酶法测定尿液草酸和枸橼酸的方法学性能验证及分析 前影响因素研究
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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)


Performance verification of urinary oxalate and citrate measurement kits using enzymic method and study on influencing fac⁃ tors before analysis
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    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,R2 = 0.999);枸橼酸在 0.19 ~ 17.85 mmol / L 范围内线性良好(Y= 0.953X+0.044,R2 = 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。

    Abstract:

    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 pre?treatment process of u? rine 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 pre?analysis 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, R2 = 0.999) for ox? alate 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, R2 = 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 oftotal 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 tem? perature, 4 ℃ or -20 ℃ without any preservative, the concentration of oxalate was significantly decreased but the concentration of cit? rate kept stable. No significant difference of the concentrations of both oxalate and citrate was found when 6 mol / L of HCl at proportion of 50 ∶1 was added to the samples immediately or 24 h after collection of urine samples (P>0.05). The oxalate and citrate in urine sam? ples showed good stability and kept stable for at least 30 days when the samples were frozen at -20 ℃ and acidified by adding 6 mol / L HCl in a ratio of 50 ∶1 before detection. Conclusion The enzymatic kits for oxalate and citrate in urine could be used for metabolic e? valuation of kidney stones and the results are comparable. The acidification of urine samples may keep oxalate and citrate stable, and no special requirements are needed for acidizing time.

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秦东芳,龚珂,王学晶,张曼.酶法测定尿液草酸和枸橼酸的方法学性能验证及分析 前影响因素研究[J].临床检验杂志,2021,39(10):762-767

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  • 收稿日期:2021-06-17
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  • 在线发布日期: 2021-12-07
  • 出版日期: 2021-10-28
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