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Development and Clinical Evaluation of Fast Tests for Tuberculosis Diagnosis
Framework programme:
Project number:
EC contribution:
€ 1,217,800
36 Months
Starting date:
1 December 2006

Keywords: Tuberculosis, TB diagnosis, Serology, Antigen discovery, TB-Fast Test Development, Clinical Evaluation


It is widely accepted that rapid, cost-effective diagnosis of high sensitivity and specificity is a prerequisite for the prevention and control of tuberculosis (TB); a global disease in humans, killing more than 3 million people annually. Methods and devices currently in use do not meet these requirements.

New strategies are urgently needed for combating the problems of TB diagnosis. First-generation detection tests using a novel, high-speed device for quantitative measurement of antigens in sputum and urine of TB patients have recently been developed. The device also enables simultaneous measurement of antigens and antibodies within 20 minutes. The main objectives of this proposal are to:

  1. Identify novel antigens using genomic and proteomic approaches
  2. Purify sufficient quantities of antigens and raise antibodies
  3. Optimise immobilisation conditions for the specific antigens
  4. and antibodies on different Carriers
  5. Manufacture and evaluate different, fast tests using approximately 6 000 clinical specimens (sputum, saliva, serum, urine) from TB patients at study sites in Asia, Africa, America and Europe.

Such tests and devices would be a major breakthrough in the early diagnosis and prevention of tuberculosis. The Coordinator (LIONEX, an SME) in cooperation with a WHO centre, a lung hospital in Germany and additional expert scientists from low-resource, TB-endemic countries (India, Turkey, Nigeria, Mexico) shall in this project, evaluate the clinical potential of antigen and antibody detection using the high speed, cost-effective Point of Care (POC) tests, with which results can be obtained on site within 20 minutes. Finally, the project also aims at developing TB-HIV dual antibody detection POC Fast tests.

The outcome of this project will lead to new inexpensive and fast diagnostic tests that can be performed on site without the requirement of any complicated or expensive instruments. The tests will provide results within 15-20 minutes and shall be preferably non-invasive.


The current methods of diagnosis (microscopy, culture, chest x-ray, PPD, PCR) are inadequate for the diagnosis of tuberculosis, as these are either too slow, not sensitive enough or too expensive. The usual means of diagnosing TB in the majority of developing countries where culture facilities are not available is by the detection of acid fast bacteria in sputum by direct microscopy. But this test is laborious and insensitive as only 40-60% of all adults with pulmonary TB can be identified by the current smear test using Ziehl-Neelsen staining. In low-resource TB endemic countries, poor access to high-quality microscopy services and/ or paucibacillary nature of pulmonary TB in HIV positive patients results in even lower rates of sensitivity of AFB (acid fast bacilli) detection. Thus, the two main problems concerning TB diagnosis are:

  1. Sputum microscopy, currently the most widely used method
  2. to detect tuberculosis is cumbersome and insensitive, leaving many patients undetected and
  3. Bacterial culture, the gold standard, is more sensitive, but takes 4-6 weeks to complete, and is too complex for most settings where TB is endemic.
    The HIV pandemic has led to a resurgence of TB as a major public health problem. Immunodeficient HIV-positive patients are particularly vulnerable to TB and are even more difficult to diagnose than those who are diagnosed HIV negative.

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