AX-4280尿干化学分析仪性能验证及方法探讨  

Performance verification and method discussion of AX-4280 automatic urine analyzer

作　　者：周渝蓉[1] 张燕琳[1] 

机构地区：[1]成都市疾病预防控制中心,四川成都610041

出　　处：《现代预防医学》2017年第11期2056-2059,2075,共5页Modern Preventive Medicine

摘　　要：目的对AX-4280型尿干化学分析仪及配套试纸条进行性能验证并探讨其方法。方法依据相关标准对仪器及试纸条不同量级参考溶液进行确证、精密度、准确度、携带污染率和生物参考区间的验证,计算其符合率。结果仪器的确证实验、精密度、准确度、携带污染率和生物参考区间验证结果均符合相关行业标准。结论 AX-4280型尿干化学分析仪及配套试纸能满足临床需求,但其检测系统的验证方法尚待统一标准。Objective To verify the performance of AX - 4280 automatic urine analyzer and it＇ s testing strips, and to discuss the methods. Methods Based on relative standards, different levels of referenced solution were applied to test the confirmatory, precision, accuracy, pollution rate of carry - over and biology reference interval of the instrument and strips. Meanwhile, the coincidence rate was calculated. Results The confirmatory, precision, accuracy, pollution rate of carry - over and biology reference interval all met with the professional standards. Conclusion AX -4280 automatic urine analyzer and it＇ s testing strips could meet clinical needs, but the standard of verification methods of the testing system remains was needed to be unified.

关 键 词：尿干化学分析 性能验证 符合率 

分 类 号：R118[医药卫生—公共卫生与预防医学]