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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 correctness of Doumas reference method for the determination of serum total bilirubin by bilirubin chemical oxidation and diazo method. Methods Doumas reference method was used to determine the total bilirubin in IFCC-RELA samples and 20 fresh single serum samples. The chemical and diazo methods were used to determine 20 fresh serums and A, B calibrators on automatic biochemical analyzer In the total bilirubin, according to EP9-A3 file on the two kinds of routine testing system for the correctness evaluation; according to EP14-A2 file A, B calibrator interchangeability evaluation. Results The results of diazotization and chemical oxidation were inconsistent with those of Doumas method. A calibrator is interchangeable, B calibrator poor interchangeability. Conclusion The Doumas method can accurately determine the total bilirubin content in serum samples. To ensure the accuracy of clinical sample testing, it is necessary to use the reference method to evaluate the accuracy of routine methods.