Skip to content Skip to navigation
University of Warwick
  • Study
  • |
  • Research
  • |
  • Business
  • |
  • Alumni
  • |
  • News
  • |
  • About

University of Warwick
Publications service & WRAP

Highlight your research

  • WRAP
    • Home
    • Search WRAP
    • Browse by Warwick Author
    • Browse WRAP by Year
    • Browse WRAP by Subject
    • Browse WRAP by Department
    • Browse WRAP by Funder
    • Browse Theses by Department
  • Publications Service
    • Home
    • Search Publications Service
    • Browse by Warwick Author
    • Browse Publications service by Year
    • Browse Publications service by Subject
    • Browse Publications service by Department
    • Browse Publications service by Funder
  • Statistics
  • Help & Advice
University of Warwick

The Library

  • Login

Evaluation of molecular techniques in prediction and diagnosis of cytomegalovirus disease in immunocompromised patients

Tools
- Tools
+ Tools

Szczepura, Ala, Westmoreland, D., Vinogradova, Y., Fox, J. and Clark, M. D. (Michael D.). (2006) Evaluation of molecular techniques in prediction and diagnosis of cytomegalovirus disease in immunocompromised patients. Health Technology Assessment, Vol.10 (No.10). pp. 1-176. ISSN 1366-5278

[img]
Preview
Text
WRAP_Szczepura_Evaluation_molecular_techniques.pdf - Draft Version

Download (831Kb) | Preview
[img]
Preview
Text
WRAP_coversheet_Szczepura_Evaluation_molecular_techniques.pdf - Draft Version

Download (50Kb) | Preview
Official URL: http://dx.doi.org/10.3310/hta10100

Abstract

OBJECTIVES: To evaluate selected molecular tests in diagnosis and screening of cytomegalovirus (CMV) infection in immunosuppressed patients. DESIGN: Clinical and cost-effectiveness were assessed through a prospective two-stage trial of CMV screening regimes in a routine service setting. Different molecular test results were fed back to clinicians in each stage, plus antigenaemia results. The technical performance of the molecular methods was assessed through an independent masked comparison of each molecular test against the established (antigenaemia) test. Scientists performing a particular test were blind to the other test results for that sample. Diagnostic and therapeutic impact were recorded prospectively for all tests, to include any effect on diagnostic certainty, changes to CMV therapy and any other reported impact on patient management. The cost of each test was estimated under different laboratory conditions. Prospective patients undergoing CMV screening were compared with consecutive historical controls in the same unit. Towards the end of the study, a survey of all UK virology laboratories was undertaken to identify current CMV screening practice and test preferences. In addition, all UK renal transplant surgeons and haematology transplant centres were surveyed in order to identify current clinical practice and perceptions of the benefits of CMV screening. SETTING: Study patients were recruited from University Hospital Wales (UHW), Cardiff. Staff in the Cardiff Public Health Laboratory Service virology laboratory performed the tests. PARTICIPANTS: A consecutive series of transplant patients was recruited to the prospective study over a 42-month period, totalling 98 renal and 140 haematology patients. A consecutive series of historical controls was identified, with 199 renal and 136 haematology patients who underwent transplants in the UHW during the 29 months prior to the prospective CMV screening trial.

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine
Divisions: Faculty of Medicine > Warwick Medical School > Clinical Sciences Research Institute (CSRI)
Library of Congress Subject Headings (LCSH): Cytomegalovirus infections, Medical screening -- Great Britain
Journal or Publication Title: Health Technology Assessment
Publisher: NIHR Health Technology Assessment programme
ISSN: 1366-5278
Date: April 2006
Volume: Vol.10
Number: No.10
Page Range: pp. 1-176
Identification Number: 10.3310/hta10100
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
Funder: NIHR Health Technology Assessment Programme (Great Britain)
References: 1. Rubin RH, Cosimi AB, Tulkoff-Rubin NE, Russell PS, Hirsch MS. Infectious disease syndromes attributable to cytomegalovirus recipients. Transplantation 1977;24:458–64. 2. Pass RF, Whitley RL, Dethelm AG, Whelchel JD, Reynolds DW, Alford CA. Cytomegalovirus infection in patients with renal transplants. J Infect Dis 1980;142:9–17. 3. Peterson PK, Balfour HH, Marker SC, Fryd DS, Howard RJ, Simmons RL. Cytomegalovirus disease in renal allograft recipients: prospective study of the clinical features, risk factors and impact on renal transplantation. Medicine (Baltimore) 1980;59:283–300. 4. Fox JC, Kidd M, Griffiths PD, Sweny P, Emery VC. Longitudinal analysis of cytomegalovirus load in renal transplant recipients using a quantitative polymerase chain reaction: correlation with disease. J Gen Virol 1995;76:309–19. 5. 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 2000;355:2032–6. 6. Meyers JD, Flournoy N, Thomas ED. Non bacterial pneumonia after allogeneic marrow transplantation: a review of ten years experience. Rev Infect Dis 1982;4:1119–32. 7. Meyers JD, Flournoy N, Thomas ED. Risk factors for cytomegalovirus infection after human marrow transplantation. J Infect Dis 1986;153:478–88. 8. Weiner RS, Bortin MM, Gale RP, Gluckman E, Kay HE, Kolb HJ, et al. Interstitial pneumonitis after bone marrow transplantation: assessment of risk factors. Ann Intern Med 1986;104:168–75. 9. Bowen EF, Griffiths PD, Davey CC, Emery VC, Johnson MA. Lessons from the natural history of cytomegalovirus. AIDS 1996;10(S1):37–41. 10. Bowden RA, Sayers M, Flournoy N, Newton B, Banajii M, Thomas ED, et al. Cytomegalovirus immune globulin and seronegative blood products to prevent primary cytomegalovirus infection after marrow transplantation. N Engl J Med 1986; 314:1006–10. 11. Meyers JD, Reed EC, Shepp DH, Thomquist M, Dandliker PS, Vicary CA, et al. Acyclovir for prevention of cytomegalovirus infection and disease after allogeneic marrow transplantation. N Engl J Med 1988;518:70–5. 12. D’AminoMonforte A, Vago L, Lazzarin A, Boldorini R, Bini T, Guzetti S, et al. AIDS defining disease in 250 HIV infected patients: a comparative study of clinical and autopsy diagnoses. AIDS 1992;6:1159–64. 13. Ives DV. Cytomegalovirus disease in AIDS (editorial review). AIDS 1997;11:1791–7. 14. Landry ML, Ferguson D. Comparison of quantitative cytomegalovirus antigenaemia assay with culture methods and correlation with clinical disease. J Clin Microbiol 1993;31:2851–6. 15. Boeckh M, Bowden RA, Goodrich JM, Pettinger M, Meyers JD. Cytomegalovirus antigen detection in peripheral blood leucocytes after allogeneic marrow transplantation. Blood 1992;80:1358–64. 16. Ehrnst A. The clinical relevance of different laboratory tests in CMV diagnosis. Scan J Infect Dis (Suppl) 1996;100:64–71. 17. Pedneault L, Anglow M, Alferi C, Rubin E. Diagnosis of cytomegalovirus infection in pediatric transplant patients by the antigenaemia, shell vial and conventional culture assays performed on blood: correlation with CMV disease. Clin Diagn Virol 1996;6:51–61. 18. The TH, van den Berg AP, Van Son WJ, Klompmaker IJ, Harmsen MC, Van der Giessen M, et al. Monitoring for cytomegalovirus after organ transplantation: a clinical perspective. Transplant Proc 1993;25(S4):5–9. 19. Buller RS, Gaudreault-Keener M, Rossiter-Fornoff J, Storch GA. Direct quantitative comparison of shell vial and conventional culture for detection of CMV viraemia. Clin Diagn Virol 1995;3:317–22. 20. Erice A, Holm MA, Gill PC, Henry S, Dirkson CL, Dunn DL, et al. Cytomegalovirus antigenaemia assay is more sensitive than shell vial cultures for rapid detection of CMV in polymorphonuclear blood leucocytes. J Clin Microbiol 1992;30:2822–5. 21. Van den Berg AP, Van der Bij W, Van Son WJ, Anema J, Van der Giessen M, Schirm J, et al. Cytomegalovirus antigenaemia is a useful marker of symptomatic cytomegalovirus infection after renal transplantation: a report of 130 consecutive patients. Transplantation 1989;48: 991–5. 22. Perez JL, Mariscal D, Tubau JN, Martin R. Evaluation of the CMV-vue antigenaemia assay for rapid detection of cytomegalovirus in peripheral blood leucocytes. Diagn Microbiol Infect Dis 1994; 19:15–8. 23. Wetherill PE, Landry ML, Alcabes P, Friedland G. Use of a quantitative cytomegalovirus (CMV) antigenaemia test in evaluating HIV+ patients with and without CMV disease. J Acquir Immun Defic Syndr Hum Retrovirol 1996;12:33–7. 24. Gerna G, Zipeto D, Parea M, Revello MG, Sillini E, Percivalle E, et al. Monitoring of human cytomegalovirus infections and ganciclovir treatment in heart transplant recipients by determination of viraemia, antigenaemia and DNAemia. J Infect Dis 1991;164:488–98. 25. Salzberger B, Franzen C, Fatkenheuer G, Cornely O, Schwenk A, Rasokat H, et al. CMVantigenemia in peripheral blood for the diagnosis of CMV disease in HIV-infected patients. J Acquir Immune Defic Syndrome Hum Retrovirol 1996; 11:365–9. 26. Reynes J, Montes B, Atoni N, Segondy M. Significance of cytomegalovirus (CMV) – pp65 antigenaemia in the diagnosis of CMV disease in human immunodeficiency virus infected patients. J Med Virol 1966;49:195–8. 27. Bek B, Boecth M, Lepenies J, Bieniek B, Arasteh K, Heise W, et al. High level sensitivity of quantitative pp 65 cytomegalovirus (CMV) antigenaemia assay for diagnosis of CMV disease in AIDS patients and follow up. J Clin Microbiol 1966;34:457–9. 28. Kidd IM, Fox JC, Pillay D, Charman H, Griffiths PD, Emery VC. Provision of prognostic information in immunocompromised patients by routine application of the polymerase chain reaction. Transplantation 1993;56:867–71. 29. Ehrnst A, Baskholt L, Lewensohn-Fuchs I, Ljungman P, Teodosiu I, Staland A, et al. CMV PCR monitoring in leucocytes of transplant patients clinical and diagnostic. Virology 1995; 3:139–53. 30. Fineberg HV, Bauman R, Sosman M. Computerized cranial tomography: effect on diagnostic and therapeutic plans. JAMA 1977; 238:224–30. 31. Barber L, Egan JJ, Lomax J, Yonan N, Deiraniya AK, Turner AJ, et al. Comparative study of three PCR assays with antigenaemia for the diagnosis of HCMV infection in thoracic transplant patients. J Med Virol 1996;49:137–44. 32. Bowen EF, Sabin CA, Wilson P, Griffiths PD, Davey CC, Johnson MA, et al. Cytomegalovirus viraemia detected by polymerase chain reaction identifies a group of HIV-positive patients at high risk of CMV disease. AIDS 1997;11:889–93. 33. Cope AV, Sweny P, Sabin C, Rees L, Griffiths PD, Emery VC. Quantity of cytomegalovirus viraemia is a major risk factor for cytomegalovirus disease after renal transplantation. J Med Virol. 1997; 52:200–5. 34. Zipeto D, Baldanti F, Zella D, Furione M, Cabicchini A, Milanesi G, et al. Quantification of human cytomegalovirus DNA in peripheral blood polymorphonuclear leucocytes of immunocompromised patients by the polymerase chain reaction. J Virol Methods 1993;44:45–6. 35. Fox JD, Kulkarni A, Neale ML, Jones R, Westmoreland D. The application of molecular techniques to monitoring and diagnosis of cytomegalovirus. Joint Meeting of the European Society for Clinical Virology and Society for General Microbiology (oral presentation), London, 1998. 36. Kulkarni A, Westmoreland D, Fox JD. Molecularbased strategies for assessment of CMV infection and disease in immunosuppressed transplant recipients. Clin Microbiol Infect 2001;7:179–86. 37. Kouzarides T, Bankier AT, Satchwell SC. Sequence and transcription analysis of human cytomegalovirus DNA polymerase gene. J Virol 1987;61:125–33. 38. Hiyoshi M, Tagawa S, Takubo T, Tanaka K, Nakao T, Higeno Y, et al. Evaluation of the AMPLICOR CMV test for direct detection of cytomegalovirus in plasma specimens. J Clin Microbiol 1997;35:2692–4. 39. Tong CY, Cuevas LE, Williams H, Bakran A. Prediction and diagnosis of cytomegalovirus disease in renal transplant recipients using qualitative and quantitative polymerase chain reaction. Transplantation 2000;69:985–91. 40. Solano, C, Munoz I, Gutierrez A, Farga A, Prosper F, Garcia-Conde J, et al. Qualitative plasma PCR assay (AMPLICOR CMV test) versus pp65 antigenemia assay for monitoring cytomegalovirus viremia and guiding preemptive ganciclovir therapy in allogeneic stem cell transplantation. J Clin Microbiol 2001;39:3938–41. 41. Halwachs-Baumann G, Wilders-Truschnig M, Enzinger G, Eibl M, Linkesch W, Dornbusch HJ. et al. Cytomegalovirus diagnosis in renal and bone marrow transplant recipients: the impact of molecular assays. J Clin Virol 2001;20:49–57. 42. Rollag H, Sagedal S, Kristiansen KI, Kvale D, Holter E, Degre M, et al. Cytomegalovirus DNA concentration in plasma predicts development of cytomegalovirus disease in kidney transplant recipients. Clin Microbiol Infect 2002;8:431–4. 43. Goossens VJ, Blok MJ, Christiaans MH, van Hooff JP, Sillekens P, Hockerstedt K, et al. Diagnostic value of nucleic-acid-sequence-based amplification for the detection of cytomegalovirus infection in renal and liver transplant recipients. Intervirology 1999;42:373–81. 44. Oldenburg N, Lam KM, Khan MA, Top B, Tacken NM, McKie A, et al. Evaluation of human cytomegalovirus gene expression in thoracic organ transplant recipients using nucleic acid sequencebased amplification. Transplantation 2000; 70:1209–15. 45. Witt DJ, Kemper M, Stead A, Sillekens P, Ginocchio CC, Espy MJ, et al. Analytical performance and clinical utility of a nucleic acid sequence-based amplification assay for detection of cytomegalovirus infection. J Clin Microbiol 2000;38:3994–9. 46. Amorim ML, Cabeda JM, Seca R, Mendes AC, Castro AP, Amorim JM. CMV infection of liver transplant recipients: comparison of antigenemia and molecular biology assays. BMC Infect Dis 2001;1:2. 47. Preiser W, Brauninger S, Schwerdtfeger R, Ayliffe U, Garson JA, Brink NS, et al. Evaluation of diagnostic methods for the detection of cytomegalovirus in recipients of allogeneic stem cell transplants. J Clin Virolo 2001;20:59–70 [published erratum appears in J Clin Virol 2001; 23:117]. 48. Caliendo AM, St George K, Allega J, Bullotta AC, Gilbane L, Rinaldo CR. Distinguishing cytomegalovirus (CMV) infection and disease with CMV nucleic acid assays. J Clinl Microbiol 2002; 40:1581–6. 49. Boivin G, Belanger R, Delage R, Beliveau C, Demers C, Goyette N, et al. Quantitative analysis of cytomegalovirus (CMV) viremia using the pp65 antigenemia assay and the COBAS AMPLICOR CMV MONITOR PCR test after blood and marrow allogeneic transplantation. J Clin Microbiol 2000;38:4356–60. 50. Caliendo AM, St George K, Kao SY, Allega J, Tan BH, LaFontaine R, et al. Comparison of quantitative cytomegalovirus (CMV) PCR in plasma and CMV antigenemia assay: clinical utility of the prototype AMPLICOR CMV MONITOR test in transplant recipients. J Clin Microbiol 2000;38:2122–7. 51. Sia IG, Wilson JA, Espy MJ, Paya CV, Smith TF. Evaluation of the COBAS AMPLICOR CMV MONITOR test for detection of viral DNA in specimens taken from patients after liver transplantation. J Clin Microbiol 2000;38:600–6. 52. Flexman J, Kay I, Fonte R, Herrmann R, Gabbay E, Palladino S. Differences between the quantitative antigenemia assay and the COBAS Amplicor Monitor quantitative PCR assay for detecting CMV viraemia in bone marrow and solid organ transplant patients. J Med Virol 2001; 64:275–282. 53. Razonable RR, Brown, RA, Espy MJ, Rivero A, Kremers W, Wilson J, et al. Comparative quantitation of cytomegalovirus (CMV) DNA in solid organ transplant recipients with CMV infection by using two high-throughput automated systems. J Clin Microbiol 2001;39:4472–6. 54. Piiparinen H, Hockerstedt K, Gronhagen-Riska C, Lappalainen M, Suni J, Lautenschlager I. Comparison of plasma polymerase chain reaction and pp65-antigenemia assay in the quantification of cytomegalovirus in liver and kidney transplant patients. J Clin Virol 2001;22:111–16. 55. Piiparinen H, Hockerstedt K, Lappalainen M, Suni J, Lautenschlager, I. Monitoring of viral load by quantitative plasma PCR during active cytomegalovirus infection of individual liver transplant patients. J Clin Microbiol 2002; 40:2945–52. 56. Caliendo, AM, Schuurman R, Yen-Lieberman B, Spector SA, Andersen J, Manjiry R, et al. and The CMV Working Group of the Complications of HIV Disease Research Agenda Committee, AIDS Clinical Trials Group. Comparison of quantitative and qualitative PCR assays for cytomegalovirus DNA in plasma. J Clin Microbiol 2001;39:1334–8. 57. Szczepura AK, Kankaanpää J, editors. Assessment of health care technologies: case studies, key concepts and strategic issues. Chichester: John Wiley, 1996. 58. Institute of Medicine. Assessing medical technologies. Washington, DC: National Academy Press, 1985. 59. Cochrane Screening and Diagnostic Tests Methods Group. http://www.cochrane.org/cochrane/ satdoc1.htm 60. Lijmer JG, Mol BW, Hesiterkamp S, Bonsel GJ, Prins MH, van der Meulen JH, et al. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA 1999;282:1061–6. 61. Lachs MS, Nachamkin I, Edelstein PH, Goldman J, Feinstein AR, Schwartz JS. Spectrum bias in the evaluation of diagnostic tests: lessons from the rapid dipstick test for urinary tract infection. Ann Intern Med 1992;117:135–40. 62. Szczepura AK. Efficiency in pathology laboratories: a survey of operations management in NHS bacteriology. Soc Sci Med 1991;33:531–43. 63. Drummond M, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ 1996;313:275–83. 64. European Commission. In Vitro Diagnostic Devices Directive 98/79/EC. Off J Eur Commun 7 December 1998, No L331; 1. 65. Buxton M. Problems in the economic appraisal of new health technology. In Drummond MF, editor. Economic appraisal of health technology in the European Community. Oxford: Oxford University Press, 1987. 66. Halwachs G, Zach R, Pogglitsch H, Holzer H, Tiran A, Iberer F, et al. A rapid immunocytochemical assay for CMV detection in peripheral blood of organ-transplanted patients in clinical practice. Transplantation 1993;56:338–42. 67. Boom R, Sol CJA, Salimans MMM, Jansen CL, Wertheim-van Dillen PME, van der Noordaa J. Rapid and simple method for purification of nucleic acids. J Clin Microbiol 1990;28: 495–503. 68. Fox JD, Brink NS, Zuckerman MA, Neild P, Gazzard BG, Tedder RS, et al. Detection of herpesvirus DNA by nested polymerase chain reaction in cerebrospinal fluid of human immunodeficiency virus-infected persons with neurologic disease – a prospective evaluation. J Infect Dis 1995;172:1087–90. 69. Darlington J, Super M, Patel K, Grundy JE, Griffith PD, Emery VC. Use of the polymerase chain reaction to analyse sequence variation within a major neutralizing epitope of glycoprotein B (gp58) in clinical isolates of human cytomegalovirus. J Gen Virol 1991;72: 1985–9. 70. Kearns AM, Draper B, Wipat W, Turner AJ, Wheeler J, Freeman R, et al. LightCycler-based quantitative PCR for detection of cytomegalovirus in blood, urine, and respiratory samples. J Clin Microbiol 2001;39:2364–5. 71. Kearns AM, Guiver M, James V, King J. Development and evaluation of a real-time quantitative PCR for the detection of human cytomegalovirus. J Virol Methods 2001;95:121–31. 72. Kearns AM, Turner AJ, Eltringham GJ, Freeman R. Rapid detection and quantification of CMV DNA in urine using LightCycler-based real-time PCR. J Clin Virol 2002;24:131–4. 73. Jones RN, Neale ML, Beattie B, Westmoreland D, Fox JD. Diagnostic assay for detection of Cytomegalovirus DNA by plate-hybridisation with an internal control. J Clin Microbiol 2000;38:1–6. 74. Mitchell SM, Fox JD, Tedder RS, Gazzard BG, Lightman S. Vitreous fluid sampling and viral genome detection for the diagnosis of viral retinitis in patients with AIDS. J Med Virol 1994; 43:336–40. 75. Blok M, Goossens VJ, Vanherie S, Top B, Tacken N, Middeldorp J, et al. Diagnostic value of monitoring human cytomegalovirus late pp67 mRNA expression in renal-allograft recipients by nucleic and sequence-based amplification. J Clin Microbiol 1998;36:1341–6.
URI: http://wrap.warwick.ac.uk/id/eprint/260

Data sourced from Thomson Reuters' Web of Knowledge

Request changes to a record

Actions (login required)

View Item View Item

Document Downloads

More statistics for this item...
twitter

Email us: publications@warwick.ac.uk
Contact Details
About Us