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SERO-TB
Tuberculosis
Framework programme: 6
Call: 3
Project number: LSHP-CT-2006-037796
EC contribution: € 827,313
Duration: 36 Months
Type: STREP
Starting date: December 2006
Graphic element Development of a Specific Serological Kit for the Diagnosis of TB
Keywords: Tuberculosis; serodiagnosis; antibodies; diagnostics, immunochromatographic test

Summary:

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.

Background:

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:

  1. Better TB diagnostics methods in developing countries
  2. 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.
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.

Aim:

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.

Expected results:

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.

Potential applications:

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.

Coordinator:

Karin Weldingh
Statens Serum Institut
Department of Infectious Disease Immunology, Artillerivej 5
2300 Copenhagen S, Denmark.
Tel: +45 32683817
Fax: +45 32683035
Email: kwe@ssi.dk
website: www.ssi.dk

Partners:

Principal
Scientific
Participants
Official Address Other Information
2 Arantxa Cortés VIRCELL, P.I. Dos de Octubre, Pza.
Domínguez Ortiz 1,Santa Fe
18320 Ganada
Spain
Tel: +34 958441264
Fax: +34 958510712
E-mail: qa@vircell.com
Website: www.vircell.com
3 Ismail Ceyhan Refik Saydam National Institute of
Hygiene, Cemal Gürsel Street No:18
06100 Ankara
Turkey
Tel: +90 3124355680/1304
Fax: +90 3124320946
E-mail: Ismail.ceyhan@saglik.gov.tr
Website: www.rshm.saglik.gov.tr
4 Abraham Aseffa Armauer Hansen Research Institute
ALERT Campus, Jimma Road
PO Box 1005, Addis Ababa
Ethiopia
Tel: +25 1113211334
Fax: +25 1113211563
E-mail: aseffaa@yahoo.com

 
 
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