4种国产尿液干化学分析仪的一致性研究

Study on the consistency of four domestic urine dry chemistry analyzers

目的比较UA-5800、URIT-1600、U120 Ultra、弘益尿液干化学分析仪与AX-4030的一致性。方法使用UA-5800、URIT-1600、U120 Ultra、弘益尿液干化学分析仪分别与AX-4030比较,比较酸碱度(pH值)、比重(SG)的差异百分率均值(d),比较尿胆原(URO),胆红素(BIL)、酮体(KET)、潜血(BLD)、蛋白质(PRO)、亚硝酸盐(NIT)、白细胞(WBC)、葡萄糖(GLU)的阳性率和符合率。结果UA-5800、URIT-1600、U120 Ultra、弘益与AX-4030 pH的d<10%,SG的d<1%;AX-4030与U120 Ultra的BLD、PRO阳性率比较,差异有统计学意义(χ^(2)=10.690、6.248,P<0.05),其他指标阳性率比较,差异无统计学意义(P>0.05)。UA-5800与AX-4030的Kappa值在0.64~0.92;URIT-1600与AX-4030的Kappa值在0.75~0.98;U120 Ultra与AX-4030的Kappa值在0.67~0.88;弘益与AX-4030的Kappa值在0.94~1.00。结论4种尿液干化学分析仪与AX-4030的一致性良好,基本能够满足临床需要。

Objective To compare the consistency of UA-5800,URIT-1600,U120 Ultra,Hongyi urine dry chemistry analyzer and AX-4030.Methods UA-5800,URIT-1600,U120 Ultra,Hongyi urine dry chemistry analyzer were compared with AX-4030.The mean difference percentage(d)of pH and SG were compared,the positive rates and coincidence rates of urobilinogen(URO),bilirubin(BIL),ketone body(KET),occult blood(BLD),protein(PRO),nitrite(NIT),white blood cell(WBC),and glucose(GLU)were compared.Results The pH of UA-5800,URIT-1600,U120 Ultra,Hongyi and AX-4030 of d were<10%,and the SG of d were<1%;the positive rate of BLD and PRO of AX-4030 and U120 Ultra were compared,The differences were statistically significant(χ^(2)=10.690,6.248,P<0.05),and the differences in the positive rate of other indicators were not statistically significant(P>0.05).The Kappa values of UA-5800 and AX-4030 were between 0.64 and 0.92;the Kappa values of URIT-1600 and AX-4030 were between 0.75 and 0.98;the Kappa values of U120 Ultra and AX-4030 were between 0.67 and 0.88;the Kappa values of Hongyi and AX-4030 were between 0.94 and 1.00.Conclusion The four urine dry chemistry analyzers are in good agreement with the AX-4030,which can basically meet the clinical needs.