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Development of a specific serological kit for the diagnosis of TB

Objective

Tuberculosis (TB) is a severe global problem, and a cornerstone in global TB control is the rapid and accurate diagnosis of active TB. Their is a dire need for better TB diagnostics methods in developing countries and the development of a simple and rapid test based on antibody motoring will be of great importance for controlling the global epidemic. There are currently a number of serology based TB test commercial available, but none of these have the required sensitivity and specificity. The publications of the genomic regions of difference between M. tuberculosis (M.t) and M. bovis BCG allow identification of genes that are present only in M t. From these gene regions we have screened 100 proteins specific for the M.t. complex. Out of these we have selected ten antigens which are frequently recognized by both HIV negative and HIV positive TB patients.

The goal of the proposed project is to design the best combination of the two to three of these antigens which will be incorporated into an immunochromatographic test (ICT). The antigens will be selected with the aim to achieve the highest sensitivity and specificity in a setting with a high number of latent infection and HIV coinfection. The selection will be based on evaluation in TB patients, latently infected individuals and symptomatic non-TB patients. The selected antigens will be incorporated into an ICT which will be optimised for the detection of M.t. specific antibodies. Prototypes of the test kit will be produced and in house proof of performance data generated. Finally, the performance of this test kit will be evaluated in a real life scenario in two independent hospital settings in Turkey and in Ethiopia. The outcome of this study will be the development and on site evaluation of a rapid bed-side kit for the sensitive detection of contagious TB which can be used also in countries with a high HIV background and mycobacterial exposure through latent TB, BCG vaccination and environmental mycobacteria.

Call for proposal

FP6-2005-LIFESCIHEALTH-7
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Funding Scheme

STREP - Specific Targeted Research Project

Coordinator

STATENS SERUM INSTITUT
Address
Artillerivej 5
Copenhagen S
Denmark

Participants (3)

VIRCELL,SL
Spain
Address
P.i. Dos De Octubre, Pza. Domínguez Ortiz, 1, Santa Fe
Granada
REFIK SAYDAM INSTITUTE OF HYGIENE
Turkey
Address
Cemal Gürsel Street No:18
Ankara
ARMAUER HANSEN RESEARCH INSTITUTE
Ethiopia
Address
Alert Campus, Jimma Road
Addis Ababa