比色法测定超氧化物歧化酶的临床评价及其应用研究

Clinical Evaluation and Application of Detection of Superoxide Dismutase by Colorimetry

对比色法测定超氧化物歧化酶试剂盒进行临床评价;比较健康人群与多种疾病患者的血清超氧化物歧化酶(Super-oxide dismutase,SOD)浓度,探索血清SOD对多种疾病的预警价值。用罗氏全自动生化分析仪测定,分析评价比色法测定超氧化物歧化酶试剂盒的准确性、精密度及线性等指标。选取明确诊断的多种疾病(包括冠心病、肝脏疾病和脑部疾病)共105例作为疾病组及144名健康查体者作为对照组,测定两组血清SOD浓度。结果显示,用该方法测定SOD高、低两种浓度血清的准确度分别为99.8%和97.8%,批内变异系数分别为0.59%和0.43%,批间变异系数分别为1.45%和1.09%;在12.5～200U/mL范围内,线性良好,与理论值的相关系数为0.9999(R2=0.9998)。疾病组的血清SOD水平为97.77±28.31U/mL,显著低于对照组139.79±13.88 U/mL(P<0.01);疾病组内的每种疾病血清SOD水平均明显低于对照组(P<0.01),但各种疾病之间血清SOD水平无差异;比色法测定血清SOD的ROC曲线下面积为90.5%;当界值为116.15 U/mL时,约登指数最大(0.86),此时灵敏度为97.22%,特异性为74.3%。以上结果表明,超氧化物歧化酶比色法试剂盒操作简便、稳定、快速,符合临床应用要求,适合进行临床大样本的常规检测。对多种疾病具有良好的预警价值。

To evaluate the reliability of serum superoxide dismutase colorimetry assay reagent,the precision,accuracy and linearity of reagents were evaluated by detection the quantity of serum SOD with the Roche automatic biochemical analyzer.The serum SOD levels in 105 patients who clearly diagnosed（including coronary heart disease,liver disease and brain disease） and 144 healthy people were detected.The results showed that the accuracy of the high value and low value of the serum SOD were 99.8% and 97.8 respectively.The within-run CV was 0.59% and 0.43% respectively,and the between-run CV was 1.45% and 1.09% respectively.Within the range of 12.5 to 200 U/ml,the kit had good linearity and the correlation was 0.9999（R2=0.9999）.The serum SOD level in disease group（97.77±28.31U/ml） was notably lower than that in control group（P0.01）.The serum SOD level in different disease groups were all notably lower than that in control group（P0.01）,while there was no differences in the levels of serum SOD in different disease groups.The area under the ROC curve was 90.5%.When the threshold was 116.15 U/ml,the maximum Youden index was 0.86 and the sensitivity and specificity were 97.22% and 74.3% respectively.The results indicate that the superoxide dismutase assay by colorimetry is simple,stable and fast method.It might be suitable for routine clinical detection of SOD in large scale.