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New Medical Diagnostic to Revolutionize Fight Against TB, One of the World’s Biggest Killers

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Washington D.C., 8 December 2010 -     The World Health Organization today endorsed Xpert MTB/RIF, a revolutionary new technology that, if taken to scale in endemic countries, could completely change the public health approach to diagnosing and treating tuberculosis (TB), which remains one of the greatest killers on the planet.

Among a new class of fully automated, DNA-based diagnostic tests, Xpert provides a rapid, accurate diagnosis of TB without the need for a sophisticated lab. It detects many cases that are missed by the current technology, which is more than a century old, including in people who are HIV positive - where TB mortality is highest and where the majority of cases are missed by current frontline tools. Rapid diagnosis will allow patients to start appropriate treatment in hours as opposed to weeks or even months. Since over a quarter of all AIDS-related deaths are caused by TB, Xpert is a critical tool in the fight against AIDS. If the new diagnostic is implemented broadly, there could be significant public health benefits.

Xpert also rapidly detects drug resistant TB - something the current diagnostic, which requires a human to search for TB germs under a microscope, fails to do. Xpert shows whether a person has resistance to a key first line TB drug, rifampin, in less than two hours. Because resistance to rifampin strongly suggests that a patient is resistant to other TB drugs, Xpert provides an appropriate initial diagnosis that quickly puts the patient and the health care provider on the right course. 

"Xpert is the most important public health breakthrough for tuberculosis in half a century," said Joanne Carter, executive director of RESULTS Educational Fund. "The test currently used in most endemic countries to detect TB was invented before the automobile. Xpert gives us the ability to quickly and accurately detect large numbers of TB cases that are being missed every year, including in people living with HIV - where the risk of TB is the highest and the current test is least effective. In less than two hours and with basic electricity, Xpert also tells us if a TB patient has resistance to one of the most important first-line TB drugs - something that used to take 75 days and a high-tech lab. This technology has the potential to dramatically alter the trajectory of this disease."

Studies showed that Xpert detected 30 percent more TB cases compared to the current diagnostic used in endemic countries, and improved detection of multidrug-resistant TB (MDR-TB) by 300 percent. The test is fast and easy to use, giving a diagnosis in 100 minutes through a fully automated process without the need for a high-tech laboratory. A typical TB patient infects 10-15 other people in the course of a year - so rapid diagnosis and rapid treatment means halting the disease in its tracks.

Along with today's endorsement of Xpert MTB/RIF, the WHO strongly recommends using Xpert to diagnose TB in places with high levels of HIV and MDR-TB. In time, Xpert should replace older diagnostic technologies and help usher in a phase where we can envision the elimination of the disease.

"If countries are to begin using Xpert as the WHO recommends, it is critical that donor governments provide financial and technical support to help introduce and scale up the use of Xpert in countries with the highest burdens of TB and TB-HIV," continued Carter. "The Global Fund to Fight AIDS, Tuberculosis and Malaria can be instrumental in supporting this scale-up, and that's another reason why fully financing the Global Fund is so important. And it is absolutely critical that efforts continue to drive down the cost of the test so that it becomes more accessible for all countries to use at scale."

Because the machine is self-contained and easy to use, it has only basic requirements for use, including reliable electricity, a room that can be locked, computer hard drives to store data, a health worker to operate the machine and computer, and standard medical waste removal capacity. Xpert is already being successfully piloted in clinics in low-income settings, including in South Africa's largest slum.

The Xpert machine can also be used to diagnose a number of other illnesses, including MRSA, influenza, leukemia, and other sexually transmitted infections. This means Xpert can not only play a critical role in better diagnosis of TB, but it can also serve as a platform to strengthen the diagnostic capacity of the health system more broadly.