3 years ago

Ultra-high sensitivity HBsAg assay can diagnose HBV reactivation following rituximab-based therapy in patients with lymphoma

Ultra-high sensitivity HBsAg assay can diagnose HBV reactivation following rituximab-based therapy in patients with lymphoma
Shigeru Kusumoto, Yasuhito Tanaka, Ritsuro Suzuki, Takashi Watanabe, Masanobu Nakata, Rika Sakai, Noriyasu Fukushima, Takuya Fukushima, Yukiyoshi Moriuchi, Kuniaki Itoh, Kisato Nosaka, Ilseung Choi, Masashi Sawa, Rumiko Okamoto, Hideki Tsujimura, Toshiki Uchida, Sachiko Suzuki, Masataka Okamoto, Tsutomu Takahashi, Isamu Sugiura, Yasushi Onishi, Mika Kohri, Shinichiro Yoshida, Minoru Kojima, Hiroyuki Takahashi, Akihiro Tomita, Yoshiko Atsuta, Dai Maruyama, Eiji Tanaka, Takayo Suzuki, Tomohiro Kinoshita, Michinori Ogura, Ryuzo Ueda, Masashi Mizokami

Background & Aims

The purpose of this post hoc analysis was to evaluate the efficacy of an ultra-high sensitive HBsAg assay using prospectively stored samples of HBV DNA monitoring study for lymphoma patients with resolved HBV infection following anti-CD20 antibody, rituximab-containing chemotherapy (UMIN000001299).


HBV reactivation defined as HBV DNA levels of 11 IU/mL or more was confirmed in 22 of 252 patients. Conventional HBsAg assay (ARCHITECT, cut-off value: 0.05 IU/mL) and ultra-high sensitive HBsAg assay employing a semi-automated immune complex transfer chemiluminescence enzyme technique (ICT-CLEIA, cut-off value: 0.0005 IU/mL) were measured at baseline, at confirmed HBV reactivation and monitored after HBV reactivation.


Baseline HBsAg was detected using ICT-CLEIA in 4 patients, in all of whom precore mutants with high replication capacity were reactivated. Of the 6 patients with HBV DNA detected below the level of quantification at baseline, 5 showed HBV reactivation and 3 of the 5 had precore mutations. Sensitivity for detection by ARCHITECT and ICT-CLEIA HBsAg assays at HBV reactivation or the next sampling after HBV reactivation was 18.2% (4 of 22) and 77.3% (17 of 22), respectively. Of the discrepant 5 patients undetectable by ICT-CLEIA, 2 patients resolved spontaneously. All 6 patients reactivated with precore mutations including preS deletion could be diagnosed by ICT-CLEIA HBsAg assay at an early stage of HBV reactivation. Multivariate analysis showed that an anti-HBs titer of less than 10 mIU/mL, detected HBV DNA below the level of quantification, and detected ICT-CLEIA HBsAg at baseline were independent risk factors for HBV reactivation (adjusted hazard ratios, 15.4, 31.2 and 8.7, respectively; p<0.05).


A novel ICT-CLEIA HBsAg assay would be an alternative method to diagnose HBV reactivation.

Publisher URL: https://www.sciencedirect.com/science/article/pii/S0168827820301677

DOI: 10.1016/j.jhep.2020.03.009

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