羟苯磺酸钙对7种基于Trinder反应原理的生化检验项目的干扰性研究

Interference of calcium dobesilate on seven biochemical tests based on Trinder reaction principle

目的 探讨羟苯磺酸钙对7种基于Trinder反应原理的临床生化检验项目的体外干扰。方法 参照美国临床和实验室标准协会(CLSI)的EP7-A3干扰试验指南,选取血清肌酐(Cr)、尿酸(UA)、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、脂肪酶(LPS)高、低浓度5份标本,设计配对差异实验,研究羟苯磺酸钙对以上测定是否存在干扰;对于有干扰的项目,通过剂量效应实验分析不同药物浓度对各项目的干扰程度。结果 Cr、UA、TC、TG、HDL-C、LDL-C和LPS的最大允许误差分别为±3.96%、±4.87%、±4.10%、±9.57%、±5.61%、±5.46%和±11.31%。当羟苯磺酸钙浓度为15 mg/L(血浆稳态浓度)时,对LDL-C检测无干扰,但Cr、UA、LPS(低浓度)检测均显示出药物负干扰。通过点对点分析估算其对各项目的最小干扰浓度,结果分别是Cr(低浓度)0.8 mg/L,Cr(高浓度)1.4 mg/L;UA(低浓度)6.3 mg/L,UA(高浓度)8.3 mg/L;TC(低浓度)20.7 mg/L,TC(高浓度)22.5 mg/L;TG(低浓度)17.7 mg/L,TG(高浓度)34.1 mg/L;HDL-C(低浓度)16.1 mg/L,HDL-C(高浓度)32.2 mg/L;LPS(低浓度)7.8 mg/L,LPS(高浓度)24.2 mg/L。结论 羟苯磺酸钙对基于Trinder反应原理的LDL-C检测无干扰;对Cr、UA、TG、TC、HDL-C和LPS的检测有负干扰,其干扰程度随着药物浓度的升高而增大,在Cr、UA、TG和LPS的检测中干扰效果尤为明显。

Objective To investigate the in vitro interference of calcium dobesilate on seven clinical biochemical tests based on Trinder reaction principle.Methods According to Clinical and Laboratory Standards Institute(CLSI)EP7-A3 interference test guidelines,serum creatinine(Cr),uric acid(UA),total cholesterol(TC),triglyceride(TG),high density lipoprotein cholesterol(HDL-C),low density lipoprotein cholesterol(LDL-C),lipase(LPS)high and low concentration 5 samples were selected,and paired difference experiment was designed to study whether there was interference of calcium dobesilate on the above measurement.For the items with interference,the interference degree of different drug concentrations on each item was analyzed by dose effect experiment.Results The maximum allowable errors of Cr,UA,TC,TG,HDL-C,LDL-C and LPS were±3.96%,±4.87%,±4.10%,±9.57%,±5.61%,±5.46%and±11.31%,respectively.When the concentration of calcium dobesilate was 15 mg/L(steady plasma concentration),there was no interference on the detection of LDL-C,but Cr,UA and LPS(low concentration)showed drug negative interference.By point-to-point analysis,the minimum interfering concentrations of Cr(low concentration)0.8 mg/L,Cr(high concentration)1.4 mg/L,UA(low concentration)6.3 mg/L,UA(high concentration)8.3 mg/L,TC(low concentration)20.7 mg/L,TC(high concentration)22.5 mg/L,TG(low concentration)17.7 mg/L,TG(high concentration)34.1 mg/L,HDL-C(low concentration)16.1 mg/L,HDL-C(high concentration)32.2 mg/L,LPS(low concentration)7.8 mg/L,LPS(high concentration)24.2 mg/L,respectively.Conclusion Calcium dobesilate has no interference on the detection of LDL-C based on Trinder reaction principle.It negatively interfered the detection of Cr,UA,TG,TC,HDL-C and LPS,and the degree of interference increased with the increase of drug concentration,especially in the detection of Cr,UA,TG and LPS.