Department of Microbiology, Maulana Azad Medical College & Associated Lok Nayak Hospital, New Delhi, India.
Braz J Infect Dis. 2013 May-Jun;17(3):369-74. doi: 10.1016/j.bjid.2012.10.028. Epub 2013 Apr 18.
Hepatitis C virus infects over 15 million patients from India and 2.86 million from Brazil. Detection of anti-hepatitis C virus antibodies has limited sensitivity during acute phase: the pre-seroconversion window period. Hepatitis C virus-RNA detection techniques are used to overcome this shortfall, but are costly and unavailable widely in developing countries. Estimation of hepatitis C virus core-antigen, a protein with highly conserved sequence, by enzyme-immunoassays is an economic and simpler alternative to RNA detection. This study was conducted in Delhi, involving 300 acute and chronic liver disease patients, tested for anti-hepatitis C virus 3rd-generation ELISA, hepatitis C virus core-antigen-ELISA and hepatitis C virus-RNA reverse transcription-polymerase chain reaction. Among the acute patients, hepatitis C virus core-antigen assay could identify 13 out of 14 pre-seroconversion window period cases and 6 out of 8 seroconverted cases, with a pre-seroconversion window period sensitivity of 92.9% and specificity of 100%. In hepatitis C virus core-antigen-positive cases, the viral load was in the range of 4900 to 1.46×10(6)IU/mL, whereas in hepatitis C virus core-antigen-negative cases, the range of viral load was 100-4500IU/mL. The cost of the hepatitis C virus core-antigen-ELISA was estimated around 3-4 times lesser than the in-house reverse transcription-polymerase chain reaction and 9-10 times lesser than the United States Food and Drug Administration approved reverse transcription-polymerase chain reaction. With a good sensitivity and specificity in the acute phase of infection, hepatitis C virus core-antigen-ELISA can thus be a useful alternative in the developing nations.
丙型肝炎病毒感染了超过 1500 万印度患者和 286 万巴西患者。在急性感染期间，检测抗丙型肝炎病毒抗体的灵敏度有限：即前血清转化窗口期。丙型肝炎病毒 RNA 检测技术可用于克服这一缺陷，但在发展中国家成本高且无法广泛应用。酶免疫测定法检测丙型肝炎病毒核心抗原（一种具有高度保守序列的蛋白质）是一种经济且简单的 RNA 检测替代方法。本研究在德里进行，涉及 300 例急性和慢性肝病患者，他们接受了第三代抗丙型肝炎病毒酶联免疫吸附试验、丙型肝炎病毒核心抗原酶联免疫吸附试验和丙型肝炎病毒 RNA 逆转录聚合酶链反应检测。在急性患者中，丙型肝炎病毒核心抗原检测可在 14 例前血清转化窗口期病例和 6 例血清转化病例中识别出 13 例，前血清转化窗口期的敏感性为 92.9%，特异性为 100%。在丙型肝炎病毒核心抗原阳性病例中，病毒载量范围为 4900 至 1.46×10(6)IU/mL，而在丙型肝炎病毒核心抗原阴性病例中，病毒载量范围为 100-4500IU/mL。丙型肝炎病毒核心抗原酶联免疫吸附试验的成本估计比内部逆转录聚合酶链反应低 3-4 倍，比美国食品和药物管理局批准的逆转录聚合酶链反应低 9-10 倍。在感染的急性阶段具有良好的灵敏度和特异性，因此丙型肝炎病毒核心抗原酶联免疫吸附试验可以成为发展中国家的有用替代方法。
