title: Novel monitoring of hepatitis B reactivation based on ultra-high sensitive hepatitis B surface antigen assay.
abstract: Occult hepatitis B virus (HBV) infection should be evaluated before systemic chemotherapy to prevent HBV reactivation-related hepatitis. We investigated HBV reactivation using high sensitivity HB surface antigen (HBsAg) chemiluminescent enzyme immunoassay (HBsAg-HQ) and ultra-high sensitive HBsAg assay employing a semi-automated immune complex transfer chemiluminescence enzyme technique (ICT-CLEIA).
  
  
  
  Of 120 HBV-resolved patients with haematological malignancy receiving systemic chemotherapy from 2012 to 2015 in our hospital, 13 patients had HBV DNA reactivation (in 12/13 patients HBV DNA became quantifiable) according to HBV DNA monitoring. These patients were applied for Architect HBsAg-QT (detection limit:50 mIU/mL), HBsAg-HQ (5 mIU/mL) and ICT-CLEIA (0.5 mIU/mL) using stored samples.
  
  
  
  When HBV DNA was firstly quantifiable by regular HBV DNA monitoring, HBsAg-QT was detected in 1/12 patients (8%), HBsAg-HQ was detected in 4/12 patients (33%) and ICT-CLEIA was detected in all 12 patients (100%), suggesting that the sensitivity of ICT-CLEIA was comparable to that of HBV DNA quantification. Interestingly, two patients were HBsAg positive by ICT-CLEIA before HBV DNA became detectable. Median difference of detectable point between HBV DNA and ICT-CLEIA was zero (range from -28 to 56 days), while median delay by HBsAg-QT or HBsAg-HQ was 52.5 days after HBV DNA became detectable. Although anti-HBs titres were high (131.9 mIU, 80.4 mIU) in two patients with escape mutations (Saa126V, Saa145R), HBsAg by ICT-CLEIA and HBV DNA were detectable concurrently.
  
  
  
  ICT-CLEIA is a novel assay for HBV monitoring to prevent hepatitis caused by HBV reactivation.
authors.affiliation: Departments of Virology & Liver unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Noboru
authors.identifier: 0000-0003-1120-2188
authors.initials: N
authors.lastname: Shinkai
authors.affiliation: Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Kusumoto
authors.affiliation: Departments of Virology & Liver unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Shuko
authors.initials: S
authors.lastname: Murakami
authors.affiliation: Departments of Virology & Liver unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Shintaro
authors.initials: S
authors.lastname: Ogawa
authors.affiliation: Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Ri
authors.affiliation: Departments of Virology & Liver unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.|Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan.
authors.forename: Tekeshi
authors.initials: T
authors.lastname: Matsui
authors.affiliation: Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Tamori
authors.affiliation: Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan.
authors.forename: Hidenori
authors.initials: H
authors.lastname: Toyoda
authors.affiliation: Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ishida
authors.affiliation: Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Iida
authors.affiliation: Departments of Virology & Liver unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Yasuhito
authors.initials: Y
authors.lastname: Tanaka
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006509:Hepatitis B / Q000175:diagnosis* / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence
chemical_list: D006514:Hepatitis B Surface Antigens
keywords: HBV DNA monitoring; HBV reactivation; HBsAg monitoring; ICT-CLEIA