CAJ | 학술논문

目的：对 ABBOTT ARCHITECT C16000生化分析仪主要性能进行评价，判断其是否能够满足本科实验室需求。方法依照实验室管理办法及国家实验室认可的要求，分别采用美国临床和实验室标准化协会（CLSI）的 EP5-A2、EP9-A2和EP6-A 文件评价方法分析尿素（Urea）、肌酐（Cre）、尿酸（UA）和葡萄糖（Glu）等17项检测项目的精密度、准确度和线性；并对各检测项目引用的参考区间进行验证。结果 ABBOTT ARCHITECT C16000生化分析仪 Urea、Cre、UA、Glu 等17项检测项目批内精密度变异系数（CV）均小于或等1／4CLIA′88标准，批间精密度 CV 均小于或等于1／3CLIA′88标准；在准确度试验中，该17项检测项目的相对偏倚均小于或等于1／2CLIA′88标准；线性良好（r2＞0.95）；各检测项目引用的参考区间合适。结论 ABBOTT ARCHITECT C16000生化分析仪性能满足本实验室需求。
목적：대 ABBOTT ARCHITECT C16000생화분석의주요성능진행평개，판단기시부능구만족본과실험실수구。방법의조실험실관리판법급국가실험실인가적요구，분별채용미국림상화실험실표준화협회（CLSI）적 EP5-A2、EP9-A2화EP6-A 문건평개방법분석뇨소（Urea）、기항（Cre）、뇨산（UA）화포도당（Glu）등17항검측항목적정밀도、준학도화선성；병대각검측항목인용적삼고구간진행험증。결과 ABBOTT ARCHITECT C16000생화분석의 Urea、Cre、UA、Glu 등17항검측항목비내정밀도변이계수（CV）균소우혹등1／4CLIA′88표준，비간정밀도 CV 균소우혹등우1／3CLIA′88표준；재준학도시험중，해17항검측항목적상대편의균소우혹등우1／2CLIA′88표준；선성량호（r2＞0.95）；각검측항목인용적삼고구간합괄。결론 ABBOTT ARCHITECT C16000생화분석의성능만족본실험실수구。
Objective To evaluate the main performance of ABBOTT ARCHITECT C160000 biochemistry analyzer,and to judge whether the performance meets the laboratory requirement.Methods According to the clinical laboratory management meth-od and the requirement of accreditation of national laboratory,the precision,accuracy and linearity of the 17 test items(Urea,Cre, UA,Glu,etc.)were analyzed by the CLSI EP5-A2 document,CLSI EP9-A2 document and CLSI EP6-P document;the quotative ref-erence ranges of the 17 test items were verified.Results The coefficient of variation(CV)in within-batch precision of Urea,Cre, UA,Glu,etc.was ≤1/4 CLIA′88 standard and CV in the between-batch precision ≤1/3CLIA′88 standard;in the accuracy test,the relative bias of the 17 test items≤1/2CLIA′88 standard;the linearity of the 17 items was good(r2 >0.95);the cited reference range of various detection items was suitable.Conclusion The performance of the ABBOTT ARCHITECT C160000 automatic biochem-istry analyzer meets the laboratory demand.