Hepatitis B Biomarker Quantification Protocol

Blood collections were performed at study entry and follow-ups. Tests on serum markers were performed using commercial kits: HBsAg and HBeAg by radioimmunoassay (Abbott Laboratories, North Chicago, IL), ALT by serum chemistry autoanalyzer (model 736; Hitachi Co., Tokyo, Japan) using commercial reagents, serum HBV DNA levels by polymerase chain reaction (COBAS Amplicor; Roche Diagnostics, Indianapolis, IN) for baseline samples, and by real-time polymerase chain reaction (COBAS TaqMan; Roche Diagnostics, Indianapolis, IN) for follow-up samples. Serum HBsAg levels were quantified using the Elecsys HBsAg II Quant assay (Roche Diagnostics GmbH, Mannheim, Germany). M2BPGi was quantified with a novel sandwich immunoassay using the fully automated chemiluminescence enzyme immunoanalyzer, HISCL-5000 (Sysmex Co., Kobe, Japan)^{21 (link)}. Raw counts of M2BPGi were converted to a standardized cut-off index (COI) for analysis^{32 (link)}.

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Liu J., Hu H.H., Lee M.H., Korenaga M., Jen C.L., Batrla-Utermann R., Lu S.N., Wang L.Y., Mizokami M., Chen C.J, & Yang H.I. (2017). Serum Levels of M2BPGi as Short-Term Predictors of Hepatocellular Carcinoma in Untreated Chronic Hepatitis B Patients. Scientific Reports, 7, 14352.

Publication 2017

radioimmunoassay COBAS Amplicor COBAS TaqMan Elecsys HBsAg II Quant assay HISCL-5000

Assay Blood Chemiluminescence Diagnostics Enzyme Hbsag Immunoassay Polymerase chain reaction Radioimmunoassay Real time polymerase chain reaction Serum

Corresponding Organization :

Other organizations : Genomics Research Center, Academia Sinica, National Yang Ming University Hospital, National Yang Ming Chiao Tung University, National Center for Global Health and Medicine, Roche (Switzerland), Kaohsiung Chang Gung Memorial Hospital, Mackay Medical College, National Taiwan University

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Variable analysis

independent variables

Blood collections were performed at study entry and follow-ups

dependent variables

HBsAg and HBeAg levels measured by radioimmunoassay
ALT levels measured by serum chemistry autoanalyzer
Serum HBV DNA levels measured by polymerase chain reaction
Serum HBsAg levels quantified using the Elecsys HBsAg II Quant assay
M2BPGi levels quantified with a novel sandwich immunoassay

control variables

Commercial kits and reagents were used for the various tests

positive controls

Not explicitly mentioned

negative controls

Not explicitly mentioned

Annotations

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