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Evaluation of locally established reference intervals for hematology and biochemistry parameters in Western Kenya.

ABSTRACT: Important differences have been demonstrated in laboratory parameters from healthy persons in different geographical regions and populations, mostly driven by a combination of genetic, demographic, nutritional, and environmental factors. Despite this, European and North American derived laboratory reference intervals are used in African countries for patient management, clinical trial eligibility, and toxicity determination; which can result in misclassification of healthy persons as having laboratory abnormalities.An observational prospective cohort study known as the Kisumu Incidence Cohort Study (KICoS) was conducted to estimate the incidence of HIV seroconversion and identify determinants of successful recruitment and retention in preparation for an HIV vaccine/prevention trial among young adults and adolescents in western Kenya. Laboratory values generated from the KICoS were compared to published region-specific reference intervals and the 2004 NIH DAIDS toxicity tables used for the trial.About 1106 participants were screened for the KICoS between January 2007 and June 2010. Nine hundred and fifty-three participants aged 16 to 34 years, HIV-seronegative, clinically healthy, and non-pregnant were selected for this analysis. Median and 95% reference intervals were calculated for hematological and biochemistry parameters. When compared with both published region-specific reference values and the 2004 NIH DAIDS toxicity table, it was shown that the use of locally established reference intervals would have resulted in fewer participants classified as having abnormal hematological or biochemistry values compared to US derived reference intervals from DAIDS (10% classified as abnormal by local parameters vs. >40% by US DAIDS). Blood urea nitrogen was most often out of range if US based intervals were used: <10% abnormal by local intervals compared to >83% by US based reference intervals.Differences in reference intervals for hematological and biochemical parameters between western and African populations highlight importance of developing local reference intervals for clinical care and trials in Africa.

SUBMITTER: Odhiambo C

PROVIDER: S-EPMC4395286 | biostudies-other | 2015

REPOSITORIES: biostudies-other

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Project description:BackgroundReference intervals are assessment tools for interpretation of clinical test results. These intervals describe the dispersion of test parameter values of apparently healthy persons in defined populations as health status indicators. Using reference intervals obtained and validated in populations outside the geographical region of derivation for medical decision-making may impact negatively on clinical interpretation and patient management. Many countries have established their reference values, current studies on these data for Nigeria are however scarce. Determination of clinical biochemistry reference intervals for young Nigerian adults which is of particular importance in routine clinical management and conduct of clinical trials in response to existing and emerging diseases will add significantly to the existing body of knowledge.ObjectiveThe objective was to establish reference intervals for 24biochemistry analytes among Nigerians aged 18 to 26 years.MethodsThis was a cross-sectional study among 7,797 consenting male and female military applicants aged 18 to 26 years from 37 States of Nigeria. It was a total study among volunteers for military service. Blood samples were collected and subjected to serological testing for HIV-1 and 2, hepatitis-B, malaria, pregnancy and haematuria to restrict our study population to apparently healthy participants. Biochemical assays were performed on 6,169 participant samples that met the inclusion criteria. Generated data was entered into MS Excel® and exported into SPSS® software version 16 for analysis. Statistical tools used were frequencies, median, mid 95th percentile range with 2.5th and 97.5th percentiles as limits. Reference intervals were estimated using nonparametric methods. No intergender statistical comparison was made.ResultsComplete records were obtained for 6,169 eligible participants. Median values and associated reference intervals were similar in both genders.ConclusionThe findings from this study will help in clinical decision-making and play a significant role in supporting the current global rapid expansion of clinical trials in response to the urgent need for preventive and therapeutic solutions to existing and emerging diseases.

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Evaluation of locally established reference intervals for hematology and biochemistry parameters in Western Kenya.

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