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1 Title The development and assessment of assays for quantitation of hepatitis B virus DNA (HBV DNA) and the clinical significance of low HBV DNA level in patients with chronic hepatitis B Author(s) Sum, Siu-man, Simon; 岑紹文 Citation Issue Date 2004 URL Rights unrestricted

2 THE DEVELOPMENT AND ASSESSMENT OF ASSAYS FOR QUANTITATION OF HEPATITIS B VIRUS DNA (HBV DNA) AND THE CLINICAL SIGNIFICANCE OF LOW HBV DNA LEVEL IN PATIENTS WITH CHRONIC HEPATITIS B by Simon Siu Man SUM ( 岑紹文 ) B.Sc. (HKU) A thesis submitted in fulfillment of the requirements for the Degree of Master of Philosophy at The University of Hong Kong July 2004

3 Declarations DECLARATION I declare that this thesis represents my own work, except where due acknowledgement is made, and that it has not been previously included in a thesis, dissertation or report submitted to this University or to any other institution for a degree, diploma or other qualifications. Signed Simon Siu-man SUM i

4 Acknowledgements ACKNOWLEDGEMENTS This thesis is the research output of the efforts made by many people and colleagues and I would like to express my great attitude to all of them. Firstly, I would like to express my deepest appreciation to my primary supervisor, Professor Ching-lung Lai. Professor Lai is a sincere and devoted teacher who is very enthusiastic in guiding and supervising me continuously since my enrollment as a research postgraduate student. He spends his precious time in teaching me hepatology and the way in performing good quality researches. His encouragement and support are the key elements for me to complete this thesis. Secondly, I would like to thank my co-supervisor, Dr. Man-fung Yuen, who is both a responsible doctor and a devoted researcher. During the period of my study, he is continuously giving me guidance and supervision on the research projects conducted for this thesis. He always gives me his professional advice which is very important for me to improve the quality of my researches. It is my great pleasure to thank my colleagues for their support and assistance in different aspects of my researches. Dr. Danny Ka-ho Wong and Dr. He-jun Yuan, devoted hepatology researchers, have taught me the basis in the scientific researches in the field of hepatology, from basic science to clinical studies. Ms. Doreen So-fun Siu needs special thanks for her expert and efficient secretary support. I would also like to thank my colleagues who assisted in the clinical studies: Mr. Charles Tze-kin Cheng, Mr. ii

5 Acknowledgements Ringo Chi-hang Wu, Mr. John Chi-hang Yuen and Mr. John Lap-ping Young. Last but not least, my father Kwong-sang Sum, my mother Yi-la Kong and my sister Oliver Sze-nga Sum have given me unlimited support to complete my research studies, and I would like to express my sincere gratitude to all of them. iii

6 Contribution to Medical Literature CONTRIBUTION TO MEDICAL LITERATURE Data from the studies embodied in the present thesis have published in the literature listed below: Orignial articles and abstracts: 1. Simon Siu-man Sum, Danny Ka-ho Wong, Man-fung Yuen, He-jun Yuan, Jian Yu, Ching-lung Lai, David Ho, Linqi Zhang. A real-time PCR assay using molecular beacon (HBV Beacon Assay) for the quantitation of hepatitis B virus DNA. Journal of Clinical Microbiology 2004 (in press). 2. He-jun Yuan, Man-fung Yuen, Danny Ka-ho Wong, Siu-man Sum, Ching-lung Lai. Clinical evaluation of digene hybrid capture II test and COBAS amplicor monitor test for determination of HBV DNA levels. Journal of Clinical Microbiology 2004 (in press). 3. Simon Siu-man Sum, Man-fung Yuen, Danny Ka-ho Wong, John Chi-hang Yuen, Ching-lung Lai. Comparison of the Versant Branched DNA Assay (HBV DNA 3.0) with COBAS Amplicor Monitor Test for Measurement of Hepatitis B virus DNA in Serum. February 7-8, th Medical Research Conference, Hong Kong. (Abstract) iv

7 Contribution to Medical Literature 4. Simon Siu-man Sum, Danny Ka-ho Wong, Man-fung Yuen, He-jun Yuan, Jian Yu, Ching-lung Lai, David Ho, Linqi Zhang. A real-time PCR assay using molecular beacon (HBV Beacon Assay) for the quantitation of hepatitis B virus DNA. December 14-18, HEP DART Frontiers in Drug Development for Viral Hepatitis. Island of Kauai, Hawaii, USA. (Abstract) v