The Global Health and Diagnostic (Flow) Cytometry-Breakthroughs in HIV and Tuberculosis

The global HIV/AIDS pandemic has progressed to where current estimates suggest that at least 33 million individuals are now infected with HIV (1). The unprecedented nature of the HIV/AIDS epidemic has led policy makers to mobilize political and financial resources worldwide to bring treatment options to those who are most in need. During the last 5 years, three major global initiatives have been launched to bring together the required financial resources and develop operational plans to accelerate resource poor areas access to antiretroviral (ART) medications and other care and prevention programs. In late 2001, shortly after U.N. Secretary-General Kofi Annan convened a U.N. Special Session on HIV/AIDS, the multilateral Global Fund to Fight AIDS, Tuberculosis, and Malaria was established to provide money rapidly for country-owned initiatives. Then, in his 2003 State of the Union Address, President George Bush proposed $15 billion US dollars of unilateral aid to international AIDS activities. This program subsequently became known as the President's Emergency Plan for AIDS Relief (PEPFAR) with a target of treating two million HIV-infected people in the poorest and most afflicted countries of Africa and the Caribbean and in Vietnam. Later that year the World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS launched their “3-by-5” campaign, with the target of providing ART to three million people infected with HIV/AIDS in resource poor settings by the end of 2005. The US Congress will soon consider reauthorization of PEPFAR and will likely increase its commitment to 30–50 billion dollars for another 5-year period. Such increases have resulted and will continue to lead to more and more individuals receiving ART treatment, placing additional strains on the health systems in many countries. A number of challenges or limitations have already been observed. They include few or inadequately trained health care/laboratory workers, poorly equipped health care facilities, and lack of laboratory technology to diagnose or monitor HIV/AIDS patients. From the laboratory side, development and use of simple low cost methods to monitor organ function, viral load, and CD4 levels are essential in meeting worldwide treatment goals. Since the onset of HIV/AIDS, now more than 25 years ago, it has been recognized that the HIV/AIDS disease process targets the CD4 lymphocyte. Measuring CD4 cells is routine in first world settings as a part of the HIV/AIDS staging process and in assessing response or failure to ART. However, this is not the case in many resource limited settings. The global scale up of CD4 testing currently requires acquisition of technology such as flow cytometry, training of staff, developing performance or validation criteria, establishing reference ranges, setting polices for internal/external quality control/assurance programs, and planning for long-term sustainability of the testing once it is introduced. Though these tasks can be challenging in fully developed settings they can become daunting in resource poor environments. The articles in this Supplement address many of these challenges. Michael H. Merson Michael H. Merson, M.D., is the founding Director of the Duke Global Health Institute and Professor of Medicine, Community and Family Medicine, and Public Policy at Duke University. Prior to this position, he served for 10 years as the first Dean of Public Health at Yale University School of Medicine and 7 years as Director of the Center for Interdisciplinary Research on AIDS at Yale. Previously he worked for 17 years with the World Health Organization (WHO) serving first as Director of the Diarrheal Diseases Control and Acute Respiratory Control Programs and subsequently as Executive Director of the WHO Global Program on AIDS. Thomas N. Denny Thomas N. Denny, MSc., is the Chief Operating Officer of the Duke Human Vaccine Institute and Center for HIV/AIDS Vaccine Immunology and Associate Professor of Medicine. Most recently he was an Associate Professor of Pathology, Laboratory Medicine and Pediatrics, Associate Professor of Preventive Medicine and Community Health and Assistant Dean for Research in Health Policy at the New Jersey Medical School, Newark, New Jersey. Mr. Denny was a 2002–2003 Robert Wood Johnson Foundation Health Policy Fellow at the Institute of Medicine of the National Academies (IOM). As a fellow, he served on the US Senate Health, Education, Labor and Pensions Committee with legislation/policy responsibilities in Global AIDS, Bioterrorism, Clinical Trials/Human Subject Protection and Vaccine related issues. Tom has more than 30 years of CD4/immune monitoring experience working in a number of global settings.