Following is the text of a joint statement by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), U.S. Agency for International Development and U.S. Department of Health and Human Services.
The United States welcomes the policy statement and roadmap issued today by the World Health Organization (WHO) charting the rollout of the Xpert MTB/RIF rapid diagnostic test for tuberculosis (TB) and rifampicin resistance, a proxy for multidrug resistant tuberculosis (MDR-TB).
The limitations of traditional smear microscopy, along with the cost and long delays to receive culture results, have limited the ability to expeditiously diagnose and treat TB. The impact is witnessed daily in healthcare facilities and communities in the highest burden areas: increases in deaths that can be prevented, prolonged transmission of the TB bacteria, and delays in detecting drug resistance to the antibiotics we rely on to treat TB. The capacity to improve the diagnosis of TB has thus been a global priority, but the prospect of access to such a test was unthinkable just a few short years ago.
With today's release of normative guidance and an implementation roadmap by WHO, we have reason to be hopeful. With funding from the U.S. National Institutes of Health and the Bill and Melinda Gates Foundation, FIND (Foundation for Innovative New Diagnostics) spearheaded a novel public-private partnership with Cepheid, Inc. and the University of Medicine and Dentistry of New Jersey to develop a TB-specific, automated nucleic amplification assay (Xpert MTB/RIF). This fully integrated and automated instrument has the capacity to detect the presence of TB disease and resistance to rifampicin in less than two hours. Of special importance to global health programs in rural areas, the tool can be decentralized to settings very close to where patients seek services in their communities.
The rapid test will be critical for programs supported by the U.S. Government, primarily through the bilateral programs of U.S. Agency for International Development (USAID) and in high HIV-prevalence contexts benefitting from PEPFAR support. The U.S. Government agencies contributing to global TB control, namely USAID, PEPFAR, and the U.S. Centers for Disease Control and Prevention (CDC), are committed to working together to support the rapid scale-up and appropriate use of this new technology.
Ambassador Eric Goosby, M.D., U.S. Global AIDS Coordinator commented, "WHO's endorsement is welcome news to PEPFAR given the real impact this new rapid test will have on saving lives. With this endorsement, PEPFAR now has validation of the evidence base for this tool as well as a roadmap for implementation and field-level evaluations to be accelerated in 2011. HIV-associated TB is the leading cause of death among people living with HIV in the Africa region. During the early years of PEPFAR, the U.S. has partnered with Ministries of Health, strengthening and expanding laboratory services to support HIV testing, care of opportunistic infections (including TB diagnosis and treatment), and monitoring of antiretroviral treatment. We look forward to further partnering with Ministries of Health, WHO, FIND and other partners to ensure that we use the platform established through PEPFAR to facilitate the rapid uptake of this critical new technology."
Dr. Raj Shah, USAID Administrator said, "Rapid diagnosis, coupled with improved health delivery systems and stronger community awareness, is critical to the early detection and treatment of TB. To win the fight against TB we must slow the growth of drug resistance by providing quality basic TB control, investing in the rapid and appropriate uptake of Xpert MTB/RIF and other new technologies and continuing to support the research and development of new tools. USAID stands ready to support the roll-out of this new technology, including the advancement of sound international policy, training and impact monitoring."
Dr. Thomas Frieden, CDC Director said, "Having a reliable test that can detect TB and MDR-TB in less than two hours from a patient's sputum specimen is a great tool. This is especially important in caring for HIV-infected persons who are at greatest risk for rapid progression of TB disease, and in whom this disease is a leading cause of death. It is also important to prevent prolonged delays in diagnosis and to ensure appropriate treatment in areas where multidrug resistant TB is common. Xpert MTB/RIF rapid diagnostic test for TB and MDR TB, in conjunction with effective tuberculosis diagnosis, treatment, and monitoring, will help reduce disease and death from TB."
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