某品牌全自动尿液干化学分析仪性能评估

Performance evaluation of automatic urine dry chemistry analyzer

目的:根据ISO 15189实验室认可的相关要求对某全自动尿液干化学分析仪的精密度和符合率进行评估。方法:选取2014年8—9月住院患者和体检者的新鲜尿液标本,采用伯乐公司的质控品验证批内精密度、批间精密度、日间精密度,采用2015年度卫生部室间质评结果验证阴阳性符合率。结果:该全自动尿液干化学分析仪各检测项目的批内精密度、批间精密度和日间精密度均符合要求,阴阳性符合率也达到要求。结论:该全自动尿液干化学分析仪的性能合格,可以满足临床应用。

Objective To evaluate the precision and coincidence rate of some automatic urine dry chemistry analyzer according to ISO 15189 laboratory accreditation requirements. Methods The fresh urine specimens of the in-patients and examinees from August to September 2014 underwent test on within-run, between-run and inter-day precision with the quality control serum from Bio-Rad company, and then the negative and positive coincidence rates were verified with 2015 External Quality Assessment in Laboratory Medicine of Ministry of Health. Results The urine dry chemistry analyzer behaved well in within-run, between-run and inter-day precision as well as negative and positive coincidence rates. Conclusion The analyzer involved has the performance meet the requirements, and can be applied clinically.