van der Poel C L
Red Cross Blood Bank Amsterdam, The Netherlands.
FEMS Microbiol Rev. 1994 Jul;14(3):241-6. doi: 10.1111/j.1574-6976.1994.tb00094.x.
The addition of second-generation HCV epitopes in antibody detection assays has increased the sensitivity and specificity of blood donor testing, to prevent post-transfusion hepatitis non-A, non-B (PTH-NANB), later characterized as Hepatitis C. However, it is not clear whether all HCV infectious donors are detected by second-generation anti-HCV testing. Prospective studies on PTH-NANB were left with some unresolved cases. The use of second-generation anti-HCV assays in blood banks presented a problem with a relatively large number of indeterminate reactivities in supplemental assay such as RIBA-2. These indeterminate reactivities may be solved by the use of polymerase chain reaction (PCR). PCR is more and more used as an extra confirmatory assay to resolve RIBA indeterminate results on blood donors. However, a European study on the proficiency of HCV PCR in different countries revealed that only a minority of the reference laboratories perform this test faultless. Lately, third-generation RIBA was developed, which was originally designed to resolve RIBA-2 indeterminate cases. RIBA-3 was shown to be more sensitive and specific in early HCV infection and blood donors than RIBA-2. Third-generation anti-HCV testing will become standard practice. Some questions, however, remain unanswered. Do we miss any rare HCV infectious donors, of other genotypes, with third-generation assays, based only on the type 1 sequence of HCV? Can we improve HCV detection in the early phase of infection? What is the role of sporadic HCV transmission? How can we standardize HCV nucleic acid detection methods?
在抗体检测试验中添加第二代丙型肝炎病毒(HCV)表位,提高了献血者检测的灵敏度和特异性,以预防输血后非甲非乙型肝炎(PTH-NANB),后来该疾病被确定为丙型肝炎。然而,尚不清楚第二代抗-HCV检测是否能检测出所有感染HCV的献血者。关于PTH-NANB的前瞻性研究仍有一些未解决的病例。血库中使用第二代抗-HCV检测法在补充检测(如RIBA-2)中出现了较多不确定反应性的问题。这些不确定反应性可通过聚合酶链反应(PCR)解决。PCR越来越多地被用作额外的确认检测,以解决献血者RIBA检测结果不确定的问题。然而,一项关于不同国家HCV PCR检测水平的欧洲研究表明,只有少数参考实验室能完美地进行这项检测。最近,第三代RIBA检测法被开发出来,其最初设计目的是解决RIBA-2检测结果不确定的情况。结果显示,在早期HCV感染和献血者中,RIBA-3比RIBA-2更敏感、更具特异性。第三代抗-HCV检测将成为标准做法。然而,一些问题仍未得到解答。仅基于HCV 1型序列的第三代检测法,是否会遗漏其他基因型的罕见HCV感染献血者?我们能否在感染早期改善HCV检测?散发性HCV传播的作用是什么?我们如何规范HCV核酸检测方法?