野战（应急）快速检验系统尿液分析模块性能的综合评价

摘要

Objective:To evaluate the performance of urine analysis module of Biochem POCT Solutions. Methods:The precision of the urine analysis module of Biochem POCT Solutions was estimated in indoor environment and simulated field environment, and then compared the results. Fresh urine samples of 200 patients were detected with the urine analysis module and DIRUI(H-800) urine analyzer respectively, and the results were compared. Results:The compliance rate of the measured values and the target value of urine analysis module was 100%indoor or in simulated field environment, and URO,GlU,PRO,BIL,BLD,LEU,Ph and KET's Kappa values were 0.66, 0.94, 0.91, 0.94, 0.93, 0.92, 0.81, 0.76 and 1 between two different environments. There were no significant difference of GLU,BIL,PRO,URO,BLD,KET,NIT and LEU between the urine analysis module and DIRUI(H-800) urine analyzer. The accordance rates of GLU,BIL,PRO,URO,BLD,KET,NIT and LEU by the two analyzers were all above 80%, and the Kappa values of GLU,BIL,PRO,URO,BLD,KET,NIT,LEU, PH and SG were all more than 0.7. Conclusion:The urine analysis module has good precision in indoor environment or simulated field, and the results show good consistency between two environments. The results of the urine analysis module and DIRUI(H-800) urine analyzer have no significant difference and show good consistency.%目的：综合评价野战(应急)快速检验系统尿液分析模块(PU4010)的性能。方法：对野战(应急)快速检验系统的尿液分析模块分别在室内环境与模拟野战环境下进行精密度评价、并对其在2种不同环境下的检测结果进行对比；利用尿液分析模块和迪瑞H-800尿液分析仪对200例尿液标本进行平行检测，分析二者的可比性。结果：尿液分析模块所有项目测定值与靶值的符合率均为100%。尿液分析模块环境对比实验URO，GLU、PRO、BIL、BLD、LEU、PH、SG、KET的Kappa值分别为0.66、0.94、0.91、0.94、0.93、0.92、0.81、0.76、1；尿液分析模块和迪瑞H-800尿液分析仪测定其各项结果的阳性率基本一致，完全符合率均为80%以上，其各项环境对比实验Kappa值均＞0.7，二者无显著性差异。结论：在室内和模拟野战环境下，野战(应急)快速检验系统尿液分析模块精密度良好；与常规实验室尿液分析仪的检测结果无显著性差异，检测结果的一致性良好。