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Clinical evaluation of a novel and highly sensitive immunoassay for anti‐hepatitis B core antigen using a fully automated immunochemical analyzer
Author(s) -
Izumida Kyo,
Kaneko Atsushi,
Takahashi Kazuya,
Kusumoto Shigeru,
Narita Tomoko,
Takami Akiyoshi,
Iida Shinsuke,
Aoyagi Katsumi,
Tanaka Yasuhito
Publication year - 2018
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/hepr.13229
Subject(s) - immunoassay , hepatitis b virus , medicine , antigen , hepatitis b , hbsag , virology , immunology , virus , antibody
Aim Recently, the measurement of hepatitis B surface antigen and anti‐hepatitis B core antigen (HBcAb) and/or anti‐hepatitis B surface antigen has been recommended before various therapies to identify patients at risk of hepatitis B virus (HBV) reactivation. However, a recent study reported that HBV reactivation occurred in HBcAb‐negative patients, indicating that it is challenging to identify patients with a history of HBV infection using conventional HBcAb reagent. We developed a highly sensitive HBcAb (HBcAb‐HS) assay for reducing the risk of HBV reactivation. Methods The HBcAb‐HS assay is an automated chemiluminescent enzyme immunoassay system, which is suitable for clinical use. The cut‐off was set at 0.020 IU/mL from the distribution patterns of HBcAb‐negative specimens, and we evaluated the performance of this assay compared with conventional reagents. Results This new assay showed a 27–81‐fold greater sensitivity than conventional HBcAb reagents; the quantified measurement range was from 0.005 IU/mL to 1.500 IU/mL, and it showed excellent quantitative performance and correlated well with two conventional assays, using the HBcAb‐positive specimens. Moreover, it showed 100% specificity for the 469 purchased HBcAb‐negative specimens. Notably, this newly developed HBcAb‐HS assay showed positivity in the preserved specimens before HBV reactivation, for which conventional HBcAb reagents gave negative results, and the HBcAb‐HS assay could detect the lower HBcAb levels even after intensive immunosuppressive therapies, including autologous hematopoietic stem cell transplantation. Conclusions The clinical efficacy of the newly developed, highly sensitive HBcAb assay would enable the identification of patients at risk of HBV reactivation more accurately.