Division of Enteric and Hepatitis Viruses, Center for Infectious Diseases, National Institute of Health, Korea Centers for Disease Control and Prevention, Seoul, South Korea.
Virol J. 2010 Jul 19;7:164. doi: 10.1186/1743-422X-7-164.
Hepatitis A virus (HAV) is a causative agent of acute hepatitis, which is transmitted by person-to-person contact and via the faecal-oral route. Acute HAV infection is usually confirmed by anti-HAV IgM detection. In order to detect anti-HAV IgM in the serum of patients infected with HAV, we developed a rapid assay based on immunochromatography (ICA) and evaluated the sensitivity of this assay by comparing it with a commercial microparticle enzyme immunoassay (MEIA) that is widely used for serological diagnosis.
The newly developed ICA showed 100% sensitivity and specificity when used to test 150 anti-HAV IgM-positive sera collected from infected patients and 75 negative sera from healthy subjects. Also, the sensitivity of ICA is about 10 times higher than MEIA used in this study by determining end point to detect independent on infected genotype of HAV. In addition, the ICA was able to detect 1 positive sample from among 50 sera from acute hepatitis patients that had tested negative for anti-HAV IgM using the MEIA.
Conclusively, ICA for the detection of anti-HAV IgM will be very effective for rapid assay to apply clinical diagnosis and epidemiological investigation on epidemics due to the simplicity, rapidity and specificity.
甲型肝炎病毒（HAV）是引起急性肝炎的病原体，通过人际接触和粪-口途径传播。急性 HAV 感染通常通过抗-HAV IgM 检测来确认。为了在感染 HAV 的患者血清中检测抗-HAV IgM，我们开发了一种基于免疫层析（ICA）的快速检测方法，并通过与广泛用于血清学诊断的商业微粒子酶免疫分析（MEIA）进行比较来评估该方法的灵敏度。
当用于检测从感染患者中收集的 150 份抗-HAV IgM 阳性血清和 75 份来自健康受试者的阴性血清时，新开发的 ICA 显示出 100%的灵敏度和特异性。此外，通过确定终点来检测独立于 HAV 感染基因型，ICA 的灵敏度比本研究中使用的 MEIA 高约 10 倍。此外，ICA 能够检测到 MEIA 检测为抗-HAV IgM 阴性的 50 份急性肝炎患者血清中的 1 份阳性样本。
综上所述，ICA 检测抗-HAV IgM 将非常有效，可用于快速检测，应用于临床诊断和流行病学调查，因为其具有简单、快速和特异性。
