Comparison of currently available assays for detection of hepatitis B virus DNA in the routine diagnostic laboratory

Expert Review of Molecular Diagnostics

Volumn 5, Issue 4, 2005, Pages 531-536

  Kessler, Harald H ^a  

^a MEDICAL UNIVERSITY OF GRAZ   (Austria)

Author keywords

Hepatitis B virus; Molecular testing; Routine diagnostic laboratory

Indexed keywords

VIRUS DNA;

ALGORITHM; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; LABORATORY DIAGNOSIS; NONHUMAN; PATIENT MONITORING; POLYMERASE CHAIN REACTION; REVIEW; SEROLOGY; STAGING; VIRUS DETECTION;

DNA, VIRAL; HEPATITIS B; HEPATITIS B ANTIBODIES; HEPATITIS B VIRUS; HUMANS; IMMUNOTHERAPY;

EID: 22044432322     PISSN: 14737159     EISSN: None     Source Type: Journal    
DOI: 10.1586/14737159.5.4.531     Document Type: Review

References (46)

1. Lai CL, Ratziu V, Yuen MF, Poynard T. Viral hepatitis B. Lancet 362, 2089-2094 (2003). Useful review of different aspects of hepatitis B infection.
2. Haushofer AC, Hauer R, Brunner H et al. No evidence of hepatitis B virus activity in patients with antiHBc antibody positivity with or without antihepatitis C virus antibody positivity. J. Clin. Virol. 29, 221-223 (2004).
3. Kramvis A, Kew MC. The core promoter of hepatitis B virus. J. Viral Hepatitis 6, 415-427 (1999).
4. Weber B. Genetic variability of the S gene of hepatitis B virus: clinical and diagnostic impact. J. Clin. Virol. 32, 102-112 (2005). Comprehensive review of the manifold impact of hepatitus B virus mutants.
5. Jackson BR, Busch MP, Stramer SL, AuBuchon JP. The cost-effectiveness of NAT for HIV, HCV, and HBV in whole-blood donations. Transfusion 43, 721-729 (2003).
6. Tabor E, Epstein JS. NAT screening of blood and plasma donations: evolution of technology and regulatory policy. Transfusion 42, 1230-1237 (2002). Very useful review of the value of nucleic acid amplification tests in transfusion medicine.
7. Kessler HH, Preininger S, Stelzl E et al. Identification of different states of hepatitis B virus infection with a quantitative PCR assay. Clin. Diagn. Lab. Immunol. 7, 298-300 (2000).
8. Berger A, Preiser W, Doerr HW. The role of viral load determination for the management of human immunodeficiency virus, hepatitis B virus and hepatitis C virus infection. J. Clin. Virol. 20, 23-30 (2001).
9. Lok AS, McMahon BJ. Practice Guidelines Committee, American Association for the Study of Liver Diseases (AASLD). Chronic hepatitis B. Update on recommendations. Hepatology 39, 857-861 (2004).
10. Lok ASF, Zoulim F, Locarnini S et al. Monitoring drug resistance in chronic hepatitis B virus (HBV)-infected patients during lamivudine therapy: evaluation of performance of INNO-LiPA HBV DR assay. J. Clin. Microbiol. 40, 3729-3734 (2002).
11. Kessler HH, Stelzl E, Marth E, Stauber RE. Detection of mutations in the hepatitis B virus polymerase gene. Clin. Chem. 49, 989-992 (2003).
12. Roque-Afonso AM, Ferey MP, Mackiewicz V, Fki L, Dussaix E. Monitoring the emergence of hepatitis B virus polymerase gene variants during lamivudine therapy in human immunodeficiency virus coinfected patients: performance of CLIP sequencing and line probe assay. Antivir. Ther. 8, 627-634 (2003).
13. Al-Soud WA, Radström P. Purification and characterization of PCR-inhibitory components in blood cells. J. Clin. Microbiol. 39, 485-493 (2001).
14. Rosenstraus M, Wang Z, Chang SY, DeBonville D, Spadoro JP. An internal control for routine diagnostic PCR: design, properties, and effect on clinical performance. J. Clin. Microbiol. 36, 191-197(1998). The original article about internal controls.
15. Marin IJ, Poljak M, Seme K et al. Comparative evaluation of three commercial assays for quantitative measurement of hepatitis B virus DNA in serum samples. Hepatogastroenterology 49, 1390-1394 (2002).
16. Yuan HJ, Yuen MF, Wong DKH, Sum SSM, Lai CL. Clinical evaluation of the Digene Hybrid Capture II test and the COBAS AMPLICOR Monitor test for determination of hepatitis B virus DNA levels. J. Clin. Microbiol. 42, 3513-3517 (2004).
17. Hendricks DA, Stowe BJ, Hoo BS et al. Quantitation of HBV DNA in human serum using a branched DNA (bDNA) signal amplification assay. Am. J. Clin. Pathol. 104, 537-546 (1995).
18. Yao JDC, Beld MGHM, Oon LLE et al. Multicenter evaluation of the VERSANT hepatitis B virus DNA 3.0 assay. J. Clin. Microbiol. 42, 800-806 (2004).
19. Noborg U, Gusdal A, Pisa EK, Hedrum A, Lindh M. Automated quantitative analysis of hepatitis B virus DNA by using the Cobas Amplicor HBV Monitor test. J. Clin. Microbiol. 37, 2793-2797 (1999).
20. Kessler HH, Stelzl E, Daghofer E et al. Semiautomated quantitation of hepatitis B virus DNA in a routine diagnostic laboratory. Clin. Diagn. Lab. Immunol. 7, 853-855 (2000).
21. Wittwer CT, Herrmann MG, Moss AA, Rasmussen RP. Continuous fluorescence monitoring of rapid cycle DNA amplification. Biotechniques 22, 130-138 (1997). The birth of a fascinating new molecular technology.
22. Abe A, Inoue K, Tanaka T et al. Quantitation of hepatitis B virus genomic DNA by real-time detection of PCR. J. Clin. Microbiol. 37, 2899-2903 (1999).
23. Loeb KR, Jerome KR, Goddard J, Huang ML, Cent A, Corey L. High-throughput quantitative analysis of hepatitis B virus DNA in serum using the TaqMan fluorogenic detection system. Hepatology 32, 626-629 (2000).
24. Weinberger KM, Wiedenmann E, Böhm S, Jilg W. Sensitive and accurate quantitation of hepatitis B virus DNA using a kinetic fluorescence detection system (TaqMan PCR). J. Virol. Methods 85, 75-83 (2000).
25. Brechtbuehl K, Walley SA, Dusheiko GM, Saunders NA. A rapid real-time quantitative polymerase chain reaction for hepatitis B virus. J. Virol. Methods 93, 105-113 (2001).
26. Chen RW, Piiparinen H, Seppänen M, Koskela P, Sarna S, Lappalainen M. Real-time PCR for detection and quantitation of hepatitis B virus DNA. J. Med. Virol. 65, 250-256 (2001).
27. Jardi R, Rodriguez F, Buti M et al. Quantitative detection of hepatitis B virus DNA in serum by a new rapid real-time fluorescence PCR assay. J. Virol Hepat. 8, 465-471 (2001).
28. Paraskevis D, Haida C, Tassopoulos N et al. Development and assessment of a novel real-time PCR assay for quantitation of HBV DNA. J. Virol. Methods 103, 210-212 (2002).
29. Zanella I, Rossini A, Domenighini D, Albertini A, Cariani E. Quantitative analysis of hepatitis B virus DNA by real-time amplification. Eur. J. Clin. Microbiol. Infect. Dis. 21, 22-26 (2002).
30. Leb V, Stöcher M, Valentine-Thon E et al. Fully automated, internally controlled quantification of hepatitis B virus DNA by real-time PCR by use of the MagNA Pure LC and LightCycler instruments. J. Clin. Microbiol. 42, 585-590 (2004).
31. Stelzl E, Muller Z, Marth E, Kesslet HH. Rapid quantification of hepatitis B virus DNA by automated sample preparation and real-time PCR. J. Clin. Microbiol. 42, 2445-2449 (2004).
32. Weiss J, Wu B, Farrenkopf B et al. Real time TaqMan PCR detection and quantitation of HBV genotypes A-G with the use of an internal quantitation standard. J. Clin. Virol. 30, 86-93 (2004).
33. Clewley JP. The polymerase chain reaction, a review of the practical limitations for human immunodeficiency virus diagnosis. J. Virol. Methods 25, 179-187 (1989).
34. Kwok S, Higuchi R. Avoiding false positives with PCR. Nature 339, 237-238 (1989).
35. Kramvis A, Bukofzer S, Kew MC. Comparison of hepatitis B virus DNA extractions from serum by the QIAamp blood kit, GeneReleaser, and the phenol-chloroform method. J. Clin. Microbiol. 34, 2731-2733 (1996).
36. Kleines M, Schellenberg K, Ritter K. Efficient extraction of viral DNA and viral RNA by the Chemagic Viral DNA/RNA Kit allows sensitive detection of cytomegalovirus, hepatitis B virus, and hepatitis G virus by PCR. J. Clin. Microbiol. 41, 5273-5276 (2003).
37. Jungkind D. Automation of laboratory testing for infectious diseases using the polymerase chain reaction - our past, our present, our future. J. Clin. Virol. 20, 1-6 (2001).
38. Kessler HH, Mühlbauer G, Stelzl E, Daghofer E, Santner BI, Marth E. Fully automated nucleic acid extraction: MagNA Pure LC. Clin. Chem. 47, 1124-1126 (2001).
39. Berger A, Scherzed L, Stürmer M, Preiser W, Doerr HW, Rabenau HF. Evaluation of the Cobas AmpliPrep/Cobas Amplicor HIV-1 Monitor Ultrasensitive Test: comparison with the Cobas Amplicor HIV-1 Monitor test (manual specimen preparation). J. Clin. Virol. 25, S103-S107 (2002).
40. Stelzl E, Kormann-Klement A, Haas J et al. Evaluation of an automated sample preparation protocol for quantitative detection of hepatitis C virus RNA. J. Clin. Microbiol. 40, 1447-1450 (2002).
41. Cook L, Ng KW, Bagabag A, Corey L, Jerome KR. Use of the MagNA Pure LC automated nucleic acid extraction system followed by real-time reverse transcription-PCR for ultrasensitive quantitation of hepatitis C virus RNA. J. Clin. Microbiol. 42, 4120-4136 (2004).
42. Schorling S, Schalasta G, Enders G, Zauke M. Quantification of parvovirus B19 DNA using COBAS AmpliPrep automated sample preparation and LightCycler real-time PCR. J. Mol. Diagn. 6, 37-41 (2004).
43. Germer JJ, Harmsen WS, Mandrekar JN, Mitchell PS, Yao JD. Evaluation of the COBAS TaqMan HCV test with automated sample processing using the MagNA Pure LC instrument. J. Clin. Microbiol. 43, 293-298 (2005).
44. Dai CY, Yu ML, Chen SC et al. Clinical evaluation of the COBAS Amplicor HBV monitor test for measuring serum HBV DNA and comparison with the Quantiplex branched DNA signal amplification assay in Taiwan. J. Clin. Pathol. 57, 141-145 (2004).
45. Saldanha J, Gerlich W, Lelie N et al. An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques. Vox Sang. 80, 63-71 (2001).
46. Heermann KH, Gerlich WH, Chudy M et al. Quantitative detection of hepatitis B virus DNA in two international reference plasma preparations. J. Clin. Microbiol. 37, 68-73 (1999).