Study On The Resultes Consistency Between Biochemistry Analytical Systems In Clinical Laboratory

OBJECTIVE:To meet the requirement of comparability and consistency of testing results among different testing systems in clinical laboratories,the performance of three biochemical testing systems in clinical laboratories of our hospital was validated,and the consistency of testing results among them was evaluated;in order to explore the establishment of clinical laboratories with different testing systems for instrumentality in secondary general hospitals.The evaluation scheme of reagent performance and comparability among different detection systems were discussed.The essential measures will be taken when the test results are not comparable,meanwhile,the consistency of test results is not achieved by discussing.Methods:1.The precision,accuracy and maximum detection limit of the three detection systems were confirmed under the guidance about the EP series documents of CLSI and the recommended scheme of WST420-2013."Validation of the analytical performance of commercial quantitative kits in clinical laboratories".2.Referring to the requirements of EP9-A2 document,taking Hitachi 7600 as the reference method,Merry Biochemical BS2000 and Johnson Vitros 350（dry chemistry）as the evaluation method,linear regression analysis of the same project results and calculation of the deviation between methods at the level of medical decision were carried out.The standard was 1/2 of the allowable error range of external quality assessment stipulated in CLIA88.Clinical acceptability of severed bias.3.For projects with large deviation,different normal reference intervals are established.Results:1.The performance validation of three biochemical analyzers conformed to the industry standard;the intra-batch precision of 20 evaluation items of Hitachi 7600automatic biochemical analyzer and 20 evaluation items of Mindray BS2000automatic biochemical analyzer and 10 evaluation items of Vitros 350（dry chemistry）biochemical analyzer were less than 1/4 of the maximum allowable error of each index,and the inter-day precision was less than that of each index.The large approved error is 1/3 and the accuracy is not more than 1/2 of the maximum allowable error,which can meet the needs of clinical application.2.Hitachi 7600system is superior to the other two detection systems in the light of instrument precision and sampling accuracy,and the precision of most detection items is also superior to the other two detection systems,so it is listed as a reference system.The other two systems are used as the evaluation system for comparative experiments.3.The comparative experimental results showed that the Ca²⁺correlation coefficient r²between Mindray BS2000 and Hitachi 7600 was less than 0.95,and there were two other items:bias between ALP and Phos methods exceeded the allowable error range;10 items of the same items between Hitachi 7600 and Vitros 350（dry chemistry）,one of which was CK-MB correlation coefficient r²<0.95,and three AST,Crea and Ca methods exceeded the allowable error rangeConclusion:1.At present,most hospitals in China have two or more detection systems.This study finds that there is a great risk of consistency among different detection systems for the same test item.The laboratory department should establish a regular consistency comparison plan to eliminate the results deviation among different detection systems in time.When the deviation can not be eliminated,the application scope of different detection systems should be clearly specified,such as Vitros 350（dry chemistry）detection system only applied to outpatient or emergency patients,and clearly identified in the laboratory sheet,prompting clinicians to pay attention.2.By evaluating the main performance indicators of Mindray BS2000 automatic biochemical analyzer:precision,accuracy,linear range of measurement and other performance indicators can well meet the needs of clinical application.3.The matching use of different reagents and instruments will cause the issue of whether the traceability chain of quantities is complete.When selecting reagents,attention should be paid to the matching of using the calibration products,reagents and instruments to ensure the accuracy of the test results.