CAJ | 학술논문

目的对索林LIAISON XL化学发光免疫分析系统主要性能进行评价。方法以CLSI(美国临床实验室标准化委员会)制定的评价标准,通过一系列实验设计,对索林LIAISON XL化学发光免疫分析系统乙肝两对半检测的精密度、线性范围、符合率、分析灵敏度等进行评价。结果 LIAISON XL化学发光免疫分析系统进行乙肝两对半检测,批内不精密度CV在1.56~3.07%,批间不精密度在2.64~5.44%,HBsAg、HBsAb、HBeAg的分析灵敏度分别为0.03IU/ml、5 mlU/ml、0.01PEIU/ml。结论 LIAISON XL化学发光免疫分析系统各方面性能良好,测定样本快速,准确度精密度可靠,能适应医院临床样本的检测需要。
목적대색림LIAISON XL화학발광면역분석계통주요성능진행평개。방법이CLSI(미국림상실험실표준화위원회)제정적평개표준,통과일계렬실험설계,대색림LIAISON XL화학발광면역분석계통을간량대반검측적정밀도、선성범위、부합솔、분석령민도등진행평개。결과 LIAISON XL화학발광면역분석계통진행을간량대반검측,비내불정밀도CV재1.56~3.07%,비간불정밀도재2.64~5.44%,HBsAg、HBsAb、HBeAg적분석령민도분별위0.03IU/ml、5 mlU/ml、0.01PEIU/ml。결론 LIAISON XL화학발광면역분석계통각방면성능량호,측정양본쾌속,준학도정밀도가고,능괄응의원림상양본적검측수요。
Objective Analytical performance of the chemiluminescence immunoassay system in Liaison. Methods The precision, accuracy, linearity and sensitivity analysis of HBV markers were validated according to Clinical and Laboratory Standards Institute (CLSI) documents through a series of experimental design. Results The intra-and inter-precisions of HBV markers by LIAISON XL were 1.56%~3.07%and 2.64%~5.44%, respectively. The sensitivity analysis of HBsAg, HBsAb and HBeAg were 0.03IU/ml, 5 mlU/ml and 0.01 PEIU/ml, respectively. Conclusion Liaison is suitable for clinical application with good precision, accuracy and faster detection speed.