Department of Clinical Laboratory Science, College of Medicine and Health Sciences, Wollo University, Dessie, Ethiopia.
Department of Medical Laboratory Science, College of Health Sciences, Mekelle University, Mekelle, Ethiopia.
PLoS One. 2022 Nov 2;17(11):e0276825. doi: 10.1371/journal.pone.0276825. eCollection 2022.
Clinical chemistry reference intervals are important tools for health evaluation, diagnosis, prognosis and monitoring adverse events. Currently used reference intervals in most African countries including Ethiopia are mainly derived from Western populations, despite studies reporting differences that could lead to incorrect clinical decisions. The aim of this study was to establish reference intervals for commonly used clinical chemistry parameters for healthy adults in Northeast Ethiopia.
A community based cross-sectional study was conducted among 328 apparently healthy adults between the ages of 18 and 57 years. Blood samples were collected for clinical chemistry analysis using Dirui CS-T240 auto-analyzer and serological testing to screen the population. Medians and 95% reference intervals were computed using non-parametric method according to the Clinical and Laboratory Standards Institute guideline. The Mann-Whitney U test was used to compare reference values between males and females.
Reference intervals established were: ALT 11.2-48.0 U/L, AST 16-60 U/L, ALP 53-342.3 U/L, total protein 5.4-8.9 mg/dL, total bilirubin 0.1-1.23 mg/dL, glucose 65-125 mg/dL, total cholesterol 69-213 mg/dL, triglycerides 46-207 mg/dL, creatinine 0.3-1.2 mg/dL and urea 9.5-46.3 mg/dL. Significant sex-differences were observed for ALT, AST, ALP, total cholesterol, triglycerides, creatinine and urea. We found that the established reference intervals substantially differ from the reference ranges currently in use. Up to 43.1% of apparently healthy adults are considered as having abnormal test values on the bases of the currently in use reference ranges. If the reference values from the United States based intervals were applied to the study population, 81.8% would have been classified as having abnormal laboratory test results.
Local population-specific reference intervals were established for commonly used clinical chemistry parameters in adult population of Northeast Ethiopia. Although further study is needed, these reference intervals may have the potential to facility the decision-making process based on laboratory test results in this population.
临床化学参考区间是健康评估、诊断、预后和监测不良事件的重要工具。目前,包括埃塞俄比亚在内的大多数非洲国家使用的参考区间主要来自西方人群,尽管有研究报告称存在差异,可能导致临床决策错误。本研究旨在为东北埃塞俄比亚的健康成年人建立常用临床化学参数的参考区间。
采用社区为基础的横断面研究,在 18-57 岁的 328 名看似健康的成年人中进行。使用迪瑞 CS-T240 自动分析仪采集血样进行临床化学分析,并进行血清学检测以筛查人群。中位数和 95%参考区间根据临床和实验室标准协会指南使用非参数方法计算。采用 Mann-Whitney U 检验比较男性和女性的参考值。
建立的参考区间为:ALT 11.2-48.0 U/L、AST 16-60 U/L、ALP 53-342.3 U/L、总蛋白 5.4-8.9 mg/dL、总胆红素 0.1-1.23 mg/dL、血糖 65-125 mg/dL、总胆固醇 69-213 mg/dL、甘油三酯 46-207 mg/dL、肌酐 0.3-1.2 mg/dL 和尿素 9.5-46.3 mg/dL。ALT、AST、ALP、总胆固醇、甘油三酯、肌酐和尿素存在显著的性别差异。我们发现,所建立的参考区间与当前使用的参考范围有很大差异。根据目前使用的参考范围,多达 43.1%的看似健康成年人被认为存在异常检测值。如果将基于美国的参考区间的参考值应用于研究人群,81.8%的人将被归类为实验室检测结果异常。
为东北埃塞俄比亚成年人建立了常用临床化学参数的本地人群特异性参考区间。尽管还需要进一步研究,但这些参考区间可能有潜力在该人群中基于实验室检测结果做出决策。