Architect乙肝表面抗原定性和Architect乙肝表面抗原定性确证检

StephenW

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

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

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.

StephenW

谷歌翻译
不是100％准确，仅供参考使用。

诊断微生物学及传染病

70卷第4期，页479-485（2011年8月）

乙肝表面抗原的血液进行筛查和诊断：绩效评价
Architect乙肝表面抗原定性和Architect乙肝表面抗原定性确证
检测

多丽丝Kramsa，基督教Beckerta，基督教波帕，卡斯滕Buenninga，
露辛达Queirósb，Loredana Piroc，滨海Lucianic，马库斯Roebbeckea，
汉斯 - 彼得Kapprella

2011年1月26日，2011年3月28日。在网上公布6月09日
2011年。

摘要
重要的是时间和较低的初始筛选试验的反应速率
成本效益的传染性疾病检测。因此，新的Architect
乙肝表面抗原定性筛选实验，结合新的Architect
乙肝表面抗原定性的验证性实验，进行了介绍。由于作用
乙肝表面抗原（HBsAg），乙肝决议的替代标记
监测药物的有效性正变得越来越
重要的是，乙肝表面抗原定量检测仍然既定的Architect
可在市场上。精度，灵敏度和特异性
新开发的筛选实验范围内建立了乙肝表面抗原
检测。相比其他血清转换灵敏度略优于
市售的检测。最初的反应率0.2％（不
乙肝表面抗原确认的0.17％）为建筑师乙肝表面抗原阳性标本
定性分析观察。由于新的筛选试验是1步
检测的格式，“高剂量钩状效应”进行了调查，以评估
假阴性结果的风险，但即使是非常高的HBsAg阳性
样品获得的信号明显高于截止。

一个雅培制药有限两合公司，德国威斯巴登Delkenheim，

b葡萄牙学会Sangue，葡萄牙波尔图

彗星SIMT Policlinico翁贝托一世萨皮恩扎Università罗马，意大利罗马

通讯作者。电话：+49-（0）6122/58-1409;传真：+49（0）6122/58-1473。

有价证券投资收益：S0732 - 8893（11）00144-1

DOI：10.1016/j.diagmicrobio.2011.03.022

© 2011爱思唯尔公司保留所有权利。