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目的评价胆红素对肌氨酸氧化酶法测定肌酐(Cr)的干扰。方法随机选择国内威高、长征、九强、生之源、基蛋、利德曼6种肌氨酸氧化酶法Cr试剂盒,按照美国临床实验室标准化协会EP 7-A2文件中“配对差异”和“剂量效应”方案,在正常和高值Cr血清中添加不同浓度结合胆红素(CBIL)和游离胆红素(FBIL)干扰物,进行干扰评价试验。结果 CBIL和FBIL对肌氨酸氧化酶法测定Cr存在不同程度的干扰。Cr正常水平,CBIL和FBIL≥120μmol/L时对威高、基蛋Cr试剂产生明显干扰,CBIL≥621μmol/L或FBIL≥481μmol/L时对九强、生之源、长征Cr试剂产生干扰;Cr高值水平,CBIL或FBIL≥120μmol/L时对威高Cr试剂产生干扰,CBIL≥962μmol/L或FBIL≥1083μmol/L时对长征Cr试剂产生干扰。干扰所产生的相对偏倚差异显著,CBIL较比FBIL干扰作用更加明显。“剂量效应”结果显示,胆红素对Cr测定产生负干扰并呈线性关系。结论国内肌氨酸氧化酶法测定Cr试剂抗胆红素干扰能力不同,胆红素对Cr测定产生负干扰并呈线性关系。临床实验室在应用肌氨酸氧化酶法测定Cr时应进行胆红素干扰试验验证。
Objective To evaluate the interference of bilirubin in the determination of creatinine (Cr) by sarcosine oxidase. Methods Six kinds of sarcosine oxidase Cr kit were selected randomly from domestic Weigao, Long March, Nine strong, raw source, base egg and Leadman. According to the standard of American Society of Clinical Laboratory Standards EP 7-A2, Difference “and” Dose-Response “protocols were performed to evaluate the interferences by adding different concentrations of CBIL and FBIL to normal and high-Cr serum. Results CBIL and FBIL had different degrees of interference on the determination of Cr by sarcosine oxidase. Cr normal level, CBIL and FBIL≥120μmol / L produced significant interference with the high-base and basal Cr reagent, while CBIL≥621μmol / L or FBIL≥481μmol / L, Cr high value, when CBIL or FBIL≥120μmol / L, it will interfere with the Cr-Cr reagent when CBIL≥962μmol / L or FBIL≥1083μmol / L. The relative bias generated by the interference was significantly different, and the effect of CBIL was more pronounced than that of FBIL. ”The dose effect" results show that bilirubin negatively interfered with Cr determination and showed a linear relationship. Conclusions The domestic sarcosine oxidase method has different ability to detect the anti-bilirubin interference of Cr reagent. The bilirubin has negative interference with Cr determination and has a linear relationship. Clinical laboratory in the application of sarcosine oxidase method for the determination of bilirubin interference test should be verified.