丙型肝炎病毒核心抗原：定量自动化免疫分析法的分析性能、与病毒血症的相关性及其潜在应用。

Hepatitis C virus core antigen: analytical performances, correlation with viremia and potential applications of a quantitative, automated immunoassay.

机构信息

Virology Unit, Section of Microbiology, University of Parma, Italy.

出版信息

J Clin Virol. 2011 Aug;51(4):264-9. doi: 10.1016/j.jcv.2011.05.003. Epub 2011 May 28.

DOI:10.1016/j.jcv.2011.05.003

PMID:21621454

Abstract

BACKGROUND

Testing for hepatitis C virus core antigen (HCV Ag) may represent a complementary tool to anti-HCV and HCV-RNA in the diagnosis and monitoring of HCV infection.

OBJECTIVE

To evaluate the performance characteristics of the automated Abbott ARCHITECT HCV Ag assay.

STUDY DESIGN

Five sites analyzed over 3000 routine serum samples from populations at different risk, comparing HCV Ag results with anti-HCV screening and supplemental assay results and with HCV-RNA.

RESULTS

The HCV Ag assay showed a specificity of 100%, a good precision (CV<10%) and excellent dilution linearity (r>0.999). The sensitivity (3 fmol/L) corresponds to 700-1100 IU/mL of HCV-RNA. A non-linear correlation with HCV-RNA was found: r=0.713 vs. Siemens bDNA (523 specimens), r=0.736 vs. Roche Cobas TaqMan (356 specimens) and r=0.870 vs. Abbott Real-Time PCR (273 specimens). HCV Ag quantitation was equally effective on different HCV genoypes (239 for genotype 1/1a/1b/1c, 108 for genotype 2/2a/2c, 86 for genotype 3/3a, 50 for genotype 4/4a/4c/4d). Testing of subjects at high risk for HCV and with potential or actual impairment of the immune system identified 2 cases negative for anti-HCV and positive for HCV Ag on 361 hemodialyzed (0.6%) and 7 cases on 97 (7.2%) among transplant recipients. HCV Ag positivity anticipated anti-HCV seroconversion in all three cases of acute hepatitis C.

CONCLUSIONS

HCV Ag may be used as reflex testing on anti-HCV positive individuals to confirm or exclude an active infection, and on subjects with acute hepatitis or belonging to high risk groups.

摘要

背景

检测丙型肝炎病毒核心抗原 (HCV Ag) 可能成为丙型肝炎病毒感染诊断和监测的一种补充工具，可与抗 HCV 和 HCV-RNA 联合使用。

目的

评估自动 Abbott ARCHITECT HCV Ag 检测的性能特征。

研究设计

五个地点分析了来自不同风险人群的 3000 多个常规血清样本，将 HCV Ag 结果与抗 HCV 筛查和补充检测结果以及 HCV-RNA 进行比较。

结果

HCV Ag 检测的特异性为 100%，精密度良好（<10%CV），稀释线性度极好（r>0.999）。灵敏度（3 fmol/L）相当于 700-1100 IU/mL HCV-RNA。与 HCV-RNA 呈非线性相关：r=0.713 与 Siemens bDNA（523 个标本），r=0.736 与 Roche Cobas TaqMan（356 个标本），r=0.870 与 Abbott Real-Time PCR（273 个标本）。HCV Ag 定量对不同 HCV 基因型同样有效（1 型/1a/1b/1c 型 239 例，2 型/2a/2c 型 108 例，3 型/3a 型 86 例，4 型/4a/4c/4d 型 50 例）。对丙型肝炎高危人群和免疫功能受损或实际受损的人群进行检测，在 361 名血液透析患者（0.6%）中发现 2 例抗 HCV 阴性和 HCV Ag 阳性，在 97 名移植受者（7.2%）中发现 7 例。在所有 3 例急性丙型肝炎中，HCV Ag 阳性均预示着抗 HCV 血清转换。