摘要
目的为了保证检测结果的可比性并规范尿液前处理过程,对酶法检测尿液草酸和枸橼酸的试剂盒进行性能验证及分析前影响因素研究。方法参考相关行业标准,对草酸和枸橼酸酶法试剂盒进行精密度、正确度、线性范围及干扰的性能验证。分析前影响因素研究包括:不加防腐剂,比较在室温、4℃和-20℃条件下放置不同时间的草酸和枸橼酸浓度;按照不同比例(100∶1,50∶1)、在不同时间(收样即刻,收样24 h后,冻存标本检测前)加入6 mol/L HCl酸化尿液对草酸和枸橼酸浓度的影响。结果在低浓度下,草酸和枸橼酸的重复性(以CV表示)为0.92%和1.41%,实验室内不精密度为1.79%和1.75%,偏倚为-1.77%和-2.68%;在高浓度下,草酸和枸橼酸的重复性(以CV表示)为0.32%和0.91%,实验室内不精密度为1.20%和3.14%,偏倚为-0.81%和-4.62%。草酸在1.65~210.71 mg/L范围内线性良好(Y=0.993X-0.216,R^(2)=0.999);枸橼酸在0.19~17.85 mmol/L范围内线性良好(Y=0.953X+0.044,R^(2)=0.999)。血红蛋白对草酸检测干扰较大,1 g/L以下时无干扰,2 g/L以上有明显负干扰;总蛋白低于1.5 g/L时对草酸和枸橼酸均没有干扰。不加任何防腐剂,尿液在室温、4℃及-20℃保存后,草酸浓度显著降低,枸橼酸浓度保持稳定。在尿液收集即刻和收集后24 h,按照50∶1的比例加入6 mol/L HCl,草酸和枸橼酸浓度无显著变化(P>0.05)。尿液标本-20℃冻存,检测前按50∶1的比例加入6 mol/L HCl酸化,草酸和枸橼酸稳定性良好,至少可稳定30 d。结论酶法尿液草酸和枸橼酸试剂盒可用于结石代谢评估,检测结果具有可比性。尿液酸化可保持草酸和枸橼酸稳定,酸化时间无特殊要求。
Objective To validate the performance of measurement kits for urinary oxalate and citrate using enzymic method and study the influencing factors before analysis in order to ensure the comparability of test results and standardize the pretreatment process of urine test.Methods Referring to relevant professional standard,the precision,accuracy,linear range and interference of the enzymic kits for oxalate and citrate were assessed for performance verification.The stydies for influencing factors in preanalysis included:no preservatives;comparison of the concentrations of oxalate and citrate at room temperature,4℃and-20℃for different time;the effects of adding 6 mol/L HCl to acidify the urine samples in different proportions(100∶1 or 50∶1)at different times(immediately,24 hours after sample collection and frozing specimens before test)on the concentrations of oxalate and citrate.Results The performance verification was carried out at low and high concentrations.At low concentration,the repeatabilities of results of oxalate and citrate were 0.92%and 1.41%,the laboratory imprecisions were 1.79%and 1.75%,and the biases were-1.77%and-2.68%respectively.At high concentration,the repeatabilities of results of oxalate and citrate were 0.32%and 0.91%,the laboratory imprecisions were 1.20%and 3.14%,and the biases were-0.81%and-4.62%respectively.A good linear correlation(Y=0.993X-0.216,R^(2)=0.999)for oxalate in the range of 1.65 to 210.71 mg/L was verified,and good linearity for citrate in the range of 0.19 to 17.85 mmol/L(Y=0.953X+0.044,R^(2)=0.999)was verified.Hemoglobin significantly interfered with the results for oxalate detection.No interference was found below 1 g/L of hemoglobin but significant negative interference occurred above 2 g/L of hemoglobin concentration.The concentration of total protein lowed than 1.5 g/L did not affect the results of both oxalate and citrate.When the urine samples were stored at room temperature,4℃or-20℃without any preservative,the concentration of oxalate was significa
作者
秦东芳
龚珂
王学晶
张曼
QIN Dongfang;GONG Ke;WANG Xuejing;ZHANG Man(Department of Clinical Laboratory,Peking University Civil Aviation School of Clinical Medicine,Beijing 100123;Center of Clinical Laboratory,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038;Beijing Key Laboratory of Urinary Cellular Molecular Diagnostics,Beijing 100038,China)
出处
《临床检验杂志》
CAS
2021年第10期762-767,共6页
Chinese Journal of Clinical Laboratory Science
基金
尿液细胞分子诊断北京市重点实验室开放课题(2018-KF07)
民航总医院(民航医学中心)院级课题(201945)。
关键词
草酸
枸橼酸
酶法
性能验证
分析前因素
泌尿系结石
oxalate
citrate
enzymic method
performance verification
factor before analysis
urinary calculi
