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Chapter 32 : Molecular Detection and Characterization of Hepatitis B Virus

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Molecular Detection and Characterization of Hepatitis B Virus, Page 1 of 2

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Abstract:

Hepatitis B virus (HBV) infection is one of the most widespread infectious diseases in the world. Serological evidence suggests that up to one-third of the global population has been infected, with current estimates of up to 240 million chronic infections worldwide and more than 780,000 HBV-related deaths annually (http://www.who.int/mediacentre/factsheets/fs204/en/). Despite the availability of an effective vaccine, enhanced blood screening strategies, and new therapeutics, the burden of chronic HBV infection (CHB), including cirrhosis and hepatocellular carcinoma (HCC), continues to affect populations worldwide, especially in the developing world (1, 2).

Citation: Germer J, Yao J. 2016. Molecular Detection and Characterization of Hepatitis B Virus, p 449-464. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch32
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Image of FIGURE 1
FIGURE 1

Organization of the HBV genome. The inner circles depict the plus (+) and minus (−) strands of the partially double-stranded DNA genome (3.2 kb). The overlapping ORFs pre-C/C, pre-S/S, P, and X encoded by the genome are represented by the bold arrows. Outer circles indicate the lengths of transcribed viral RNAs (3.5 kb, 2.4 kb, 2.1 kb, and 0.7 kb). The approximate location of the YMDD motif located in the reverse transcriptase domain of ORF P is also shown.

Citation: Germer J, Yao J. 2016. Molecular Detection and Characterization of Hepatitis B Virus, p 449-464. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch32
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Image of FIGURE 2
FIGURE 2

Replication cycle of HBV. Following entry of the virion into the host hepatocyte via receptor-mediated endocytosis and shedding of the envelope, viral DNA is translocated to the nucleus where it is processed to produce cccDNA, which serves as a template for the transcription of pgRNA and subgenomic RNAs (3.5 kb, 2.4 kb, 2.1 kb, and 0.7 kb). These viral RNAs exit the nucleus and are translated to produce viral proteins. The pgRNA serves as a template for reverse transcription to negative-strand DNA, which in turn serves as a template for positive-strand DNA synthesis. Newly synthesized genomic DNA is either packaged into complete virions for eventual release or directed back to the nucleus to maintain the cccDNA pool. Reprinted from Buti ( ) with the permission of the publisher (© Clinical Care Options, LLC, 2009).

Citation: Germer J, Yao J. 2016. Molecular Detection and Characterization of Hepatitis B Virus, p 449-464. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch32
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Image of FIGURE 3
FIGURE 3

Natural history of CHB. The various recognized phases of HBV infection are depicted along with associated histopathological features, HBV serologic status, and relative HBV DNA levels.

Citation: Germer J, Yao J. 2016. Molecular Detection and Characterization of Hepatitis B Virus, p 449-464. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch32
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References

/content/book/10.1128/9781555819071.ch32
1. Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. 2006. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol 45:529538[CrossRef].[PubMed]
2. Lavanchy D. 2004. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat 11:97107[CrossRef].[PubMed]
3. Blumberg BS, Alter HJ, Visnich S. 1965. A “new” antigen in leukemia sera. JAMA 191:541546[CrossRef].[PubMed]
4. Dane DS, Cameron CH, Briggs M. 1970. Virus-like particles in serum of patients with Australia-antigen-associated hepatitis. Lancet 1:695698[CrossRef].[PubMed]
5. Galibert F, Mandart E, Fitoussi F, Tiollais P, Charnay P. 1979. Nucleotide sequence of the hepatitis B virus genome (subtype ayw) cloned in E. coli. Nature 281:646650[CrossRef].[PubMed]
6. Sninsky JJ, Siddiqui A, Robinson WS, Cohen SN. 1979. Cloning and endonuclease mapping of the hepatitis B viral genome. Nature 279:346348[CrossRef].[PubMed]
7. Valenzuela P, Gray P, Quiroga M, Zaldivar J, Goodman HM, Rutter WJ. 1979. Nucleotide sequence of the gene coding for the major protein of hepatitis B virus surface antigen. Nature 280:815819[CrossRef].[PubMed]
8. European Association For The Study Of The Liver. 2012. EASL clinical practice guidelines: management of chronic hepatitis B virus infection. J Hepatol 57:167185[CrossRef].[PubMed]
9. Liaw Y-F, Kao J-H, Piratvisuth T, Chan HLY, Chien RN, Liu C-J, Gane E, Locarnini S, Lim SG, Han K-H, Amarapurkar D, Cooksley G, Jafri W, Mohamed R, Hou J-L, Chuang W-L, Lesmana LA, Sollano JD, Suh D-J, Omata M. 2012. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatol Int 6:531561[CrossRef].[PubMed]
10. Terrault NA, Bzowej NH, Chang K-M, Hwang JP, Jonas MM, Murad MH. 2016. AASLD guidelines for treatment of chronic hepatitis B. Hepatology 63:261283[CrossRef].[PubMed]
11. Koziel MJ, Thio CL,. 2010. Hepatitis B virus and hepatitis Delta virus, p 20592086. In Mandell GL, Bennett JE, Dolin R (ed), Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases, 7th ed. Churchill Livingstone Elsevier, Philadelphia, PA.[CrossRef]
12. Seeger C, Mason WS. 2000. Hepatitis B virus biology. Microbiol Mol Biol Rev 64:5168[CrossRef].[PubMed]
13. Ganem D, Prince AM. 2004. Hepatitis B virus infection—natural history and clinical consequences. N Engl J Med 350:11181129[CrossRef].[PubMed]
14. Ryu WS. 2003. Molecular aspects of hepatitis B viral infection and the viral carcinogenesis. J Biochem Mol Biol 36:138143[CrossRef].[PubMed]
15. Lai CL, Dienstag J, Schiff E, Leung NW, Atkins M, Hunt C, Brown N, Woessner M, Boehme R, Condreay L. 2003. Prevalence and clinical correlates of YMDD variants during lamivudine therapy for patients with chronic hepatitis B. Clin Infect Dis 36:687696[CrossRef].[PubMed]
16. Beck J, Nassal M. 2007. Hepatitis B virus replication. World J Gastroenterol 13:4864[CrossRef].[PubMed]
17. Bock CT, Schwinn S, Locarnini S, Fyfe J, Manns MP, Trautwein C, Zentgraf H. 2001. Structural organization of the hepatitis B virus minichromosome. J Mol Biol 307:183196[CrossRef].[PubMed]
18. Zoulim F, Locarnini S. 2009. Hepatitis B virus resistance to nucleos(t)ide analogues. Gastroenterology 137:1593608.e1, 2[CrossRef].[PubMed]
19. Summers J, Mason WS. 1982. Replication of the genome of a hepatitis B—like virus by reverse transcription of an RNA intermediate. Cell 29:403415[CrossRef].[PubMed]
20. Gurtsevitch VE. 2008. Human oncogenic viruses: hepatitis B and hepatitis C viruses and their role in hepatocarcinogenesis. Biochemistry (Mosc) 73:504513[CrossRef].[PubMed]
21. Paterlini-Bréchot P, Saigo K, Murakami Y, Chami M, Gozuacik D, Mugnier C, Lagorce D, Bréchot C. 2003. Hepatitis B virus-related insertional mutagenesis occurs frequently in human liver cancers and recurrently targets human telomerase gene. Oncogene 22:39113916[CrossRef].[PubMed]
22. Hovat RT, Tegtmeier GE,. 2007. Hepatitis B and D viruses, p 16411659. In Murray PR, Baron EJ, Jorgensen JH, Landry ML, Pfaller MA (ed), Manual of Clinical Microbiology, 9th ed. ASM Press, Washington, DC.
23. Yim HJ, Lok AS. 2006. Natural history of chronic hepatitis B virus infection: what we knew in 1981 and what we know in 2005. Hepatology 43(Suppl 1):S173S181[CrossRef].[PubMed]
24. Chang MH, Hsu HY, Hsu HC, Ni YH, Chen JS, Chen DS. 1995. The significance of spontaneous hepatitis B e antigen seroconversion in childhood: with special emphasis on the clearance of hepatitis B e antigen before 3 years of age. Hepatology 22:13871392.[PubMed]
25. Lok AS, Lai CL. 1988. A longitudinal follow-up of asymptomatic hepatitis B surface antigen-positive Chinese children. Hepatology 8:11301133[CrossRef].[PubMed]
26. Liaw YF, Tai DI, Chu CM, Chen TJ. 1988. The development of cirrhosis in patients with chronic type B hepatitis: a prospective study. Hepatology 8:493496[CrossRef].[PubMed]
27. Hsu YS, Chien RN, Yeh CT, Sheen IS, Chiou HY, Chu CM, Liaw YF. 2002. Long-term outcome after spontaneous HBeAg seroconversion in patients with chronic hepatitis B. Hepatology 35:15221527[CrossRef].[PubMed]
28. Chu CM, Liaw YF. 2010. Hepatitis B surface antigen seroclearance during chronic HBV infection. Antivir Ther 15:133143[CrossRef].[PubMed]
29. Hadziyannis SJ, Vassilopoulos D. 2001. Hepatitis B e antigen-negative chronic hepatitis B. Hepatology 34:617624[CrossRef].[PubMed]
30. Chan HL, Hussain M, Lok AS. 1999. Different hepatitis B virus genotypes are associated with different mutations in the core promoter and precore regions during hepatitis B e antigen seroconversion. Hepatology 29:976984[CrossRef].[PubMed]
31. Li JS, Tong SP, Wen YM, Vitvitski L, Zhang Q, Trépo C. 1993. Hepatitis B virus genotype A rarely circulates as an HBe-minus mutant: possible contribution of a single nucleotide in the precore region. J Virol 67:54025410.[PubMed]
32. Bréchot C, Thiers V, Kremsdorf D, Nalpas B, Pol S, Paterlini-Bréchot P. 2001. Persistent hepatitis B virus infection in subjects without hepatitis B surface antigen: clinically significant or purely “occult”? Hepatology 34:194203[CrossRef].[PubMed]
33. Conjeevaram HS, Lok AS. 2001. Occult hepatitis B virus infection: a hidden menace? Hepatology 34:204206[CrossRef].[PubMed]
34. Gandhi RT, Wurcel A, Lee H, McGovern B, Boczanowski M, Gerwin R, Corcoran CP, Szczepiorkowski Z, Toner S, Cohen DE, Sax PE, Ukomadu C. 2003. Isolated antibody to hepatitis B core antigen in human immunodeficiency virus type-1-infected individuals. Clin Infect Dis 36:16021605[CrossRef].[PubMed]
35. Zhang YY, Hansson BG, Kuo LS, Widell A, Nordenfelt E. 1993. Hepatitis B virus DNA in serum and liver is commonly found in Chinese patients with chronic liver disease despite the presence of antibodies to HBsAg. Hepatology 17:538544[CrossRef].[PubMed]
36. Chen YC, Sheen IS, Chu CM, Liaw YF. 2002. Prognosis following spontaneous HBsAg seroclearance in chronic hepatitis B patients with or without concurrent infection. Gastroenterology 123:10841089[CrossRef].[PubMed]
37. Huo TI, Wu JC, Lee PC, Chau GY, Lui WY, Tsay SH, Ting LT, Chang FY, Lee SD. 1998. Sero-clearance of hepatitis B surface antigen in chronic carriers does not necessarily imply a good prognosis. Hepatology 28:231236[CrossRef].[PubMed]
38. Simonetti J, Bulkow L, McMahon BJ, Homan C, Snowball M, Negus S, Williams J, Livingston SE. 2010. Clearance of hepatitis B surface antigen and risk of hepatocellular carcinoma in a cohort chronically infected with hepatitis B virus. Hepatology 51:15311537[CrossRef].[PubMed]
39. McMahon BJ. 2010. Natural history of chronic hepatitis B. Clin Liver Dis 14:381396[CrossRef].[PubMed]
40. Trépo C, Chan HL, Lok A. 2014. Hepatitis B virus infection. Lancet 384:20532063[CrossRef].[PubMed]
41. Vivekanandan P, Singh OV. 2010. Molecular methods in the diagnosis and management of chronic hepatitis B. Expert Rev Mol Diagn 10:921935[CrossRef].[PubMed]
42. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF. 2010. Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther 15(Suppl 3):3544[CrossRef].[PubMed]
43. Hussain M, Chu CJ, Sablon E, Lok AS. 2003. Rapid and sensitive assays for determination of hepatitis B virus (HBV) genotypes and detection of HBV precore and core promoter variants. J Clin Microbiol 41:36993705[CrossRef].[PubMed]
44. Okamoto H, Tsuda F, Akahane Y, Sugai Y, Yoshiba M, Moriyama K, Tanaka T, Miyakawa Y, Mayumi M. 1994. Hepatitis B virus with mutations in the core promoter for an e antigen-negative phenotype in carriers with antibody to e antigen. J Virol 68:81028110.[PubMed]
45. Alavian SM, Carman WF, Jazayeri SM. 2013. HBsAg variants: diagnostic-escape and diagnostic dilemma. J Clin Virol 57:201208[CrossRef].[PubMed]
46. Servant-Delmas A, Mercier-Darty M, Ly TD, Wind F, Alloui C, Sureau C, Laperche S. 2012. Variable capacity of 13 hepatitis B virus surface antigen assays for the detection of HBsAg mutants in blood samples. J Clin Virol 53:338345[CrossRef].[PubMed]
47. Janssen HL, Sonneveld MJ, Brunetto MR. 2012. Quantification of serum hepatitis B surface antigen: is it useful for the management of chronic hepatitis B? Gut 61:641645[CrossRef].[PubMed]
48. Liaw YF. 2011. Clinical utility of hepatitis B surface antigen quantitation in patients with chronic hepatitis B: a review. Hepatology 54:E1E9[CrossRef].[PubMed]
49. Kuhns MC, Busch MP. 2006. New strategies for blood donor screening for hepatitis B virus: nucleic acid testing versus immunoassay methods. Mol Diagn Ther 10:7791[CrossRef].[PubMed]
50. Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, Huang GT, Iloeje UH, REVEAL-HBV Study Group. 2006. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 295:6573[CrossRef].[PubMed]
51. Iloeje UH, Yang HI, Su J, Jen CL, You SL, Chen CJ, Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-In HBV (the REVEAL-HBV) Study Group. 2006. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 130:678686[CrossRef].[PubMed]
52. Liaw YF. 2005. Prevention and surveillance of hepatitis B virus-related hepatocellular carcinoma. Semin Liver Dis 25(Suppl 1):4047[CrossRef].[PubMed]
53. Chen CJ, Yang HI, Iloeje UH, REVEAL-HBV Study Group. 2009. Hepatitis B virus DNA levels and outcomes in chronic hepatitis B. Hepatology 49(Suppl):S72S84[CrossRef].[PubMed]
54. Yu MW, Yeh SH, Chen PJ, Liaw YF, Lin CL, Liu CJ, Shih WL, Kao JH, Chen DS, Chen CJ. 2005. Hepatitis B virus genotype and DNA level and hepatocellular carcinoma: a prospective study in men. J Natl Cancer Inst 97:265272[CrossRef].[PubMed]
55. Chen CJ, Yang HI. 2011. Natural history of chronic hepatitis B REVEALed. J Gastroenterol Hepatol 26:628638[CrossRef].[PubMed]
56. Coffin CS, Fung SK, Ma MM, Canadian Association for the Study of the Liver. 2012. Management of chronic hepatitis B: Canadian Association for the Study of the Liver consensus guidelines. Can J Gastroenterol 26:917938.[PubMed]
57. Chu CJ, Hussain M, Lok AS. 2002. Quantitative serum HBV DNA levels during different stages of chronic hepatitis B infection. Hepatology 36:14081415[CrossRef].[PubMed]
58. Kwak MS, Kim YJ. 2014. Occult hepatitis B virus infection. World J Hepatol 6:860869[CrossRef].[PubMed]
59. Carreño V, Bartolomé J, Castillo I, Quiroga JA. 2008. Occult hepatitis B virus and hepatitis C virus infections. Rev Med Virol 18:139157[CrossRef].[PubMed]
60. Hollinger FB, Sood G. 2010. Occult hepatitis B virus infection: a covert operation. J Viral Hepat 17:115[CrossRef].[PubMed]
61. Funk ML, Rosenberg DM, Lok AS. 2002. World-wide epidemiology of HBeAg-negative chronic hepatitis B and associated precore and core promoter variants. J Viral Hepat 9:5261[CrossRef].[PubMed]
62. Chu CM, Liaw YF. 2005. Genotype C hepatitis B virus infection is associated with a higher risk of reactivation of hepatitis B and progression to cirrhosis than genotype B: a longitudinal study of hepatitis B e antigen-positive patients with normal aminotransferase levels at baseline. J Hepatol 43:411417[CrossRef].[PubMed]
63. Orito E, Ichida T, Sakugawa H, Sata M, Horiike N, Hino K, Okita K, Okanoue T, Iino S, Tanaka E, Suzuki K, Watanabe H, Hige S, Mizokami M. 2001. Geographic distribution of hepatitis B virus (HBV) genotype in patients with chronic HBV infection in Japan. Hepatology 34:590594[CrossRef].[PubMed]
64. Hadziyannis SJ, Papatheodoridis GV. 2006. Hepatitis B e antigen-negative chronic hepatitis B: natural history and treatment. Semin Liver Dis 26:130141[CrossRef].[PubMed]
65. Erhardt A, Blondin D, Hauck K, Sagir A, Kohnle T, Heintges T, Häussinger D. 2005. Response to interferon alfa is hepatitis B virus genotype dependent: genotype A is more sensitive to interferon than genotype D. Gut 54:10091013[CrossRef].[PubMed]
66. Janssen HL, van Zonneveld M, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, Simon C, So TM, Gerken G, de Man RA, Niesters HG, Zondervan P, Hansen B, Schalm SW, HBV 99-01 Study Group, Rotterdam Foundation for Liver Research. 2005. Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet 365:123129[CrossRef].[PubMed]
67. Kao JH, Wu NH, Chen PJ, Lai MY, Chen DS. 2000. Hepatitis B genotypes and the response to interferon therapy. J Hepatol 33:9981002[CrossRef].[PubMed]
68. Wai CT, Chu CJ, Hussain M, Lok AS. 2002. HBV genotype B is associated with better response to interferon therapy in HBeAg(+) chronic hepatitis than genotype C. Hepatology 36:14251430.[PubMed]
69. Carman WF, Owsianka A, Wallace LA, Dow BC, Mutimer DJ. 1999. Antigenic characterization of pre- and post-liver transplant hepatitis B surface antigen sequences from patients treated with hepatitis B immune globulin. J Hepatol 31:195201[CrossRef].[PubMed]
70. Carman WF, Zanetti AR, Karayiannis P, Waters J, Manzillo G, Tanzi E, Zuckerman AJ, Thomas HC. 1990. Vaccine-induced escape mutant of hepatitis B virus. Lancet 336:325329[CrossRef].[PubMed]
71. Ghany MG, Ayola B, Villamil FG, Gish RG, Rojter S, Vierling JM, Lok AS. 1998. Hepatitis B virus S mutants in liver transplant recipients who were reinfected despite hepatitis B immune globulin prophylaxis. Hepatology 27:213222[CrossRef].[PubMed]
72. Protzer-Knolle U, Naumann U, Bartenschlager R, Berg T, Hopf U, Meyer zum Büschenfelde KH, Neuhaus P, Gerken G. 1998. Hepatitis B virus with antigenically altered hepatitis B surface antigen is selected by high-dose hepatitis B immune globulin after liver transplantation. Hepatology 27:254263[CrossRef].[PubMed]
73. Ueda Y, Marusawa H, Egawa H, Okamoto S, Ogura Y, Oike F, Nishijima N, Takada Y, Uemoto S, Chiba T. 2011. De novo activation of HBV with escape mutations from hepatitis B surface antibody after living donor liver transplantation. Antivir Ther 16:479487[CrossRef].[PubMed]
74. Weber B. 2005. Genetic variability of the S gene of hepatitis B virus: clinical and diagnostic impact. J Clin Virol 32:102112[CrossRef].[PubMed]
75. Gish R, Jia JD, Locarnini S, Zoulim F. 2012. Selection of chronic hepatitis B therapy with high barrier to resistance. Lancet Infect Dis 12:341353[CrossRef].[PubMed]
76. Poordad F, Chee GM. 2010. Viral resistance in hepatitis B: prevalence and management. Curr Gastroenterol Rep 12:6269[CrossRef].[PubMed]
77. Locarnini SA, Yuen L. 2010. Molecular genesis of drug-resistant and vaccine-escape HBV mutants. Antivir Ther 15(3 Pt B):451461[CrossRef].[PubMed]
78. Levrero M, Pollicino T, Petersen J, Belloni L, Raimondo G, Dandri M. 2009. Control of cccDNA function in hepatitis B virus infection. J Hepatol 51:581592[CrossRef].[PubMed]
79. Li L, Chen PJ, Chen MH, Chak KF, Lin KS, Tsai SJ. 2008. A pilot study for screening blood donors in Taiwan by nucleic acid amplification technology: detecting occult hepatitis B virus infections and closing the serologic window period for hepatitis C virus. Transfusion 48:11981206[CrossRef].[PubMed]
80. Lin KT, Chang CL, Tsai MH, Lin KS, Saldanha J, Hung CM. 2014. Detection and identification of occult HBV in blood donors in Taiwan using a commercial, multiplex, multi-dye nucleic acid amplification technology screening test. Vox Sang 106:103110[CrossRef].[PubMed]
81. Yang MH, Li L, Hung YS, Hung CS, Allain JP, Lin KS, Tsai SJ. 2010. The efficacy of individual-donation and minipool testing to detect low-level hepatitis B virus DNA in Taiwan. Transfusion 50:6574[CrossRef].[PubMed]
82. Caliendo AM, Valsamakis A, Bremer JW, Ferreira-Gonzalez A, Granger S, Sabatini L, Tsongalis GJ, Wang YF, Yen-Lieberman B, Young S, Lurain NS. 2011. Multilaboratory evaluation of real-time PCR tests for hepatitis B virus DNA quantification. J Clin Microbiol 49:28542858[CrossRef].[PubMed]
83. Valsamakis A. 2007. Molecular testing in the diagnosis and management of chronic hepatitis B. Clin Microbiol Rev 20:426439[CrossRef].[PubMed]
84. Pawlotsky JM, Dusheiko G, Hatzakis A, Lau D, Lau G, Liang TJ, Locarnini S, Martin P, Richman DD, Zoulim F. 2008. Virologic monitoring of hepatitis B virus therapy in clinical trials and practice: recommendations for a standardized approach. Gastroenterology 134:405415[CrossRef].[PubMed]
85. Yao JD, Beld MG, Oon LL, Sherlock CH, Germer J, Menting S, Se Thoe SY, Merrick L, Ziermann R, Surtihadi J, Hnatyszyn HJ. 2004. Multicenter evaluation of the VERSANT hepatitis B virus DNA 3.0 assay. J Clin Microbiol 42:800806[CrossRef].[PubMed]
86. Garbuglia AR, Angeletti C, Lauria FN, Zaccaro P, Cocca AM, Pisciotta M, Solmone M, Capobianchi MR. 2007. Comparison of Versant HBV DNA 3.0 and COBAS AmpliPrep-COBAS TaqMan assays for hepatitis B DNA quantitation: possible clinical implications. J Virol Methods 146:274280[CrossRef].[PubMed]
87. Pol J, Le Pendeven C, Beby-Defaux A, Rabut E, Jais JP, Pilloux M, Osada C, Zatla F, Assami H, Grange JD, Kremsdorf D, Nicolas JC, Soussan P. 2008. Prospective comparison of Abbott RealTime HBV DNA and Versant HBV DNA 3.0 assays for hepatitis B DNA quantitation: impact on HBV genotype monitoring. J Virol Methods 154:16[CrossRef].[PubMed]
88. Allice T, Cerutti F, Pittaluga F, Varetto S, Gabella S, Marzano A, Franchello A, Colucci G, Ghisetti V. 2007. COBAS AmpliPrep-COBAS TaqMan hepatitis B virus (HBV) test: a novel automated real-time PCR assay for quantification of HBV DNA in plasma. J Clin Microbiol 45:828834[CrossRef].[PubMed]
89. Konnick EQ, Erali M, Ashwood ER, Hillyard DR. 2005. Evaluation of the COBAS amplicor HBV monitor assay and comparison with the ultrasensitive HBV hybrid capture 2 assay for quantification of hepatitis B virus DNA. J Clin Microbiol 43:596603[CrossRef].[PubMed]
90. Sum SS, Wong DK, Yuen JC, Lai CL, Yuen MF. 2005. Comparison of the COBAS TaqMan HBV test with the COBAS Amplicor monitor test for measurement of hepatitis B virus DNA in serum. J Med Virol 77:486490[CrossRef].[PubMed]
91. Weiss J, Wu H, Farrenkopf B, Schultz T, Song G, Shah S, Siegel J. 2004. Real time TaqMan PCR detection and quantitation of HBV genotypes A-G with the use of an internal quantitation standard. J Clin Virol 30:8693[CrossRef].[PubMed]
92. Hochberger S, Althof D, Gallegos de Schrott R, Nachbaur N, Röck H, Leying H. 2006. Fully automated quantitation of hepatitis B virus (HBV) DNA in human plasma by the COBAS AmpliPrep/COBAS TaqMan system. J Clin Virol 35:373380[CrossRef].[PubMed]
93. Chevaliez S, Bouvier-Alias M, Laperche S, Pawlotsky JM. 2008. Performance of the Cobas AmpliPrep/Cobas TaqMan real-time PCR assay for hepatitis B virus DNA quantification. J Clin Microbiol 46:17161723[CrossRef].[PubMed]
94. Berger A, Gohl P, Stürmer M, Rabenau HF, Nauck M, Doerr HW. 2010. Detection and quantitation of HBV DNA in miniaturized samples: multi centre study to evaluate the performance of the COBAS ® AmpliPrep/COBAS ® TaqMan ® hepatitis B virus (HBV) test v2.0 by the use of plasma or serum specimens. J Virol Methods 169:404408[CrossRef].[PubMed]
95. Goedel S, Rullkoetter M, Weisshaar S, Mietag C, Leying H, Boehl F. 2009. Hepatitis B virus (HBV) genotype determination by the COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 in serum and plasma matrices. J Clin Virol 45:232236[CrossRef].[PubMed]
96. Chevaliez S, Bouvier-Alias M, Laperche S, Hézode C, Pawlotsky JM. 2010. Performance of version 2.0 of the Cobas AmpliPrep/Cobas TaqMan real-time PCR assay for hepatitis B virus DNA quantification. J Clin Microbiol 48:36413647[CrossRef].[PubMed]
97. Lindh M, Hannoun C. 2005. Dynamic range and reproducibility of hepatitis B virus (HBV) DNA detection and quantification by Cobas Taqman HBV, a real-time semiautomated assay. J Clin Microbiol 43:42514254[CrossRef].[PubMed]
98. Morris CJ, Hill M, de Medina M, Herman C, Cloherty GA, Martin P. 2013. Comparison of detection and quantification of HBV DNA in chronic HBeAg negative and positive patients by Abbott RealTime HBV and Roche Cobas TaqMan HBV assays. J Virol Methods 193:391393[CrossRef].[PubMed]
99. Pyne MT, Vest L, Clement J, Lee J, Rosvall JR, Luk K, Rossi M, Cobb B, Hillyard DR. 2012. Comparison of three Roche hepatitis B virus viral load assay formats. J Clin Microbiol 50:23372342[CrossRef].[PubMed]
100. Yeh ML, Huang CF, Huang CI, Liu SF, Yang HL, Hsieh MY, Huang JF, Dai CY, Chuang WL, Yu ML. 2014. Abbott RealTime HBV assay is more sensitive in detection of low viral load and little impacted by drug resistant mutation in chronic hepatitis B patients under nucleot(s)ide analogues therapy. PLoS One 9:e101790[CrossRef].[PubMed]
101. Cloherty GA, Rhoads J, Young TP, Parkin NT, Holzmayer V, Yuen L, Mullen C. 2013. Sequence conservation of the region targeted by the Abbott RealTime HBV viral load assay in clinical specimens. J Clin Microbiol 51:12601262[CrossRef].[PubMed]
102. Ismail AM, Sivakumar J, Anantharam R, Dayalan S, Samuel P, Fletcher GJ, Gnanamony M, Abraham P. 2011. Performance characteristics and comparison of Abbott and artus real-time systems for hepatitis B virus DNA quantification. J Clin Microbiol 49:32153221[CrossRef].[PubMed]
103. Yeh ML, Huang CF, Hsieh MY, Huang JF, Dai CY, Yu ML, Chuang WL. 2014. Comparison of the Abbott Real-Time HBV assay with the Roche Cobas AmpliPrep/Cobas TaqMan HBV assay for HBV DNA detection and quantification. J Clin Virol 60:206214[CrossRef].[PubMed]
104. Fang J, Wichroski MJ, Levine SM, Baldick CJ, Mazzucco CE, Walsh AW, Kienzle BK, Rose RE, Pokornowski KA, Colonno RJ, Tenney DJ. 2009. Ultrasensitive genotypic detection of antiviral resistance in hepatitis B virus clinical isolates. Antimicrob Agents Chemother 53:27622772[CrossRef].[PubMed]
105. Guirgis BS, Abbas RO, Azzazy HM. 2010. Hepatitis B virus genotyping: current methods and clinical implications. Int J Infect Dis 14:e941e953[CrossRef].[PubMed]
106. Lindström A, Odeberg J, Albert J. 2004. Pyrosequencing for detection of lamivudine-resistant hepatitis B virus. J Clin Microbiol 42:47884795[CrossRef].[PubMed]
107. Mallory MA, Page SR, Hillyard DR. 2011. Development and validation of a hepatitis B virus DNA sequencing assay for assessment of antiviral resistance, viral genotype and surface antigen mutation status. J Virol Methods 177:3137[CrossRef].[PubMed]
108. Tadokoro K, Suzuki F, Kobayashi M, Yamaguchi T, Nagano M, Egashira T, Kumada H. 2011. Rapid detection of drug-resistant mutations in hepatitis B virus by the PCR-Invader assay. J Virol Methods 171:6773[CrossRef].[PubMed]
109. Tran N, Berne R, Chann R, Gauthier M, Martin D, Armand MA, Ollivet A, Teo CG, Ijaz S, Flichman D, Brunetto M, Bielawski KP, Pichoud C, Zoulim F, Vernet G. 2006. European multicenter evaluation of high-density DNA probe arrays for detection of hepatitis B virus resistance mutations and identification of genotypes. J Clin Microbiol 44:27922800[CrossRef].[PubMed]
110. Woo HY, Park H, Kim BI, Jeon WK, Cho YK, Kim YJ. 2007. Comparison of mass spectrometric analysis and TRUGENE HBV genotyping for monitoring lamivudine resistance in chronic hepatitis B patients. Antivir Ther 12:713.[PubMed]
111. Basaras M, Arrese E, Blanco S, Arroyo LS, Ruiz P, Cisterna R. 2013. Comparison of INNO-LIPA and TRUGENE assays for genotyping and drug-resistance mutations in chronic hepatitis B virus infection. Intervirology 56:190194[CrossRef].[PubMed]
112. Saldanha J, Gerlich W, Lelie N, Dawson P, Heermann K, Heath A, WHO Collaborative Study Group. 2001. An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques. Vox Sang 80:6371[CrossRef].[PubMed]
113. Baylis SA, Heath AB, Chudy M, Pisani G, Klotz A, Kerby S, Gerlich W. 2008. An international collaborative study to establish the 2nd World Health Organization International Standard for hepatitis B virus DNA nucleic acid amplification technology-based assays. Vox Sang 94:358362[CrossRef].[PubMed]
114. Fryer JF, Heath AB, Wilkinson DE, Minor PD, WHO Collaborative Study Group. 2011. Collaborative study to evaluate the proposed 3rd WHO International Standard for hepatitis B virus (HBV) for nucleic acid amplification technology (NAT)-based assays. World Health Organization, Geneva, Switzerland. http://whqlibdoc.who.int/hq/2011/WHO_BS_2011.2170_eng.pdf.
115. Huang S, Salituro J, Tang N, Luk KC, Hackett J Jr, Swanson P, Cloherty G, Mak WB, Robinson J, Abravaya K. 2007. Thermodynamically modulated partially double-stranded linear DNA probe design for homogeneous real-time PCR. Nucleic Acids Res 35:e101[CrossRef].[PubMed]
116. Sizmann D, Glaubitz J, Simon CO, Goedel S, Buergisser P, Drogan D, Hesse M, Kröh M, Simmler P, Dewald M, Gilsdorf M, Fuerst M, Ineichen R, Kirn A, Pasche P, Wang Z, Weisshaar S, Young K, Haberhausen G, Babiel R. 2010. Improved HIV-1 RNA quantitation by COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 using a novel dual-target approach. J Clin Virol 49:4146[CrossRef].[PubMed]
117. Zitzer H, Heilek G, Truchon K, Susser S, Vermehren J, Sizmann D, Cobb B, Sarrazin C. 2013. Second-generation Cobas AmpliPrep/Cobas TaqMan HCV quantitative test for viral load monitoring: a novel dual-probe assay design. J Clin Microbiol 51:571577[CrossRef].[PubMed]
118. Chudy M, Hanschmann KM, Kress J, Nick S, Campos R, Wend U, Gerlich W, Nübling CM. 2012. First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA. J Clin Virol 55:303309[CrossRef].[PubMed]
119. Chang TT, Lai CL, Kew Yoon S, Lee SS, Coelho HS, Carrilho FJ, Poordad F, Halota W, Horsmans Y, Tsai N, Zhang H, Tenney DJ, Tamez R, Iloeje U. 2010. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology 51:422430[CrossRef].[PubMed]
120. Marcellin P, Gane E, Buti M, Afdhal N, Sievert W, Jacobson IM, Washington MK, Germanidis G, Flaherty JF, Aguilar Schall R, Bornstein JD, Kitrinos KM, Subramanian GM, McHutchison JG, Heathcote EJ. 2013. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet 381:468475[CrossRef].[PubMed]
121. Osiowy C, Giles E. 2003. Evaluation of the INNO-LiPA HBV genotyping assay for determination of hepatitis B virus genotype. J Clin Microbiol 41:54735477[CrossRef].[PubMed]
122. Degertekin B, Hussain M, Tan J, Oberhelman K, Lok AS. 2009. Sensitivity and accuracy of an updated line probe assay (HBV DR v.3) in detecting mutations associated with hepatitis B antiviral resistance. J Hepatol 50:4248[CrossRef].[PubMed]
123. Mercier M, Laperche S, Girault A, Sureau C, Servant-Delmas A. 2011. Overestimation of incidence of hepatitis B virus mixed-genotype infections by use of the new line probe INNO-LiPA genotyping assay. J Clin Microbiol 49:11541156[CrossRef].[PubMed]
124. Germer JJ, Abraham P, Mandrekar JN, Yao JD. 2013. Evaluation of the Abbott HBV RUO sequencing assay combined with laboratory-modified interpretive software. J Clin Microbiol 51:95100[CrossRef].[PubMed]
125. Chevaliez S, Rodriguez C, Pawlotsky JM. 2012. New virologic tools for management of chronic hepatitis B and C. Gastroenterology 142:13031313.e1[CrossRef].[PubMed]
126. Gong L, Han Y, Chen L, Liu F, Hao P, Sheng J, Li XH, Yu DM, Gong QM, Tian F, Guo XK, Zhang XX. 2013. Comparison of next-generation sequencing and clone-based sequencing in analysis of hepatitis B virus reverse transcriptase quasispecies heterogeneity. J Clin Microbiol 51:40874094[CrossRef].[PubMed]
127. Rodriguez-Frías F, Tabernero D, Quer J, Esteban JI, Ortega I, Domingo E, Cubero M, Camós S, Ferrer-Costa C, Sánchez A, Jardí R, Schaper M, Homs M, Garcia-Cehic D, Guardia J, Esteban R, Buti M. 2012. Ultra-deep pyrosequencing detects conserved genomic sites and quantifies linkage of drug-resistant amino acid changes in the hepatitis B virus genome. PLoS One 7:e37874[CrossRef].[PubMed]
128. Buti M. 2009. Mechanisms of resistance to anti-HBV agents. Clinical Care Options, Reston, VA. http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/Preventing%20HBV%20Resistance/Modules/Mechanisms%20of%20Resistance/Pages/Page%202.aspx.

Tables

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TABLE 1

Antiviral drug classes and antiviral resistance in HBV

Citation: Germer J, Yao J. 2016. Molecular Detection and Characterization of Hepatitis B Virus, p 449-464. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch32
Generic image for table
TABLE 2

Select commercially available HBV assays for screening of donors of blood, human cell, tissue, and tissue products

Citation: Germer J, Yao J. 2016. Molecular Detection and Characterization of Hepatitis B Virus, p 449-464. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch32
Generic image for table
TABLE 3

Select commercially available assays for HBV viral load testing

Citation: Germer J, Yao J. 2016. Molecular Detection and Characterization of Hepatitis B Virus, p 449-464. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch32
Generic image for table
TABLE 4

Select commercially available HBV assays for genotyping and antiviral resistance testing

Citation: Germer J, Yao J. 2016. Molecular Detection and Characterization of Hepatitis B Virus, p 449-464. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch32

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