尿干化学分析仪的定量改进及应用初探

Quantitative improvement and application of urine chemical dipstick analyzer

目的探索尿干化学分析仪由定性向定量的改进方法并以此为基础开发新的检测项目提升尿干化学仪的检测能力。方法利用伯乐质控品采用倍比稀释的方法测定并解析尿十项的各浓度定量值与反射率之间的关系,并以实测标本对关系曲线进行验证,同时以红细胞定量曲线为基础,统计分析肾脏相关疾病在新指标“尿未溶血红细胞比例”下的特点。结果解析出尿十项各项目与反射率之间的关系:1.隐血(BLD):y=88.042 ln(x)+1436.5(R^(2)=0.8884);2.胆红素(BIL):y=256.77 ln(x)+599.2(R^(2)=0.9938);3.酮体(KET):y=241.99 ln(x)+497.15(R^(2)=0.9683);4.尿白细胞(LEU):y=182.22 ln(x)+770.1(R^(2)=0.9602);5.亚硝酸盐(NIT):y=125.41 ln(x)+787.3(R^(2)=0.9546);6.尿糖(GLU):y=218.86 ln(x)+895.62(R^(2)=0.9415);7.酸碱度(pH):y=-194.8 ln(x)+4781.9(R^(2)=0.8744);8.蛋白(PRO):y=241 ln(x)+855.48(R^(2)=0.9590);9.尿胆原(UBG):y=6.7351 ln(x)+1083.3(R^(2)=0.9162);10.比重(SG):y=-8.3269 ln(x)+9866.3(R^(2)=0.9808)。同时验证的四个指标结果和上面做的反射率曲线一致,具有良好的相关性。以红细胞定量曲线为基础对收集了78例血尿患者尿标本进行了新指标“尿未溶血红细胞比例”应用分析,在其对有无实质性肾损伤的诊断过程中,灵敏度为89.80%,特异度为51.72%,阳性预测值为75.90%,阴性预测值为75.00%。结论通过对尿干化学分析仪进行解析与验证,说明基于同类原理的尿干化学分析仪由定性向定量改进是可行的,同时在此基础上重点结合红细胞的定量曲线,利用新的参数再结合异形红细胞比例,对肾有实质性或无实质性疾病的诊断提供了新的思路。未来需逐步推动尿干化学分析仪的定量革新,从而提升并扩展尿干化学的检测水平。

Objective To explore the improvement method of urine chemistry dipstick analyzer from qualitative to quantitative,and based on this,to develop new detection items to improve the detection ability of urine chemistry dipstick analyzer.Methods Using the quality product of BIO-RAD by equivalency proportional dilution method to determine and analyze the relationship between the concentration of urine 10 quantitative values and the reflectance,and to the measured samples to verify this relationship curve,at the same time,on the basis of quantitative curve of red blood cells,the statistical analysis of kidney disease in the new index the characteristics of the"proportion of the insoluble red blood cells in urine".Results The logarithmic or linear curves of the 10 items of urine and reflectance were listed as follows:1.BLD:y=88.042 ln(x)+1436.5(R^(2)=0.8884);2.BIL:y=256.77 ln(x)+599.2(R^(2)=0.9938);3.KET:y=241.99 ln(x)+497.15(R^(2)=0.9683);4.LEU:y=182.22 ln(x)+770.1(R^(2)=0.9602);5.NIT:y=125.4 ln(x)+787.3(R^(2)=0.9546);6.GlU:y=218.8 ln(x)+895.62(R^(2)=0.9415);7.pH:y=-194.8 ln(x)+4781.9(R^(2)=0.8744);8.PRO:y=241 ln(x)+245.48(R^(2)=0.9590);9.UBG:y=6.7351 ln(x)+1083.3(R^(2)=0.9162);10.SG:y=-8.3269 ln(x)+9866.3(R^(2)=0.9808).The verification results of the four items show good correlation.Based on the quantitative curve of red blood cells,the new index"proportion of insoluble red blood cells in urine"was applied to analyze the urine samples of 78 hematuria patients.The proportion of insoluble red blood cells in urine was more advantageous in the process of detecting the presence of substantial kidney injury because of its sensitivity was 89.80%,specificity was 51.72%,positive predictive value was 75.90%,negative predictive value was 75.00%.Conclusion It was indicated that the urine chemical dipstick analyzer based on the same principle could be improved from qualitative to quantitative by analyzing and verifying the urine chemical dipstick analyzer.At the same time,combining with the quantitative curve of red blood cells,using the new parameters and combining with the parameter of"proportion of heteromorphic red blood cells in urine",it provides a new way of thinking for the diagnosis of renal diseases with or without substantial diseases.It shows that the application based on quantitative improvement is feasible.It is indicated that the market application based on quantitative improvement is also possible,and the quantitative innovation of urine chemistry dipstick analyzer should be gradually promoted in the future,so as to improve and expand the detection level of urine dry chemistry.