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Performance characteristics of the high sensitivity Alinity i & ARCHITECT HBsAg Next Qualitative/Confirmatory assays.
Diagnostic Microbiology and Infectious Disease ( IF 2.9 ) Pub Date : 2020-03-10 , DOI: 10.1016/j.diagmicrobio.2020.115033
Eva Sickinger 1 , Hans-Bertram Braun 1 , Tobias Meyer 1 , Kathrin Schmid 1 , David Daghfal 2 , Michael Oer 1 , Jan Schultess 1
Affiliation  

Despite improvement in vaccinations, Hepatitis B remains a major health concern due to the difficulty of prevention even in low endemic areas such as Europe. In this report we describe the performance characteristics of the new HBsAg Next Qualitative and HBsAg Next Confirmatory assays designed for blood screening and diagnostic purposes on the Alinity i and ARCHITECT fully automated systems. The new assays were evaluated in comparison to the ARCHITECT HBsAg Qualitative II and Confirmatory assays on seroconversion, analytical sensitivity, and mutant panels along with testing of over 400 clinical positive samples demonstrating excellent improvements in sensitivity. Additionally, specificity was shown to be improved with testing of over 6000 donors and 240 diagnostic specimens. Overall, the Alinity i & ARCHITECT HBsAg Next assays have taken a step forward in improving the detection of Hepatitis B virus.

中文翻译:

高灵敏度Alinity i和ARCHITECT HBsAg Next定性/确证分析的性能特征。

尽管疫苗接种有所改善,但即使在欧洲等低流行地区,由于难以预防,乙型肝炎仍然是主要的健康问题。在本报告中,我们描述了专为Alinity i和ARCHITECT全自动系统上的血液筛查和诊断目的而设计的新型HBsAg Next定性检测和HBsAg Next Confirmative检测的性能特征。与ARCHITECT HBsAg定性II和确证性分析相比,对新分析进行了评估,包括血清转化,分析灵敏度和突变检测,以及对400多个临床阳性样品的测试,证明了灵敏度的显着提高。此外,通过测试6000多个供体和240个诊断样本可以提高特异性。总体而言,Alinity i&
更新日期:2020-04-20
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