目的:探讨羟苯磺酸钙对市售7种尿酸酶-过氧化物酶偶联法尿酸( UA)检测系统的干扰及对临床的影响。方法配制含不同浓度羟苯磺酸钙的干扰样本,最终干扰样本中药物终浓度分别为0、2、4、8、16、32、64μg/ml。用7种尿酸酶-过氧化物酶偶联法检测系统以及1种尿酸酶-紫外法UA系统分别测定UA,计算与药物浓度为0时的百分偏差。监测了志愿者服药前后不同时间(实验前、0 h、1 h、2 h、3 h、4 h、6 h)血清中羟苯磺酸钙和UA浓度的变化。以LC-IDMS/MS法作为参考,比较了不同检测系统的干扰程度。采用HPLC法测定40份服药患者血清中羟苯磺酸钙浓度,选择其中10份血清,比较过氧化物酶偶联法和紫外法UA系统测定UA的偏差以评估临床状态影响。结果在体外添加实验中,当血清中羟苯磺酸钙浓度为16μg/ml时,7种尿酸酶-过氧化物酶偶联法UA测定值与药物浓度为0时的偏差在-6.3%--21.2%之间。志愿者服药后1 h,2 h,3 h,4 h,6 h血清UA采用过氧化物酶偶联法测定值与0 h相比偏差分别为-3.33%,-6.79%,-7.49%,-6.07%,-4.09%。志愿者服药0 h和2 h血清中UA采用7种过氧化物酶偶联法UA系统的检测值与LC-IDMS/MS法相比的平均偏差分别在-3.75%--6.89%和-14.0%--20.13%。结论羟苯磺酸钙对7种尿酸酶-过氧化物酶偶联法UA检测系统均产生明显负干扰,且不同检测系统受干扰程度有显著差异。临床患者服药期间,若采用酶法测定UA值可导致假性降低。(中华检验医学杂志,2015,38:600-604)
Objective To assess the interference by calcium dobesilatein 7 peroxidase-baseduric acid assays and to determine its clinical significance.Methods In the in vitro experiments, uric acid in pooled serum with final concentrations of calcium dobesilate additions (0, 2, 4, 8, 16, 32, and 64μg/ml) were measured by 7 peroxidase-based assays.Percent Bias (%) was calculated relative to the drug-free specimen.In the in vivo experiments, changes in serum uric acid and calcium dobesilate concentrations were observed before and after calcium dobesilate administration ( baseline, 0 h, 1 h, 2 h, 3 h, 4 h, 6 h ) involunteers.The interference in different assays was assessed compared with LC-IDMS/MS method. Calcium dobesilate levels in 40 specimens from those taking calcium dobesilate were measured by HPLC method.Of the 40 specimens, 10 were selected to analyse the levels of uric acid by both peroxidase and UV measurement method to assess the impact in clinical status.Results In the in vitro study, concentrations of uric acid measured by 7 peroxidase-based assays were reduced by -6.3%to -21.2%compared with drug-free serum, when theconcentration of calcium dobesilate was16μg/ml.In the in vivo study, comparedto UA levels at 0 h, the biasesof serum uric acid determined by peroxidase method after calcium dobesilate administration(1 h, 2 h, 3 h, 4 h, 6 h) were of -3.33%, -6.79%, -7.49%, -6.07%, -4.09%, respectively.The observed uric acid concentrations for 8 participants measured by enzymatic assays were inhibited by -3.75% to -6.89% at 0 hour and by -16.9% to-22.22% at 2 hours relative to the concentrations measured by the LC-IDMS/MS method. Conclusions Calcium dobesilate produced a clinically significant negative interference with uric acid in all peroxidase-based uric acid assays,which may result in false evaluation of uric acid level in clinical status.Significant differences in the degree of interference were observed among the assays.