Comparison of Serum HBsAg Quantitation by Four Immunoassays, and Relationships o

StephenW

PLoS One. 2012;7(3):e32143. Epub  2012 Mar 5.
Comparison of Serum HBsAg Quantitation by Four Immunoassays, and Relationships of HBsAg Level with HBV Replication and HBV Genotypes.Tuaillon E, Mondain AM, Nagot N, Ottomani L, Kania D, Nogue E, Rubbo PA, Pageaux GP, Van de Perre P, Ducos J.
SourceUniversité de Montpellier 1, INSERM Unité 1058, Montpellier, France.

AbstractBACKGROUND: 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.
Figure 2
Correlation of HBsAg (log IU/mL) and HBV DNA (log IU/mL).
(A) Abbott, (B) Diasorin, (C) Bio-Rad, (D) Roche immunoassays.






Figure 3
Plots of Log10 IU/ml HBV-DNA/HBsAg ratio by levels of HBV replication.

Figure 4
Temporal evolution of HBsAg and HBV DNA in five patients with persistente HBV infection.
HBsAg log10 IU/ml ( and solid line), HBV DNA (▵ and dotted line).

StephenW

公共科学图书馆之一。 2012年7（3）：e32143。 EPUB 2012年3月5日。
血清HBsAg定量比较四免疫，乙肝表面抗原与乙肝病毒复制水平和HBV基因型的关系。
，蒙丹上午tuailloné，Nagot列印，Ottomani大号，卡尼亚ð，Nogueé，Rubbo扩音，Pageaux大奖赛，范·佩列带够，Ducos J​​.
源

蒙彼利埃大学，蒙彼利埃，法国INSERM的团结1058 1。
抽象
背景：

在乙肝病毒表面抗原（HBsAg）的下降可能是B型肝炎病毒（HBV）治疗病毒性肝炎疗效的早期预测。 HBsAg的水平不同免疫获得现在需要比较和沿着HBsAg和基因型的HBsAg和HBV DNA水平之间的关系，必须进行评估。
方法/主要结果：

其中80例使用雅培Architect法，商业免疫，乙肝表面抗原检测和定量的批准，并从三个其他检测，乙肝表面抗原检测（由Diasorin，Bio-Rad公司和罗氏公司生产）批准的免疫HBsAg水平进行了比较。良好的相关性协议狭窄95％的限制和小的平均差异：-0.06到0.11，-0.09日志（10）IU /毫升; -0.57至0.64之间方丈与Diasorin，Bio-Rad公司和罗氏检测发现 - 0.04日志（10）IU /毫升; -0.09至0.45，-0.27日志（10）IU /毫升，分别。这些协议并没有受到影响，基因型A或D。乙肝表面抗原与HBV DNA的弱相关性，无论使用的乙肝表面抗原检测：雅培，ρ= 0.36，P = 0.001，Diasorinρ= 0.34，P = 0.002; Bio-Rad公司ρ= 0.37， P <0.001或罗氏ρ= 0.41，P <0.001。 HBsAg和HBV DNA水平之间的这种关系似乎取决于基因型。而乙肝表面抗原（雅培法）往往关联基因型与乙型肝炎病毒DNA（ρ= 0.44，P = 0.02），没有这样的相关基因型D类（ρ= 0.29，P = 0.15）显着。
结论/意义：

在日常临床标本中HBsAg的定量是参考法和适应的检测与可接受的精度限制，水平低的变异和最低的差距之间的相媲美。虽然乙肝表面抗原定量不影响HBV基因型，观察到HBsAg和HBV DNA水平之间的关联似乎基因型依赖。