New test can detect TB in two hours

A new molecular test for tuberculosis (TB) can accurately detect the disease within two hours, a study showed.

The study published in The New England Journal of Medicine involved about 1,730 patients with suspected drug-sensitive pulmonary tuberculosis. When used on these patients, the Xpert MTB/RIF test successfully identified 98 percent of all TB cases.

The test also accurately identified resistance to rifampin - a critical first-line drug for treatment of the disease - in more than 97 percent of patients, providing results in less than two hours, the researchers said.

The current clinical trial findings are from a study conducted by the Foundation for Innovative New Diagnostics (FIND), a Swiss-based nonprofit organization. The test is co-developed by FIND and its partners Cepheid and the University of Medicine and Dentistry of New Jersey.

“The results of this study confirm that the Xpert MTB/RIF test provides a faster, more accurate result than the standard tests used today,” Giorgio Roscigno, chief executive of FIND said, “Once WHO has issued a recommendation on the use of the test, FIND will work with international partners and national health programmes to accelerate global access to this potentially lifesaving technology.”

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The study was spread across five centers in Peru, Azerbaijan, South Africa and India between July 2008 and March 2009.

“These results suggest that it has the potential to revolutionize TB care, and WHO will treat it as a top priority.” said Mario Raviglione, Director of the World Health Organization's Stop TB Department.

California-based molecular diagnostics company Cepheid has devised the automated test for use with its flagship GeneXpert system to identify TB. The test is currently available outside the U.S., marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. It is currently expected to be available in the U.S. within the 2012-2013 timeframe.

"I’m sure Koch and Pasteur would not only be delighted with the technological advance, they would probably say, ‘It’s about time’." says Fred Tenover, Cepheid Senior Director of Scientific Affairs.

According to World Health Organization (WHO), about two billion people are currently infected with multi-drug resistant (MDR)-TB worldwide. Current testing for drug resistance can take more than 4 weeks, leading to higher mortality and the further spread of MDR strains.

TB is an airborne disease caused by a pathogen belonging to the species mycobacterium tuberculosis (MTB). Like the common cold, it spreads through the air. Only people who are sick with TB in their lungs are infectious. When infectious people cough, sneeze, talk or spit, they propel TB germs, known as bacilli, into the air. A person needs only to inhale a small number of these to be infected.