

In view of the urgent need for a simple confirmatory test for TB infection, we will explore a pragmatic alternative strategy which uses antigen tests in a completely novel fashion: In short, to utilize antigen tests in a "treat-to-test" strategy, as we expect that this would result in a significant increase in the accuracy of TB diagnosis than what can currently be achieved using conventional methods.

To identify the kinetic profile of biomarker excretion (by ELISA and MS) as a result of initiation of active treatment of TB.

Part 3: Diagnostic test for Trachoma

Trachoma is one of the neglected infectious diseases for which a control strategy (SAFE) is available. The SAFE strategy, which is partly based in mass drug administration, has proven to be highly effective and several countries now have been declared free including Morocco where the disease is virtually eliminated. To detect and confirm remaining foci and cases in endemic countries like Ethiopia a diagnostic (screening) test is urgently needed. Trachoma is a chronic blinding disease caused by mechanical rubbing of the inward turned eyelid after irritation due to repeated infection with the Chlamydia trachomatis. To fulfill in the need for a simple, reliable, robust and affordable field test we will make use of stabilised biomaterials and use a potent fluorophore as detector. The signal will be easily read using a hand-held device.

Improvement of the detection of trachomatis infections in endemic populations by the application of novel field test technology for stabilizing of biomaterials and improved signal.

Fast facts
Full project title: Methods for Therapeutic monitoring of Leishmania, Tuberculosis and Trachoma
Start date: Feb 2011
End date: Nov 2013
Goal: Development of a diagnostic test for Leishmania and Trachoma and a treat to test assay for Tuberculosis
Principal investigator: Paul Klatser, KIT, The Dutch Royal Tropical Institute
Project size: 12 FTE's Partners: The Dutch Royal Tropical Institute, Foundation for Innovative New Diagnostics (FIND), Life Assay Diagnostics, Leiden University Medical Center, TI Pharma

“What TI Pharma can deliver from collaborations is more efficient healthcare, faster time to market and quicker patient benefit.”

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