摘要
目的：研究外周血乙肝病毒表面抗体定量和定性检测结果之间的一致性。方法采用微粒子酶免疫分析法定量检测，酶联免疫吸附法定性检测。结果以 CMIA 为参考实验，ELISA 法检测 anti-HBs 的 Se 、Sp 、J 、PV ＋、PV －分别为0.95、0.53、0.48、0.74、0.88，k ＝0.51；吸光度为0.4009时 Se 、Sp 、J 、PV ＋、PV －分别为0.50、0.95、0.45、0.93、0.43；对吸光度0.1043～0.4009范围外样本分析，ELISA 定性检测的 Se 、Sp 、J 、PV＋、PV－分别为0.90、0.91、0.81、0.93、0.88，k ＝0.81。结论吸光度值0.105为 ELISA 检测结果判定的 Cut-off 值具有良好的检测灵敏度（Se ＝0.95）和较好的阴性预测值（PV－＝0.88），ELISA 检测 Anti-HBs 阴性可认为 Anti-HBs 浓度小于10 mIU／mL 而不具有保护价值；当样本吸光度大于或等于0.4009时可认为 Anti-HBs 浓度大于或等于10 mIU／mL，具有保护意义；ELISA 检测 Anti-HBs 灰区范围主要是吸光度0.105～0.4009，应定量检测以判定 Anti-HBs 真实水平。
Objective To analyze the conformance between the quantitative and qualitative tests of hepatitis B surface antibody （anti-HBs）.Methods The chemiluminecence microparticle enzyme immunoassay（CMIA）was adopted to quantitatively detect anti-HBs and the enzyme linked immunosorbent assay（ELISA）was adopted to qualitatively detect anti-HBs.Results With the CMIA as the reference experiment,Se ,Sp ,J ,PV＋ and PV-of anti-HBs detected by ELISA were 0.95,0.53,0.48,0.74 and 0.88 respec-tively,k=0.51;when the absorbance was 0.400 9,Se ,Sp ,J ,PV＋ and PV-were 0.50,0.95,0.45,0.93 and 0.43 respectively;for the samples exceeding the absorbance range of 0.104 3 -0.400 9,Se ,Sp ,J ,PV＋ and PV-qualitatively detected by ELISA were 0.90,0.91,0.81,0.93 and 0.88 respectively,k =0.81.Conclusion Determining cutoff value with the absorbance value 0.105 as the ELISA detection result has the good detection sensitivity（Se =0.95）and the better negative prediction value（PV-=0.88）,the negative anti-HBs detected by ELISA may be considered that the anti-HBs concentration was less than 10 mIU/mL without the conservation value;when the sample absorbance ≥0.400 9,the anti-HBs concentration is ≥10 mIU/mL,which may be considered to have the conservation value;the gray area range of anti-HBs detected by ELISA is mainly the absorbance of 0.105-0.400 9,the true anti-HBs level should be quantitatively detected.
出处
《国际检验医学杂志》
CAS
2014年第23期3239-3240,3243,共3页
International Journal of Laboratory Medicine
关键词
乙型肝炎病毒表面抗体
酶联免疫吸附法
微粒子酶免疫分析法
灰区
hepatitis B surface antibody enzyme-linked immunosorbent assay chemiluminecence microparticle enzyme im-munoassay gray area
