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Performance characteristics of the high sensitivity Alinity i & ARCHITECT HBsAg Next Qualitative/Confirmatory assays.

Abstract：

: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.

journal_name

Diagn Microbiol Infect Dis

journal_title

Diagnostic microbiology and infectious disease

authors

Sickinger E,Braun HB,Meyer T,Schmid K,Daghfal D,Oer M,Schultess J

doi

10.1016/j.diagmicrobio.2020.115033

subject

Has Abstract

pub_date

2020-06-01 00:00:00

pages

115033

issue

2

eissn

0732-8893

issn

1879-0070

pii

S0732-8893(19)31282-9

journal_volume

97

pub_type

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