CAJ | 학술논문

目的对化学发光法定量检测乙型肝炎病毒标志物的I临床应用进行评价.方法用标准参考血清和定值质控血清,对化学发光法定量检测乙型肝炎病毒标志物进行评价,评价内容为符合率、分析灵敏度、分析特异性、批内和批间精密度、最低检出限等指标.结果 HBsAg符合率为97.5%,其他四项符合率大于92%;HBsAg分析灵敏度100%、分析特异性96.15%;五项的批内和批间精密度均小于15%;最低检出限分别为HBsAg 0.06 IU/mL、HBsAb 0.5 mIU/mL、HBeAg 0.05NCU/mL、HBeAb 0.5 NCU/mL、HBcAb 0.5 NCU/mL.结论化学发光法定量检测乙型肝炎病毒标志物各项性能指标能满足临床要求,但操作需注意标本质量.
목적 대화학발광법정량검측을형간염병독표지물적I림상응용진행평개.방법 용표준삼고혈청화정치질공혈청,대화학발광법정량검측을형간염병독표지물진행평개,평개내용위부합솔、분석령민도、분석특이성、비내화비간정밀도、최저검출한등지표.결과 HBsAg부합솔위97.5%,기타사항부합솔대우92%;HBsAg분석령민도100%、분석특이성96.15%;오항적비내화비간정밀도균소우15%;최저검출한분별위HBsAg 0.06 IU/mL、HBsAb 0.5 mIU/mL、HBeAg 0.05NCU/mL、HBeAb 0.5 NCU/mL、HBcAb 0.5 NCU/mL.결론 화학발광법정량검측을형간염병독표지물각항성능지표능만족림상요구,단조작수주의표본질량.
Objective To evaluate clinical application of quantitative determination of HBVM with ehemiluminesence immunoassay. Methods Reference serum and rating quality control serum were used to evaluate quantitative determination of HBVM with chemiluminesence immunoassay, including the accordance rate,sensitivity,specificity,intra- and inter-batch precision,minimal detection limit,and so on. Results The accordance rate of HBsAg was 97.5%, and that of the other four items exceeded 920% ; sensitivity of HBsAg was 100%, specificity 96.15% ; the imprecisions of all five items were be-low 15% ; the minimal detection limits were HBsAg 0.06 IU/mL, HBsAb 0. 5 mIU/mL, HBeAg 0.05 NU/mI,HBeAb 0.5 NCU/m, and HBcAb 0.5 NCU/mL. Conclusion Quantitative determination ofHBVM with chemiluminesence imrnunoassay could satisfy clinical demands, but the sample's quality should be noticed during the practical operation.