三种尿液干化学分析仪检测一致性的比较

Comparison on the Consistency of Three Urine Dry Chemistry Analyzers

目的比较罗氏Urisys2400,爱科来AX4030和美侨Mejer600三种尿液干化学分析仪检测结果的一致性。方法 AX4030和Mejer600分别与靶机Urisys2400进行比对,计算酸碱度(pH值)、比重(SG)的均值差异百分率,计算白细胞(LEU)、红细胞(ERY)、亚硝酸盐(NIT)、蛋白质(PRO)、葡萄糖(Glu)、胆红素(Bil)、尿胆原(URO)和酮体(KET)结果的阳性检出率和符合率。通过确证实验,对所有尿液标本的红细胞(ERY)、白细胞(LEU)、蛋白(PRO)进行确认,分别计算三种仪器各自符合率和假阴性率。结果 AX4030和Mejer600与靶机Urisys 2400pH均值差异百分率<10%,SG均值差异百分率<1%,一致性符合要求;AX4030与Urisys2400相比,ERY和PRO阳性检出率存在显著差异(χ2=5.114,5.921,均P<0.05);Mejer600ERY阳性检出率与Urisys2400ERY存在显著差异(χ2=5.692,P<0.05);AX4030和Mejer600与Urisys2400相比,除SG,pH外,其他项目一般符合率>80%,Kappa>0.4,结果一致性良好;三种仪器ERY,LEU,PRO检测结果与确证实验比较,ERY符合率为69.8%～79.3%,假阴性率为7.2%～12.4%,LEU符合率为70.1%～76.2%,假阴性率为17.4%～29.6%,PRO符合率为63.4%～88.3%,假阴性率为4.2%～15.9%。结论三种尿液干化学分析仪检测一致性良好,均可满足临床需要,但对部分可疑标本,需要结合其他沉渣仪器及确证实验综合分析。

Objective To compare the consistency of the results of the three urine dry chemical analyzers of Roche Urisys2400,AIKELA AX4030 and Mejer600.Methods AX4030 and Mejer600 were compared with the target machine Urisys2400.Calculated the percentage difference in mean value of pH and specific gravity(SG),and Calculated the positive detection rate and compliance rate of leulcocytes(LEU),leulcocytes(ERY),nitrite(NIT),protein(PRO),glucose(Glu),bilirubin(Bil),urobilinogen(URO)and ketone body(KET).Results The mean difference percentage of pH between AX4030/Mejer600 and Urisys 2400 was<10%.The mean difference percentage of SG between AX4030/Mejer600 and Urisys 2400 was<1%,and the percentage difference of SG average was less than 1%.The consistency mets the requirements.There was significantly difference between AX4030 and Mejer600 in the positive detection rates of ERY and PRO(χ^2=5.114,5.921,all P<0.05).Compared with Urisys2400,AX4030/Mejer600 had a general compliance rate of >80%,Kappa >0.4,except for SG and pH,and the results were in good agreement.Compared with results and confirmatory experiments of three kinds of instruments in ERY,LEU and PRO showed that the coincidence rate of ERY was 69.4%~79.3%,the false negative rate was 7.2%~12.4%,the LEU compliance rate was 70.1%~76.2%,the false negative rate was 17.4%~29.6%,the PRO compliance rate was 63.3%~88.3%,and the false negative rate was 4.2%~15.9%.Conclusion The three urine dry chemical analyzers had good consistency and could meet clinical needs.However,for some of the suspicious specimens,it is necessary to combine other sedimentation instruments and confirmation experiments for comprehensive analysis.