ISO15189认可中UF-4000尿液有形成份分析仪的性能验证及比对方案的建立

The Establishment of Performance Verification and Comparison Protocols forUF-4000 Urine Sediment Analyzer According to ISO15189 Accreditation

目的按照ISO15189认可的要求,对UF-4000尿液有形成份分析仪进行性能评价,同时建立一种同一型号仪器的比对方案,以应用于临床。方法对UF-4000的五项主要参数(RBC、WBC、EC、CAST、BACT)进行批内精密度、批间精密度、准确度、携带污染率、临床可报告范围、参考区间验证,与同机型检测结果的一致性比对。结果UF-4000的批内精密度、批间精密度、准确度、携带污染率、临床可报告范围、参考区间验证等验证结果及UF-4000同机型检测结果的一致性比对结果均符合要求。结论Sysmex公司生产的UF-4000尿液有形成分分析仪性能良好,能够满足临床需求。仪器间比对结果通过能满足同一机型组成流水线时检验结果的一致性要求,可明显提升工作效率。

Objective In accordance with ISO 15189 accreditation requirements,a performance evaluation was conducted for UF-4000 urine sediment analyzer,and a comparative study was established for the same model of instrument to be applied in clinical analysis.Methods Five main parameters of UF-4000 urine sediment analyzer(RBC,WBC,EC,CAST,BACT)were evaluated for within-run precision,between-run precision,accuracy,carryover,clinically reportable range,and reference interval verification.The results were compared to the testing results of the same model of instrument to determine their consistency and reliability in producing accurate test results.Results The validation results,including within-run precision,between-run precision,accuracy,carryover,clinically reportable range,and reference interval verification,for UF-4000 urine sediment analyzer,as well as the comparative results with the testing results of the same model,were found to be consistent with the expected requirements.Conclusion Sysmex UF-4000 urine sediment analyzer has demonstrated an excellent performance and is capable of meeting expected clinical demands.The comparative results between instruments in this study have suggested that it can meet the consistency requirements of test results when used in the same model pipeline,which can significantly improve work efficiency.