摘要
目的验证新投入使用的罗氏Cobas 8000全自动生化分析仪检测系统性能,以提高检验科工作质量,确保检验结果的准确与可靠。方法根据CNAS-CL02-A003:2018《医学实验室质量和能力认可准则在临床化学检验领域的应用说明》的要求,对该仪器检测系统中包括丙氨酸氨基转移酶(ALT)、总蛋白(TP)、碱性磷酸酶(ALP)、谷氨酰基转移酶(GGT)、胆固醇(TCH)、三酰甘油(TG)、尿素氮(BUN)、肌酐(CREA)、葡萄糖(GLU)、钙(Ca)、镁(Mg)、肌酸激酶(CK)、乳酸脱氢酶(LDH)、钾(K)、钠(Na)共15个项目的准确度、精密度、线性、最大稀释度及临床可报告范围进行性能验证及评价。结果15个项目的相对偏倚均<1/2允许总误差(TEa);精密度批内变异系数(CV)均<1/4TEa,总CV均<1/3TEa;15个项目的b值均在1.00±0.03范围内,且r2≥0.95;最大稀释度及临床可报告范围均通过验证,符合需求。结论所验证15个检测项目的准确度、精密度、线性、最大稀释度及临床可报告范围均符合质量目标的要求,可以满足临床需求。
Objective In order to improve the work quality of the clinical laboratory and ensure the accuracy and reliability of the test results,the performance of the new Roche Cobas 8000 automatic biochemical analyzer detection system was performed.Methods According to the requirements of the CNAS-CL02-A003:2018 Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Chemistry,the accuracy,precision,linearity,maximum dilution and clinical reportable range of the instrument testing system,including ALT,TP,ALP,GGT,TCH,TG,BUN,CREA,GLU,Ca,Mg,CK,LDH,K and Na,a total of 15 projects,were verified and evaluated.Results The relative bias of the 15 items was<1/2TEa.The precision of within CV was<1/4TEa,and the total CV was<1/3TEa.The b values of the 15 items were all within the range of 1.00±0.03,and the correlation coefficient r2 was≥0.95.The maximum dilution and the range of clinical reports have been verified and meet the requirements.Conclusion The accuracy,precision,linearity,maximum dilution and clinical reactable range of the 15 items all meet the requirements of quality objectives and meet clinical requirements.
作者
赵巧燕
颜巍
ZHAO Qiaoyan;YAN Wei(Department of Clinical Laboratory,Affiliated Hospital of Integrated Traditional Chinese and Western Medicine,Nanjing University of Chinese Medicine/Jiangsu Provincial Research Institute of Traditional Chinese Medicine,Nanjing,Jiangsu 210028,China)
出处
《检验医学与临床》
CAS
2020年第23期3425-3428,共4页
Laboratory Medicine and Clinic
基金
江苏省中医药局课题(FY201809)。
