Validation Of Reference Intervals For Blood Cell Analysis And Common Clinical Biochemistry For Healthy Han Population In Changchun

Objective:Reference intervals of clinical tests are the basic measures for interpreting test results and analyzing experimental information,and it is necessary for health evaluation,diagnosis,treatment and prognosis of diseases.The Ministry of Health published the standard WS/T 405-2012 Reference intervals for blood cell analysis in 2012 and WS/T 404 Reference intervals for common clinical biochemistry from 2012 to 2015.These standards stipulate the reference intervals of clinical tests commonly used for Chinese adults,thus their publication as well as implementation has essential clinical significance.However,blood cell analysis and common clinical biochemistry are usually affected by comprehensive factors such as genetic reasons,environmental factors,nutritional status and living habits.Therefore the guidelines of ISO 15189 issued by International Federation of Standards Institute deem that assessement and validation of reference intervals regularly are required.The purpose of this study is to validate the newly published standards WS/T 405-2012 Reference intervals for blood cell analysis and WS/T 404 Reference intervals for common clinical biochemistry and to determine whether these criteria are applicable to this area.Methods:According to the methods recommended for validating reference intervals in WS/T 402-2012 Setting of Clinical Laboratory Test Reference Interval,20 to 79 years old healthy Han individuals were selected from physical examination center of The First Hospital of Jilin University.Qualification was evalued based on set criteria for results of physical examination,laboratory examination and imaging examination.Sysmex XE-2100 automatic hematology analyzer was used to detect white blood cell count(WBC),neutrophil count(Neut#),lymphocyte count(Lymph#),eosinophil count(Eos#),basophil count(Baso#),monocyte count(Mono#),neutrophil ratio(Neut%),lymphocyte ratio(Lymph%),eosinophil ratio(Eos%),basophil ratio(Baso%),monocyte ratio(Mono%),red blood cell count(RBC),hemoglobin(Hb),hematocrit(Hct),mean corpuscular volume(MCV),mean corpuscular hemoglobin(MCH),mean corpuscular hemoglobin concentration(MCHC)and platelet count(PLT).Serum alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(ALP),gamma-glutamyl transferase(GGT),serum total protein(TP),albumin(ALB),serum urea(UREA),and creatinine(CREA)were measured by Hitachi 7600-210 automatic biochemical analyzer.The data were statistically described and analyzed by EXCEL and SPSS 22.0 statistical software.After rejecting outliers,the data was judged for normal distribution.Z test and one-way analysis of variance(ANOVA)was used to determine whether there are statistically significant differences between different genders and age subgroups.Trend of each item of healthy Han adults from 20 to 79 years old in Changchun was plotted to observe the change with age.Spearman analysis was used to analyze correlation of all parameters with age and gender seperately.The result of each subgroup was compared with standards issued by the Ministry of Health before analyzing individual distribution beyond reference intervals.Results:A total of 537 subjects including 250 males and 287 females who met the criteria were all Han individuals.Numbers of 20~29,30~39,40~49,50~59,60~69,and 70~79 years old for male were 30,59,44,54,31,and 32,respectively;numbers of 20~29,30~39,40~49,50~59,60~69,and 70~79 years old for female were 30,81,79,37,30,and 30,respectively.The ratio of male to female was 1:1.15.WBC of each age subgroup in female and RBC,Hb and Hct of each age subgroup in male showed a gradual downward trend with age.MCV and MCH in male in all age subgroups increased gradually with age.However,the average value in each subgroup was within the recommended reference intervals.Over 90% of 18 blood cell analysis parameters in all 12 subgroups of both genders were within the reference intervals and all passed validation consequently.ALB among different age periods in male showed downward trend.AST in male,ALP and GGT in female showed upward trend with the age.ALT in female,ALT and GGT in male showed upward trend from 20 to 59 years,whereas a downward trend was shown from 60 to 79 years.However,the average values of subgroups were all within the recommended reference intervals.Over 96% of values for 8 common clinical biochemistry tests in all 12 subgroups of both genders were in reference intervals and validated consequently.ALB in male declined gradually with age,while AST in male and ALP in female went up increasingly with age.ALT in female,ALT and GGT in male ascended with age inreasingly among 20 to 59 years old,but descended with age gradually among groups aged beyond 60 to 79 years old,average values in allsubgroups were within the recommended reference intervals.More than 96% of values of 8 routine biochemical tests in 6 subgroups of male and 6 subgroups of female were within the reference intervals and were validated conclusively.Conclution:There are age and gender differences in blood cell analysis and common biochemical tests of healthy Han adults in Changchun.WS/T 405-2012 Reference intervals for blood cell analysis and WS/T 404 Reference intervals for common clinical biochemistry are applicable for healthy Han population in Changchun area.