三种尿液干化学分析仪检测一致性的比较

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 2400 pH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)；Mejer600 ERY阳性检出率与Uri sys2400 ERY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ER Y，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%～1 2.4%，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%～8 8.3%，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。

Comparison on the Consistency of Three Urine Dry Chemistry Analyz ers

Objective To compare the consistency of the res ul ts of the three urine dry chemical analyzers of Roche Urisys 2400，AIKELA AX4030 and Mejer600．Methods AX4030 and Mejer600 were compared with the target machine Urisys 2400．Calculated the percentage difference in mea n value of pH and specific gravity (SG)，and Calculated the positive detection r ate and compliance rate of leulcocytes (LEU)，leulcocytes (ERY)，nitrite (NIT)， protein (PRO)，glucose (Glu)，bilirubin (Bil)，urobilinogen (URO) and ketone bod y (KET)．Results The mean difference percentage of pH bet ween AX4030/Mejer600 and Urisys 2400 was ＜10%．The mean difference percentage o f SG between AX4030/Mejer600 and Urisys 2400 was ＜1%，and the percentage differ ence of SG average was less than 1%．The consistency mets the requirements．Ther e was significantly difference between AX4030 and Mejer600 in the positive detec tion rates of ERY and PRO( χ 2=5.114，5.921，all P <0.05)．Compared w ith Urisys 2400，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 con firmatory experiments of three kinds of instruments in ERY，LEU and PRO showed t hat 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 r ate was 17.4%～29.6%，the PRO compliance rate was 63.3%～88.3%，and the fals e negative rate was 4.2%～15.9%．Conclusion The three u rine 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 analysi s．