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Novel monitoring of hepatitis B reactivation based on ultra-high sensitive hepatitis B surface antigen assay
Authors
First published: 29 January 2017Full publication history
DOI: 10.1111/liv.13349 View/save citation
Cited by (CrossRef): 0 articles Check for updates
Funding information
This work was supported in part by a grant-in-aid from the Research Program on Hepatitis from Japan Agency for Medical Research and Development (AMED) and a grant-in-aid from the Ministry of Education, Culture, Sports, Science and Technology (Scientific Research (C) no. 90423855 to S.K.)
Handling Editor: Francesco Negro
Abstract
Background & Aims
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).
Methods
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.
Results
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.
Conclusions
ICT-CLEIA is a novel assay for HBV monitoring to prevent hepatitis caused by HBV reactivation.
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