Community based reference interval of selected clinical chemistry parameters among apparently healthy Adolescents in Mekelle City, Tigrai, Northern Ethiopia.

Getachew Belay,Hagos Haileslasie,Kebede Tesfay,Gebreslassie Gebremariam,Brhane Berhe,Mistire Wolde,Gebreyohanes Teklehaymanot,Ataklti Gebretsadik,Aster Tsegaye,Getachew Kahsu,Kelali Kaleaye,Gebremedhin Gebremichail,Brhane Tesfanchal,Lemlem Legesse,Colin Johnson

doi:10.1371/journal.pone.0231017

Getachew Belay, Hagos Haileslasie + Show 13 more

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https://doi.org/10.1371/journal.pone.0231017

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Abstract

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.

Highlights

Since the day of Grasbeck and Fellman who introduced the concept of ‘Normal Values and Statistics’ and the subsequent launching of a new concept of reference values in 1969 by Grasbeck and Saris, the terminology come in to common practice[1, 2]
When a test is used for disease screening, diagnosis or prognosis, the test result is normally compared with a normal range that is defined as reference value for a healthy population [5]
A total of 45 male and 38 female study participants who had any finding in urine, stool and positive for serological tests were excluded before clinical chemistry tests analysis was performed

Summary

Introduction

Since the day of Grasbeck and Fellman who introduced the concept of ‘Normal Values and Statistics’ and the subsequent launching of a new concept of reference values in 1969 by Grasbeck and Saris, the terminology come in to common practice[1, 2]. From1987 to 1991, the International Federation of Clinical Chemistry (IFCC) published a series of 6 papers, in which it was recommended that each laboratory follow defined procedures to produce its own reference interval[3]. When a test is used for disease screening, diagnosis or prognosis, the test result is normally compared with a normal range that is defined as reference value for a healthy population [5]. International guidelines recommend each clinical laboratory and diagnostic test manufacturers to establish their own RIs belonging to a group of homogenous population. 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

Objectives

Methods

Results