Establishment of biochemistry reference values for healthy Tanzanian infants, children and adolescents in Kilimanjaro Region.

OBJECTIVE: To establish common biochemistry reference intervals for Tanzanian infants, children and adolescents living in the Kilimanjaro Region. METHODS: We recruited healthy, HIV-uninfected Tanzanian infants, children and youth between the ages of 1 month and 17 years from local schools and clinics to participate in this study. Only afebrile children without signs of physical or chronic illness were enrolled. Nonparametric methods were used to determine 95% reference limits and their 90% confidence intervals, with outliers removed by the Tukey method. RESULTS: A total of 619 healthy infants, children and adolescents were enrolled into the study. Twenty-three biochemistry parameters were measured. Compared to US reference intervals, several of the biochemistry parameters showed notable differences, namely alkaline phosphatase, phosphorus, amylase and lipase. Comparing our data to the US National Institutes of Health (NIH) Division of AIDS (DAIDS) grading criteria for classification of adverse events, we found that for selected parameters, up to 15% of infants or children in certain age groups would have been categorised as having an adverse event as defined by DAIDS. CONCLUSIONS: Our study further confirms the need to use locally established reference intervals to define reference laboratory parameters among children in Africa, rather than relying on those derived from US or European populations. To our knowledge, this study provides the first set of locally validated biochemistry reference ranges for a paediatric population in Tanzania.