Tuberculosis (TB)

Accelerating the global scale-up in use of Xpert MTB/RIF

A novel financing collaboration was announced this week to significantly reduce the cost of the Xpert MTB/RIF assay, a rapid molecular test simultaneously detecting TB and rifampicin resistance in under two hours.

The new, rapid and fully automated Xpert® MTB/RIF test is a real time cartridge-based automated DNA amplification test that will deliver a highly accurate diagnosis of the disease in less than two hours.

The reduced cost of the test cartridge - from USD16.86 to USD9.98 - will take immediate effect in 145 high-burden, low- and middle-income countries, following the signing of a novel financing agreement between the manufacturer Cepheid and the Bill and Melinda Gates Foundation, the US Agency for International Development (USAID), PEPFAR and UNITAID.

The catalytic effect of the price reduction is widely expected to accelerate global scale-up, which will be facilitated by a recently approved UNITAID grant to the WHO Stop TB Department and the Stop TB Partnership. The TBXpert Project, a new three-year UNITAID-funded collaboration, will make available up to USD25.9 million for roll-out of the Xpert MTB/RIF technology to 21 recipient countries. The project will link a broad network of implementing partners with existing initiatives for TB laboratory strengthening and use innovative approaches to expand access to vulnerable populations in both the public and private sector.

“This is a game-changer for TB and MDR-TB care delivery and I applaud the visionary support of all partners and UNITAID” says Dr Mario Raviglione, Director of the WHO Stop TB Department. “We see innovation happening in real time – scientific evidence rapidly translated into policy, policy quickly adapted into practice, and scale-up significantly accelerated by innovative funding mechanisms effectively addressing cost and affordability.”

Dr Lucica Ditiu, Executive Secretary of the Stop TB Partnership, echoes these words: “When motivated partners work together, interventions accelerate at all levels. This is a huge step forward in the fight against TB”.

“The Xpert MTB/RIF assay, which was endorsed by WHO in December 2010, allows for significantly improved detection of TB compared to smear microscopy and simultaneously detects rifampicin resistance in a system that requires minimal biosafety prerequisites and training for use” says Dr Karin Weyer, STB Coordinator of Laboratories, Diagnostics and Drug Resistance, whose team led policy guidance on the new test and the proposal to UNITAID, and coordinates global support for Xpert MTB/RIF roll-out by Member States. “The assay therefore offers great potential for rapid case detection, enabling timely and appropriate patient care in settings facing high burdens of HIV-associated TB and multidrug-resistant TB”.