An improved Abbott ARCHITECT assay for the detection of hepatitis B virus surface antigen (HBsAg)

[Guest guest]

http://www.journalofclinicalvirology.com/article/PIIS1386653211000485/abstract?r\

ss=yes

JOURNAL OF CLINICAL VIROLOGY

An improved Abbott ARCHITECT® assay for the detection of hepatitis B virus

surface antigen (HBsAg)

Sheng C. Lou, K. Pearce, X. Lukaszewska, E. , Gregg

T. , P. Leary

Received 16 December 2010; received in revised form 17 January 2011; accepted 19

January 2011. published online 03 March 2011.

Corrected Proof

Abstract

Background

The sensitive and accurate detection of hepatitis B virus surface antigen

(HBsAg) is critical to the identification of infection and the prevention of

transfusion transmitted disease. Improvement in HBsAg assay sensitivity is

essential to reduce the window to detect an acute HBV infection. Additionally,

the sensitive detection of HBsAg mutants that continue to evolve due to vaccine

escape, immune selection and an error prone reverse transcriptase is a

necessity.

Objectives and study design

A fully automated HBsAg prototype assay on the Abbott ARCHITECT® instrument was

developed to improve sensitivity and mutant detection. This magnetic

microparticle-based assay utilizes anti-HBsAg monoclonal antibodies to capture

antigen present in serum or plasma. Captured antigen is then detected using

anti-HBsAg antibody conjugated with the chemiluminescent compound, acridinium.

Results

The sensitivity of the ARCHITECT® HBsAg prototype assay was improved as compared

to the current ARCHITECT®, PRISM®, and competitor HBsAg assays. The enhancement

in assay sensitivity was demonstrated by the use of commercially available HBV

seroconversion panels. The prototype assay detected more panel members (185 of

383) vs. the current ARCHITECT® (171), PRISM (181), or competitor HBsAg assays

(73/140 vs. 62/140, respectively). The ARCHITECT® prototype assay also

efficiently detected all mutants evaluated. Finally, the sensitivity improvement

did not compromise the specificity of the assay (99.94%).

Conclusions

An improved Abbott ARCHITECT® HBsAg prototype assay with enhanced detection of

HBsAg and HBsAg mutants, as well as equivalent specificity was developed for the

detection, diagnosis, and management of HBV infection.

Research Assay Prototyping, Diagnostics Research, Abbott Laboratories, 100

Abbott Park Road, Abbott Park, IL 60064, USA

Corresponding author. Present address: Dept. 09PX, Bldg. AP20, Abbott

Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, USA. Tel.: +1 847 937

4564; fax: +1 847 937 1401.

PII: S1386-6532(11)00048-5

doi:10.1016/j.jcv.2011.01.019

© 2011 Published by Elsevier Inc.

[Guest guest]

http://www.journalofclinicalvirology.com/article/PIIS1386653211000485/abstract?r\

ss=yes

JOURNAL OF CLINICAL VIROLOGY

An improved Abbott ARCHITECT® assay for the detection of hepatitis B virus

surface antigen (HBsAg)

Sheng C. Lou, K. Pearce, X. Lukaszewska, E. , Gregg

T. , P. Leary

Received 16 December 2010; received in revised form 17 January 2011; accepted 19

January 2011. published online 03 March 2011.

Corrected Proof

Abstract

Background

The sensitive and accurate detection of hepatitis B virus surface antigen

(HBsAg) is critical to the identification of infection and the prevention of

transfusion transmitted disease. Improvement in HBsAg assay sensitivity is

essential to reduce the window to detect an acute HBV infection. Additionally,

the sensitive detection of HBsAg mutants that continue to evolve due to vaccine

escape, immune selection and an error prone reverse transcriptase is a

necessity.

Objectives and study design

A fully automated HBsAg prototype assay on the Abbott ARCHITECT® instrument was

developed to improve sensitivity and mutant detection. This magnetic

microparticle-based assay utilizes anti-HBsAg monoclonal antibodies to capture

antigen present in serum or plasma. Captured antigen is then detected using

anti-HBsAg antibody conjugated with the chemiluminescent compound, acridinium.

Results

The sensitivity of the ARCHITECT® HBsAg prototype assay was improved as compared

to the current ARCHITECT®, PRISM®, and competitor HBsAg assays. The enhancement

in assay sensitivity was demonstrated by the use of commercially available HBV

seroconversion panels. The prototype assay detected more panel members (185 of

383) vs. the current ARCHITECT® (171), PRISM (181), or competitor HBsAg assays

(73/140 vs. 62/140, respectively). The ARCHITECT® prototype assay also

efficiently detected all mutants evaluated. Finally, the sensitivity improvement

did not compromise the specificity of the assay (99.94%).

Conclusions

An improved Abbott ARCHITECT® HBsAg prototype assay with enhanced detection of

HBsAg and HBsAg mutants, as well as equivalent specificity was developed for the

detection, diagnosis, and management of HBV infection.

Research Assay Prototyping, Diagnostics Research, Abbott Laboratories, 100

Abbott Park Road, Abbott Park, IL 60064, USA

Corresponding author. Present address: Dept. 09PX, Bldg. AP20, Abbott

Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, USA. Tel.: +1 847 937

4564; fax: +1 847 937 1401.

PII: S1386-6532(11)00048-5

doi:10.1016/j.jcv.2011.01.019

© 2011 Published by Elsevier Inc.