用临床生化分析仪的室间质评回报靶值结果评价干式生化分析仪回归校准后的准确度

目的：用日立7170生化分析仪的室间质评回报靶值结果来评价Vitros350干式生化分析仪回归校准后的10个项目的准确度。方法用相同质控品分别在两台仪器上测试后上报卫生部临床检验中心，将 Vitros350卫生部室间质评回报结果代入回归校准方程后所得的数据与日立7170室间质评回报靶值结果进行偏差分析，以美国临床实验室修正法案（CLIA’88）规定的总误差范围为标准，在参考区间内，偏差＜1／2CLIA’88允许总误差，作为可比性的判断标准，即符合要求，在参考区间外，偏差＜CLIA’88允许总误差，作为可行性的判断标准，也符合要求，仪器也无需校准。如不符合要求的项目，则必须以日立7170为标准仪器，重新做 Vitros350的回归校准工作。结果7个项目的偏差均＜1／2CLIA’88允许总误差的要求，偏差（％）范围分别为 LDH 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，URIC 1.04～3.0，不需要重新校准。而 GLU和CREA只有1份在参考区间外的标本的偏差＞1／2 CLIA’88允许总误差，而＜CLIA’88允许总误差的要求，其余标本的偏差范围均＜1／2 CLIA’88允许总误差，偏差（％）范围分别为 GLU －0.99～5.41，CREA－2.0～9.6，按规定，也无需校准，而BUN所求的偏差（％）范围为－23.7～－29.6，＞CLIA’88允许总误差，则必须重新做回归校准工作，以保证仪器的准确度。结论用临床生化分析仪的卫生部室间质评回报靶值结果来评价 Vitros350回归校准后的准确度是可行的，是经济的、适用的。

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

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 ＆lt;CLIA’88 allowable total error.The error range of all other samples were all 〈1/2CLIA’88 allowable total error. The range of variation of GLU was -0.99～5.41 and CREA was -2.0～9.6,and based on some 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 t