Doumas参考方法对总胆红素常规检测系统的正确度评价

Tureness evaluation of routine measurement system for serum total bilirubin based on Doumas reference method

目的采用Doumas参考方法评价胆红素化学氧化法和重氮法检测血清总胆红素含量的正确度。方法采用Doumas参考方法测定IFCC-RELA样本及20份新鲜单人份血清样本中总胆红素;采用化学氧化法和重氮法在自动生化分析仪上测定20份新鲜血清及A、B校准品中的总胆红素,按EP9-A3文件对2种常规检测系统进行正确度评价;根据EP14-A2文件对A、B校准品进行互换性评价。结果重氮法和化学氧化法与Doumas方法正确度性能不一致。A校准品具有互换性,B校准品互换性不佳。结论 Doumas方法能准确测定血清样本中的总胆红素含量。为保证临床样本检测的准确性,有必要采用参考方法对常规方法进行正确度评价。

Objective To evaluate the tureness of chemical oxidation method and diazo method for serum total bilirubin based on Doumas reference method. Methods IFCC-RELA samples and 20 fresh serum samples from single human were conducted for the detection of total serum bilirubin; and that in calibration A and B were simultaneously measured by using Doumas reference method,chemical oxidation method and diazo method,and 2 normal detection systems were conducted for the tureness evaluation according to EP9-A3,and the calibration products of A and B were conducted for interchangeability evaluation according to EP14-A2. Results The accuracy performance of diazo method and chemical oxidation method was not consistent with Doumas reference method. Calibration A is commutable,while Calibration B is not commutable. Conclusion Doumas reference method can accurately determine the total bilirubin in serum samples. In order to ensure accuracy of measurement results,it is necessary to evaluate tureness of routine measurement system by reference method.