Reference values for clinical laboratory parameters in young adults in Maputo, Mozambique.
BACKGROUND
Clinical laboratory reference values from North American and European populations are currently used in most Africans countries due to the absence of locally derived reference ranges, despite previous studies reporting significant differences between populations. Our aim was to define reference ranges for both genders in 18 to 24 year-old Mozambicans in preparation for clinical vaccine trials.


METHODS
A cross-sectional study including 257 volunteers (102 males and 155 females) between 18 and 24 years was performedat a youth clinic in Maputo, Mozambique. All volunteers were clinically healthy and human immunodeficiency virus, Hepatitis B virus and syphilis negative.Median and 95% reference ranges were calculated for immunological, hematological and chemistry parameters. Ranges were compared with those reported based on populations in other African countries and the US. The impact of applying US NIH Division of AIDS (DAIDS) toxicity tables was assessed.


RESULTS
The immunology ranges were comparable to those reported for the US and western Kenya.There were significant gender differences in CD4+ T cell values 713 cells/µL in males versus 824 cells/µL in females (p<0.0001). Hematologic values differed from the US values but were similar to reports of populations in western Kenya and Uganda. The lower and upper limits of the ranges for hemoglobin, hematocrit, red blood cells, white blood cells and lymphocytes were somewhat lower than those from these African countries. The chemistry values were comparable to US values, with few exceptions. The upper limits for ALT, AST, bilirubin, cholesterol and triglycerides were higher than those from the US. DAIDStables for adverse events predicted 297 adverse events and 159 (62%) of the volunteers would have been excluded.


CONCLUSIONS
This study is the first to determine normal laboratory parameters in Mozambique. Our results underscore the necessity of establishing region-specific clinical reference ranges for proper patient management and safe conduct of clinical trials.
Instituto Nacional de Saúde, Maputo, Mozambique; Department of Laboratory Medicine, Karolinska Institutet, Huddinge, Sweden; Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique.
Nelson
N
Tembe
Instituto Nacional de Saúde, Maputo, Mozambique.
Orvalho
O
Joaquim
Instituto Nacional de Saúde, Maputo, Mozambique.
Eunice
E
Alfai
Instituto Nacional de Saúde, Maputo, Mozambique.
Nádia
N
Sitoe
Instituto Nacional de Saúde, Maputo, Mozambique; Department of Laboratory Medicine, Karolinska Institutet, Huddinge, Sweden; Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique.
Edna
E
Viegas
Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique; Hospital Central de Maputo, Maputo, Mozambique.
Eulalia
E
Macovela
Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique; Hospital Central de Maputo, Maputo, Mozambique.
Emilia
E
Gonçalves
Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique; Hospital Central de Maputo, Maputo, Mozambique.
Nafissa
N
Osman
Örebro University Hospital, Örebro, Sweden.
Sören
S
Andersson
Instituto Nacional de Saúde, Maputo, Mozambique.
Ilesh
I
Jani
Department of Laboratory Medicine, Karolinska Institutet, Huddinge, Sweden; Public Health Agency of Sweden, Solna, Sweden; Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.
Charlotta
C
Nilsson
D000293:Adolescent; D000328:Adult; D015496:CD4-Positive T-Lymphocytes / Q000737:chemistry; D064790:Clinical Laboratory Services; D003430:Cross-Sectional Studies; D004906:Erythrocyte Count / Q000379:methods; D004912:Erythrocytes / Q000737:chemistry; D005260:Female; D006400:Hematocrit / Q000379:methods; D006403:Hematologic Tests / Q000379:methods; D006405:Hematology / Q000379:methods; D006454:Hemoglobins / Q000737:chemistry; D006801:Humans; D007958:Leukocyte Count / Q000379:methods; D007962:Leukocytes / Q000737:chemistry; D008297:Male; D009073:Mozambique; D012016:Reference Values; D055815:Young Adult
D006454:Hemoglobins