野战卫生检验装备PU4210与实验室常规尿液分析仪的对比分析

Comparison on the Field Operation Clinical Laboratory Equipment PU4210 and Routine Laboratory Urine Analyzers

目的将野战检验装备PU4210和实验室常规使用的尿液分析手段进行比对分析,评价其性能。方法对123例尿液标本在PU4210、SIMENS干化学尿液分析仪、Sysmex UF-1000i尿流式细胞仪进行平行检测,并均进行沉渣镜检。计算出PU4210和SIMENS干化学分析仪间各项目的符合率,进行kappa检验评价两者的一致性;并分析PU4210及尿沉渣分析仪与沉渣镜检在检测红细胞和白细胞时的一致性。结果两台干化学尿液分析仪多数项目一致性较高,KET、PRO、NIT、LEU、URO、BIL、GLU、BLD的kappa值分别为1.0、0.929、0.895、0.877、0.805、0.723、0.656、0.573,但SG、PH的完全符合率仅为48.8%,结果间的差异具有统计学意义(P<0.01);PU4210检测红细胞的灵敏度为90.0%,特异性为85.7%,检测白细胞的灵敏度为82.6%、特异性为88.9%。结论野战检验装备PU4210与实验室常规干化学分析仪一致性较好,基本能够满足平时和战时临床对疾病诊断的需要。

Objective To evaluate the performance of PU4210 through comparing the patients results tested by field operation clinical laboratory equipment PU4210 and routine laboratory urine analyzers. Methods 123 urine samples were examined by PU4210, SIMENS dry chemistry method urine analyzer, Sysmex UF-1000i urine flow cytometer or urine sediment microscopic examination respectively. We then calculated the compliance rates of PU4210 and SIMENS,evaluated the consistency of the two analyzers by kappa test also analyzed the consistency of PU4210, urine flow cytometer and microscopic examination on the tests of erythrocyte and leukocyte. Results There is good correspondence between the two dry chemistry method urine analyzers on KET, PRO, NIT, LEU, URO, BIL, GLU, BLD, and the Kappa values were 1.0,0.929,0. 895, 0. 877,0. 805,0. 723,0. 656,0. 573. But the completely accordance rates of SG and PH were 48.8%, with significantly difference. The sensitivity and specificity of PU4210 were 90.0% and 85.7% when testing erythrocyte, were 82. 6% and 88. 9% when testing leukocyte. Conclusion The field operation clinical laboratory equipment PU4210 is able to ensure the requirement of disease diagnosis both in peacetime and wartime, according to the good correspondence with routine laboratory urine analyzer.