Establishment of normal reference range for alkaline phosphatase in children in a certain region

Zhou Xinbo; Xiao Huaxiang; Li Yanwei; Li Jia; Liang Weiling

doi:10.3969/j.issn.1674-7151.2025.03.012

Abstract：Objective To establish a normal reference range for alkaline phosphatase(ALP)applicable to children in Cenxi area,Guangxi Zhuang Autonomous Region based on the evaluation system of standard reference interval.Methods The clinical data of 6 083 apparently healthy children(0-14 years old)who underwent physical examinations at Cenxi Maternal and Child Health Hospital from January 1,2021 to December 30,2023 were collected.The participants were categorized into the following age groups:<1 month group(283 cases),1-12 months group(284 cases),1-3 years old group(4 457 cases),4-6 years old group(715 cases),7-12 years old group(157 cases)and 13-14 years old group(187 cases).The serum level of ALP was measured using standardized colorimetric method,the reference interval[M(P2.5,P97.5)]for each group was calculated using non parametric method,and the 90%confidence interval(90%CI)was estimated.The distribution characteristics of serum ALP in children of different age groups were analyzed,differential analysis was performed on the ALP levels of adjacent groups and the grouping and reference interval were re-established.The detection range of 6 083 children and the established normal reference range were compared,and the conformity rate was calculated.Results The reference ranges for ALP in<1 month group,1-12 months group,1-3 years old group,4-6 years old group,7-12 years old group and 13-14 years old group were 172.00(99.60,400.70)U/L,310.00(175.13,550.25)U/L,220.00(142.00,357.00)U/L,213.00(137.00,329.90)U/L,214.00(119.40,418.20)U/L and 178.00(69.70,414.20)U/L,respectively.The serum ALP distribution data of 6 083 healthy children showed a non normal distribution,with the median ALP level being the highest in children aged 1-12 months.The differences in ALP levels between adjacent age groups were compard,the final grouping was determined as<1 month group,1-12 months group,1-3 years old group,4-6 years old group,7-12 years old group and 13-14 years old group.The detection value range was compared with the established normal reference value range,and the conformity rates were≥90%.Conclusions The established normal reference range is applicable to healthy children aged 0-14 years old in Cenxi area.The establishment of the normal reference range for ALP in children helps to solve the lack of normal reference range for routine biochemical indicators in clinical laboratories,providing reference for pediatricians in clinical disease diagnosis,efficacy observation,prognosis judgment and health assessment,and protecting children's physical health.