CLSI derived hematology and biochemistry reference intervals for healthy adults in eastern and southern Africa
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.
Karita E, Ketter N, Price MA, Kayitenkore K, Kaleebu P, Nanvubya A, Anzala O, Jaoko W, Mutua G, Ruzagira E, Mulenga J, Sanders EJ, Mwangome M, Allen S, Bwanika A, Bahemuka U, Awuondo K, Omosa G, Farah B, Amornkul P, Birungi J, Yates S, Stoll-Johnson L, Gilmour J, Stevens G, Shutes E, Manigart O, Hughes P, Dally L, Scott J, Stevens W, Fast P, Kamali A