Department of Clinical Chemistry, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
Department of Hematology and Immunohematology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
PLoS One. 2018 Aug 2;13(8):e0201782. doi: 10.1371/journal.pone.0201782. eCollection 2018.
Clinical laboratory reference intervals (RIs) are essential for clinical diagnosis, treatment and therapeutic monitoring. Locally established RIs are required to correctly interpret clinical laboratory results. In Ethiopia, clinical laboratory test results are interpreted based on RIs derived from a western population.
A multicenter cross-sectional study was conducted among blood donors in Amhara National Regional State, Ethiopia from March 2016 to May 2017. A total of 1,175 apparently healthy study participants were included in the study from four blood banks in the region. All clinical chemistry parameters were analyzed using Mindray BS-200E full automated clinical chemistry analyzer. The 95% RIs were estimated using reference limits at 2.5th percentile for the lower reference limit and 97.5th percentile for the upper reference limit. Kolmogorov-Sminorv and Wilcoxon rank-sum tests were used to check data distribution normality and whether partitions were needed between variables, respectively.
RIs established include: ALT 5.13-42.88 U/L for males and 4.3-37 U/L for females; AST 12.13-46.88 for males and 10-43.8 U/L for females; ALP 77.2-475.8 U/L for males and 89-381 U/L for females; amylase 29-309.8 U/L for males and 29-287.9 U/L for females; GGT 7-69.8 U/L for males and 6-39.1 U/L for females; total bilirubin 0.11-1.18 mg/dl for males and 0.08-0.91 mg/dl for females; creatinine 0.48-1.13 mg/dl for males and 0.47-1.09 mg/dl for females; total cholesterol 78.13-211.75 mg/dl for males and 83.6-202.7 mg/dl for females; total protein 5.7-9.7 g/dl for males and 5.6-9.47 for females; triglycerides 36-221.9 mg/dl for males and 35.3-201.5 mg/dl for females; urea 12-43 mg/dl for males and 10-38.7 mg/dl for females; and uric acid 2.7-6.9 mg/dl for males and 2.1-5.9 mg/dl for females.
This study has established RIs for routine clinical chemistry parameters. These RIs are important as they support the interpretation of clinical laboratory results for medical decision making and other health-related activities.
临床实验室参考区间(RIs)对于临床诊断、治疗和治疗监测至关重要。需要建立本地参考区间来正确解读临床实验室结果。在埃塞俄比亚,临床实验室检测结果是基于来自西方人群的 RIs 进行解释的。
本研究为 2016 年 3 月至 2017 年 5 月在埃塞俄比亚阿姆哈拉州进行的一项多中心横断面研究。从该地区的四个血库中纳入了 1175 名看似健康的研究参与者。使用 Mindray BS-200E 全自动临床化学分析仪分析所有临床化学参数。使用 2.5%分位数作为下限参考值和 97.5%分位数作为上限参考值来估计 95%的 RIs。分别使用 Kolmogorov-Sminorv 和 Wilcoxon 秩和检验来检查数据分布正态性以及变量之间是否需要分区。
确定的 RIs 包括:男性 ALT 5.13-42.88 U/L,女性 4.3-37 U/L;AST 男性 12.13-46.88,女性 10-43.8 U/L;男性 ALP 77.2-475.8 U/L,女性 89-381 U/L;男性淀粉酶 29-309.8 U/L,女性 29-287.9 U/L;男性 GGT 7-69.8 U/L,女性 6-39.1 U/L;男性总胆红素 0.11-1.18 mg/dl,女性 0.08-0.91 mg/dl;男性肌酐 0.48-1.13 mg/dl,女性 0.47-1.09 mg/dl;男性总胆固醇 78.13-211.75 mg/dl,女性 83.6-202.7 mg/dl;男性总蛋白 5.7-9.7 g/dl,女性 5.6-9.47;男性甘油三酯 36-221.9 mg/dl,女性 35.3-201.5 mg/dl;男性尿素 12-43 mg/dl,女性 10-38.7 mg/dl;男性尿酸 2.7-6.9 mg/dl,女性 2.1-5.9 mg/dl。
本研究建立了常规临床化学参数的 RIs。这些 RIs 很重要,因为它们支持为医疗决策和其他健康相关活动解读临床实验室结果。