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Evaluation of an enzyme immunoassay for hepatitis C virus antibody detection using a recombinant protein derived from the core region of hepatitis C virus genome

机译:使用源自丙型肝炎病毒基因组核心区域的重组蛋白评估用于丙型肝炎病毒抗体的酶免疫测定

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摘要

This study was undertaken to evaluate an enzyme immunoassay (EIA) for hepatitis C virus antibody detection (anti-HCV), using just one antigen. Anti-HCV EIA was designed to detect anti-HCV IgG using on the solid-phase a recombinant C22 antigen localized at the N-terminal end of the core region of HCV genome, produced by BioMérieux. The serum samples diluted in phosphate buffer saline were added to wells coated with the C22, and incubated. After washings, the wells were loaded with conjugated anti-IgG, and read in a microtiter plate reader (492 nm). Serum samples of 145 patients were divided in two groups: a control group of 39 patients with non-C hepatitis (10 acute hepatitis A, 10 acute hepatitis B, 9 chronic hepatitis B, and 10 autoimmune hepatitis) and a study group consisting of 106 patients with chronic HCV hepatitis. In the study group all patients had anti-HCV detected by a commercially available EIA (Abbott®), specific for HCV structural and nonstructural polypeptides, alanine aminotransferase elevation or positive serum HCV-RNA detected by nested-PCR. They also had a liver biopsy compatible with chronic hepatitis. The test was positive in 101 of the 106 (95%) sera from patients in the study group and negative in 38 of the 39 (97%) sera from those in the control group, showing an accuracy of 96%. According to these results, our EIA could be used to detect anti-HCV in the serum of patients infected with hepatitis C virus.
机译:这项研究旨在评估仅使用一种抗原的丙型肝炎病毒抗体检测(anti-HCV)的酶联免疫测定(EIA)。抗HCV EIA设计为在固相上使用BioMérieux生产的位于HCV基因组核心区域N末端的重组C22抗原检测抗HCV IgG。将在磷酸盐缓冲液中稀释的血清样品添加至涂有C22的孔中,并进行孵育。洗涤后,向孔中加载缀合的抗IgG,并在微量滴定板读数器(492 nm)中读取。 145例患者的血清样本分为两组:对照组39例非C型肝炎(10例急性甲型肝炎,10例急性乙型肝炎,9例慢性乙型肝炎和10例自身免疫性肝炎)和一个由106例患者组成的研究组慢性HCV肝炎患者。在研究组中,所有患者均通过市售EIA(Abbott®)检测到抗HCV,该抗体对HCV结构和非结构多肽具有特异性,丙氨酸转氨酶升高或巢式PCR检测到血清HCV-RNA阳性。他们还进行了与慢性肝炎相容的肝活检。在研究组患者的106份血清中,有101份呈阳性(95%),对照组的39份血清中有38份(97%)呈阴性,显示准确性为96%。根据这些结果,我们的EIA可以用于检测感染丙型肝炎病毒的患者血清中的抗HCV。

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