四种免疫分析法检测血清 HBsAg 定量的比较，以及 HBsAg 水平与 HBV 复制和 HBV 基因型的关系。

BACKGROUND

The decline in hepatitis B virus surface antigen (HBsAg) may be an early predictor of the viral efficacy of Hepatitis B virus (HBV) therapy. The HBsAg levels obtained by different immunoassays now need comparing and the relationships between levels of HBsAg and HBV DNA alongside HBsAg and genotype must be evaluated.

METHODOLOGY/PRINCIPAL FINDINGS: HBsAg levels were compared among 80 patients using the Abbott Architect assay, a commercial immunoassay approved for HBsAg detection and quantitation, and three other assays derived from immunoassays approved for HBsAg detection (manufactured by Diasorin, Bio-Rad and Roche). Good correlation was found between the Abbot vs. Diasorin, Bio-Rad and Roche assays with narrow 95% limits of agreement and small mean differences: -0.06 to 0.11, -0.09 log(10) IU/mL; -0.57 to 0.64, -0.04 log(10) IU/mL; -0.09 to 0.45, -0.27 log(10) IU/mL, respectively. These agreements were not affected by genotypes A or D. HBsAg was weakly correlated with HBV DNA, whatever the HBsAg assay used: Abbott, ρ = 0.36 p = 0.001, Diasorin ρ = 0.34, p = 0.002; Bio-Rad ρ = 0.37, p<0.001; or Roche ρ = 0.41, p<0.001. This relationship between levels of HBsAg and HBV DNA seemed to depend on genotypes. Whereas HBsAg (Abbott assay) tended to correlate with HBV DNA for genotype A (ρ = 0.44, p = 0.02), no such correlation was significant for genotypes D (ρ = 0.29, p = 0.15).

CONCLUSION/SIGNIFICANCE: The quantitation of HBsAg in routine clinical samples is comparable between the reference assay and the adapted assays with acceptable accuracy limits, low levels of variability and minimum discrepancy. While HBsAg quantitation is not affected by HBV genotype, the observed association between levels of HBsAg and HBV DNA seems genotype dependent.

背景

乙肝病毒表面抗原 (HBsAg) 的下降可能是乙型肝炎病毒 (HBV) 治疗病毒疗效的早期预测指标。现在需要比较不同免疫测定法获得的 HBsAg 水平，并评估 HBsAg 水平与 HBV DNA 以及 HBsAg 与基因型之间的关系。

方法/主要发现：使用 Abbott Architect 检测法（一种用于检测和定量 HBsAg 的商业免疫测定法）对 80 名患者的 HBsAg 水平进行了比较，该检测法来自于三种其他免疫测定法（由 Diasorin、Bio-Rad 和 Roche 生产），这些免疫测定法均被批准用于 HBsAg 检测。Abbott 与 Diasorin、Bio-Rad 和 Roche 检测法之间具有良好的相关性，95%一致性区间较窄，平均差异较小：-0.06 至 0.11，-0.09 log(10) IU/mL；-0.57 至 0.64，-0.04 log(10) IU/mL；-0.09 至 0.45，-0.27 log(10) IU/mL。这些一致性不受基因型 A 或 D 的影响。无论使用哪种 HBsAg 检测法，HBsAg 与 HBV DNA 均呈弱相关：Abbott，ρ=0.36，p=0.001，Diasorin ρ=0.34，p=0.002；Bio-Rad ρ=0.37，p<0.001；或 Roche ρ=0.41，p<0.001。HBsAg 水平与 HBV DNA 之间的这种关系似乎取决于基因型。对于基因型 A（ρ=0.44，p=0.02），HBsAg（Abbott 检测法）倾向于与 HBV DNA 相关，而对于基因型 D（ρ=0.29，p=0.15），这种相关性则不显著。

结论/意义：在常规临床样本中，参考检测法与适应检测法的 HBsAg 定量具有可比性，具有可接受的准确度限值、较低的变异性和最小的差异。虽然 HBsAg 定量不受 HBV 基因型的影响，但观察到的 HBsAg 水平与 HBV DNA 之间的关联似乎依赖于基因型。