Hepatol Int. 2010 Aug 3;4(3):601-7. doi: 10.1007/s12072-010-9198-y.
Restriction fragment length polymorphism (RFLP) and enzyme-linked immunosorbent assay (ELISA) with monoclonal antibodies (mAbs) were used in this study to detect genotypes of HBV, and the efficiency and precision of ELISA using the mAbs for HBV genotype detection were also estimated.
The ELISA with mAbs method was used for the detection of HBV genotype in a Taiwanese population. The HBV genotypes of 100 chronic hepatitis B patients were determined by ELISA and were then compared with those obtained using RFLP.
Genotype B was found to be the most prevalent in this study (63% by RFLP; 62% by ELISA) followed by genotype C (31% by RFLP; 35% by ELISA). There was no significant difference between the results obtained by RFLP and ELISA (P = 0.75). The ELISA overall genotypeable rate, the correct genotyping rate from genotypeable specimens, and the concordance of the HBV genotyping assay was 96.00, 94.79, and 91.00%; for the ELISA HBV genotyping assay for genotype B specimens was 96.77, 100.00, and 96.77%; and for genotype C specimens was 97.14, 91.18, and 88.57%, respectively. The mean HBV DNA level was higher in the specimens that could be genotyped by both RFLP and ELISA samples (6.24 ± 1.77 vs. 2.34 ± 0.90, log IU/ml), and a significant difference in terms of HBV DNA level of more than 2 × 10(3) IU/ml was identified between the genotyped RFLP samples (P < 0.001).
ELISA is a practical and a useful method for HBV genotyping in a clinical setting in Taiwan, in particular for patients with lower levels of HBV DNA.
本研究采用限制片段长度多态性（RFLP）和酶联免疫吸附试验（ELISA）与单克隆抗体（mAbs）检测 HBV 基因型，并评估使用 mAbs 检测 HBV 基因型的 ELISA 的效率和精度。
使用 mAbs ELISA 法检测台湾人群的 HBV 基因型。通过 ELISA 和 RFLP 检测 100 例慢性乙型肝炎患者的 HBV 基因型，并进行比较。
本研究中最常见的基因型为 B 型（RFLP 检测为 63%；ELISA 检测为 62%），其次为 C 型（RFLP 检测为 31%；ELISA 检测为 35%）。RFLP 和 ELISA 检测结果无显著差异（P=0.75）。ELISA 总可分型率、可分型标本正确分型率和 HBV 基因分型检测的一致性分别为 96.00%、94.79%和 91.00%；对于 ELISA 检测 B 型标本的 HBV 基因分型检测，其分别为 96.77%、100.00%和 96.77%；对于 C 型标本，其分别为 97.14%、91.18%和 88.57%。可同时用 RFLP 和 ELISA 检测的标本 HBV DNA 水平较高（6.24±1.77 与 2.34±0.90，log IU/ml），且 RFLP 可分型标本 HBV DNA 水平差异有统计学意义（P<0.001）。
ELISA 是台湾临床环境中检测 HBV 基因型的一种实用且有效的方法，特别是对于 HBV DNA 水平较低的患者。
