摘要
目的研究某国产抗-HCV试剂样本吸光度/临界值(S/Co)的意义,探讨国产试剂检测抗-HCV的初步程序和标准。方法采用某国产试剂通过ELISA法检测295 000例无偿献血者的抗-HCV,对其阳性反应的样本采用Ortho抗-HCV试剂通过ELISA法进行检测。Ortho试剂阳性反应的样本进行HCV重组免疫印迹实验(RIBA),并对其中的106例Ortho试剂阳性反应的样本进行核酸检测。结果在295 000例样本中,某国产试剂抗-HCV阳性反应为681例,阳性率为0.23%。某国产试剂阳性反应的样本经Ortho试剂检测后阳性反应为367例,符合率为53.8%,其中Ortho试剂S/Co值≥3.8为66.2%。在Ortho试剂S/Co值≥3.8的样本中,某国产试剂S/Co值≥8.0的占94.2%;而Ortho试剂S/Co值<3.8的样本中,某国产试剂S/Co值<8.0的占99.2%。367例Ortho阳性反应样本中,RIBA HCV阳性223例,阳性率为60.8%;在国产试剂S/Co值≥8.0的样本中,RIBA阳性率为95.7%;而同一种国产试剂S/Co值<8.0的样本中,RIBA阳性率为2.2%。106例Ortho试剂阳性反应样本中核酸检测阳性为42例。结论国产抗-HCV试剂在检测无偿献血者样本中存在较高的假阳性率,一定程度上造成了血源和血液的浪费。某国产试剂S/Co值≥8.0和Ortho试剂S/Co值≥3.8具有一定的相关性,在实验室检测抗-HCV上具有一定诊断价值。
Objective To study the significance of the sample S/Co ratio when using a domestic reagent for anti-hepatitis C virus（HCV） antibody detection and to explore the procedure and standard of anti-HCV antibody diagnosis by using this domestic reagent. Methods Anti-HCV antibody was detected in 295 000 blood donors by a domestic anti-HCV reagent with enzyme-linked immunosorbent assay（ELISA） method and the reactive samples were tested again by ortho anti-HCV antibody reagent. The samples which anti-HCV antibodies were determined as positive by ortho anti-HCV reagent were examined by recombinant immunoblot assay（RIBA） reagent and 106 samples of them were also tested for HCV RNA. Results Six hundred and eighty-one samples were reactive in 295 000 samples screened by the domestic ELISA reagent,the reactive ratio was 0.23%. Among the reactive samples screened by the domestic ELISA reagent, 367 samples were determined as positive by ortho anti-HCV reagent while 66. 2% of them showed a S/Co ratio≥3. 8. The consistency rate between positive results determined by the domestic reagent and RIBA reagent respectively was 53. 8%. For the samples showing S/Co ratio≥3.8 by ortho anti-HCV reagent, 94. 2% had a S/Co ratio≥8. 0 when using the domestic ELISA reagent, while the percentage of samples showing S/Co ratio〈8.0 by domestic reagent was 99. 2% among the samples showing S/Co ratio〈3. 8 by ortho anti-HCV reagent. Two hundred and twenty-three（60.8%） samples were HCV RIBA positive in 367 positive samples determined by ortho reagent. HCV RIBA positive rate was 95. 7% in S/Co≥8. 0 samples determined by the domestic ELISA reagent and only 2.2 % in S/Co〈8.0 samples. Forty-two samples were HCV RNA positive in 106 HCV antibody positive samples determined by ortho anti-HCV reagent. Conclusions There is a high false positive rate when using the domestic ELISA reagent for HCV antibody screening in blood donors. This problem will result in the waste of the blood resource and donors. There is a relationship between samples showing S/Co≥8. 0 by domestic ELISA HCV reagent and samples showing S/Co≥3.8 by ortho anti-HCV reagent, which may be helpful for anti- HCV antibody detection.
出处
《中华传染病杂志》
CAS
CSCD
北大核心
2007年第4期206-210,共5页
Chinese Journal of Infectious Diseases
关键词
肝炎病毒
丙型
分光光度法
抗体
病毒
Hepatitis C virus
Spectrophotometry
Antibodies, viral
