丙型肝炎患者IFN治疗前后肝内HCV-Ag表达状况的研究

应用抗HCV NS4 McAb以酶标链霉亲和素生物素化二抗方法(LAB法),对IFN_2治疗前后肝组织进行免疫组化研究。结果显示HCV-Ag位于肝细胞浆中,治疗前后肝内HCV-Ag定位相似。但是治疗后HCV-Ag阳性肝细胞数量有明显变化,IFN有效者HCV-Ag阳性肝细胞数量明显减少或消失,且与血清HCV-RNA的变化基本一致。治疗前后肝HCV-Ag染色的变化与肝HAI计分变化的符合程度优于血清ALT和HCV-RNA。提示肝内HCV-Ag的检测可能有助于IFN疗效的预测和评价。     

Hepatitis C core antigen highly correlated to HCV RNA

Hepatitis C virus core antigen (HCV-Ag) immunoassay has been proposed as a more cost and time efficient one-step alternative to the current two-step screening and diagnostic process. This study investigates the correlation between the HCV-Ag immunoassay and the current gold standard of Hepatitis C Virus (HCV) ribonucleic acid (RNA) molecular assay. Stored sera of 221 consecutive treatment-naive patients tested anti-HCV positive were selected to undergo both HCV-Ag immunoassay and HCV RNA molecular assay. Active infection status and HCV genotype were determined using both assays, and correlation was calculated using a logarithmic scale. Among 221 anti-HCV-positive sera, 197 were positive for both HCV Ag (≥3 fmol/L) and HCV RNA (>15 IU/mL), 22 were negative for both tests, while 2 were positive to HCV RNA only. The sensitivity and specificity for HCV Ag in predicting HCV RNA were 99% and 100%, respectively. Out of 199 patients (90%) tested positive for HCV viremia, 107 (56%) were of genotype 1, 77 (38.7%) of genotype 2 and 15 of other genotypes. Analysis of 221 anti-HCV-positive patient sera found a strong positive correlation between HCV RNA and HCV-Ag (r = 0.960, p < 0.001). Genotype 1 (log [HCV RNA] = 0.988 x log [HCV-Ag] + 2.768), with correlation coefficient 0.945, exhibited a stronger correlation than genotype 2 (log [HCV RNA] = 0.859 x log [HCV-Ag] + 2.859; r = 0.862). Given the strong positive correlation between HCV-Ag immunoassay and HCV RNA molecular assay in genotyping affected individuals, we propose that HCV-Ag immunoassay is a more cost and time efficient alternative to the current two-step diagnostic process.     

HCV不同标志物检测结果比较分析

目的分析丙型肝炎病毒抗原、抗体及核酸标志物实验室检测结果之间的关联性。方法用丙型肝炎病毒抗体(HCV-Ab)、丙型肝炎病毒核酸(HCV-RNA)扩增(PCR)荧光定量、丙型肝炎病毒核心抗原(HCV-CAg)及丙型肝炎病毒抗原(HCV-Ag)检测试剂盒,分别检测血清或血浆样品中的HCV-Ab、HCV-RNA、HCV-CAg和HCV-Ag丙型肝炎病毒4种标志物,对检测结果之间的关联性进行分析。结果在1551份血清或血浆样品中,共检出HCV-Ab阳性样品565份(36.43%)、HCV-Ag(游离抗原)阳性样品48份(3.09%)、HCV-RNA阳性样品317份(20.44%)、HCV-CAg阳性样品25份(1.61%),HCV-Ab及HCV-RNA检出率明显高于抗原检出率(P<0.01),其阳性样品检出率按高低顺序依次为HCV-Ab、HCV-RNA、HCV-Ag和HCV-CAg。结论 4种标志物的检测可以联合运用,能有效降低HCV-Ab检测带来的漏检风险。     

丙型肝炎病毒核心抗原检测的临床应用

目的探讨HCV核心抗原(HCV-Ag)ELISA法检测的方法及临床价值。方法采用ELISA法检测77份疑为HCV感染患者血清中的HCV-Ag,并将HCV-Ag检测与HCV-RNAPCR法和抗-HCV检测相比较。结果 HCV-RNAPCR、HCV-Ag、抗-HCV阳性率分别为42.86%、44.16%、38.96%;同HCV-RNA检测结果比较,HCV-Ag检测符合率90.91%、假阳性率3.90%、假阴性率5.19%;抗-HCV检测符合率84.42%、假阳性率6.49%、假阴性率9.09%。结论 ELISA法检测HCV-Ag敏感性和特异性较好,与PCR检测的符合率较高。方法简捷、价廉,早期检测可明显缩短窗口期,适合大规模筛查和多数基层医院。