Applicability Evaluation Of Reference Intervals For Ten Common Biochemical Analytes In Ningxia

Objective The purpose of this subject is to understand the current status of the use of reference intervals of the common biochemical analytes in Ningxia,explore the feasibility of establishing common reference intervals in this region and evaluate the applicability of the current reference intervals,provide a theoretical basis for mutual recognition of laboratory test results.Methods 1.A questionnaire was designed to assess the detection methods,measurement systems,the rage and Sources of reference intervals of the ten common biochemical analytes(including ALT,AST,TP,ALB,UREA,CREA,UA,GLU,TC,and TG)in Ningxia,and other aspects.2.Refer to the indirect method for establishing the reference interval,the physical examination population in October1,2015 to December 31,2016 from Shizuishan first Hospital,Shizuishan Second Hospital,General Hospital of Ningxia Medical University,People’s Hospital of Lingwu,Guyuan and Jingyuan were randomly selected as the subjects of the study.Collect the relevant test results including the ten common biochemical tests,inspection results and other physical examination information in this study.The exclusion and inclusion criteria for this study to identify the reference population was developed according to Approved Guideline-Third Edition of Clinical and Laboratory Standards Institute(CLSI C28-A3)and Standard of Healthcare industry of 《Define and determine the reference intervals for common clinical biochemistry tests》(WS/T404.1-2012)of China who use direct method to establish reference intervals.3.Establish the reference intervals of this region based on the data obtained.4.Compare the new and current reference intervals to evaluate their applicability,and compare the differences between this study and other multi-center studies.Results 1.The detection methods used by ten common biochemical analytes in each laboratory of Ningxia are basically the same,and most of the measurement systems are open systems.The sources of reference intervals are wide,most of them are manuals of reagent and instrument manufactureers.2.Some analytes have significant regional differences(SDR-region > 0.3)such as ALT,AST,CREA and GLU,and ALT,AST,UREA,CREA and UA were observed for Significant gender differences(SDR-sex>0.3).3.We established common reference intervals for TP,ALB,UREA,UA,TC and TG.4.There are certain differences between the new and current reference intervals and other multi-center research results of ALT,AST,UREA,CREA,UA,GLU,TC and TG in some regions.Conclusion 1.The inconsistency of the reference intervals in Ningxia increases the difficulty of mutual recognition of test results.2.It is feasible for Some analytes such as TP,ALB,UREA,UA,TC,and TG in Ningxia to establish common reference intervals,but verification is needed in further research.The other four tests need to be grouped to establish reference intervals due to geographical difference.3.The current reference intervals of ALT,AST,UREA,CREA,UA,GLU,TC and TG are inconsistent in some regions.Therefore,we need to verify the current reference interval by the recommended method of Standard of Healthcare industry established by Original Ministry of Health in China or other organizations.