Etienne Karita|Nzeera Ketter|Matthew A. Price|Kayitesi Kayitenkore|Pontiano Kaleebu|Annet Nanvubya|Omu Anzala|Walter Jaoko|Gaudensia Mutua|Eugene Ruzagira|Joseph Mulenga|Eduard J. Sanders|Mary Mwangome|Susan Allen|Agnes N. Bwanika|Ubaldo Bahemuka|Ken Awuondo|Gloria Omosa|Bashir Farah|Pauli N. Amornkul|Josephine Birungi|Sarah Yates|Lisa Stoll-Johnson|Jill Gilmour|Gwynneth Stevens|Erin Shutes|Olivier Manigart|Peter Hughes|Len Dally|Janet Scott|Wendy Stevens|Pat Fast|Anatoli Kamali
CLSI-Derived Hematology and Biochemistry Reference Intervals for Healthy Adults in Eastern and Southern Africa
San Francisco Foundation|Johnson & Johnson (United States)|International AIDS Vaccine Initiative|San Francisco Foundation|Uganda Virus Research Institute|Uganda Virus Research Institute|Kenya AIDS Vaccine Initiative|Kenya AIDS Vaccine Initiative|Kenya AIDS Vaccine Initiative|Uganda Virus Research Institute|Kenya Medical Research Institute|University of Oxford|Kenya Medical Research Institute|Emory University|Uganda Virus Research Institute|Uganda Virus Research Institute|Kenya Medical Research Institute|Kenya AIDS Vaccine Initiative|Kenya AIDS Vaccine Initiative|International AIDS Vaccine Initiative|International AIDS Vaccine Initiative|International AIDS Vaccine Initiative|Cerritos College|University of Oxford|International AIDS Vaccine Initiative|San Francisco Foundation|Uganda Virus Research Institute|Emmes (United States)|University of Oxford|National Health Laboratory Service|University of the Witwatersrand|International AIDS Vaccine Initiative|Uganda Virus Research Institute
background clinical laboratory reference intervals established many african countries nonlocal intervals commonly used clinical trials screen monitor adverse events aes among african participants using laboratory reference intervals derived populations excludes potential trial volunteers africa makes ae assessment challenging objective study establish clinical laboratory reference intervals 25 hematology immunology biochemistry values among healthy african adults typical might join clinical trial methods findings equal proportions men women invited participate cross sectional study seven clinical centers kigali rwanda masaka entebbe uganda two nairobi one kilifi kenya lusaka zambia laboratories used hematology immunology biochemistry analyzers validated independent clinical laboratory clinical laboratory standards institute guidelines followed create study consensus intervals comparison ae grading criteria published us national institute allergy infectious diseases division aids daids us reference intervals used 2990 potential volunteers screened 2105 1083 men 1022 women included analysis significant gender regional differences observed creating consensus african study intervals complete data possible 18 25 analytes compared reference intervals us found lower hematocrit hemoglobin levels particularly among women lower white blood cell neutrophil counts lower amylase genders elevated eosinophil counts immunoglobulin g total direct bilirubin lactate dehydrogenase creatine phosphokinase latter pronounced among women graded usderived daids ae grading criteria observed 774 353 volunteers grade one higher results 314 149 elevated total bilirubin 201 96 low neutrophil counts otherwise healthy volunteers would excluded would require special exemption participate many clinical trials conclusions accelerate clinical trials africa improve scientific validity locally appropriate reference ranges used study provides ranges inform inclusion criteria evaluation adverse events studies regions africa