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
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.
- Better TB diagnostics methods in developing countries
- The development of a simple and rapid test based on antibody
monitoring, which will be of great importance in controlling
the global epidemic. There are currently a number of serology-based
commercial TB tests available, but none with the required
sensitivity and specificity.
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.
Statens Serum Institut
Department of Infectious Disease Immunology, Artillerivej
2300 Copenhagen S, Denmark.
Tel: +45 32683817
Fax: +45 32683035
||VIRCELL, P.I. Dos de Octubre, Pza.
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||Refik Saydam National Institute of
Hygiene, Cemal Gürsel Street No:18
|Tel: +90 3124355680/1304
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||Armauer Hansen Research Institute
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