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TB-trDNA
Tuberculosis
Framework programme: 6
Call: 3
Project number: LSHP-CT-2006-037785
EC contribution: € 2,000,000
Duration: 36 Months
Type: STREP
Starting date: December 2006
Graphic element Evaluation of Transrenal-DNA Detection to Diagnose Tuberculosis
Keywords: Transrenal DNA; Tuberculosis, Diagnosis

Summary:

Tuberculosis (TB) continues to be a global threat to public health. This is of important social and financial concern to the expanding European Union, as well as a cause of increasing morbidity and mortality rates in much of the developing world. Timely and accurate diagnosis is a critical obstacle to TB control. The currently available diagnostic methods are often insensitive, slow, and/or cumbersome to use. Nucleic acid amplification is the only rapid detection method with proven sensitivity and specificity, but is difficult to implement, in its current format. A method that avoided complex sputum processing and cell lysis steps and that was applicable across multiple amplification formats (e.g. in addition to PCR) would be a tremendous advantage.

There is growing evidence that short DNA fragments arising from human or bacterial cells, dying throughout the body, pass through the renal barrier and appear in urine as transrenal DNA (Tr-DNA). In a preliminary study conducted at the National Institute of Infectious Diseases in Rome, it was shown that Tr-DNA from M. tuberculosis was detectable in the urine by polymerase chain reaction (PCR) in 100% of patients with pulmonary tuberculosis and that these DNA fragments disappeared following anti-TB drug therapy. TB tr-DNA aims to:

  1. Validate the diagnostic potential of Tr-DNA detection for TB
  2. Optimize and simplify the sample preparation methods
  3. Explore the feasibility of using a diagnostic approach based on this method within a developing world setting.

Background:

TB remains among the most prevalent causes of death from an infectious disease in the world.While global targets for rates of cure have been reached in many areas, case detection remains a significant bottleneck to effective diseases control. Microscopy, the only widely available laboratory diagnostic test for TB, is both difficult to implement and insensitive. Consequently, the availability of new diagnostic tools that are more accurate and accessible may greatly benefit individual patients and significantly contribute to the control of the disease.

Aim:

TB tr-DNA aims to develop a new and highly innovative platform for the detection of poverty-related diseases (TB followed by HIV and malaria). This platform is based on the principle that dying cells release cell-free DNA into the blood stream that then passes through the renal barrier and can subsequently be detected in urine.

Expected results:

TB-trDNA is designed to develop a rapid diagnostic procedure for utilising transrenal DNA as a target sample for the identification of Tuberculosis patients. The findings of TB-trDNA will also contribute to policy development through knowledge and awareness of the importance of TB diagnosis; and having close association with the respective Ministries of Health and international organisations like the World Health Organisation.

Potential applications:

Given the significant challenges of Mtb detection and monitoring in developing countries, the application of the Tr-DNA test could provide a very useful new diagnostic tool. By simplifying the sampling procedure and combining this with improved molecular detection methods, (which could eventually lead to simple dip stick methods) the findings of TB tr-DNA could ensure that simple, cheap, efficacious TB diagnosis, is made available to the developing world; ensuring a targeted use of the available therapy.

Coordinator:

Mr Jim Huggett
Centre for Infectious Diseases
and International Health
Windeyer Institute, University College
London, 46 Cleveland St. London
W1T 4JF
UK
Tel/fax. +44 20 76799311
E-mail: j.huggett@ucl.ac.uk

Partners:

Principal
Scientific
Participants
Official Address Other Information
2 David Tomei Spaxen Italia
C/o National Institute of Infectious Diseases in Rome
Lazzaro Spallanzani – IRCCS, Via Portuense 292
00149 Roma
Italy

Tel: +39 06 9557 0030
E-mail: ldtomei@xenomics.com
3 Alimuddin Zumla Centre for Infectious Diseases
and International Health
Windeyer Institute, University College
London, 46 Cleveland St. London
W1T 4JF
UK
Tel/fax. +44 20 76799311
E-mail a.zumla@ucl.ac.uk
4 Peter Mwaba Department of Medicine
UNZA-UCLMS project
University Teaching Hospital D Block
Lusaka
Zambia
Tel: +260 97775354
E-mail: Pbmwaba2000@yahoo.com
5 Michael Hoelscher Dep. Infectious Diseases & Tropical
Medicine, University of Munich
Leopoldstrasse 5, 80802 Munich
Germany
Tel: +49-89-2180-3830
Fax: +49-89-336038
E-mail: hoelscher@lrz.uni-muenchen.de
6 Leonard Maboko Mbeya Medical Research Programme
P O. Box 2410, Mbeya
Tanzania
Tel. +255-25-2503364
Fax +255-25-2503134
E-mail: Maboko.tz@lrz.uni-muenchen.de
7 Enrico Girardi, MD Dipartimento di Epidemiologia
Istituto Nazionale per le Malattie Infettive
L. Spallanzani – IRCCS, Via Portuense
292, 00149 Roma
Italy
Tel + 39 0655170901
Fax +39 065582825
E-mail: girardi@inmi.it
8 Giorgio Roscigno FIND, Foundation for Innovative New
Diagnostics
71 avenue Louis Casai, PO Box 93
1216 Cointrin
Switzerland
Tel: +41 (22) 710 05 92
Fax: +41 (22) 710 05 99
E-mail: mark.perkins@finddiagnostics.org
Web: www.finddiagnostics.org

 
 
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