Establishment of haematological and immunological reference values for healthy Tanzanian children in Kilimanjaro Region.

OBJECTIVE: To determine the normal haematological and immunological reference intervals for healthy Tanzanian children. METHODS: We analysed data from 655 HIV-seronegative, healthy children from 1 month to 18 years of age from the Kilimanjaro Region of Tanzania for this cross-sectional study. Median and 95% reference ranges were determined for haematological and immunological parameters and analysed by age cohorts, and by gender for adolescents. RESULTS: Median haemoglobin (Hb) and haematocrit (Hct) for all age groups were higher than established East African reference intervals. Compared to U.S. intervals, reference ranges encompassed lower values for Hb, Hct, mean corpuscular volume, and platelets. Applying the U.S. National Institute of Health Division of AIDS (DAIDS) adverse event grading criteria commonly used in clinical trials to the reference range participants, 128 (21%) of 619 children would be classified as having an adverse event related to Hb level. CD4-positive T-lymphocyte absolute counts declined significantly with increasing age (P < 0.0001). For those aged under five years, CD4-positive T-lymphocyte percentages are lower than established developed country medians. CONCLUSIONS: Country-specific reference ranges are needed for defining normal laboratory parameters among children in Africa. Knowledge of appropriate reference intervals is critical not only for providing optimal clinical care, but also for enrolling children in medical research. Knowledge of normal CD4-positive T-lymphocyte parameters in this population is especially important for guiding the practice of HIV medicine in Tanzania.

Prevalence of Sickle Cell Disease Among Anaemic Children Attending Mbeya Referral Hospital in Southern Tanzania.

BACKGROUND: Sickle cell disease (SCD) is a common genetic haematological disorder present in most countries in sub-Saharan Africa. In Tanzania, between 50% and 75% of the children born with SCD die before reaching the age of 5 years. The objective of this study was to determine the prevalence of SCD in children under 5 years of age attending Mbeya Referral Hospital between March and April 2014. METHODS: We conducted a hospital-based, cross-sectional, descriptive study in which 50 children under 5 were included at Mbeya Referral Hospital in southern Tanzania. Full blood counts were conducted using SYSMEX KX 21 and SYSMEX XT 2000i haematology analysers. The presence of haemoglobin S was determined using the sodium metabisulfite sickling test on blood samples with haemoglobin levels less than 10 g/dl. RESULTS: Blood samples from 50 infants and children under 5 were tested for sickle cell anaemia. Of these, 9 (18%) participants were found to be sickling test positive, 5 (55.6%) of whom were male and 4 (44.4%) were female. Almost half (n=4, 44.4%) of the SCD-positive children were between 25 and 36 months old, while the rest were between 13 and 24 months (n=2, 22.2%), 37 and 48 months (n=1, 11.1%), and 49 and 60 months (n=2, 22.2%) of age. CONCLUSION: At our facility, among children under 5 with serum haemoglobin levels <10 g/dl, the prevalence of SCD was 18%. This might pose a substantial public health challenge in the region. More and larger studies are needed to help map out the sickle cell burden throughout the country to guide policy and management strategies.

Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings: A Health Program Evaluation Framework Case Study From East Africa.

OBJECTIVES: Using a clinical research laboratory as a case study, we sought to characterize barriers to maintaining Good Clinical Laboratory Practice (GCLP) services in a developing world setting. METHODS: Using a US Centers for Disease Control and Prevention framework for program evaluation in public health, we performed an evaluation of the Kilimanjaro Christian Medical Centre-Duke University Health Collaboration clinical research laboratory sections of the Kilimanjaro Clinical Research Institute in Moshi, Tanzania. Laboratory records from November 2012 through October 2014 were reviewed for this analysis. RESULTS: During the 2-year period of study, seven instrument malfunctions suspended testing required for open clinical trials. A median (range) of 9 (1-55) days elapsed between instrument malfunction and biomedical engineer service. Sixteen (76.1%) of 21 suppliers of reagents, controls, and consumables were based outside Tanzania. Test throughput among laboratory sections used a median (range) of 0.6% (0.2%-2.7%) of instrument capacity. Five (55.6%) of nine laboratory technologists left their posts over 2 years. CONCLUSIONS: These findings demonstrate that GCLP laboratory service provision in this setting is hampered by delays in biomedical engineer support, delays and extra costs in commodity procurement, low testing throughput, and high personnel turnover.