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**Chapter 15** 

© 2012 Zeh et al., licensee InTech. This is an open access chapter distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

© 2012 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution,

© 2012 Zeh et al., licensee InTech. This is a paper distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

and reproduction in any medium, provided the original work is properly cited.

**Laboratory Reference Intervals in Africa** 

Over the last decade, there has been a significant increase in the number of clinical trials taking place in sub-Saharan Africa in a concerted effort to identify safe and effective prevention and treatment strategies to combat the heavy burden of infectious diseases in this region [1-3]. This is because numerous viral, parasitic and bacterial diseases are endemic in this region, including: 66% of the global HIV/AIDS infections, 31% of tuberculosis infections, and 86% of malaria cases [3, 4]. Routine capacity for clinical laboratory testing is also increasing in Africa. Clinical trials and clinical care in sub-Saharan Africa require accurate laboratory reference intervals for appropriate assessment of patients/participants, monitoring disease progression, and reporting of possible toxicity and adverse events.

This is particularly important in phase I and II clinical trials. Phase I trials often enroll a small group of healthy participants in order to determine the metabolic and pharmacologic actions of drugs, side effects associated with increasing doses and early evidence of efficacy. Phase II trials on the other hand are controlled clinical studies conducted to evaluate efficacy of drug/vaccine for a particular indication in a larger group of participants and to further evaluate its safety. Many HIV vaccine trials are slated for Phase I–III trials in Africa. The inception of the US President's Emergency Plan for AIDS Relief in 2004, with a mandate to treat 2 million HIV infections with anti-retroviral therapy by 2008 has accelerated the implementation of lymphocyte immunophenotyping in urban and rural areas in Africa as initiation of therapy is often predicated on absolute CD4 T- lymphocyte counts. Central to any HIV vaccine and/or care and treatment program is the capability to measure absolute CD4 counts. CD4 counts are important in the context of breakthrough infections during HIV vaccine trials and informing treatment. Correct diagnosis in patient management often involves accurate interpretation of results from laboratory testing [5]. Hence it is critical for medical professionals to have access to an accurate management resource such as reference

Clement E. Zeh, Collins O. Odhiambo and Lisa A. Mills

Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/48250

**1. Introduction** 

intervals.
