丙型肝炎病毒核心抗原检测在临床诊断HCV感染的价值

The value of HCVcAg detection by a sandwich-ELISA system in clinical diagnosis of HCV infection

目的:评估丙型肝炎病毒核心抗原(HCVcAg)诊断试剂在临床运用对HCV感染的诊断价值。方法:对临床214例确认HCV感染者、60例健康体检者、40例非HCV感染的其他肝炎患者同时检测HCVcAg、抗HCV和HCV RNA,并对78例HIV感染者进行HCV感染筛查,分析HCVcAg试剂的敏感性、特异性。结果:214例确认丙肝患者HCVcAg检测162例(75.7%)阳性,且HCV RNA水平越高,HCVcAg检出率也越高。当HCV RNA载量>106/ml时,HCVcAg与HCV RNA检测的符合率达98.7%;60例健康对照和40例非HCV感染的各种肝炎HCVcAg检测均为阴性,显示了HCVcAg对诊断HCV感染得高度特异性。对78份HIV感染者样本进行HCV RNA测定,有16例阳性,以HCVcAg法测定有15例阳性,以抗HCV法测定仅有9例阳性。结论:HCVcAg可作为HCV感染诊断的血清病毒标志物,也可用于使用免疫抑制剂,抗HCV产生受到抑制的患者,以及在一些不具备开展PCR的医院实验室作为HCV RNA检测的替代试验。

Objective：To evaluate the utility of HCVcAg detection system in clinical diagnosis of hepatitis C infection. Methods： HCVcAg and anti-HCV in sera of 214 hepatitis C patients,60 health control and 40 patients with other hepatic disease were detected by ELISA, and sera HCV RNA was measured by real-time quantitative PCR. Meanwhile, the sera from 78 patients with HIV infection were screened for HCV infection. Results： 162 patients （75.7%） were HCVcAg positive in 214 hepatitis C patients. The positive ratio of HCVcAg increased with the HCV RNA copies. The HCV RNA copies were highly related with the HCVeAg with HCV RNA copies over 106/ml. Of 78 samples with HIV, 16 were HCV RNA positive, 15 were HCVcAg positive,9 were anti-HCV positive. Conclusions： HCVcAg is a serological marker for early identification of HCV. The measurement of HCVcAg significantly shortens the window period of HCV detection, especially for the individuals with negative anti-HCV detection resuhs who use immunosuppressant,and is substituted for HCV RNA detection in where PCR cannot be carried out.