CAJ | 학술논문

目的按照ISO15189要求对两台强生VITROS 3600化学发光分析仪上的相同项目进行比对试验,以评估检测结果的一致性.方法分别使用两台仪器对anti-HCV的精密度,准确度进行验证试验,并对临床收集的Anti-HCV阴性10份、阳性10份和弱阳性20份血清样本共40份进行比对试验,检测结果行统计学分析.结果两台仪器阴性和阳性质控品批内精密度变异系数分别为5％、4％、7.14％和7.23％,批间精密度分别为9.47％、7.7％和8.04％、7.6％,均小于ISO15189要求的CV(15％),两仪器准确度为100％,质控品检测结果差异无统计学意义(P＜0.05).临床样本检测结果相关性分析R2 =0.9984,具有良好的一致性.结论两台强生VITROS 3600化学发光分析仪检测结果,一致性良好,具有可比性.
목적 안조ISO15189요구대량태강생VITROS 3600화학발광분석의상적상동항목진행비대시험,이평고검측결과적일치성.방법 분별사용량태의기대anti-HCV적정밀도,준학도진행험증시험,병대림상수집적Anti-HCV음성10빈、양성10빈화약양성20빈혈청양본공40빈진행비대시험,검측결과행통계학분석.결과 량태의기음성화양성질공품비내정밀도변이계수분별위5％、4％、7.14％화7.23％,비간정밀도분별위9.47％、7.7％화8.04％、7.6％,균소우ISO15189요구적CV(15％),량의기준학도위100％,질공품검측결과차이무통계학의의(P＜0.05).림상양본검측결과상관성분석R2 =0.9984,구유량호적일치성.결론 량태강생VITROS 3600화학발광분석의검측결과,일치성량호,구유가비성.
Objective To estimate the consistency of two VITROS 3600 chemiluminescent analyzers according to the requirement of ISO15189.Methods Verification tests were made for precision and accuracy of anti-HCV in two instruments.While 40 serum samples including Anti-HCV negative (10 cases),positive (10 cases),and weakly positive (20 cases).and the test results were statistical analised.Results Two instruments negative and positive control samples intra-batch precision and coefficients of variation were 5％,4％ and 7.14％,7.23％,inter-batch precision and coefficients of variation were 9.47％,7.7％ and 8.04％,7.6％,are less than requirement CV (15％) by ISO15189.The accuracy of two instrument were 100％,The test results of the control samples showed no significant difference (P ＜0.05).The correlation analysis of the test results of clinical samples R2 =0.9984,with good consistency.Conclusion Test results of two Vitros 3600 has good consistency and comparability.