Orito E, Mizokami M, Tanaka T, Lau J Y, Suzuki K, Yamauchi M, Ohta Y, Hasegawa A, Tanaka S, Kohara M
Second Department of Medicine, Nagoya City University Medical School, Japan.
Gut. 1996 Dec;39(6):876-80. doi: 10.1136/gut.39.6.876.
BACKGROUND/AIM: A novel fluorescent enzyme immunoassay (FEIA) for the detection and quantification of serum hepatitis C virus (HCV) core protein was developed. The aim of this study was to evaluate the relation among serum HCV core protein level, HCV RNA level, and HCV genotype in patients with chronic HCV infection.
Serum HCV core protein, HCV RNA, HCV genotype were determined in 175 patients using the FEIA, branched DNA assay (Quantiplex HCV RNA ver 1.0), and serologically defined genotyping assay, respectively. For the specificity, all 13 patients seronegative for anti-HCV were negative for serum core antigen and HCV RNA by FEIA and bDNA, respectively.
FEIA assay seems to be more sensitive than bDNA for patients with HCV type 2 infection (detection: 83.4% v 63.4%, p < 0.01). There was a good overall correlation between the FEIA and bDNA results. However, when the patients were stratified into their HCV types, a correlation was observed in HCV type 1 but not in type 2 infection. Patients with HCV type 2 infection had a lower serum HCV core protein level (median 56 RFI) compared with type 1 infection (median 149 RFI, p < 0.01). Thirty seven patients subsequently received interferon alpha therapy, patients who showed a complete and sustained response had a lower pretreatment serum HCV core protein level compared with patients who had a relapse and nonresponders (36 v 338 RFI, p < 0.01).
This study showed that FEIA (1) is a good assay for the detection and quantification of serum HCV core protein level, (2) is also very sensitive in detecting HCV core protein in patients with HCV type 2 infection, and (3) may have a role as a predictor of subsequent response to interferon therapy.
背景/目的：开发了一种用于检测和定量血清丙型肝炎病毒（HCV）核心蛋白的新型荧光酶免疫测定法（FEIA）。本研究的目的是评估慢性HCV感染患者血清HCV核心蛋白水平、HCV RNA水平和HCV基因型之间的关系。
分别采用FEIA、分支DNA测定法（Quantiplex HCV RNA ver 1.0）和血清学定义的基因分型测定法，对175例患者的血清HCV核心蛋白、HCV RNA、HCV基因型进行测定。为评估特异性，13例抗-HCV血清学阴性患者的血清核心抗原和HCV RNA通过FEIA和bDNA检测分别均为阴性。
对于2型HCV感染患者，FEIA测定法似乎比bDNA更敏感（检测率：83.4%对63.4%，p<0.01）。FEIA和bDNA结果之间总体相关性良好。然而，当将患者按HCV类型分层时，1型HCV感染患者中观察到相关性，而2型感染患者中未观察到。与1型感染患者（中位数149 RFI）相比，2型HCV感染患者的血清HCV核心蛋白水平较低（中位数56 RFI，p<0.01）。37例患者随后接受了α干扰素治疗，与复发患者和无反应者相比，显示完全和持续反应的患者治疗前血清HCV核心蛋白水平较低（36对338 RFI，p<0.01）。
本研究表明，FEIA（1）是检测和定量血清HCV核心蛋白水平的良好测定法，（2）在检测2型HCV感染患者的HCV核心蛋白方面也非常敏感，（3）可能作为后续干扰素治疗反应的预测指标。
