HBsAg blood screening and diagnosis: performance evaluation of the ARCHITECT HBsAg qualitative and ARCHITECT HBsAg qualitative confirmatory assays

[Guest guest]

http://www.dmidjournal.com/article/PIIS0732889311001441/abstract?rss=yes

JOURNAL OF DIAGNOSTIC MICROBIOLOGY & INFECTIOUS DISEASE

Volume 70, Issue 4, Pages 479-485 (August 2011)

HBsAg blood screening and diagnosis: performance evaluation of the ARCHITECT

HBsAg qualitative and ARCHITECT HBsAg qualitative confirmatory assays

Christian Poppa, Doris Kramsa, Christian Beckerta, Carsten Buenninga, Lucinda

Queirósb, Loredana Piroc, Marina Lucianic, Markus Roebbeckea, Hans-

Kapprella

Received 26 January 2011; accepted 28 March 2011. published online 09 June 2011.

Abstract

A low initial reactive rate for screening assays is important for time- and

cost-effective infectious disease testing. Therefore, the new ARCHITECT HBsAg

Qualitative screening assay, in conjunction with the new ARCHITECT HBsAg

Qualitative Confirmatory assay, was introduced. As the role of hepatitis B

surface antigen (HBsAg) as surrogate marker for HBV resolution and the

monitoring of drug effectiveness are becoming increasingly important, the

established ARCHITECT HBsAg Quantitative assay remains available on the market.

Precision, sensitivity, and specificity of the newly developed screening assay

were in the range of established HBsAg assays. Seroconversion sensitivity was

slightly superior compared to other commercially available assays. An initial

reactive rate of 0.2% (without HBsAg-confirmed positive samples of 0.17%) for

the ARCHITECT HBsAg Qualitative assay was observed. As the new screening assay

is a 1-step assay format, the “high-dose hook effect” was investigated to assess

the risk of false-negative results, but even very high positive HBsAg samples

obtained signals clearly above the cutoff.

a Abbott GmbH & Co. KG, Wiesbaden-Delkenheim, Germany

b Instituto Português do Sangue, Porto, Portugal

c SIMT Policlinico Umberto I Sapienza Università di Roma, Rome, Italy

Corresponding author. Tel.: +49-(0)6122/58-1409; fax: +49(0)6122/58-1473.

PII: S0732-8893(11)00144-1

doi:10.1016/j.diagmicrobio.2011.03.022

© 2011 Elsevier Inc. All rights reserved.

[Guest guest]

http://www.dmidjournal.com/article/PIIS0732889311001441/abstract?rss=yes

JOURNAL OF DIAGNOSTIC MICROBIOLOGY & INFECTIOUS DISEASE

Volume 70, Issue 4, Pages 479-485 (August 2011)

HBsAg blood screening and diagnosis: performance evaluation of the ARCHITECT

HBsAg qualitative and ARCHITECT HBsAg qualitative confirmatory assays

Christian Poppa, Doris Kramsa, Christian Beckerta, Carsten Buenninga, Lucinda

Queirósb, Loredana Piroc, Marina Lucianic, Markus Roebbeckea, Hans-

Kapprella

Received 26 January 2011; accepted 28 March 2011. published online 09 June 2011.

Abstract

A low initial reactive rate for screening assays is important for time- and

cost-effective infectious disease testing. Therefore, the new ARCHITECT HBsAg

Qualitative screening assay, in conjunction with the new ARCHITECT HBsAg

Qualitative Confirmatory assay, was introduced. As the role of hepatitis B

surface antigen (HBsAg) as surrogate marker for HBV resolution and the

monitoring of drug effectiveness are becoming increasingly important, the

established ARCHITECT HBsAg Quantitative assay remains available on the market.

Precision, sensitivity, and specificity of the newly developed screening assay

were in the range of established HBsAg assays. Seroconversion sensitivity was

slightly superior compared to other commercially available assays. An initial

reactive rate of 0.2% (without HBsAg-confirmed positive samples of 0.17%) for

the ARCHITECT HBsAg Qualitative assay was observed. As the new screening assay

is a 1-step assay format, the “high-dose hook effect” was investigated to assess

the risk of false-negative results, but even very high positive HBsAg samples

obtained signals clearly above the cutoff.

a Abbott GmbH & Co. KG, Wiesbaden-Delkenheim, Germany

b Instituto Português do Sangue, Porto, Portugal

c SIMT Policlinico Umberto I Sapienza Università di Roma, Rome, Italy

Corresponding author. Tel.: +49-(0)6122/58-1409; fax: +49(0)6122/58-1473.

PII: S0732-8893(11)00144-1

doi:10.1016/j.diagmicrobio.2011.03.022

© 2011 Elsevier Inc. All rights reserved.

[Guest guest]

http://www.dmidjournal.com/article/PIIS0732889311001441/abstract?rss=yes

JOURNAL OF DIAGNOSTIC MICROBIOLOGY & INFECTIOUS DISEASE

Volume 70, Issue 4, Pages 479-485 (August 2011)

HBsAg blood screening and diagnosis: performance evaluation of the ARCHITECT

HBsAg qualitative and ARCHITECT HBsAg qualitative confirmatory assays

Christian Poppa, Doris Kramsa, Christian Beckerta, Carsten Buenninga, Lucinda

Queirósb, Loredana Piroc, Marina Lucianic, Markus Roebbeckea, Hans-

Kapprella

Received 26 January 2011; accepted 28 March 2011. published online 09 June 2011.

Abstract

A low initial reactive rate for screening assays is important for time- and

cost-effective infectious disease testing. Therefore, the new ARCHITECT HBsAg

Qualitative screening assay, in conjunction with the new ARCHITECT HBsAg

Qualitative Confirmatory assay, was introduced. As the role of hepatitis B

surface antigen (HBsAg) as surrogate marker for HBV resolution and the

monitoring of drug effectiveness are becoming increasingly important, the

established ARCHITECT HBsAg Quantitative assay remains available on the market.

Precision, sensitivity, and specificity of the newly developed screening assay

were in the range of established HBsAg assays. Seroconversion sensitivity was

slightly superior compared to other commercially available assays. An initial

reactive rate of 0.2% (without HBsAg-confirmed positive samples of 0.17%) for

the ARCHITECT HBsAg Qualitative assay was observed. As the new screening assay

is a 1-step assay format, the “high-dose hook effect” was investigated to assess

the risk of false-negative results, but even very high positive HBsAg samples

obtained signals clearly above the cutoff.

a Abbott GmbH & Co. KG, Wiesbaden-Delkenheim, Germany

b Instituto Português do Sangue, Porto, Portugal

c SIMT Policlinico Umberto I Sapienza Università di Roma, Rome, Italy

Corresponding author. Tel.: +49-(0)6122/58-1409; fax: +49(0)6122/58-1473.

PII: S0732-8893(11)00144-1

doi:10.1016/j.diagmicrobio.2011.03.022

© 2011 Elsevier Inc. All rights reserved.

[Guest guest]

http://www.dmidjournal.com/article/PIIS0732889311001441/abstract?rss=yes

JOURNAL OF DIAGNOSTIC MICROBIOLOGY & INFECTIOUS DISEASE

Volume 70, Issue 4, Pages 479-485 (August 2011)

HBsAg blood screening and diagnosis: performance evaluation of the ARCHITECT

HBsAg qualitative and ARCHITECT HBsAg qualitative confirmatory assays

Christian Poppa, Doris Kramsa, Christian Beckerta, Carsten Buenninga, Lucinda

Queirósb, Loredana Piroc, Marina Lucianic, Markus Roebbeckea, Hans-

Kapprella

Received 26 January 2011; accepted 28 March 2011. published online 09 June 2011.

Abstract

A low initial reactive rate for screening assays is important for time- and

cost-effective infectious disease testing. Therefore, the new ARCHITECT HBsAg

Qualitative screening assay, in conjunction with the new ARCHITECT HBsAg

Qualitative Confirmatory assay, was introduced. As the role of hepatitis B

surface antigen (HBsAg) as surrogate marker for HBV resolution and the

monitoring of drug effectiveness are becoming increasingly important, the

established ARCHITECT HBsAg Quantitative assay remains available on the market.

Precision, sensitivity, and specificity of the newly developed screening assay

were in the range of established HBsAg assays. Seroconversion sensitivity was

slightly superior compared to other commercially available assays. An initial

reactive rate of 0.2% (without HBsAg-confirmed positive samples of 0.17%) for

the ARCHITECT HBsAg Qualitative assay was observed. As the new screening assay

is a 1-step assay format, the “high-dose hook effect” was investigated to assess

the risk of false-negative results, but even very high positive HBsAg samples

obtained signals clearly above the cutoff.

a Abbott GmbH & Co. KG, Wiesbaden-Delkenheim, Germany

b Instituto Português do Sangue, Porto, Portugal

c SIMT Policlinico Umberto I Sapienza Università di Roma, Rome, Italy

Corresponding author. Tel.: +49-(0)6122/58-1409; fax: +49(0)6122/58-1473.

PII: S0732-8893(11)00144-1

doi:10.1016/j.diagmicrobio.2011.03.022

© 2011 Elsevier Inc. All rights reserved.