JOURNAL OF DIAGNOSTIC MICROBIOLOGY & INFECTIOUS DISEASE
Volume 70, Issue 4, Pages 479-485 (August 2011)
Architect乙肝表面抗原定性和Architect
乙肝表面抗原定性确证检测
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-Peter 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