Using the External Quality Assessment Return Target Value Obtained from Clinical Biochemical Analyzer to Evaluate the Accuracy After the Regression Calibration of Dry-type Biochemical Analyzer / 现代检验医学杂志

ABSTRACT

Objective Using Hitachi 7170 external quality assessment return target value to evaluate the accuracy of 10 items after Regression calibration of the Vistros 350 dry-type Biochemical Analyzer.Methods The same quality control samples were separately tested on two instruments,and results were reported to the clinical National Center for Clinical Laborato-ries.Substituted the external quality assessment return target value result from the National Center for Clinical Laboratories by using Vitros350 into regression calibration equation,then the getting data were compared with the external quality assess-ment return target value obtained from Hitachi 7170,and the deviation analysis was processed.The total error range from the America Clinical Laboratory Amended Bill was used as the standard.For the results within the reference range,error less than 1/2CLIA’88 total error,taken as the comparable judging standard,as it satisfied the requirement.For the results out off the reference range,error less than CLIA’88 total error,those still satisfied the requirement.For those items not meet the requirements,it must to do the regression calibration for Vitros350,using Hitachi 7170 as the standard instrument.Results The deviations of 7 items were all less than 1/2CLIA’88 allowed total error,with LDH was 0.16~-9.89,CK 2.92~6.25, ALT -4.64~-8.07,TBIL 0.08~2.67,TP -0.37~4.41,ALB 2.74~4.77 and URIC 1.04~3.0 respectively,and did not need re-calibration.For GLU and CREA,only one out of the reference range sample,the error range was >1/2CLIA’ 88,but regulation,did not need calibration either.However,the range of variation of BUN was -23.7~-29.6,and was more than CLIA’88 allowable er-ror.It must do the correlation and regression calibration again to ensure the accuracy of instrument.Conclusion Using the external quality assessment return target value of the National Center for Clinical Laboratories from clinical biochemical ana-lyzer to evaluate the accuracy of Vitros 350 after regression calibration is economic and applicable.