HCV serology: an unfinished agenda.

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Claudio Galli, Mario Plebani
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引用次数: 0

Abstract

Over 50 years have elapsed since the clinical definition of non-A, non-B hepatitis and 36 years since the unveiling of hepatitis C virus (HCV) and the availability of specific serological assays, but few advances in the serological diagnosis of HCV infection have occurred. Testing for anti-HCV is still based on the detection of reactivity towards the structural Core region of HCV, which appears to be dominant throughout the different phases of infection, plus antibodies towards antigens expressed by several non-structural regions. Unlike testing for other viral diseases, antibodies towards the envelope region are not detectable by the first line assays employed for screening or diagnosis and are scarcely represented in the supplementary assays employed to confirm the reactivity by screening assays. Clinical laboratories are often confronting issues on samples that give discrepant results among assays and are not confirmed by supplemental testing. Results obtained on those samples are usually labelled as 'indeterminate' and are often considered as false positive - though a true reference to define anti-HCV positivity is still lacking. The diagnostic answer is then deprived of clinical significance and affects patient management and counselling. The only advance, though not recent, has been the availability of assays detecting the HCV core antigen, which is considered as a surrogate of HCV RNA, with lesser sensitivity but bearing some operational and economic advantages in diagnosis and population screening, and lately of assays combining HCV antigen and anti-HCV detection. This paper summarizes the history of HCV serology and provides some insights on its limitations and potential developments.

HCV血清学:一个未完成的议程。
自非甲、非乙型肝炎的临床定义以来已经过去了50多年,自丙型肝炎病毒(HCV)的发现和特定血清学检测的可用性以来已经过去了36年,但在HCV感染的血清学诊断方面几乎没有进展。抗丙型肝炎病毒检测仍然是基于检测对丙型肝炎病毒结构核心区的反应性,这在感染的不同阶段似乎占主导地位,加上对几个非结构区域表达的抗原的抗体。与其他病毒性疾病的检测不同,用于筛选或诊断的一线分析无法检测到针对包膜区域的抗体,并且在用于通过筛选分析确认反应性的补充分析中几乎没有代表。临床实验室经常面临的问题是,样品的分析结果不一致,不能通过补充测试来证实。在这些样本上获得的结果通常被标记为“不确定”,并且通常被认为是假阳性——尽管仍然缺乏定义抗- hcv阳性的真正参考。然后,诊断答案被剥夺了临床意义,并影响了患者的管理和咨询。唯一的进步,虽然不是最近的,是检测HCV核心抗原的检测方法的可用性,HCV核心抗原被认为是HCV RNA的替代品,灵敏度较低,但在诊断和人群筛查方面具有一定的操作和经济优势,以及最近的HCV抗原和抗HCV检测相结合的检测方法。本文总结了HCV血清学的历史,并对其局限性和潜在发展提出了一些见解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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