摘要
目的评价Sysmex UF-4000尿液有形成分分析仪的性能。方法依据CNAS-CL02-A001:2018《医学实验室质量和能力认可准则》相关要求,对Sysmex UF-4000尿液有形成分分析仪进行相关的性能验证。结果 UF-4000尿液有形成分分析仪仪器状态记录、批内精密度、携带污染率、线性与临床可报告范围、批间精密度、参考区间验证等符合要求。结论结果符合仪器说明书相关要求,满足临床需求。
Objective To evaluate the performance of Sysmex UF-4000 urine analyzer.Methods According to the relevant requirements of CNAS-CL02-A001:2018:Accreditation Criteria for Quality and Ability of Medical Laboratories,the performance of Sysmex UF-4000 urine analyzer was validated.Results The status record,in-batch precision,contamination rate,linear and clinically reportable range,inter-batch precision,reference interval validation of Sysmex UF-4000 urine analyzer met the requirements.Conclusion The validation results meet the relevant requirements of the instrument instructions and meet the clinical needs.
作者
张志明
肖改娥
马莹
刘琳
姜小建
ZHANG Zhiming;XIAO Gaie;MA Ying;LIU Lin;JIANG Xiaojian(Department of Clinical Laboratory,Xi′an Central Hospital,Xi′an,Shaanxi 710003,China)
出处
《检验医学与临床》
CAS
2021年第10期1407-1409,共3页
Laboratory Medicine and Clinic
