A comparison of two assays for quantification of Hepatitis B surface Antigen in patients with chronic hepatitis B

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http://www.journalofclinicalvirology.com/article/PIIS1386653211001454/abstract?r\

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JOURNAL OF CLINICAL VIROLOGY

A comparison of two assays for quantification of Hepatitis B surface Antigen in

patients with chronic hepatitis B

Milan J. Sonnevelda, Rijckborsta, A.B. Boucherb, Louwerens

Zwangc, Matthias F.C. Beersmab, Bettina E. Hansenad, Harry L.A. Janssena

Received 16 December 2010; received in revised form 7 April 2011; accepted 11

April 2011. published online 18 May 2011.

Corrected Proof

Abstract

Background and objectives

Serum Hepatitis B surface Antigen (HBsAg) levels correlate with hepatitis B

virus intrahepatic covalently closed circular DNA and may predict response to

treatment. Currently, 2 commercial platforms are available for HBsAg

quantification in clinical practice, the Architect HBsAg QT and the Elecsys

HBsAg. We aimed to directly compare the results of these assays.

Study design

HBsAg levels were measured in 1427 serum samples from HBeAg-positive chronic

hepatitis B patients who participated in a randomized trial of peginterferon

alfa-2b±lamivudine. Samples were extracted from our serum bank, thawed, and

subsequently analysed for HBsAg levels using both assays.

Results

Of 1427 samples, 242 (17%) were taken before and 1185 during the treatment phase

of the study. Distribution of HBV genotypes was 447 (31%) genotype A, 125 (9%)

B, 210 (15%) C and 534 (37%) D. Correlation between Architect and Elecsys

results was high (r=0.96, p<0.001). By Bland–Altman analysis, agreement

between the two assays was close (mean difference between Architect and Elecsys:

−0.01logIU/mL, 95% CI: −0.55–0.52logIU/mL), also when analysed separately

for HBV genotypes A–D. Additionally, the performance of our recently published

stopping rule for HBeAg-positive patients treated with peginterferon was

comparable: the negative predictive values were 96% and 98% for Elecsys and

Architect, respectively.

Conclusions

There is a high correlation and close agreement between quantitative HBsAg

measurements conducted with the Architect and the Elecsys. Clinical prediction

rules derived from data from one platform can be applied on the other; both can

therefore be used in clinical practice.

Abbreviations: CHB, chronic hepatitis B, HBsAg, Hepatitis B surface Antigen,

HBV, hepatitis B virus, cccDNA, covalently closed circular DNA, PEG-IFN,

peginterferon, HBeAg, hepatitis B e antigen

a Department of Gastroenterology and Hepatology, Erasmus MC University Medical

Center, Rotterdam, The Netherlands

b Department of Virology, Erasmus MC University Medical Center, Rotterdam, The

Netherlands

c Department of Clinical Chemistry, Erasmus MC University Medical Center,

Rotterdam, The Netherlands

d Department of Biostatistics, Erasmus MC University Medical Center, Rotterdam,

The Netherlands

Corresponding author at: Department of Gastroenterology and Hepatology, Erasmus

MC, University Medical Center Rotterdam, ‘s Gravendijkwal 230, Room Ha 204,

3015 CE, Rotterdam, The Netherlands. Tel.: +31 010 703 5942; fax: +31 010 436

5916.

PII: S1386-6532(11)00145-4

doi:10.1016/j.jcv.2011.04.005

© 2011 Elsevier B.V. All rights reserved.

[Guest guest]

http://www.journalofclinicalvirology.com/article/PIIS1386653211001454/abstract?r\

ss=yes

JOURNAL OF CLINICAL VIROLOGY

A comparison of two assays for quantification of Hepatitis B surface Antigen in

patients with chronic hepatitis B

Milan J. Sonnevelda, Rijckborsta, A.B. Boucherb, Louwerens

Zwangc, Matthias F.C. Beersmab, Bettina E. Hansenad, Harry L.A. Janssena

Received 16 December 2010; received in revised form 7 April 2011; accepted 11

April 2011. published online 18 May 2011.

Corrected Proof

Abstract

Background and objectives

Serum Hepatitis B surface Antigen (HBsAg) levels correlate with hepatitis B

virus intrahepatic covalently closed circular DNA and may predict response to

treatment. Currently, 2 commercial platforms are available for HBsAg

quantification in clinical practice, the Architect HBsAg QT and the Elecsys

HBsAg. We aimed to directly compare the results of these assays.

Study design

HBsAg levels were measured in 1427 serum samples from HBeAg-positive chronic

hepatitis B patients who participated in a randomized trial of peginterferon

alfa-2b±lamivudine. Samples were extracted from our serum bank, thawed, and

subsequently analysed for HBsAg levels using both assays.

Results

Of 1427 samples, 242 (17%) were taken before and 1185 during the treatment phase

of the study. Distribution of HBV genotypes was 447 (31%) genotype A, 125 (9%)

B, 210 (15%) C and 534 (37%) D. Correlation between Architect and Elecsys

results was high (r=0.96, p<0.001). By Bland–Altman analysis, agreement

between the two assays was close (mean difference between Architect and Elecsys:

−0.01logIU/mL, 95% CI: −0.55–0.52logIU/mL), also when analysed separately

for HBV genotypes A–D. Additionally, the performance of our recently published

stopping rule for HBeAg-positive patients treated with peginterferon was

comparable: the negative predictive values were 96% and 98% for Elecsys and

Architect, respectively.

Conclusions

There is a high correlation and close agreement between quantitative HBsAg

measurements conducted with the Architect and the Elecsys. Clinical prediction

rules derived from data from one platform can be applied on the other; both can

therefore be used in clinical practice.

Abbreviations: CHB, chronic hepatitis B, HBsAg, Hepatitis B surface Antigen,

HBV, hepatitis B virus, cccDNA, covalently closed circular DNA, PEG-IFN,

peginterferon, HBeAg, hepatitis B e antigen

a Department of Gastroenterology and Hepatology, Erasmus MC University Medical

Center, Rotterdam, The Netherlands

b Department of Virology, Erasmus MC University Medical Center, Rotterdam, The

Netherlands

c Department of Clinical Chemistry, Erasmus MC University Medical Center,

Rotterdam, The Netherlands

d Department of Biostatistics, Erasmus MC University Medical Center, Rotterdam,

The Netherlands

Corresponding author at: Department of Gastroenterology and Hepatology, Erasmus

MC, University Medical Center Rotterdam, ‘s Gravendijkwal 230, Room Ha 204,

3015 CE, Rotterdam, The Netherlands. Tel.: +31 010 703 5942; fax: +31 010 436

5916.

PII: S1386-6532(11)00145-4

doi:10.1016/j.jcv.2011.04.005

© 2011 Elsevier B.V. All rights reserved.