Keywords: Tuberculosis; serodiagnosis; antibodies; diagnostics, immunochromatographic test
There is a great need for simple and robust diagnostic methods for the diagnosis of tuberculosis (TB). From the basis of a through-screening process ten M. tuberculosis antigens have been identified, exhibiting potential as serodiagnostic TB antigens. Two to three of these antigens will be selected with the aim of achieving the highest sensitivity and specificity in a setting with a high number of latent TB infections and HIV co-infection. The selection will be based on evaluating patients with TB, latently infected individuals and symptomatic non-TB patients.
The selected antigens will be incorporated into an immunochromatographic test (ICT) which will be optimised for the detection of M. tuberculosis-specific antibodies. Prototypes of the test kit will be produced and inhouse 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 Ethiopia.
Globally, TB is a severe problem, and the rapid and accurate diagnosis of active TB is the cornerstone of TB control. There is a direct need for:
The publications of the genomic regions of difference between
M. tuberculosis and M. bovis BCG allows identification of genes that are present
only in M. tuberculsosis. From these gene regions 100 proteins have been
screened, specific for the M.tuberculosis complex. Out of these, ten antigens
have been selected, which are frequently recognised by both HIV negative
and HIV positive TB patients.
To identify the best combination of two to three antigens to be incorporated into an immunochromatographic test, which will be evaluated for performance in two real life settings.
By the end of this project, it is expected that the identification of two or three M. tuberculosis antigens, which can form part of a serodiagnostic assay as a tool for detecting active TB in a high and a medium TB incident setting, will have been achieved. Furthermore, performance data on the ICT prototype are also expected. As a part of this, data which highlight the influence of TB incidence on the performance of an antibody based kit for diagnosis of active TB are expected.
The development of the proposed ICT assay would lead to an inexpensive and more accessible diagnostic TB tool whilst enabling local and family physicians in the field to perform the TB diagnosis from the bed-side. This will permit an earlier diagnosis of the disease and therefore an early initiation of the treatment of a contagious disease which will lead to a decrease of the transmission. Only by preventing the spread of the disease in the local community can long-term control of TB be achieved.
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|3||Ismail Ceyhan||Refik Saydam National Institute of
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|4||Abraham Aseffa||Armauer Hansen Research Institute
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