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

BACKGROUND: 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

Avaliação das espécies de plantas avicennia schaueriana, laguncularia racemosa e rhizophora mangle como bioindicadoras de poluição por metais pesados em ambientes de mangues Assessment of avicennia schaueriana, laguncularia racemosa e rhizophora mangle plant species as bioindicator of heavy metal pollution in mangrove environments

Neste trabalho, investigou-se o nível de contaminação por Cd, Cr, Cu, Pb e Zn, nos ambientes de mangues próximos ao Rio Cubatão, utilizando como bioindicador as espécies de plantas A. schaueriana, L. racemosa e R. mangle. As amostras de folhas destas plantas foram coletadas em quatro pontos de amostragem situados fora da área povoada da cidade de Cubatão. O conteúdo de metais pesados nas folhas foi determinado utilizando a técnica de Espectrometria por Absorção Atômica (FAAS). Os resultados obtidos indicam uma contaminação por cádmio e cromo em diversas amostras analisadas neste trabalho. De uma forma geral, as três espécies de plantas apresentaram resultados muito similares tanto no teor como na ordem em que bioacumulam os metais estudados: Zn > Pb > Cr > Cu > Cd. Desta forma, em princípio, qualquer uma delas poderia ser utilizada como bioindicador de poluição ambiental por metais pesados naquela região.<br>In this work, the contamination level by Cd, Cr, Cu, Pb and Zn in mangrove environments near the Cubatão River has been investigated using as bioindicator the plant species A. schaueriana, L. racemosa and R. mangle. Leave samples of these plants were collected in four locals situated out of the populated area of the Cubatão town. The heavy metals content in the leaves were determined by the Flame Atomic Absorption Spectrometry (FAAS) technique. The results obtained have shown some contamination by cadmium and cromium for several leave samples analysed in this work. In general, the three species of plants presented similar results concerning the content as well as the bioaccumulation order for the studied metals: Zn > Pb > Cr > Cu > Cd. In this way, any one of them could, in principle, be employed as bioindicator of heavy metal environmental pollution in that region