Health-e (Cape Town)

South Africa: Price for Rapid TB Test Slashed

The price of a rapid diagnostic test, which slashes the time to reach a diagnosis for the most common drug-resistant strain of tuberculosis, has almost been halved - including in South Africa.

The United States President's Emergency Plan for AIDS Relief (PEPFAR), the United States Agency for International Development (USAID), UNITAID, and the Bill & Melinda Gates Foundation announced an agreement that will significantly reduce the cost of the rapid TB diagnostic test Xpert MTB/RIF in 145 high-burden and developing countries.

Funds provided by this partnership will reduce the cost of Xpert MTB/RIF cartridges (in which the sputum sample is gathered before being placed in the machine) from U$16.86 to U$9.98, a price, which will not increase until 2022. The effective date of this price decrease was on Monday this week.

To date, the high unit cost of Xpert MTB/RIF cartridges produced by the medical device manufacturer Cepheid has proven a barrier to their introduction and widespread use in low- and middle-income countries.

The new agreement will immediately reduce the cost of cartridges used to diagnose TB by more than 40 percent.

Xpert is a molecular diagnostic system that can detect TB disease in patients co-infected with HIV and resistance to the antibiotic rifampicin - a widely accepted indicator of the presence of multi-drug resistant TB - in less than two hours.

The system also can be used outside of conventional laboratories because it is self-contained and does not require specialised training.

The World Health Organisation (WHO) endorsed the Xpert MTB/RIF assay in December 2010.

"We are proud that the WHO Stop TB Department and Stop TB Partnership laid the groundwork for this exciting initiative by developing and advancing a proposal for UNITAID to lower the price of the Xpert test," said Dr Lucica Ditiu, Executive Secretary of the Stop TB Partnership. "This agreement will translate into life-saving TB care for people affected by TB."

TB is the leading cause of death among people living with HIV in Africa and there is a belief that greater access to the Xpert test offers a significant advance in the capacity of health care workers to diagnose TB quickly and help reduce TB transmission, the development of TB disease, and premature TB deaths.

"This is a game-changer for TB and MDR-TB care delivery and I applaud the visionary support of all partners and UNITAID" said 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."

The capacity of the Xpert MTB/RIF assay to yield a rapid and accurate diagnosis has the potential to improve TB diagnosis and treatment in rural clinical settings. A large percentage of people with TB disease fail to start treatment promptly because of the long wait for results of older conventional tests, which can take weeks or months, and the need for them to return to the clinic, which may be far from where they live.

Using the Xpert system, clinics in poor and rural settings can deliver rapid diagnosis and immediately start patients on appropriate treatment, including second-line drugs in cases of drug-resistant.

Research suggests that the incremental scale up of Xpert in countries with high TB burdens could allow for the rapid diagnosis of 700 000 cases of TB disease and save health systems in low- and middle-income countries more than U.S. U$18 million in direct health costs.

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