Unit of Clinical Chemistry, Department of Medical Laboratory Sciences, College of Medicine and Health Sciences, Adigrat University, Adigrat, Ethiopia.
Unit of Hematology and Immuno-Hematology, Department of Medical Laboratory Sciences, College of Medicine and Health Sciences, Mekelle University, Mekelle, Ethiopia.
PLoS One. 2020 Apr 7;15(4):e0231017. doi: 10.1371/journal.pone.0231017. eCollection 2020.
Locally established clinical laboratory reference intervals (RIs) are required to interpret laboratory test results for screening, diagnosis and prognosis. The objective of this study was establishing reference interval of clinical chemistry parameters among apparently healthy adolescents aged between 12 and 17 years in Mekelle, Tigrai, northern part of Ethiopia.
Community based cross sectional study was employed from December 2018 to March 2019 in Mekelle city among 172 males and 172 females based on Multi stage sampling technique. Blood samples were tested for Fasting blood sugar (FBS), alanine aminino transferase (ALT), aspartate amino transferase (AST), alkaline phosphatase (ALP), Creatinine, urea, total protein, albumin (ALB), direct and indirect bilirubin (BIL.D and BIL.T) using 25 Bio system clinical chemistry analyzer. Results were analyzed using SPSS version 23 software and based on the Clinical Laboratory Standard Institute (CLSI)/ International Federation of Clinical Chemistry (IFCC) C 28-A3 Guideline which defines the reference interval as the 95% central range of 2.5th and 97.5th percentiles. Mann Whitney U test, descriptive statistics and box and whisker were statistical tools used for analysis.
This study observed statistically significant differences between males and females in ALP, ALT, AST, Urea and Creatinine Reference intervals. The established reference intervals for males and females, respectively, were: ALP (U/L) 79.48-492.12 versus 63.56-253.34, ALT (U/L) 4.54-23.69 versus 5.1-20.03, AST 15.7-39.1 versus 13.3-28.5, Urea (mg/dL) 9.33-24.99 versus 7.43-23.11, and Creatinine (mg/dL) 0.393-0.957 versus 0.301-0.846. The combined RIs for Total Protein (g/dL) was 6.08-7.85, ALB (g/dL) 4.42-5.46, FBS(mg/dL) 65-110, BIL.D (mg/dL) 0.033-0.532, and BIL.T (mg/dL) 0.106-0.812.
The result showed marked difference among sex and with the company derived values for selected clinical chemistry parameters. Thus, use of age and sex specific locally established reference intervals for clinical chemistry parameters is recommended.
为了进行筛查、诊断和预后,需要建立当地的临床实验室参考区间(RI)来解释实验室检测结果。本研究的目的是在埃塞俄比亚北部提格雷地区的梅克莱市,建立 12 至 17 岁青少年的临床化学参数参考区间。
2018 年 12 月至 2019 年 3 月,采用多阶段抽样技术,在梅克莱市进行了一项基于社区的横断面研究,共纳入 172 名男性和 172 名女性。使用 25 台 Bio 系统临床化学分析仪检测空腹血糖(FBS)、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)、肌酐、尿素、总蛋白、白蛋白(ALB)、直接和间接胆红素(BIL.D 和 BIL.T)。结果采用 SPSS 版本 23 软件进行分析,并根据临床实验室标准协会(CLSI)/国际临床化学联合会(IFCC)C28-A3 指南进行定义,该指南将参考区间定义为第 2.5 和第 97.5 百分位的 95%中央范围。采用曼-惠特尼 U 检验、描述性统计和箱线图进行分析。
本研究观察到男性和女性在 ALP、ALT、AST、尿素和肌酐参考区间方面存在统计学显著差异。男性和女性分别建立的参考区间为:ALP(U/L)79.48-492.12 与 63.56-253.34、ALT(U/L)4.54-23.69 与 5.1-20.03、AST 15.7-39.1 与 13.3-28.5、尿素(mg/dL)9.33-24.99 与 7.43-23.11,以及肌酐(mg/dL)0.393-0.957 与 0.301-0.846。总蛋白(g/dL)的合并参考区间为 6.08-7.85、白蛋白(g/dL)4.42-5.46、空腹血糖(mg/dL)65-110、直接胆红素(mg/dL)0.033-0.532,以及间接胆红素(mg/dL)0.106-0.812。
结果表明,性别之间存在显著差异,并且与所选临床化学参数的公司得出的值存在差异。因此,建议使用年龄和性别特异性的当地建立的临床化学参数参考区间。