CLSI-Derived Hematology and Biochemistry Reference Intervals for Healthy Adults in Eastern and Southern Africa

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dc.contributor.authorKarita, Etienne
dc.contributor.authorKetter, Nzeera
dc.contributor.authorPrice, Matt A
dc.contributor.authorKayitenkore, Kayitesi
dc.contributor.authorKaleebu, Pontiano
dc.contributor.authorNanvubya, Annet
dc.contributor.authorAnzala, Omu
dc.contributor.authorJaoko, Walter
dc.contributor.authorMutua, Gaudensia
dc.contributor.authorRuzagira, Eugene
dc.contributor.authorMulenga, Joseph
dc.contributor.authorSanders, Eduard J.
dc.contributor.authorMwangome, Mary
dc.contributor.authorAllen, Susan
dc.contributor.authorBwanika, Agnes
dc.contributor.authorBahemuka, Ubaldo
dc.contributor.authorAwuondo, Ken
dc.contributor.authorOmosa, Gloria
dc.contributor.authorFarah, Bashir
dc.contributor.authorAmornkul, Pauli
dc.contributor.authorBirungi, Josephine
dc.contributor.authorYates, Sarah
dc.contributor.authorStoll-Johnson, Lisa
dc.contributor.authorGilmour, Jill
dc.contributor.authorStevens, Gwynn
dc.contributor.authorShutes, Erin
dc.contributor.authorManigart, Olivier
dc.contributor.authorHughes, Peter
dc.contributor.authorDally, Len
dc.contributor.authorScott, Janet
dc.contributor.authorStevens, Wendy
dc.contributor.authorFast, Pat
dc.contributor.authorKamali, Anatoli
dc.date.accessioned2018-07-26T07:20:31Z
dc.date.available2018-07-26T07:20:31Z
dc.date.issued2009-02-06
dc.descriptionThe objective of this study was to establish clinical laboratory reference intervals for 25 hematology, immunology and biochemistry values among healthy African adults typical of those who might join a clinical trial.en_US
dc.description.abstractBackground: Clinical laboratory reference intervals have not been established in many African countries, and non-local intervals are commonly used in clinical trials to screen and monitor adverse events (AEs) among African participants. Using laboratory reference intervals derived from other populations excludes potential trial volunteers in Africa and makes AE assessment challenging. The objective of this study was to establish clinical laboratory reference intervals for 25 hematology, immunology and biochemistry values among healthy African adults typical of those who might join a clinical trial. Methods and Findings: Equal proportions of men and women were invited to participate in a cross sectional study at seven clinical centers (Kigali, Rwanda; Masaka and Entebbe, Uganda; two in Nairobi and one in Kilifi, Kenya; and Lusaka, Zambia). All laboratories used hematology, immunology and biochemistry analyzers validated by an independent clinical laboratory. Clinical and Laboratory Standards Institute guidelines were followed to create study consensus intervals. For comparison, AE grading criteria published by the U.S. National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) and other U.S. reference intervals were used. 2,990 potential volunteers were screened, and 2,105 (1,083 men and 1,022 women) were included in the analysis. While some significant gender and regional differences were observed, creating consensus African study intervals from the complete data was possible for 18 of the 25 analytes. Compared to reference intervals from the U.S., we found lower hematocrit and hemoglobin levels, particularly among women, lower white blood cell and neutrophil counts, and lower amylase. Both genders had elevated eosinophil counts, immunoglobulin G, total and direct bilirubin, lactate dehydrogenase and creatine phosphokinase, the latter being more pronounced among women. When graded against U.S.-derived DAIDS AE grading criteria, we observed 774 (35.3%) volunteers with grade one or higher results; 314 (14.9%) had elevated total bilirubin, and 201 (9.6%) had low neutrophil counts. These otherwise healthy volunteers would be excluded or would require special exemption to participate in many clinical trials. Conclusions: To accelerate clinical trials in Africa, and to improve their scientific validity, locally appropriate reference ranges should be used. This study provides ranges that will inform inclusion criteria and evaluation of adverse events for studies in these regions of Africa.en_US
dc.description.sponsorshipThis study and report were made possible in part by the generous support of the American people through the United States Agency for International Development (USAID), the Klingenstein Fund, Gates Challenge Fund, Government of Netherlands TMF, Government of Norway, European Union East Africa Fund, Canadian International Development Agency, Development Cooperation Ireland, Department for InternationalDevelopment, Danish Ministry for Foreign Affairs, Swedish Ministry of Foreign Affairs, and the World Bank. The contents are the responsibility of the International AIDS Vaccine Initiative and do not necessarily reflect the views of USAID or the United States Government.en_US
dc.identifier.citationKarita, Etienne, Ketter, Nzeera, Price, Matt A., Kayitenkore, Kayitesi, Kaleebu, Pontiano, Nanvubya, Annet, Anzala, Omu, Jaoko, Walter, Mutua, Gaudensia, Ruzagira, Eugene, Mulenga, Joseph, Sanders, Eduard J., Mwangome, Mary, Allen, Susan, Bwanika, Agnes, Bahemuka, Ubaldo, Awuondo, Ken, Omosa, Gloria, Farah, Bashir, Amornkul, Pauli, Birungi, Josephine, Yates, Sarah, Stoll-Johnson, Lisa, Gilmour, Jill, Stevens, Gwynn, Shutes, Erin, Manigart, Olivier, Hughes, Peter, Dally, Len, Scott, Janet, Stevens, Wendy, Fast, Pat, Kamali, Anatoli, 2009. CLSI-Derived Hematology and Biochemistry Reference Intervals for Healthy Adults in Eastern and Southern Africa.en_US
dc.identifier.urihttps://hdl.handle.net/20.500.11951/307
dc.language.isoenen_US
dc.subjectCLSI-Derived Hematologyen_US
dc.subjectBiochemistryen_US
dc.subjectHealthy Adultsen_US
dc.subjectEastern and Southern Africaen_US
dc.titleCLSI-Derived Hematology and Biochemistry Reference Intervals for Healthy Adults in Eastern and Southern Africaen_US
dc.typeArticleen_US
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The final, definitive version of this paper has been published in the PLoS ONE, Volume 4, Issue 2, February/2009. https://doi.org/10.1371/journal.pone.0004401.
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