羟苯磺酸钙对肌酐检测的干扰效应评价

Evaluation of dose effect of creatinine detection reagents on calcium dobesilate interference

目的评价不同浓度羟苯磺酸钙对常见肌酐检测试剂的干扰剂量效应情况。方法依据WS/T 416-2013干扰实验指南,参考医学决定浓度选取4种肌酐浓度的新鲜标本,定量配制成8种药物浓度梯度,比较3种肌酐检测试剂对不同浓度羟苯磺酸钙干扰剂量效果,以1/3允许总误差(4%)为最大允许干扰限。结果3种检测肌酐试剂随羟苯磺酸钙剂量增加,负干扰效应愈加明显。血清标本肌酐浓度为40μmol/L时,随羟苯磺酸钙浓度增加,普通酶法负偏差高达64.17%,新酶法最大负偏差仅为3.07%;血清标本浓度为141μmol/L时,新酶法、普通酶法和干化学试剂在羟苯磺酸钙浓度为15 mg/L时负偏差分别为3.91%、29.67%、6.53%;血清标本浓度为1000μmol/L、干扰物浓度为15 mg/L时,新酶法、普通酶法和干化学法负偏差依次为3.21%、9.09%、2.39%。结论新酶法在检测肌酐过程中对于羟苯磺酸钙药物产生负干扰在最大允许干扰限内,普通酶法肌酐试剂基本无抗干扰能力,干化学法在高肌酐浓度检测中其抗干扰能力更优越。

Objective To evaluate the interference dose effect of common creatinine detection reagents on different concentrations of calcium dobesilate.Methods On basis of the WS/T 416-2013 interference test guide,according to the medical decision level,4 fresh samples with creatinine concentration levels were selected and quantitatively prepared into 8 drug concentration gradients.The interference dose effects of 3 creatinine detection reagents on different concentrations of calcium dobesilate were compared,and the maximum allowable interference limit was 1/3 of the allowable total error(4%).Results The negative interference effect of 3 creatinine reagents was more obvious with the increase of calcium dobesilate dose.When serum creatinine concentration was 40μmol/L,the negative deviation of common enzyme method was as high as 64.17%.The maximum negative deviation of dry chemical reagent was 13.81%,while the maximum negative deviation of new enzyme method was only 3.07%.When 141μmol/L,the negative deviations of the new enzyme method,the common enzyme method and the dry chemical reagent were 3.91%,29.67%and 6.53%,respectively,which the concentration of Calcium dobesilate was 15 mg/L.When 1000μmol/L and the interference concentration was 15 mg/L,the negative deviation of the new enzyme method,common enzyme method and dry chemical method were 2.31%,9.09%and 2.39%respectively.Conclusion The negative interference causes by calcium dobesilate in the new enzyme method was within the maximum allowable interference limit,while the normal enzyme creatinine reagent has basically no anti-interference ability,while the dry chemical method has performed better in the detection of high creatinine concentration.