Tanaka T, Lau J Y, Mizokami M, Orito E, Tanaka E, Kiyosawa K, Yasui K, Ohta Y, Hasegawa A, Tanaka S
Liver Unit, The Tokyo Metropolitan Komagome Hospital, Japan.
J Hepatol. 1995 Dec;23(6):742-5. doi: 10.1016/0168-8278(95)80043-3.
The viral load of hepatitis C virus, as reflected by hepatitis C virus viremia, has been shown to have important clinical implications. In this study the hepatitis C virus core protein level in serum was evaluated for the detection and quantification of hepatitis C virus viremia. Hepatitis C virus core protein in serum was detected using a simple and sensitive fluorescent enzyme immunoassay. Hepatitis C virus core protein was quantitated in 100 healthy subjects, 258 patients with hepatitis C virus infection and 108 patients with non-hepatitis-C-virus-related chronic liver diseases. HCV-RNA was determined using the branched DNA (bDNA) assay and reverse-transcription polymerase chain reaction. The detection limit of this fluorescent enzyme immunoassay was found between 10(4) - 10(5) copies/ml HCV-RNA equivalent. There was a good correlation between the core protein and bDNA assay results (p <0.01). Hepatitis C virus core protein was detected in 81% of patients with hepatitis C virus infection (acute hepatitis 4/5, chronic hepatitis 85/104, cirrhosis 64/73 and hepatocellular carcinoma 56/76) but in none of the healthy subjects and patients with non-hepatitis C virus chronic liver diseases. The amount of hepatitis C virus core protein in patients with hepatitis-C-virus-related hepatocellular carcinoma was lower compared to chronic hepatitis and cirrhosis (p <0.05). All 26 patients treated with interferon-alpha showed parallel changes between HCV-RNA and core protein levels. This fluorescent enzyme immunoassay is simple and quick (assay time <3 h) with sensitivity at least matching the bDNA assay. Similar levels of hepatitis C virus core protein were detected in patients with chronic hepatitis and cirrhosis, but patients with hepatocellular carcinoma tended to have a lower level of hepatitis C virus core protein.
丙型肝炎病毒载量，如通过丙型肝炎病毒血症所反映的，已显示出具有重要的临床意义。在本研究中，对血清中丙型肝炎病毒核心蛋白水平进行评估，以检测和定量丙型肝炎病毒血症。使用一种简单且灵敏的荧光酶免疫测定法检测血清中的丙型肝炎病毒核心蛋白。对100名健康受试者、258名丙型肝炎病毒感染患者和108名非丙型肝炎病毒相关慢性肝病患者的丙型肝炎病毒核心蛋白进行定量。使用分支DNA（bDNA）测定法和逆转录聚合酶链反应测定HCV-RNA。发现这种荧光酶免疫测定法的检测限在10(4)-10(5)拷贝/ml HCV-RNA当量之间。核心蛋白与bDNA测定结果之间存在良好相关性（p<0.01）。在81%的丙型肝炎病毒感染患者（急性肝炎4/5、慢性肝炎85/104、肝硬化64/73和肝细胞癌56/76）中检测到丙型肝炎病毒核心蛋白，但在健康受试者和非丙型肝炎病毒慢性肝病患者中均未检测到。与慢性肝炎和肝硬化相比，丙型肝炎病毒相关肝细胞癌患者的丙型肝炎病毒核心蛋白量较低（p<0.05）。所有26名接受α干扰素治疗的患者在HCV-RNA和核心蛋白水平之间显示出平行变化。这种荧光酶免疫测定法简单快速（测定时间<3小时），灵敏度至少与bDNA测定法相当。慢性肝炎和肝硬化患者中检测到的丙型肝炎病毒核心蛋白水平相似，但肝细胞癌患者的丙型肝炎病毒核心蛋白水平往往较低。
