Hosein B, Fang C T, Popovsky M A, Ye J, Zhang M, Wang C Y
United Biomedical, Inc., Lake Success, NY 11042.
Proc Natl Acad Sci U S A. 1991 May 1;88(9):3647-51. doi: 10.1073/pnas.88.9.3647.
Cloning and expression of hepatitis C virus have allowed the development of immunoassays to detect hepatitis C virus infection. However, currently available recombinant fusion protein C100-3 assays, based on a nonstructural protein of the virus, are limited in sensitivity, particularly for detecting acute infection. In this report seroconversion panels showed that an assay based on synthetic peptides, derived from immunodominant regions of both capsid and nonstructural proteins, accelerated hepatitis C virus antibody detection by 4-10 weeks. In screening, this enzyme immunoassay increased detection from 47% to 64% in plasmapheresis donors with elevated alanine aminotransferase levels (greater than 100 international units per liter), from 15% to 24% in anti-hepatitis B core antigen-positive blood donors, and from 28% to 42% in renal dialysis patients when compared with nonstructural peptide-based assays. The screening assay was repeatedly reactive for 27 of 2902 volunteer blood donor samples (0.93%); four sera reacted only with the capsid antigen. The peptide test distinguished true from false positive results in agreement with recombinant immunoblot assay in 96% of blood donor samples repeatably reactive on a recombinant hepatitis C virus enzyme immunoassay.
丙型肝炎病毒的克隆与表达推动了用于检测丙型肝炎病毒感染的免疫测定方法的发展。然而，目前基于该病毒非结构蛋白的重组融合蛋白C100-3测定法在灵敏度方面存在局限性，尤其是在检测急性感染时。在本报告中，血清转化样本显示，一种基于源自衣壳蛋白和非结构蛋白免疫显性区域的合成肽的测定法，可将丙型肝炎病毒抗体检测提前4至10周。在筛查中，与基于非结构肽的测定法相比，这种酶免疫测定法在丙氨酸氨基转移酶水平升高（大于每升100国际单位）的血浆置换供者中，检测率从47%提高到64%；在抗乙型肝炎核心抗原阳性的献血者中，检测率从15%提高到24%；在肾透析患者中，检测率从28%提高到42%。在2902名志愿献血者样本中，有27份（0.93%）的筛查测定法呈反复阳性反应；4份血清仅与衣壳抗原发生反应。在重组丙型肝炎病毒酶免疫测定中反复呈阳性反应的献血者样本中，肽检测法与重组免疫印迹测定法一致，在96%的样本中能够区分真阳性和假阳性结果。
