Correlation between the Elecsys HBsAg II assay and the Architect assay for the quantification of hepatitis B surface antigen (HBsAg) in the serum

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JOURNAL OF CLINICAL VIROLOGY

Articles in Press

Correlation between the Elecsys HBsAg II assay and the Architect assay for the

quantification of hepatitis B surface antigen (HBsAg) in the serum

Karsten Wursthorna, Jerzy Jaroszewiczab, Behrend J. Zachera, a Darneddea,

Regina Raupacha, Ingmar Mederackea, Markus Cornberga, P. Mannsa, Heiner

Wedemeyera

Received 23 July 2010; received in revised form 8 December 2010; accepted 21

December 2010. published online 28 January 2011.

Corrected Proof

Abstract

Background

Hepatitis B surface antigen (HBsAg) clearance during chronic hepatitis B (CHB)

infection is associated with improved long-term clinical outcome, so is

considered an important therapeutic goal in CHB. Studies have shown that serum

HBsAg quantification during, and at end of, treatment may predict long-term

HBsAg loss.

Objectives

Performance comparison of the qualitative Elecsys HBsAg II assay using a

quantitative research protocol and an established quantitative HBsAg assay.

Study design

A dilution algorithm was developed for the Elecsys HBsAg II assay to allow

quantification of HBsAg levels; this was used to measure HBsAg levels in a range

of samples including sera from patients infected with different HBV genotypes,

HBV mutants, and longitudinal samples from patients undergoing antiviral

treatment. Results were compared with those from the quantitative Architect

HBsAg assay.

Results

There was significant overall correlation between Elecsys and Architect assays

(correlation coefficient [r]=0.97; p<0.001). HBsAg levels measured with both

assays correlated well in all phases of infection (r=0.80–0.96), across all

genotypes tested (HBV genotype A, r=0.89; HBV genotype D, r=0.97), and in

samples with lamivudine-resistant mutations (r=0.94). Bland–Altman analysis

showed only minor discordance between assays in different phases of chronic

HBV-infection (3.8–5.1%). This strong correlation was also present for sera with

lower HBsAg concentrations. On-treatment HBsAg levels were similar when measured

with either assay.

Conclusions

Using a simple dilution algorithm, the quantitative Elecsys HBsAg II assay

reliably determined serum HBsAg levels in a wide range of samples, and showed

very high correlation with the Architect HBsAg assay.

a Dept. of Gastroenterology, Hepatology and Endocrinology, Hannover Medical

School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany

b Medical University of Bialystok, Poland

Corresponding author. Tel.: +49 511 532 6814; fax: +49 511 532 8662.

PII: S1386-6532(11)00022-9

doi:10.1016/j.jcv.2010.12.008

© 2011 Published by Elsevier Inc.

[Guest guest]

http://www.journalofclinicalvirology.com/article/PIIS1386653211000229/abstract?r\

ss=yes

JOURNAL OF CLINICAL VIROLOGY

Articles in Press

Correlation between the Elecsys HBsAg II assay and the Architect assay for the

quantification of hepatitis B surface antigen (HBsAg) in the serum

Karsten Wursthorna, Jerzy Jaroszewiczab, Behrend J. Zachera, a Darneddea,

Regina Raupacha, Ingmar Mederackea, Markus Cornberga, P. Mannsa, Heiner

Wedemeyera

Received 23 July 2010; received in revised form 8 December 2010; accepted 21

December 2010. published online 28 January 2011.

Corrected Proof

Abstract

Background

Hepatitis B surface antigen (HBsAg) clearance during chronic hepatitis B (CHB)

infection is associated with improved long-term clinical outcome, so is

considered an important therapeutic goal in CHB. Studies have shown that serum

HBsAg quantification during, and at end of, treatment may predict long-term

HBsAg loss.

Objectives

Performance comparison of the qualitative Elecsys HBsAg II assay using a

quantitative research protocol and an established quantitative HBsAg assay.

Study design

A dilution algorithm was developed for the Elecsys HBsAg II assay to allow

quantification of HBsAg levels; this was used to measure HBsAg levels in a range

of samples including sera from patients infected with different HBV genotypes,

HBV mutants, and longitudinal samples from patients undergoing antiviral

treatment. Results were compared with those from the quantitative Architect

HBsAg assay.

Results

There was significant overall correlation between Elecsys and Architect assays

(correlation coefficient [r]=0.97; p<0.001). HBsAg levels measured with both

assays correlated well in all phases of infection (r=0.80–0.96), across all

genotypes tested (HBV genotype A, r=0.89; HBV genotype D, r=0.97), and in

samples with lamivudine-resistant mutations (r=0.94). Bland–Altman analysis

showed only minor discordance between assays in different phases of chronic

HBV-infection (3.8–5.1%). This strong correlation was also present for sera with

lower HBsAg concentrations. On-treatment HBsAg levels were similar when measured

with either assay.

Conclusions

Using a simple dilution algorithm, the quantitative Elecsys HBsAg II assay

reliably determined serum HBsAg levels in a wide range of samples, and showed

very high correlation with the Architect HBsAg assay.

a Dept. of Gastroenterology, Hepatology and Endocrinology, Hannover Medical

School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany

b Medical University of Bialystok, Poland

Corresponding author. Tel.: +49 511 532 6814; fax: +49 511 532 8662.

PII: S1386-6532(11)00022-9

doi:10.1016/j.jcv.2010.12.008

© 2011 Published by Elsevier Inc.