Lee D S, Lesniewski R R, Sung Y C, Min W K, Park S G, Lee K H, Kim H S
Department of Clinical Pathology, Korea Cancer Center Hospital, Seoul.
J Am Soc Nephrol. 1996 Nov;7(11):2409-13. doi: 10.1681/ASN.V7112409.
A routine screening test used in the diagnosis of hepatitis C virus (HCV) infection is the anti-HCV antibody (anti-HCV) test containing core, NS3, NS4, and NS5 antigens of HCV. When HCV infection occurs in immunocompromised hosts, antibody formation against core, NS3, or NS4 antigens may be weak in the presence of HCV viremia and cannot be detected by routine anti-HCV tests. This study proposed that in immunocompromised hosts such as patients with chronic renal failure (whose capacity to form antibodies is diminished), antibody formation against the E2 region would be preserved, because the E2/NS1 region of HCV is strongly immunogenic. The aim of this study is to evaluate the significance of anti-E2 in the diagnosis of HCV infection among patients on maintenance hemodialysis who are anti-HCV-negative, using a conventional third-generation enzyme immunoassay (EIA) kit. The E2/NS1 gene of HCV encoding the amino acid sequence 388-664 was molecularly cloned into a vector containing an SV 40 promotor and was expressed in Chinese Hamster ovary cells. Using this E2 protein, the anti-E2 test was performed by EIA on 100 patients on maintenance hemodialysis, and on 50 patients with chronic hepatitis C who were anti-HCV-positive, to evaluate the antigenecity of the E2 protein. Of the 100 hemodialysis patients, 15 (15.0%) tested anti-HCV-positive using a third generation anti-HCV ELISA kit. Of the 85 patients who tested negative for anti-HCV, nine (10.6%) were anti-E2-positive and six (66.7%) of these anti-E2 positive patients showed HCV RNA viremia by HCV reverse transcription-polymerase chain reaction. Fourty-two (84.0%) of 50 patients with chronic hepatitis C were anti-E2-positive. As a control group, we tested for anti-E2 among 30 blood donors who were anti-HCV-negative, and also among 85 patients with hepatocellular carcinoma who were anti-HCV-negative, but in both groups, none (0%) was anti-E2-positive. In conclusion, these data suggest that the E2 protein of HCV should be included in a diagnostic anti-HCV kit for the detection of HCV infection in immunocompromised patients.
用于丙型肝炎病毒（HCV）感染诊断的一项常规筛查试验是抗HCV抗体（抗-HCV）试验，该试验包含HCV的核心、NS3、NS4和NS5抗原。当免疫功能低下的宿主发生HCV感染时，在存在HCV病毒血症的情况下，针对核心、NS3或NS4抗原的抗体形成可能较弱，常规抗-HCV试验无法检测到。本研究提出，在免疫功能低下的宿主如慢性肾衰竭患者（其抗体形成能力减弱）中，针对E2区域的抗体形成将得以保留，因为HCV的E2/NS1区域具有强烈的免疫原性。本研究的目的是使用传统的第三代酶免疫测定（EIA）试剂盒，评估抗-E2在诊断抗-HCV阴性的维持性血液透析患者HCV感染中的意义。将编码氨基酸序列388 - 664的HCV的E2/NS1基因分子克隆到含有SV 40启动子的载体中，并在中国仓鼠卵巢细胞中表达。使用这种E2蛋白，通过EIA对100例维持性血液透析患者和50例抗-HCV阳性的慢性丙型肝炎患者进行抗-E2检测，以评估E2蛋白的抗原性。在100例血液透析患者中，使用第三代抗-HCV ELISA试剂盒检测，15例（15.0%）抗-HCV呈阳性。在85例抗-HCV检测为阴性的患者中，9例（10.6%）抗-E2呈阳性，其中6例（66.7%）抗-E2阳性患者通过HCV逆转录-聚合酶链反应显示HCV RNA病毒血症。50例慢性丙型肝炎患者中有42例（84.0%）抗-E2呈阳性。作为对照组，我们在30例抗-HCV阴性的献血者以及85例抗-HCV阴性的肝细胞癌患者中检测抗-E2，但两组中均无（0%）抗-E2呈阳性。总之，这些数据表明，HCV的E2蛋白应包含在诊断抗-HCV试剂盒中，用于检测免疫功能低下患者的HCV感染。
