Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4

Sing’oei, Valentine; Ochola, Jew; Owuoth, John; Otieno, June; Rono, Eric; Andagalu, Ben; Otieno, Lucas; Nwoga, Chiaka; Copeland, Nathanial K.; Lawlor, John; Yates, Adam; Imbach, Michelle; Crowell, Trevor A; Eller, Leigh Anne; Kamau, Edwin; Modjarrad, Kayvon; Cowden, Jessica; Ake, Julie A; Robb, Merlin L.; Polyak, Christina S.

doi:10.1371/journal.pone.0249259

Cited by 2 publications

References 49 publications

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Establishing laboratory reference ranges for adults and children in Kilifi, Kenya

Downs,

Orindi,

Hamaluba

et al. 2024

Preprint

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Accurate laboratory reference ranges (RR) are essential for diagnosis and management of patients in routine clinical care and clinical trials. RRs vary between geographical location due to differences in population demographics and blood analysis equipment, so locally derived RRs are essential. Here we establish adult and paediatric RRs for a rural population in Kilifi, Kenya using clinical trial data from KEMRI-Wellcome Trust Research Programme (KWTRP). Data from healthy, non-pregnant participants from six clinical trials conducted between 2016 and 2020 were used. Coulter ACT 5 Diff and Ilab Aries were used for haematological and biochemical analysis respectively. Quality control was undertaken daily prior to sample analysis. Derived RRs were compared with RRs from other African countries and further afield. All analyses were performed using R version 3.6.1 (Reference Intervals package). 2338 adults and 2054 children were included, 52% of adults and 51% of children were male, median adult age was 32.5 years. Haemoglobin range was lower in women compared to men (9.5–14.2g/dL and 11.5–16.6g/dL respectively), platelet upper limit of normal (ULN) was higher in women compared to men (397 x 103/μL vs 358 x 103/ μL). Biochemistry values were higher in men (ALT ULN 57 U/L in men and 35 U/L in women, creatinine ULN 113umol/L in men and 91umol/L in women). Paediatric RRs showed differences in multiple parameters depending on the age of the child. In both adults and children, many parameters in 2023 Kilifi RRs differed from those in other countries. There was however little difference between 2023 and 2017 Kilifi paediatric RRs. This study provides RRs for adults and children in Kilifi, and the most extensive RRs available for much of East and Southern Africa. We show the need for locally derived reference ranges, highlighting differences between sex, age and geographical location.

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Establishing laboratory reference ranges for adults and children in Kilifi, Kenya

Downs,

Orindi,

Hamaluba

et al. 2024

Preprint

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Region-specific laboratory reference intervals are important: A systematic review of the data from Africa

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Mshai

et al. 2022

PLOS Glob Public Health

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Region-specific laboratory reference intervals (RIs) are important for clinical trials and these data are often sparse in priority areas for research, including Africa. We reviewed data on RIs from Africa to identify gaps in the literature with a systematic review of PubMed for RI studies from Africa published ≥2010. Search focus included clinical analytic chemistry, hematology, immunological parameters and RIs. Data from adults, adolescents, children, pregnant women, and the elderly were included. We excluded manuscripts reporting data from persons with conditions that might preclude clinical trial participation in studies enrolling healthy volunteers. Of 179 identified manuscripts, 80 were included in this review, covering 20 countries with the largest number of studies in Ethiopia (n = 23, 29%). Most studies considered healthy, nonpregnant adults (n = 55, 69%). Nine (11%) studies included pregnant women, 13 (16%) included adolescents and 22 (28%) included children. Recruitment, screening, enrollment procedures and definition of age strata varied across studies. The most common type of RIs reported were hematology (66, 83%); 14 studies (18%) included flow cytometry and/or T cell counts. Other common tests or panels included liver function assays (32, 40%), renal function assays (30, 38%), lipid chemistries (17, 21%) and serum electrolytes (17, 21%). The number of parameters characterized ranged from only one (three studies characterized either CD4+ counts, D-dimer, or hemoglobin), to as many as 40. Statistical methods for calculating RIs varied. 56 (70%) studies compared their results to international RI databases. Though most presented their data side-by-side with international data with little accompanying analysis, nearly all reported deviation from comparator RI data, sometimes with half or more of otherwise healthy participants having an “out of range” result. We found there is limited local RI data available in sub-Saharan Africa. Studies to fill this gap are warranted, including efforts to standardize statistical methods to derive RIs, methods to compare with other RIs, and improve representative participant selection.

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Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4

Cited by 2 publications

References 49 publications

Establishing laboratory reference ranges for adults and children in Kilifi, Kenya

Establishing laboratory reference ranges for adults and children in Kilifi, Kenya

Region-specific laboratory reference intervals are important: A systematic review of the data from Africa

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