胆红素氧化酶法测定直接胆红素用校准品的选择

Selection of calibrator for direct bilirubin enzymatic assay

目的选择胆红素氧化酶法(酶法)测定直接胆红素时使用的校准品。方法利用直接胆红素(酶法)试剂,分别经罗氏常规生化多项复合校准品、朗道常规生化多项复合校准品和胆红素纯品校准品定标后,检测血清样本中的直接胆红素,并对测定结果进行比对。结果酶法测定用不同校准品定标测定结果无显著性差异,相关系数r均>0. 975,P均<0. 01;相对偏差SE%均<1/2 CLIA’88允许总误差(TEa),均达到临床可接受水平,具有可比性。结论胆红素氧化酶法测定直接胆红素时,既可用胆红素纯品校准品定标,也可选用常规多项生化复合校准品定标。

Objective To select the calibrator for direct bilirubin enzymatic assay.Methods Based on direct bilirubin enzymatic method,calibration was carried out with Roche Clinical Chemistry Multiconstituent Calibrator,Randox Clinical Chemistry Multiconstituent Calibrator and bilirubin pure calibrator,and the results were compared.Results There was no significant difference in the results of direct bilirubin enzymatic assay with different calibrators(each r>0.975,each P<0.01).All the systemic errors(SE%)were less than 1/2 of total error accepted(TEa)in CLIA’88,indicating that the test results were comparable.Conclusion Either pure bilirubin or Clinical Chemistry Multiconstituent Calibrator may be used for direct bilirubin enzymatic assay.