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Diagnostic Laboratory Immunology

Comparison between Elecsys HBsAg II and Architect HBsAg QT Assays for Quantification of Hepatitis B Surface Antigen among Patients Coinfected with HIV and Hepatitis B Virus

Sarah Maylin, Anders Boyd, Constance Delaugerre, Fabien Zoulim, Fabien Lavocat, François Simon, Pierre-Marie Girard, Karine Lacombe
Sarah Maylin
aLaboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France
bInserm U941, Paris, France
cUniversité Paris-Diderot, Paris, France
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Anders Boyd
dInserm UMR-S707, Paris, France
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Constance Delaugerre
aLaboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France
bInserm U941, Paris, France
cUniversité Paris-Diderot, Paris, France
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Fabien Zoulim
eInserm, U1052, Lyon, France
fService d'Hépatologie, Hôpital de la Croix-Rousse, Hospices Civils, Lyon, France
gUniversité Lyon 1, Lyon, France
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Fabien Lavocat
eInserm, U1052, Lyon, France
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François Simon
aLaboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France
bInserm U941, Paris, France
cUniversité Paris-Diderot, Paris, France
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Pierre-Marie Girard
dInserm UMR-S707, Paris, France
hService de Maladies Infectieuses, Hôpital Saint-Antoine, Paris, France
iUniversité Pierre et Marie Curie, Paris VI, France
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Karine Lacombe
dInserm UMR-S707, Paris, France
hService de Maladies Infectieuses, Hôpital Saint-Antoine, Paris, France
iUniversité Pierre et Marie Curie, Paris VI, France
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DOI: 10.1128/CVI.05454-11
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  • Fig 1
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    Fig 1

    Correlation between Elecsys and Architect HBsAg quantification systems. Individual levels of HBsAg are plotted (gray dots), with Architect as the independent and Elecsys as the dependent variable. Univariate linear regression (black line) has also been fitted.

  • Fig 2
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    Fig 2

    Overall Bland-Altman plot. HBsAg techniques are compared by plotting the differences of Elecsys to Architect (y axis) with their means (x axis). The average between-method difference (0.2 log10 IU/ml) is represented by the middle solid line, while the limit of agreement (−0.5, 0.9 log10 IU/ml) is represented by the two outer solid lines. Five values lie outside this range.

Tables

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  • Table 1

    Precision of Architect and the Elecsys assays under repeatability conditions

    SampleaIU/ml HBsAg% CVIntra-assay correlationb
    MeanSD
    Architect
        1319.914.44.50.999
        23334.1208.06.20.999
        345 556.21232.72.70.999
    Elecsys
        4633.626.44.20.999
        56390.1174.02.70.999
        635 270.61190.73.40.999
    • ↵a All samples were retested 21 times.

    • ↵b Determined using a one-way analysis of variance model, pooled for all HBsAg levels.

  • Table 2

    Comparison of mean differences between HBsAg quantification methods by various clinical parametersa

    Clinical parameterNo. of sampleseMean differencebLimit of agreement (±2 SD)
    HBeAg status
        HBeAg positive690.182−0.560, 0.923
        HBeAg negative570.143−0.500, 0.786
    HBV DNA viral load
        >2,000 IU/ml750.180−0.655, 1.014
        ≤2,000 IU/ml510.141−0.284, 0.566
    HBV genotypec
        A590.196−0.564, 0.956
        D70.036−0.165, 0.237
        E70.030−0.251, 0.311
        G+A/G150.201−0.275, 0.676
    Precore (W28) mutation
        Yes230.111−0.279, 0.500
        No630.195−0.543, 0.933
    YMDD mutation
        Yes600.156−0.543, 0.855
        No200.234−0.403, 0.871
    s120/s145 mutationsd
        Yes6−0.078−0.403, 0.247
        No810.186−0.487, 0.859
    HCV-positive serology
        Yes150.160−0.924, 1.243
        No1100.164−0.473, 0.802
    HDV-positive serology
        Yes90.251−0.485, 0.988
        No1160.157−0.541, 0.856
    CD4+ T cell count
        >500 cells/mm3420.195−0.341, 0.732
        350–500 cells/mm3360.155−0.791, 1.102
        <350 cells/mm3480.143−0.464, 0.751
    • ↵a Bland-Altman analysis stratified on various HBV and HIV cofactors.

    • ↵b Difference of Elecsys to Architect.

    • ↵c P values of <0.1 when mean between-assay differences are compared betwen D versus G+A/G and E versus G+A/G.

    • ↵d P values of <0.1 when mean between-assay differences are compared between strata.

    • ↵e Total number of samples with available data for each stratum.

  • Table 3

    Comparison of mean differences between various clinical parameters stratified on below/above-median HBsAg levelsa

    Clinical parameterHBsAg levels below medianHBsAg levels above median
    No. of samplesdMean differencebLimit of agreement (±2 SD)No. of samplesdMean differencebLimit of agreement (±2 SD)
    Overall620.100−0.500, 0.800640.200−0.500, 0.900
    HBeAg status
        HBeAg positive130.116−0.384, 0.615560.197−0.591, 0.985
        HBeAg negative490.132−0.553, 0.81780.208−0.044, 0.460
    HBV-DNAc
        >2,000 IU/ml540.125−0.550, 0.800210.321−0.799, 1.440
        ≤2,000 IU/ml80.153−0.292, 0.597430.139−0.288, 0.565
    HBV genotype
        A150.118−0.205, 0.442440.222−0.634, 1.079
        D30.003−0.268, 0.27340.061−0.095, 0.216
        E40.077−0.215, 0.3693-0.033−0.293, 0.228
        G+A/G90.168−0.310, 0.64760.249−0.248, 0.746
    Precore (W28) mutation
        Yes120.087−0.241, 0.415110.136−0.322, 0.595
        No160.117−0.209, 0.443470.222−0.608, 1.051
    YMDD mutation
        Yes200.081−0.188, 0.349400.194−0.634, 1.022
        No50.152−0.266, 0.570150.262−0.437, 0.960
    s120/s145 mutationsc
        Yes20.0430.034, 0.0524−0.139−0.482, 0.205
        No290.108−0.238, 0.454520.230−0.559, 1.019
    HCV-positive serology
        Yes130.158−1.010, 1.32620.170−0.092, 0.431
        No490.121−0.315, 0.557610.200−0.559, 0.958
    HDV-positive serology
        Yes60.268−0.660, 1.19630.2190.139, 0.298
        No560.114−0.500, 0.727600.198−0.568, 0.963
    CD4+ T cell count
        >500 cells/mm3160.116−0.607, 0.839260.244−0.119, 0.607
        350-500 cells/mm3160.141−0.610, 0.892200.167−0.930, 1.264
        <350 cells/mm3300.129−0.435, 0.693180.167−0.521, 0.856
    • ↵a Bland-Altman analysis stratified on various HBV and HIV cofactors, presented among patients with high or low values of HBsAg quantity. HBsAg levels are given by the Elecsys technique (median = 3.98 log10 Iu/ml).

    • ↵b Difference of Elecsys to Architect.

    • ↵c P values of <0.1 when mean between-assay differences are compared between strata at HBsAg levels above the median.

    • ↵d Total number of samples with available data for each stratum.

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Comparison between Elecsys HBsAg II and Architect HBsAg QT Assays for Quantification of Hepatitis B Surface Antigen among Patients Coinfected with HIV and Hepatitis B Virus
Sarah Maylin, Anders Boyd, Constance Delaugerre, Fabien Zoulim, Fabien Lavocat, François Simon, Pierre-Marie Girard, Karine Lacombe
Clinical and Vaccine Immunology Jan 2012, 19 (2) 242-248; DOI: 10.1128/CVI.05454-11

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Comparison between Elecsys HBsAg II and Architect HBsAg QT Assays for Quantification of Hepatitis B Surface Antigen among Patients Coinfected with HIV and Hepatitis B Virus
Sarah Maylin, Anders Boyd, Constance Delaugerre, Fabien Zoulim, Fabien Lavocat, François Simon, Pierre-Marie Girard, Karine Lacombe
Clinical and Vaccine Immunology Jan 2012, 19 (2) 242-248; DOI: 10.1128/CVI.05454-11
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