Clinical utility of viral quantification as a tool fordisease monitoring

Expert Review of Molecular Diagnostics

Volumn 1, Issue 2, 2001, Pages 153-162

  Schutten, Martin ^a   Niesters, Hubert gm ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

disease management; quantitative techniques; real time technology

Indexed keywords

VIRUS DNA; VIRUS RNA;

AUTOMATION; BRANCHED DNA SIGNAL AMPLIFICATION ASSAY; DEVICE; DNA VIRUS; HUMAN; LABORATORY TEST; NONHUMAN; NUCLEIC ACID SEQUENCE BASED AMPLIFICATION; PATIENT MONITORING; POLYMERASE CHAIN REACTION; PRACTICE GUIDELINE; QUALITATIVE ANALYSIS; QUALITY CONTROL; QUANTITATIVE ANALYSIS; REVIEW; RNA VIRUS; STANDARDIZATION; VIRUS CELL INTERACTION; VIRUS DETECTION; VIRUS INFECTION; VIRUS TITRATION; VIRUS TRANSMISSION;

CHEMISTRY, CLINICAL; CYTOMEGALOVIRUS; DNA; HEPACIVIRUS; HEPATITIS B VIRUS; HERPESVIRIDAE; HERPESVIRUS 4, HUMAN; HIV-1; HIV-2; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; NUCLEIC ACID HYBRIDIZATION; QUALITY CONTROL; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION; RNA; TIME FACTORS; VIREMIA;

EID: 0035559257     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.1.2.153     Document Type: Review

References (71)

1. Boom R, Sol CJ, Salimans MM, Jansen CL, Wertheim-van Dillen PM, van der NJ. Rapid and simple method for purification of nucleic acids. J. Clin. Microbiol. 28, 495–503 (1990).
2. Niesters HG, Krajden M, Cork L et al. A multicenter study evaluation of the Digene Hybrid Capture II Signal Amplification Technique for detection of hepatitis B virus DNA in serum samples and testing of EUROHEP standards. J. Clin. Microbiol. 38, 2150–2155 (2000).
3. Notermans DW, de Wolf F, Oudshoorn P et al. Evaluation of a second-generation nucleic acid sequence-based amplification assay for quantification of HIV Type 1 RNA and the use of ultrasensitive protocol adaptations. AIDS Res. Hum. Retroviruses 16, 1507–1517 (2000).
4. Schmitt Y. Performance characteristics of quantification assays for human immunodeficiency virus Type 1 RNA. J. Clin. Virol. 20, 31–33 (2001).
5. Blok MJ, Goossens VJ, Vanherle SJ et al. Diagnostic value of monitoring human cytomegalovirus late pp67 mRNA expression in renal-allograft recipients by nucleic acid sequence-based amplification. J. Clin. Microbiol. 36, 1341–1346 (1998).
6. Leone G, van Schijndel H, van Gemen B, Kramer FR, Schoen CD. Molecular beacon probes combined with amplification by NASBA enable homogeneous, real-time detection of RNA. Nucleic Acids Res. 26, 2150–2155 (1998).
7. de Ronde A, van Dooren M, van Der HL et al. Establishment of new transmissible and drug-sensitive human immunodeficiency virus Type 1 wild types due to transmission of nucleoside analogue-resistant virus. J. Virol. 75, 595–602 (2001).
8. Livak KJ, Flood SJ, Marmaro J, Giusti W, Deetz K. Oligonucleotides with fluorescent dyes at opposite ends provide a quenched probe system useful for detecting PCR product and nucleic acid hybridization. PCR Meth. Appl. 4, 357–362 (1995).
9. Tyagi S, Kramer FR. Molecular beacons: probes that fluoresce upon hybridization. Nature Biotechnol. 14, 303–308 (1996).
10. Wittwer CT, Herrmann MG, Moss AA, Rasmussen RP. Continuous fluorescence monitoring of rapid cycle DNA amplification. Biotechniques 22, 130–131 (1997).
11. Ho DD. Viral counts count in HIV infection. Science 272, 1124–1125 (1996).
12. Mellors JW, Rinaldo CR, Jr., Gupta P, White RM, Todd JA, Kingsley LA. Prognosis in HIV-1 infection predicted by the quantity of virus in plasma. Science 272, 1167–1170 (1996).
13. OShea S, Chrystie I, Cranston R et al. Problems in the interpretation of HIV-1 viral load assays using commercial reagents. J. Med. Virol. 61, 187–194 (2000).
14. Holguin A, de Mendoza C, Soriano V. Comparison of three different commercial methods for measuring plasma viraemia in patients infected with non-B HIV-1 subtypes. Eur. J. Clin. Microbiol. Infect. Dis. 18, 256–259 (1999).
15. Schutten M, van den HB, van der Ende ME, Gruters RA, Osterhaus AD, Niesters HG. Development of a real-time quantitative RT-PCR for the detection of HIV-2 RNA in plasma. J. Virol. Methods 88, 81–87 (2000).
16. Popper SJ, Sarr AD, Travers KU et al. Lower Human Immunodeficiency Virus (HIV) Type 2 viral load reflects the difference in pathogenicity of HIV-1 and HIV-2. J. Infect. Dis. 180, 1116–1121 (1999).
17. Schutten M, van der Ende ME, Osterhaus AD. Antiretroviral therapy in patients with dual infection with human immunodeficiency virus types 1 and 2. N. Engl. J. Med. 342, 1758–1760 (2000).
18. Pawlotsky JM, Bastie A, Hezode C et al. Routine detection and quantification of hepatitis B virus DNA in clinical laboratories: performance of three commercial assays. J. Virol. Methods 85, 11–21 (2000).
19. Chan HL, Leung NW, Lau TC, Wong ML, Sung JJ. Comparison of three different sensitive assays for hepatitis B virus DNA in monitoring of responses to antiviral therapy. J. Clin. Microbiol. 38, 3205–3208 (2000).
20. Krajden M, Minor J, Cork L, Comanor L. Multi-measurement method comparison of three commercial hepatitis B virus DNA quantification assays. J. Viral. Hepat. 5, 415–422 (1998).
21. Pas SD, Fries E, de Man RA, Osterhaus AD, Niesters HG. Development of a quantitative real-time detection assay for hepatitis B virus DNA and comparison with two commercial assays. J. Clin. Microbiol. 38, 2897–2901 (2000).
22. Abe A, Inoue K, Tanaka T et al. Quantitation of hepatitis B virus genomic DNA by real-time detection PCR. J. Clin. Microbiol. 37, 2899–2903 (1999).
23. Janssen HL, Gerken G, Carreno V et al. Interferon- for chronic hepatitis B infection: increased efficacy of prolonged treatment. The European Concerted Action on Viral Hepatitis (EUROHEP). Hepatology 30, 238–243 (1999).
24. Mutimer D. Hepatitis B virus antiviral drug resistance: from the laboratory to the patient. Antiviral Ther. 3, 243–246 (1998).
25. Niesters HG, Honkoop P, Haagsma EB, de Man RA, Schalm SW, Osterhaus AD. Identification of more than one mutation in the hepatitis B virus polymerase gene arising during prolonged lamivudine treatment. J. Infect. Dis. 177, 1382–1385 (1998).
26. Seta T, Yokosuka O, Imazeki F, Tagawa M, Saisho H. Emergence of YMDD motif mutants of hepatitis B virus during lamivudine treatment of immunocompetent type B hepatitis patients. J. Med. Virol. 60, 8–16 (2000).
27. Puchhammer-Stockl E, Mandl CW, Kletzmayr J et al. Monitoring the virus load can predict the emergence of drug-resistant hepatitis B virus strains in renal transplantation patients during lamivudine therapy. J. Infect. Dis. 181, 2063–2066 (2000).
28. Allen MI, Deslauriers M, Andrews CW et al. Identification and characterization of mutations in hepatitis B virus resistant to lamivudine. Lamivudine Clinical Investigation Group. Hepatology 27, 1670–1677 (1998).
29. Stuyver L, Van Geyt C, De Gendt S et al. Line probe assay for monitoring drug resistance in hepatitis B virus-infected patients during antiviral therapy. J. Clin. Microbiol. 38, 702–707 (2000).
30. 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).
31. Poynard T, McHutchison J, Goodman Z, Ling MH, Albrecht J. Is an a la carte combination interferon -2b plus ribavirin regimen possible for the first line treatment in patients with chronic hepatitis C? The ALGOVIRC Project Group. Hepatology 31, 211–218 (2000).
32. Reichard O, Norkrans G, Fryden A, Braconier JH, Sonnerborg A, Weiland O. Randomised, double-blind, placebocontrolled trial of interferon -2b with and without ribavirin for chronic hepatitis C. The Swedish Study Group. Lancet 10 (351), 83–87 (1998).
33. Davis GL, Esteban-Mur R, Rustgi V et al. Interferon -2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. International Hepatitis Interventional Therapy Group. N. Engl. J. Med. 339, 1493–1499 (1998).
34. Poynard T, Moussali J, Ratziu V, Regimbeau C, Opolon P. Effects of interferon therapy in non-responder patients with chronic hepatitis C. J. Hepatol. 31 \(Suppl. 1), 178–183 (1999).
35. Poynard T, McHutchison J, Davis GL et al. Impact of interferon alfa-2b and ribavirin on progression of liver fibrosis in patients with chronic hepatitis C. Hepatology 32, 1131–1137 (2000).
36. EASL International Consensus Conference on hepatitis C. Paris, 26 – 27 February 1999.
37. EASL International Consensus Conference on hepatitis C. Paris, 26 – 27 February 1999. Consensus statement. J. Hepatol. 31 \(Suppl. 1), 3–8 (1999).
38. Bekkering FC, Brouwer JT, Leroux-Roels G et al. Ultrarapid hepatitis C virus clearance by daily high-dose interferon in nonresponders to standard therapy. J. Hepatol. 28, 960–964 (1998).
39. Zeuzem S. Clinical implications of hepatitis C viral kinetics. J. Hepatol. 31 \(Suppl. 1), 61–64 (1999).
40. Wiley TE, Briedi L, Lam N, Layden TJ. Early HCV RNA values after interferon predict response. Dig. Dis. Sci. 43, 2169–2172 (1998).
41. Bekkering FC, Stalgis C, McHutchison JG, Brouwer JT, Perelson AS. Estimation of early hepatitis C viral clearance in patients receiving daily interferon and ribavirin therapy using a mathematical model. Hepatology 33, 419–423 (2001).
42. Hopwood P, Crawford DH. The role of EBV in post-transplant malignancies: a review. J. Clin. Pathol. 53, 248–254 (2000).
43. Paya CV, Fung JJ, Nalesnik MA et al. Epstein-Barr virus-induced posttransplant lymphoproliferative disorders. ASTS/ASTP EBV-PTLD Task Force and The Mayo Clinic Organized International Consensus Development Meeting. Transplantation 68, 1517–1525 (1999).
44. Jabs WJ, Hennig H, Kittel M et al. Normalized quantification by real-time PCR of Epstein-Barr virus load in patients at risk for post-transplant lymphoproliferative disorders. J. Clin. Microbiol. 39, 564–569 (2001).
45. Yang J, Tao Q, Flinn IW et al. Characterization of Epstein-Barr virusinfected B cells in patients with posttransplantation lymphoproliferative disease: disappearance after rituximab therapy does not predict clinical response. Blood 96, 4055–4063 (2000).
46. Orii T, Ohkohchi N, Kikuchi H et al. Usefulness of quantitative real-time polymerase chain reaction in following up patients with Epstein-Barr virus infection after liver transplantation. Clin. Transplant. 14, 308–317 (2000).
47. Green M, Bueno J, Rowe D et al. Predictive negative value of persistent low Epstein- Barr virus viral load after intestinal transplantation in children. Transplantation 70, 593–596 (2000).
48. Niesters HG, van Esser J, Fries E, Wolthers KC, Cornelissen J, Osterhaus AD. Development of a real-time quantitative assay for detection of Epstein-Barr virus. J. Clin. Microbiol. 38, 712–715 (2000).
49. Flinn IW, ODonnell PV, Goodrich A et al. Immunotherapy with rituximab during peripheral blood stem cell transplantation for non-Hodgkins lymphoma. Biol. Blood Marrow Transplant. 6, 628–632 (2000).
50. Boeckh M, Boivin G. Quantitation of cytomegalovirus: methodologic aspects and clinical applications. Clin. Microbiol. Rev. 11, 533–554 (1998).
51. Emery VC, Cope AV, Bowen EF, Gor D, Griffiths PD. The dynamics of human cytomegalovirus replication in vivo. J. Exp. Med. 190, 177–182 (1999).
52. Emery VC, Sabin CA, Cope AV, Gor D, Hassan-Walker AF, Griffiths PD. Application of viral-load kinetics to identify patients who develop cytomegalovirus disease after transplantation. Lancet 355, 2032–2036 (2000).
53. Greijer AE, Verschuuren EA, Harmsen MC et al. Direct quantification of human cytomegalovirus immediate-early and late mRNA levels in blood of lung transplant recipients by competitive nucleic acid sequence-based amplification. J. Clin. Microbiol. 39, 251–259 (2001).
54. Goossens VJ, Blok MJ, Christiaans MH et al. Diagnostic value of nucleic-acidsequence- based amplification for the detection of cytomegalovirus infection in renal and liver transplant recipients. Intervirology 42, 373–381 (2000).
55. Boeckh M. Management of cytomegalovirus infections in blood and marrow transplant recipients. Adv. Exp. Med. Biol. 458, 89–109 (1999).
56. Limaye AP, Huang ML, Leisenring W, Stensland L, Corey L, Boeckh M. Cytomegalovirus (CMV) DNA load in plasma for the diagnosis of CMV disease before engraftment in hematopoietic stemcell transplant recipients. J. Infect. Dis. 183, 377–382 (2001).
57. Sia IG, Wilson JA, Groettum CM, Espy MJ, Smith TF, Paya CV. Cytomegalovirus (CMV) DNA load predicts relapsing CMV infection after solid organ transplantation. J. Infect. Dis. 181, 717–720 (2000).
58. Peggs KS, Preiser W, Kottaridis PD et al. Extended routine polymerase chain reaction surveillance and pre-emptive antiviral therapy for cytomegalovirus after allogeneic transplantation. Br. J. Haematol. 111, 782–790 (2000).
59. Griffiths PD, Ait-Khaled M, Bearcroft CP et al. Human herpesviruses 6 and 7 as potential pathogens after liver transplant: Prospective comparison with the effect of cytomegalovirus. J. Med. Virol. 59, 496– 501 (1999).
60. Campadelli-Fiume G, Mirandola P, Menotti L. Human herpesvirus 6: An emerging pathogen. Emerg. Infect. Dis. 5, 353–366 (1999).
61. Ljungman P, Wang FZ, Clark DA et al. High levels of human herpesvirus 6 DNA in peripheral blood leucocytes are correlated to platelet engraftment and disease in allogeneic stem cell transplant patients. Br. J. Haematol. 111, 774–781 (2000).
62. Nitsche A, Muller CW, Radonic A et al. Human herpesvirus 6A DNA is detected frequently in plasma but rarely in peripheral blood leukocytes of patients after bone marrow transplantation. J. Infect. Dis. 183, 130–133 (2001).
63. Dusheiko GM, Khakoo S, Soni P, Grellier L. A rational approach to the management of hepatitis C infection. Br. Med. J. 10 (312), 357–364 (1996).
64. Cao Y, Krogstad P, Korber BT et al. Maternal HIV-1 viral load and vertical transmission of infection: the Ariel Project for the prevention of HIV transmission from mother to infant. Nature Med. 3, 549–552 (1997).
65. van Nunen AB, de Man RA, Heijtink RA, Niesters HG, Schalm SW. Lamivudine in the last 4 weeks of pregnancy to prevent perinatal transmission in highly viremic chronic hepatitis B patients. J. Hepatol. 32, 1040–1041 (2000).
66. Damen M, Cuypers HT, Zaaijer HL et al. International collaborative study on the second EUROHEP HCV-RNA reference panel. J. Virol. Methods 58, 175–185 (1996).
67. Quint WGV, Heijtink RA, Schirm J, Gerlich WH, Niesters HGM. Reliability of methods for hepatitis B virus DNA detection. J. Clin. Microbiol. 33, 225–228 (1995).
68. Zaaijer HL, Cuypers HT, Reesink HW, Winkel IN, Gerken G, Lelie PN. Reliability of polymerase chain reaction for detection of hepatitis C virus. Lancet 341, 722–724 (1993).
69. Saldanha J, Lelie N, Heath A. Establishment of the first international standard for nucleic acid amplification technology (NAT) assays for HCV RNA. WHO Collaborative Study Group. Vox Sang. 76, 149–158 (1999).
70. Saldanha J. Validation and standardisation of nucleic acid amplification technology (NAT) assays for the detection of viral contamination of blood and blood products. J. Clin. Virol. 20, 7–13 (2001).
71. Kutyavin IV, Afonina IA, Mills A et al. 3–- Minor groove binder-DNA probes increase sequence specificity at PCR extension temperatures. Nucleic Acids Res. 28, 655–661 (2000).