CAJ | 학술논문

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。
목적：연구외주혈을간병독표면항체정량화정성검측결과지간적일치성。방법채용미입자매면역분석법정량검측，매련면역흡부법정성검측。결과이 CMIA 위삼고실험，ELISA 법검측 anti-HBs 적 Se 、Sp 、J 、PV ＋、PV －분별위0.95、0.53、0.48、0.74、0.88，k ＝0.51；흡광도위0.4009시 Se 、Sp 、J 、PV ＋、PV －분별위0.50、0.95、0.45、0.93、0.43；대흡광도0.1043～0.4009범위외양본분석，ELISA 정성검측적 Se 、Sp 、J 、PV＋、PV－분별위0.90、0.91、0.81、0.93、0.88，k ＝0.81。결론흡광도치0.105위 ELISA 검측결과판정적 Cut-off 치구유량호적검측령민도（Se ＝0.95）화교호적음성예측치（PV－＝0.88），ELISA 검측 Anti-HBs 음성가인위 Anti-HBs 농도소우10 mIU／mL 이불구유보호개치；당양본흡광도대우혹등우0.4009시가인위 Anti-HBs 농도대우혹등우10 mIU／mL，구유보호의의；ELISA 검측 Anti-HBs 회구범위주요시흡광도0.105～0.4009，응정량검측이판정 Anti-HBs 진실수평。
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.