Coordinatior: K. Reither, MD, Msc
Background / Purpose:
The lack of accurate, rapid and convenient tests for tuberculosis (TB) still hinders patient management and control of this deadly disease.
In most parts of the developing world, the microscopy smear test is the only affordable and feasible method to detect TB. However, the sensitivity and specificity of this test are highly variable and the procedures are very time- and labor-intensive. Other technologies, as for instance culture or molecular biological methods, are expensive and technically very difficult and thus are not applicable on a large scale in resource poor countries.
One of the technologies which might fulfill the requirements for a new diagnostic tool for TB is the electronic nose. It mimics the human olfactory system using chemical sensors which recognize patterns in the volatiles of samples. Advantages of the electronic nose, among others, are the simple sample preparation and the fact that no reagents or other expensive consumables are required. Additionally, results are available very quickly, which would facilitate the prevention of transmission of the disease and speed up treatment initiation.
The purpose of this project is the preclinical and clinical evaluation of an electronic nose for diagnosing pulmonary tuberculosis. The sampling method, as well as data reproducibility, sensitivity and specificity of the technology will be assessed and improved.
Approach:
The evaluation of the electronic nose is carried out in six different phases. Three of these phases take place at the Mbeya Medical Research Center:
Phase II: pre-clinical study
Phase III: training set
Phase IV: feasibility evaluation
The objectives of these phases are to test and assure clinical and operational data reproducibility on site, as well as to validate the sampling protocol, data capture software and analysis capacity. Furthermore, the diagnostic potential of an electronic nose for pulmonary tuberculosis in different types of specimen, and the sensitivity and specificity of the method are evaluated.
Sponsors:
Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland
Partners:
(1) KIT Biomedical Research, Royal Tropical Institute, Amsterdam, The Netherlands.
(2) Scensive Technologies Ltd., Normanton, United Kingdom.
(3) Department of Infectious Diseases & Tropical Medicine, Ludwig-Maximilians-University (LMU), Munich, Germany.
(4) The Mbeya Medical Research Center (MMRC), Mbeya, Tanzania.
(5) Foundation for Innovative New Diagnostics (FIND) / World Health Organization (WHO), Geneva, Switzerland