| Background:The reference interval(RI)of laboratory test is an important tool for clinical evaluation and decision-making.It is also an essential part of the quality management system of medical laboratory.The National Health Commission of the People’s Republic of China has published several industry standards which provide RIs for common laboratory tests in adults and children,while data about newborns is not available.Newborns are in the early stage of growth and development,whose physiological status and disease spectrum are significantly different from those of children and adults.Therefore,it is difficult to accurately interpret neonatal test results based on the RIs established in adults or children.Blood cell analysis and biochemistry tests are most commonly used in disease diagnosis and health assessment.They are widely used in organ function evaluation,disease diagnosis and differential diagnosis,disease progression monitoring and prognosis judgment.This study aimed to establish local RIs for blood cell analysis and common biochemistry tests in term neonates,so as to provide accurate laboratory evidence for the diagnosis and treatment of neonatal diseases.Methods:A total of 195 healthy Han term infants aged 0～3 days were recruited from the First Hospital of Jilin University as reference population.The newborns’ state of health were assessed by questionnaires,maternal medical records review and neonatal assessment.Blood cell analysis was performed by SYSMEX XE-2100 automatic blood analyzer,and analytes of 26 common biochemistries were determined by the VITROS 5600 Integrated System.The reference population was divided into subgroups according to the delivery mode,sex and day-age.The 3-level nested ANOVA and LMS method were performed together to assess the need for partitioning RI of each analyte.And RIs were derived by a nonparametric method or robust method.Multiple regression analysis was used to evaluate specific correlations between the analytes and individual characteristics including delivery mode,sex,day-age,birthweight and gestational age.Results:1)One hundred and ninety-five reference individuals(104 boys and 91 girls)fulfilled the inclusion criteria,and the proportion of different delivery mode or sex subgroups did not show significant differences among the day-age groups.2)For term infants aged 0～3 days,there was no significant difference in hematological parameters among delivery mode,sex and day-age subgroups,and then a common RI was established for each parameter.The WBC,NE,LY,MO and EO count showed a slight upward trend during the first day after birth,and other indicators changed little.Hematological parameters had no correlation with delivery mode,sex,age,birthweight and gestational age.3)For term infants aged 0～3 days,there was no sex difference in the 26 biochemical analytes.There were slight between-delivery-mode differences in K,P and BUN.There were significant between-day-age differences in Fe,BUN,Cr,UA,TCHO and TG,and the RIs for them should be established according to day-age.Serum concentrations of P,TIBC,ALT and ALP were correlated with birth weight,and the concentrations of ALT,CK and TP were correlated with gestational age.Conclusions:1)Within the 3 days after birth,the serum concentrations of Fe,TCHO and TG increased significantly in full-term neonates,while the concentrations of BUN,Cr and UA decreased.There was little change or no change in hematological parameters and other biochemical analytes.2)Many physiological factors influenced neonatal blood cell analysis and biochemistry tests.Day-age was the major related factor in the concentrations of some biochemical analytes.None of the tests was related to sex.The concentrations of some biochemical analytes were weakly correlated with the delivery mode,gestational age and birth weight.3)This study established RIs for blood cell analysis and common biochemistry tests in term newborns aged 0～3 days,which are different from those of adults or other neonatal studies. |
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