酶联免疫吸附测定法检测人血清丙型肝炎病毒NS3抗原的临床应用与分析

Clinical application and analysis of hepatitis C virus NS3 antigen detection by ELISA in human serum.

作者信息

Xie Li, Wu Xiao-dong, Huang De-zhuang, Chen Hai-lun, He Li-xiang, Wang Jian, Han Da-kang

机构信息

Institute for Viral Hepatitis, Beijing You'an Hospital, Capital Medical University, Beijing 100069, China.

出版信息

Chin Med J (Engl). 2007 Feb 20;120(4):294-9.

PMID:17374280

Abstract

BACKGROUND

Hepatitis C virus (HCV) core antigen assays have been produced to exclude infectious donations collected during the preseroconversion window phase (PWP). For the same purpose, we evaluated the specificity and sensitivity of a novel hepatitis C virus NS3 antigen detection immunoassay and the application of this assay in clinical diagnosis.

METHODS

Samples from 77 healthy subjects, 173 anti-HCV positive patients and 3708 hepatitis patients other than HCV positive were tested with the HCV NS3 antigen assay. Some HCV NS3 antigen positive samples were further validated with HCV-RNA, neutralization and immunodot assays. Twenty-five sequential samples from 11 HCV NS3 antigen positive patients were subjected to kinetic study.

RESULTS

Only 48 (1.3%) of 3708 anti-HCV negative samples were positive for HCV NS3 antigen. Among them, 44 of 3030 samples from patients only infected with HBV were HCV NS3 antigen positive, 4 of the 445 samples from patients infected with other type hepatitis were HCV NS3 antigen positive. In addition, 42 (24.3%) of 173 anti-HCV positive samples were HCV NS3 antigen positive and all 77 samples from healthy subjects were negative to HCV NS3 antigen assay. Of the 15 HCV NS3 antigen positive samples, 9 (60%) were HCV-RNA positive. The neutralization and positive percentage of immunodot assay for 23 HCV NS3 antigen positive sera were 87.0% (20/23) and 69.6% (16/23) respectively. Of the 25 sequential samples from 11 HCV NS3 antigen positive patients, there was a negative correlation between the OD values and the duration of test (r = -0.989, P < 0.05), and there were correlations among their HCV NS3 antigen, HCV-RNA and anti-HCV titres. The anti-HCV antibodies of two sera were detected while their OD values of HCV NS3 antigen decreased gradually.

CONCLUSIONS

The HCV NS3 antigen detection assay showed perfect specificity and high sensitivity. Thus, it would be useful and economical as a routine test in laboratories for early diagnosis of HCV infection and prevention.

摘要

背景

已研发出丙型肝炎病毒（HCV）核心抗原检测方法，以排除在血清阳转前窗口期（PWP）采集的具有传染性的献血。出于同样目的，我们评估了一种新型丙型肝炎病毒NS3抗原检测免疫分析法的特异性和敏感性，以及该分析法在临床诊断中的应用。

方法

采用HCV NS3抗原分析法检测了77名健康受试者、173名抗-HCV阳性患者和3708名非HCV阳性的肝炎患者的样本。部分HCV NS3抗原阳性样本进一步通过HCV-RNA、中和试验和免疫斑点试验进行验证。对11名HCV NS3抗原阳性患者的25份连续样本进行了动力学研究。

结果

3708份抗-HCV阴性样本中，仅48份（1.3%）HCV NS3抗原呈阳性。其中，仅感染HBV患者的3030份样本中有44份HCV NS3抗原呈阳性，感染其他类型肝炎患者的445份样本中有4份HCV NS3抗原呈阳性。此外，173份抗-HCV阳性样本中有42份（24.3%）HCV NS3抗原呈阳性，77份健康受试者样本的HCV NS3抗原检测均为阴性。在15份HCV NS3抗原阳性样本中，9份（60%）HCV-RNA呈阳性。23份HCV NS3抗原阳性血清的中和试验阳性率和免疫斑点试验阳性率分别为87.0%（20/23）和69.6%（16/23）。在11名HCV NS3抗原阳性患者的25份连续样本中，OD值与检测时间呈负相关（r = -0.989，P < 0.05），其HCV NS3抗原、HCV-RNA和抗-HCV滴度之间存在相关性。两份血清的抗-HCV抗体在其HCV NS3抗原OD值逐渐下降时被检测到。