CAJ | 학술논문

目的：自建血管紧张素转化酶检测系统的性能评价。方法依据临床和实验室标准化协会（CLSI）标准中EP5‐A2， EP9‐A文件的要求，采用全自动生化分析仪对九强公司的ACE试剂盒的精密度、线性、与比对试剂的相关性以及可报告范围等一些性能进行评价。结果自建系统血清ACE高低值的批内 CV分别为6．87％和2．39％，批间CV分别为6．09％和1．81％，日间CV分别为8．00％和2．8％均在厂家提供的小于10％的范围内；线性结果R2＝0．99；与比对试剂相关系数 r＝0．99056，且平均偏倚为8．55％有良好的相关性；血清ACE检测试剂盒可报告范围为9．0U／L‐600U／L。结论自建ACE检测系统各项性能可以满足临床应用的要求。
목적：자건혈관긴장소전화매검측계통적성능평개。방법의거림상화실험실표준화협회（CLSI）표준중EP5‐A2， EP9‐A문건적요구，채용전자동생화분석의대구강공사적ACE시제합적정밀도、선성、여비대시제적상관성이급가보고범위등일사성능진행평개。결과자건계통혈청ACE고저치적비내 CV분별위6．87％화2．39％，비간CV분별위6．09％화1．81％，일간CV분별위8．00％화2．8％균재엄가제공적소우10％적범위내；선성결과R2＝0．99；여비대시제상관계수 r＝0．99056，차평균편의위8．55％유량호적상관성；혈청ACE검측시제합가보고범위위9．0U／L‐600U／L。결론자건ACE검측계통각항성능가이만족림상응용적요구。
Objective To evaluate the performance of self‐established angiotensin converting enzyme (ACE) detection system . Methods The performance evaluation of ACE reagent kit produced by the Jiuqiang Company including precision ,linearity ,correla‐tion with the reference reagent and reportable range were conducted by using the automatic biochemical analyzer according to the re‐quirements of the EP5‐A2 and EP9‐A documentation in the Clinical and Laboratory Standards Institute (CLSI) .Results Intra‐as‐say CV of the system were 6 .87% ,2 .39% and inter‐assay CV were 6 .09% ,1 .81% ,respectively .During the day CV were 8 .00 %and 2 .8% respectively ,which were less than those provided by the manufacturer (<10% );the lenearity result was R2 =0 .99 .The correlation coefficient (r) of the system comparing with the reference reagent was 0 .990 56 ,moreover the average bias was 8 .55% , showing good correlation ;the repotable range was 9 .0U/L‐600U/L .Conclusion Self‐established ACE detection system can meet the requirements for clinical application .