Weber Bernard
Laboratoires Réunis Junglinster, Luxemburg und Institut für Medizinische Virologie, Universitätskliniken Frankfurt, Frankfurt, Germany.
J Med Virol. 2006;78 Suppl 1:S59-65. doi: 10.1002/jmv.20610.
The genetic variability of hepatitis B virus (HBV) represents a challenge for the sensitivity of immunologic and molecular based assays. Genotyping studies show that the genetic diversity of HBV is very high even in industrialized countries. The analytical sensitivity of HBsAg and anti-HBs assays may be dependent on HBV genotype or subtype and could possibly lead to false negative results in samples with low-level HBsAg. It is possible that the recognition of genotypes E and F may be impaired. Immunoassays based on polyclonal capture antibody show the highest sensitivity for the recognition of recombinant mutants or serum samples harboring mutant forms of HBsAg. However, they do not guarantee full sensitivity, especially for the detection of the G145R mutation and amino acid insertions or substitutions in positions 120-123. Detection of HBsAg needs to be improved by the introduction of new HBsAg assays able to recognize so far described S gene mutants and with a lower detection threshold than current immunoassays in order to detect smallest amounts of HBsAg in low level carriers. There is also a need for more complete epidemiological data on the prevalence of HBsAg mutants especially for G145R and assays for the (differential) screening of mutants need to be developed and evaluated.
乙型肝炎病毒（HBV）的基因变异性对基于免疫和分子的检测方法的灵敏度构成了挑战。基因分型研究表明，即使在工业化国家，HBV的基因多样性也非常高。HBsAg和抗-HBs检测的分析灵敏度可能取决于HBV基因型或亚型，并可能导致低水平HBsAg样本出现假阴性结果。E型和F型基因型的识别可能会受到影响。基于多克隆捕获抗体的免疫测定对识别重组突变体或携带HBsAg突变形式的血清样本具有最高的灵敏度。然而，它们并不能保证完全的灵敏度，特别是对于G145R突变以及120-123位氨基酸插入或替换的检测。需要引入能够识别迄今描述的S基因突变体且检测阈值低于当前免疫测定的新型HBsAg检测方法，以提高HBsAg的检测能力，从而检测低水平携带者中最少量的HBsAg。还需要关于HBsAg突变体流行率的更完整的流行病学数据，特别是对于G145R，并且需要开发和评估用于（差异）筛选突变体的检测方法。
