肝病

Hepatology:新方法允许一步法诊断HCV感染

作者:佚名 来源:生物谷 日期:2016-06-08
导读

         当前诊断丙型肝炎病毒(HCV)感染的标准方法需要两个连续的步骤:用于筛选的HCV抗体测试,随后进行HCV RNA RT-PCR测试来验证病毒血症性HCV(viremic HCV, V-HCV)感染(编者注:即导致病毒血症的HCV感染)。这使得它未最优化、成本高、不方便、耗时和不能够在全球广泛使用或负担得起。

       当前诊断丙型肝炎病毒(HCV)感染的标准方法需要两个连续的步骤:用于筛选的HCV抗体测试,随后进行HCV RNA RT-PCR测试来验证病毒血症性HCV(viremic HCV, V-HCV)感染(编者注:即导致病毒血症的HCV感染)。这使得它未最优化、成本高、不方便、耗时和不能够在全球广泛使用或负担得起。

  HCV核心抗原(HCVcAg)测试有潜力提供一步法诊断HCV感染。然而,它的灵敏度和特异性较低限制了它的临床应用。

  在一项新的研究中,来自美国加州大学欧文分校的研究人员开发出一种新的HCV抗原酶免疫测定法(HCV-Ags EIA),并利用365种血清样品(其中,176种未发生V-HCV感染,189种发生V-HCV感染)评估了这种一步法诊断V-HCV感染的灵敏度、特异性和实用性。相关研究结果于2016年6月6日在线发表在Hepatology期刊上,论文标题为“A Highly Specific and Sensitive Hepatitis C Virus Antigens Enzyme Immunoassay for One-step Diagnosis of Viremic HCV Infection”。

  首先,研究人员证实在HCV感染期间,除了HCV核心抗原之外,还存在HCV NS3、NS4b和NS5a蛋白。基于此,他们开发出这种新的同时检测这四种HCV蛋白的HCV-Ags EIA方法。

  这项研究首次证实血清样品变性导致释放出的HCV抗原以HCV免疫复合物的形式存在,从而降低测试特异性,因此应当不能够用于任何HCV抗原测试,包括所有当前的HCV核心抗原测试。

  另一方面,与血清HCV抗体测试和HCV RNA RT-PCR测试的结果相比较,利用未变性的血清样品,这种HCV-Ags EIA测试结果的特异性为99%,灵敏度为100%。

  利用未变性的进行过稀释的血清样品进行测试,这种HCV-Ags EIA方法的最低检测限相当于大约150~250 IU/mL的血清HCV RNA水平。

  研究人员开发出的这种HCV-Ags EIA方法是高度特异性的和高度灵敏的。利用未变性的血清样品,这种HCV-Ags EIA方法能够可靠地区分V-HCV感染和已得到控制的HCV感染,而且是一步法实现对V-HCV感染的筛选和诊断。

  论文作者写道,“慢性HCV感染影响全世界大约1.7亿人,并且与发展为肝硬化和肝细胞癌的风险相关联。尽管卫生专业实践指导方针主张对HCV感染进行筛选,但是最近的研究表明在HCV感染的筛选和诊断方面还存在重大的缺口。”

  A Highly Specific and Sensitive Hepatitis C Virus Antigens Enzyme Immunoassay for One-step Diagnosis of Viremic HCV Infection

  doi:10.1002/hep.28663

  Ke-Qin Hu,Wei Cui

  The current standard in diagnosing HCV infection requires 2 sequential steps: anti-HCV test to screen, followed by HCV RNA RT-PCR to confirm viremic HCV (V-HCV) infection. HCV core antigen (HCVcAg) tests provided potential for possible one-step diagnosis. However, low sensitivity and specificity limit their clinical utility. The present study developed a novel HCV antigens enzyme immunoassay (HCV-Ags EIA) and assessed its sensitivity, specificity, and utility for one-step diagnosis of V-HCV infection using 365 serum specimens, including 176 without, and 189 with V-HCV infection. First, we confirmed presence of HCV non-structural protein 3 (NS3), NS4b, and NS5a proteins besides HCVcAg during HCV infection, and developed a novel HCV-Ags EIA via simultaneous detection of all these 4 HCV proteins. For the first time, the presented study demonstrated that serum sample denaturation decreases the test specificity due to release of HCV-Ags sequestered in HCV-immune complexes, and should not be used in any HCV-Ags, including all the current HCVcAg assays. On the other hand, using sample non-denaturation, the HCV-Ags EIA results showed 99% specificity and 100% sensitivity compared to serum anti-HCV and HCV RNA RT-PCR results. Using serum sample dilution, and non-denaturation, the lowest limits of detection of the HCV-Ags EIA were equivalent to serum HCV RNA levels of approximate 150-250 IU/mL. CONCLUSIONS: The highly specific and sensitive HCV-Ags EIA developed in the present study has the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL. Using non-denaturation of serum samples, our HCV-Ags EIA reliably differentiated V-HCV infection from resolved HCV infection, accomplishes screening and diagnosis of V-HCV infection in one step. This article is protected by copyright. All rights reserved.

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