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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。
PURPOSE: To evaluate the diagnostic value of the HCVcAg diagnostic reagent in the clinical use of HCV infection. Methods: HCVcAg, anti-HCV and HCV RNA were detected simultaneously in 214 patients with HCV infection, 60 healthy subjects and 40 other non-HCV infected hepatitis patients, and 78 HIV-infected patients were screened and analyzed for HCV infection HCVcAg reagent sensitivity, specificity. RESULTS: Of the 214 confirmed HCVcAg tests in HCV patients, 162 (75.7%) were positive, and the higher the HCV RNA level, the higher HCVcAg detection rate. The coincidence rate of HCVcAg and HCV RNA was 98.7% when the HCV RNA load was> 106 / ml. The HCVcAg tests of 60 healthy controls and 40 non-HCV infected hepatitis were all negative, which indicated that HCVcAg was more effective in diagnosing HCV infection Highly specific. HCV RNA was detected in 78 samples of HIV-infected individuals, 16 were positive, 15 were positive by HCVcAg assay and only 9 were positive by anti-HCV assay. CONCLUSIONS: HCVcAg can be used as a serological marker for the diagnosis of HCV infection, as well as in immunosuppressive agents and in patients with suppressed anti-HCV production, as well as in alternative HCV RNA tests in hospital laboratories that do not have a PCR.