羟苯磺酸钙对不同肌酐酶法试剂检测结果干扰的对比

Comparison of the interference of calcium dobesylate on the detection results of different creatinine enzymes

目的 对不同肌酐酶法检测试剂盒的抗羟苯磺酸钙干扰能力进行性能评价,确保其抗干扰性能符合临床检验要求。方法 按照国家标准WS/T 416—2013《干扰实验指南》,使用全自动生化分析仪和罗氏、迈克生物2个厂家的肌酐酶法检测试剂,同时检测羟苯磺酸钙浓度为60、140、400μmol/L的血浆样本中的肌酐,分析2种不同试剂对抗羟苯磺酸钙干扰的性能,并评价其抗羟苯磺酸钙干扰能力。结果 低、中、高浓度血浆肌酐样本使用2种不同试剂的检测结果的批内精密度均符合要求(<4%)。样本血浆中羟苯磺酸钙浓度20~100 mg/L时,罗氏肌酐酶法试剂对不同浓度肌酐血浆样本的检测有明显负偏倚(-5.88%~-65.73%),迈克生物试剂对不同浓度肌酐血浆样本检测的偏倚较小(-5.56~2.36%)。结论 迈克生物的改良肌酐酶法检测试剂抗羟苯磺酸钙干扰能力较强,能有效对抗药物导致的肌酐假性减低。

Objective To evaluate the anti-interference ability of different creatinine enzyme detection kits,ensure that its anti-interference performance meet the requirements of clinical test verification.Methods In accordance with national standard WS/T 416-2013"Interference Experiment Guide",automatic biochemical analyzer was used to evaluate creatinine enzyme assay reagents produced by two different manufacturers of Roche and MAIKE Biology company.Meanwhile,creatinine plasma samples with different concentrations of calcium dobesylate(60,140,400μmol/L)were detected.The anti-interference performance of two different creatinase reagents against calcium dobesylate was analyzed,and their anti-interference ability was evaluated.Results The precision of plasma creatinine samples with low,medium and high concentration met the requirements(<4%)by using two different reagents.When the concentration of calcium isobenesulfonate in plasma was 20-100 mg/L,there was a significant negative bias(-5.88%~-65.73%)in the detection results of plasma samples with different concentrations of creatinine using Roche’s reagent.However,there was little bias(-5.56~2.36%)in the detection of plasma samples with different concentrations of creatinine using MAIKE Biology creatinine reagent.Conclusion The improved creatinine enzyme detection reagent produced by Michael Biological had strong anti-calcium dobesylate interference ability,and could effectively combat the false reduction of creatinine caused by drug interference,which was of great significance to improve the level of clinical diagnosis and treatment of related diseases.