Limits...
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 - PLoS ONE (2012)

Bottom Line: Good correlation was found between the Abbot vs.This relationship between levels of HBsAg and HBV DNA seemed to depend on genotypes.While HBsAg quantitation is not affected by HBV genotype, the observed association between levels of HBsAg and HBV DNA seems genotype dependent.

View Article: PubMed Central - PubMed

Affiliation: Université de Montpellier 1, INSERM Unité 1058, Montpellier, France. e-tuaillon@chu-montpellier.fr

ABSTRACT

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.

Show MeSH

Related in: MedlinePlus

Comparison of the AgHBs concentrations between Abbott and Diasorin, Bio-Rad, Roche assays.Linear regression analysis of HBsAg levels (expressed in log10 IU/ml) obtained by (A) Abbott vs. Diasorin, (B) Abbott vs. Bio-Rad, Abbott vs. Roche immunoassays, and Bland-Altman plot of HBsAg level differences between (D) Abbott and Diasorin, (E, F) Abbott and Bio-Rad, (G) Abbott and Roche immunoassays. The horizontal solid lines indicate the mean titer difference values, the dashed lines represent the ±1.96-SD limits from the means, and diagonal solid lines are the linear regression lines.
© Copyright Policy
Related In: Results  -  Collection


getmorefigures.php?uid=PMC3293872&req=5

pone-0032143-g001: Comparison of the AgHBs concentrations between Abbott and Diasorin, Bio-Rad, Roche assays.Linear regression analysis of HBsAg levels (expressed in log10 IU/ml) obtained by (A) Abbott vs. Diasorin, (B) Abbott vs. Bio-Rad, Abbott vs. Roche immunoassays, and Bland-Altman plot of HBsAg level differences between (D) Abbott and Diasorin, (E, F) Abbott and Bio-Rad, (G) Abbott and Roche immunoassays. The horizontal solid lines indicate the mean titer difference values, the dashed lines represent the ±1.96-SD limits from the means, and diagonal solid lines are the linear regression lines.

Mentions: The Diasorin assay correlated well with the reference assay, ρ = 0.88 (p<0.001) (Fig. 1.A). The difference between 7 (9%) paired results was above 0.5 log10IU/mL. The concordance plot (Fig. 1.D) confirmed the strong correlation with the Abbott method with narrow 95% limits of agreement (−0.5 to 0.68) and a weak difference mean of 0.09 log10 IU/mL.


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 - PLoS ONE (2012)

Comparison of the AgHBs concentrations between Abbott and Diasorin, Bio-Rad, Roche assays.Linear regression analysis of HBsAg levels (expressed in log10 IU/ml) obtained by (A) Abbott vs. Diasorin, (B) Abbott vs. Bio-Rad, Abbott vs. Roche immunoassays, and Bland-Altman plot of HBsAg level differences between (D) Abbott and Diasorin, (E, F) Abbott and Bio-Rad, (G) Abbott and Roche immunoassays. The horizontal solid lines indicate the mean titer difference values, the dashed lines represent the ±1.96-SD limits from the means, and diagonal solid lines are the linear regression lines.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3293872&req=5

pone-0032143-g001: Comparison of the AgHBs concentrations between Abbott and Diasorin, Bio-Rad, Roche assays.Linear regression analysis of HBsAg levels (expressed in log10 IU/ml) obtained by (A) Abbott vs. Diasorin, (B) Abbott vs. Bio-Rad, Abbott vs. Roche immunoassays, and Bland-Altman plot of HBsAg level differences between (D) Abbott and Diasorin, (E, F) Abbott and Bio-Rad, (G) Abbott and Roche immunoassays. The horizontal solid lines indicate the mean titer difference values, the dashed lines represent the ±1.96-SD limits from the means, and diagonal solid lines are the linear regression lines.
Mentions: The Diasorin assay correlated well with the reference assay, ρ = 0.88 (p<0.001) (Fig. 1.A). The difference between 7 (9%) paired results was above 0.5 log10IU/mL. The concordance plot (Fig. 1.D) confirmed the strong correlation with the Abbott method with narrow 95% limits of agreement (−0.5 to 0.68) and a weak difference mean of 0.09 log10 IU/mL.

Bottom Line: Good correlation was found between the Abbot vs.This relationship between levels of HBsAg and HBV DNA seemed to depend on genotypes.While HBsAg quantitation is not affected by HBV genotype, the observed association between levels of HBsAg and HBV DNA seems genotype dependent.

View Article: PubMed Central - PubMed

Affiliation: Université de Montpellier 1, INSERM Unité 1058, Montpellier, France. e-tuaillon@chu-montpellier.fr

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus