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目的建立全自动酶法测定尿枸橼酸含量的方法,并进行方法学性能评价。方法在AU5400生化分析仪上建立酶偶联法检测尿枸橼酸含量的方法,进行精密度、检测低限、临床可报告范围及回收试验的评价,并与离子色谱法进行方法学比对试验。结果全自动酶法测定尿枸橼酸方法的批内变异系数(CV)为2.05%~2.95%,批间CV为2.56%~4.01%,总CV为3.06%~4.68%;检测低限为8.0mg/L;临床可报告范围为28.6~9800.0mg/L;平均回收率达96.1%;与离子色谱法测定尿枸橼酸的结果具有较好的一致性(Y=0.9748X+12.012,r~2=0.9856,P<0.01)。结论成功建立全自动酶法测定尿枸橼酸含量的方法,且该方法具有精密度好、准确度高、临床可报告范围宽的优点。
Objective To establish a method of automatic enzymatic determination of urinary citrate content and to evaluate the methodological performance. Methods AU5400 biochemical analyzer established urine enzyme method to detect urinary citrate content, precision, lower limit of detection, clinical reportable range and recovery test evaluation, and ion chromatography methodological comparison test . Results The intra-assay coefficient of variation (CV) of urinary citrate method was 2.05% -2.95%, the inter-assay CV was 2.56% -4.01%, and the total CV was 3.06% -4.68%. The detection limit was 8.0 mg / L; clinical reportable range of 28.6 ~ 9800.0mg / L; average recovery rate of 96.1%; and citric acid ion chromatography with better results (Y = 0.9748X +12.012, r ~ 2 = 0.9856, P <0.01). Conclusion The method of automatic enzymatic determination of urinary citrate content was successfully established. The method has the advantages of good precision, high accuracy and wide clinical reportable range.