Study On The Reference Range Of Common Clinical Test Items For Healthy Newborns In Qingdao Urban Area

Objective: To establish the reference range of common clinical test items for healthy newborns in Qingdao urban area。Methods: This study recruited healthy full-term newborns as reference population in Qingdao Women’s and Children’s Hospital affiliated to Qingdao University and Qingdao Hospital of Peking University People’s Hospital(Chengyang District of Qingdao Women’s and Children’s Hospital),According to the industry standards of WS/T402-2012 Formulation of Reference Interval for Clinical Laboratory Test Items and the American Clinical and Laboratory Standards Institute(CLSI)C28-A3 Guidelines for the Definition,Establishment and Validation of Reference Interval for Clinical Laboratory,a comprehensive evaluation was conducted through questionnaires,physical examination and laboratory testing,and a total of 1824 healthy newborns were recruited as reference individuals.Total protein(TP),albumin(Alb),alanine aminotransferase(ALT),aspartate aminotransferase(AST),glutamyltransferase(GGT),alkaline phosphatase(ALP),creatinine(Crea),urea(Urea),calcium ionomer(Ca)and phosphorus(IP)were detected by automatic biochemical analyzer.The reference population was grouped according to age and sex.The test results were statistically processed by non～parametric method and the reference interval was calculated.Results: A total of 1824 healthy newborn reference individuals were included in this study(962 males and 862 females,the ratio of male to female was 1.2:1).There was no statistical difference in the 10 commonly used clinical biochemical test items of healthy newborn by sex;There were statistical differences in AST,ALP,Crea,Urea and Ca by age,but there were no statistical differences in ALT,GGT,TP,Alb and IP by age.The reference intervals of clinical common biochemical test items of healthy newborns in Qingdao are: the reference interval of AST1～7 day old group is 20～96 U/L,and the reference interval of 8 ～ 28 day old group is 16 ～ 69 U/L;The reference interval of ALP1～7 day old group is 88～279 U/L,the reference interval of 8～14 day old group is105～348 U/L,and the reference interval of 15～28 day old group is 159～390 U/L;The reference range of Crea1～7 day old group is 22～77 μmol/L,the reference interval of8～14 days old group is 20～47 μmol/L,the reference range of 15～28 days old group is17～46 μmol/L;The reference interval of Urea 1～7 day old group is 0.9～7.8 mmol/L,and the reference interval of 8～28 day old group is 1.0～6.1 mmol/L;The reference interval of Ca 1～7 day old group is 1.98～2.61 mmol/L,and the reference interval of8～28 day old group is 2.22～2.27 mmol/L;The reference range of ALT is 4～21 U/L;The reference range of GGT is 5～330 U/L;The reference range of TP is 42～62 g/L;The reference range of Alb is 30 ～ 41 g/L;The reference range of IP is 1.52 ～ 2.79mmol/L.In general,the serum concentrations of ALT,GGT and IP in newborns fluctuated in a relatively narrow range from the 1st to the 28 th day after birth,which was relatively stable.The serum concentration of ALP decreased slowly from 1～7 days after birth and increased slowly from 8～28 days after birth.Urea serum concentration decreased slowly from 1～7 days after birth and remained relatively stable from 8～28 days.The serum concentrations of TP and Alb decreased slowly from 1～7 days after birth,and remained relatively stable from 8～28 days.The serum concentration of Crea decreased at a faster rate from day 1 to day 7 after birth,and continued to decline at a slow rate from day 8 to day 28.The AST serum concentration decreased slowly from 1～7 days after birth and remained relatively stable from 8～ 28 days.The serum concentration of Ca increased slowly from 1～7 days after birth and remained relatively stable from 8～28 days.Conclusion:(1)There is no gender difference in the reference range of clinical common test items(including ALB,TP,ALT,AST,GGT,ALP,Crea,Urea,Ca,IP)of healthy newborns in Qingdao,and some test items have age differences.(2)There is a difference between the reference range of clinical commonly used test items of healthy newborns in Qingdao and the reference range of children published by the National Health Commission in 2021.(3)The reference range of clinical commonly used test items for healthy newborns in Qingdao urban area established in this study has been verified in other 3 hospitals(Class A)in the region,and can be applied to most laboratories in Qingdao urban area.