One of the key findings of the study, which was published in the June edition of the Journal of Clinical Microbiology*, is that technicians without molecular training can perform the test with high reproducibility in a simple laboratory, without specialized equipment.

“There is an urgent need for a fast, easy and cost-effective way to diagnose TB in order to effectively treat and contain this highly contagious bacterium that infects one-third of the world’s population,” said Dr. Giorgio Roscigno, CEO of FIND. “This is the first time that the feasibility of applying such an innovative diagnostic in the developing world has been shown. This is a major step forward in developing a TB test that is affordable and useable even in remote locations.”

The TB test uses LAMP technology developed at Eiken and is designed to detect DNA directly from clinical samples in less than two hours with minimal instrumentation. Molecular amplification methods, such as polymerase chain reaction, are proven technologies for the detection of TB but have not been routinely and widely used in developing countries due to their complexity and the need for highly trained staff.

Dr. Mark Perkins, Chief Scientific Officer of FIND, stated “Due to its simplicity, LAMP technology makes rapid and sensitive detection of TB possible even at peripheral levels of the health sector. This study confirms that developing a test that requires only minimal infrastructure, can be used at point-of-care, and delivers accurate results may be a rapidly attainable goal.”

* Published as "Operational Feasibility of Using Loop-Mediated Isothermal Amplification for Diagnosis of Pulmonary Tuberculosis in Microscopy Centers of Developing Countries", Catharina Boehme, Pamela Nabeta, German Henostroza, Rubhana Raqib, Zeaur Rahim, Martina Gerhardt, Erica Sanga, Michael Hoelscher, Tsugunori Notomi, Tetsu Hase, Mark Perkins
Journal of Clinical Microbiology, June 2007, Vol.45, No.6, p. 1936-1940

To access the article or view the abstract, please contact: http://jcm.asm.org/