罗氏Cobas c702全自动生化分析仪检测项目性能验证  

Roche Cobas c702 automatic biochemical analyzer test project performance verification

作　　者：郭东月 覃俊龙 刘小柳 张秀明 GUO Dongyue;QIN Junlong;LIU Xiaoliu;ZHANG Xiuming(Department of Clinical Laboratory,Shenzhen Luohu Maternity and Child Healthcare Hospital,Shenzhen,Guangdong 518019,China;Department of Clinical Laboratory,Shenzhen Luohu People′s Hospital,Shenzhen,Guangdong 518001,China)

机构地区：[1]广东省深圳市罗湖区妇幼保健院检验科,广东深圳518019 [2]广东省深圳市罗湖区人民医院医学检验科,广东深圳518001

出　　处：《检验医学与临床》2020年第11期1524-1527,共4页Laboratory Medicine and Clinic

基　　金：深圳市医疗卫生三名工程项目(SZSM201601062)。

摘　　要：目的从精密度、分析测量范围(AMR)、临床可报告范围(CRR)、参考区间验证及比对试验对罗氏Cobas c702全自动生化分析仪检测的41个项目进行性能验证。方法本文以临床较常见检测指标:天门冬氨酸氨基转移酶(AST)、乳酸脱氢酶(LDH)、肌酸激酶(CK)、肌酸激酶同工酶(CKMB)、α-羟丁酸脱氢酶(α-HBDH)、尿素(Urea)、肌酐(CREA)、尿酸(UA)、胱抑素C(CysC)为例进行考察。参考美国临床和实验室标准协会(CLSI)EP15-A3、CLSI EP6、美国临床实验室标准化委员会(NCCLS)C28-A2和NCCLS EP15-A2文件,使用Cobas c702的原装配套试剂及校准品,从精密度、AMR、CCR、参考区间验证及比对试验等角度对9个项目进行性能验证。结果罗氏Cobas c702全自动生化分析仪检测AST、LDH、CK、CKMB、α-HBDH、Urea、CREA、UA和CysC 9个项目的精密度验证均合格;各项目在AMR内均表现出良好的线性关系(R 2>0.95,b在0.93~1.03范围内);最大稀释倍数验证时回收率在可接受范围内,CCR为AMR的上限乘以最大的可稀释倍数;选择20份体检合格的健康人标本,在检测系统上进行测定,对结果进行统计并对仪器说明书提供的参考区间进行验证,结果显示参考区间验证通过率均≥90%,验证通过;比对试验中各项目相对偏倚小于实验室允许的偏倚或相对偏倚验证值,比对试验通过。结论罗氏Cobas c702全自动生化分析仪检测项目的精密度、AMR、CCR、参考区间验证及比对试验均验证通过。Objective From the precision,analytical measurement range(AMR),clinical reportable range(CRR),reference interval verification and comparison test,a total of 41 items are tested by the newly installed Roche Cobas c702 automatic biochemical analyzer,which is to tested for performance verification.Methods Common indicators:aspartate aminotransferase(AST),lactate dehydrogenase(LDH),creatine kinase(CK),creatine kinase isoenzyme(CKMB),alpha-hydroxybutyrate dehydrogenase(α-HBDH),urea(Urea),creatinine(CREA),uric acid(UA),and cystatin C(CysC)were examined as examples.Refer to Clinical and Laboratory Standards Institute(CLSI)EP15-A3,CLSI EP6,National Committee for Clinical Laboratory Standards(NCCLS)C28-A2 and NCCLS EP15-A2 documents,Cobas c702 original matching reagents and calibrators were used,from precision,AMR,CCR,reference interval verification and comparison test performed performance verification on 9 items.Results Roche Cobas c702 automatic biochemical analyzer tested AST,LDH,CK,CKMB,α-HBDH,Urea,CREA,UA and CysC 9 projects were all qualified for precision verification;Each project showed good linear relationship(R 2>0.95,slope 0.93~1.03.)within the AMR;Maximum dilution factor verification when the recovery rate was within the acceptable range.CRR was the upper limit of the AMR multiplied by the maximum dilutable.Select 20 healthy human that have passed the medical examination were selected,and the specimens were performed measurement on the detection system.Statistics on the results were performed and the reference interval provided by the instrument manual were verified.The pass rate of the reference interval was≥90%,and the verification passed.The relative bias of each item in the trial was less than the bias allowed by the laboratory or relative bias verification value,and the comparison passed.Conclusion The precision,AMR,CCR,reference interval verification and comparison test of the Roche Cobas c702 automatic biochemical analyzer test are verified.

关 键 词：全自动生化分析仪 性能验证 精密度 分析测量范围 临床可报告范围 参考区间 比对试验 

分 类 号：R446.1[医药卫生—诊断学]