Evaluation of a transcription-mediated amplification-based HCV and HIV-1 RNA duplex assay for screening individual blood donations: A comparison with a minipool testing system

Transfusion

Volumn 43, Issue 2, 2003, Pages 215-225

  Candotti, Daniel ^a   Richetin, Aline ^b   Cant, Barbara ^b   Temple, Jillian ^b   Sims, Cate ^b   Reeves, Ian ^b   Barbara, John A J ^b   Allain, Jean Pierre ^b  

^a East Anglia Blood Centre   (United Kingdom)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

RNA;

ARTICLE; BLOOD DONOR; COMPARATIVE STUDY; CONTAMINATION; DIAGNOSTIC ACCURACY; DIAGNOSTIC ERROR; ERROR; GENE AMPLIFICATION; GENETIC TRANSCRIPTION; HEPATITIS C VIRUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; MAJOR CLINICAL STUDY; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SAFETY; SCREENING TEST; SERODIAGNOSIS;

BASE SEQUENCE; BLOOD DONORS; HEPACIVIRUS; HEPATITIS C; HIV INFECTIONS; HIV-1; HUMANS; MASS SCREENING; MOLECULAR SEQUENCE DATA; PHYLOGENY; PREDICTIVE VALUE OF TESTS; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION; RNA, VIRAL; SENSITIVITY AND SPECIFICITY; SEQUENCE ANALYSIS, RNA;

EID: 0037322028     PISSN: 00411132     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1537-2995.2003.00308.x     Document Type: Article

References (51)

1. Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion-transmitted viral infections. The Retrovirus Epidemiology Donor Study. N Engl J Med 1996;334:1685-90.
2. Widell A, Elmud H, Persson MH, Jonsson M. Transmission of hepatitis C via both erythrocyte and platelet transfusions from a single donor in serological window-phase of hepatitis C. Vox Sang 1996;71:55-7.
3. Vernelen K, Claeys H, Verhaert H, Volckaerts A, Vermylen C. Significance of NS3 and NS5 antigens in screening for HCV antibody. Lancet 1994;343:853.
4. Loussert-Ajaka I, Ly TD, Chaix ML, et al. HIV-1/HIV-2 seronegativity in HIV-1 subtype O infected patients. Lancet 1994;343:1393-4.
5. Montagnier L, Brenner C, Chamaret S, et al. Human immunodeficiency virus infection and AIDS in a person with negative serology. J Infect Dis 1997;175:955-9.
6. Candotti D, Adu-Sarkodie Y, Davies F, et al. AIDS in an HIV-seronegative Ghanaian woman with intersubtype A/G recombinant HIV-1 infection. J Med Virol 2000; 62:1-8.
7. Allain JP. Genomic screening for blood-borne viruses in transfusion settings. Clin Lab Haematol 2000;22:1-10.
8. Stramer SL, Waldman KT, Brodsky JP, Davis JT. Comparison of HW-1/HCV nucleic acid test reactivities of diluted and undiluted donations. Transfusion 2000;40(Suppl 10):S94-040A.
9. Muller-Breitkreutz K, Baylis SA, Allain JP. Nucleic acid amplification tests for the detection of blood-borne viruses. 5th EPFA/NIBSC Workshop, Amsterdam 1998. Vox Sang 1999;76:194-200.
10. Roth WK, Weber M, Seifried E. Feasibility and efficacy of routine PCR screening of blood donations for hepatitis C virus, hepatitis B virus, and HIV-1 in a blood-bank setting. Lancet 1999;353:359-63.
11. Araujo FM, Koch MC, Henriques I, et al. Routine screening of blood donations for HCV RNA. Vox Sang 1998;74:211.
12. Lelie PN, Van Drimmelen AAJ, Cuypers HTM, et al. Sensitivity of HCV-RNA and HIV-RNA blood screening assays. ISBT VII European Congress (abstract P133). Transfus Clin Biol 2001;8(Suppl 1):96s.
13. Petrik J, Hewitt P, Barbara J, Allain JP. Large-scale HCV RNA screening in first-time blood donors: the first step towards genomic screening of blood donations. HCV RNA Screening Study Group. Vox Sang 1999;76:159-62.
14. McDonough SH, Giachetti C, Yang Y, et al. High throughput assay for the simultaneous or separate detection of human immunodeficiency virus (HIV) and hepatitis type C virus (HCV). Infusionsther Transfusionsmed 1998;25:164-9.
15. Linnen J, Giachetti C, Kolk DP, et al. Highly sensitive multiplex assay for detection of HIV-1 and HCV RNA. J Clin Microbiol 2002;40:2408-19.
16. Petrik J, Pearson GJ, Allain JP. High throughput PCR detection of HCV based on semiautomated multisample RNA capture. J Virol Methods 1997;64:147-59.
17. Candotti D, Mundy C, Kadewele G, et al. Serological and molecular screening for viruses in blood donors from Ntcheu, Malawi: high prevalence of HIV-1 subtype C and of markers of hepatitis B and C viruses. J Med Virol 2001; 65:1-5.
18. Vandamme AM, Fransen K, Debaisieux L, et al. Standardisation of primers and an algorithm for HIV-1 diagnostic PCR evaluated in patients harbouring strains of diverse geographical origin. The Belgian AIDS Reference Laboratories. J Virol Methods 1995;51:305-16.
19. Lawal Z, Petrik J, Wong VS, Alexander GJ, Allain JP. Hepatitis C virus genomic variability in untreated and immunosuppressed patients. Virology 1997;228:107-11.
20. Davies FJ, d'Almeida O, Timmers E, et al. Molecular genotyping of HIV-1 in 61 patients with AIDS from Lome, Togo. J Med Virol 1999;57:25-30.
21. Barlow KL, Tosswill JH, Parry JV, Clewley JP. Performance of the Amplicor human immunodeficiency virus type 1 PCR and analysis of specimens with false-negative results. J Clin Microbiol 1997;35:2846-53.
22. Courouce AM, Le Marrec N, Bouchardeau F, et al. Efficacy of HCV core antigen detection during the presero-conversion period. Transfusion 2000;40:1198-202.
23. Aoyagi K, Iida K, Ohue C, et al. Performance of a conventional enzyme immunoassay for hepatitis C virus core antigen in the early phases of hepatitis C infection. Clin Lab 2001;47:119-27.
24. Icardi G, Ansaldi F, Bruzzone BM, et al. Novel approach to reduce the hepatitis C virus (HCV) window period. clinical evaluation of a new enzyme-linked immunosorbent assay for HCV core antigen. J Clin Microbiol 2001;39:3110-4.
25. Jongerius JM, Sjerps MC, Cuypers HTM, et al. Validation of NucliSens extractor in combination with the Ampliscreen HIV-1 vl.5 assay for application in minipool screening. ISBT VII European Congress (abstract P105). Transfus Clin Biol 2001;8(Suppl 1):89s.
26. Jongerius JM, Sjerps MC, Cuypers HTM, et al. Validation of NucliSens extractor in combination with the Ampliscreen HCV v2.0 assay for application in minipool screening. ISBT VII European Congress (abstract P107). Transfus Clin Biol 2001;8(Suppl 1):89s.
27. Reesink HW, Cuypers HTM, Sjerps MC, et al. Minipool screening for HCV-RNA and HIV-RNA by automated extraction, amplification and detection. ISBT VII European Congress (abstract S09-03). Transfus Clin Biol 2001;8(Suppl 1):17s.
28. Busch MP, Operskalski EA, Mosley JW, et al. Factors influencing human immunodeficiency virus type 1 transmission by blood transfusion. Transfusion Safety Study Group. J Infect Dis 1996;174:26-33.
29. Operkalski EA, Mosley JW, Rawal BD, Fiebig EW, Busch MP. HCV viral load in anti-HCV positive donors and the outcome in their recipients (abstract S3-030A). Transfusion 2001;41(Suppl 9):3s.
30. Busch MP, Wright DJ, Hirschkorn DF, Baggett D, et al. Sensitivity of 1st and 2nd generation HCV antigen assays versus nucleic acid testing (NAT) for detection of ramp-up phase HCV detection (abstract S4-030A). Transfusion 2001;41(Suppl):3s.
31. Schuttler CG, Caspari G, Jursch CA, et al. Hepatitis C virus transmission by a blood donation negative in nucleic acid amplification tests for viral RNA. Lancet 2000;355:41-2.
32. Ling AE, Robbins KE, Brown TM, et al. Failure of routine HIV-1 tests in a case involving transmission with presero-conversion blood components during the infectious window period. JAMA 2000;284:210-4.
33. Murthy KK, Henrard DR, Eichberg JW, et al. Redefining the HIV-infectious window period in the chimpanzee model: evidence to suggest that viral nucleic acid testing can prevent blood-borne transmission. Transfusion 1999; 39:688-93.
34. Beld M, Penning M, van Putten M, et al. Low levels of hepatitis C virus RNA in serum, plasma, and peripheral blood mononuclear cells of injecting drug users during long antibody-undetectable periods before seroconversion. Blood 1999;94:1183-91.
35. Montoro JA, Villalba JL, Planelles D, et al. Evaluation of a simultaneous nucleic acid testing: TMA versus PCR for HCV and HIV-1 testing in a Spanish blood center. ISBT VII European Congress (abstract P177). Transfus Clin Biol 2001;8(Suppl 1):92s.
36. Fang C, Vargo J, Smith K, et al. Clinical specificity of the CHIRON PROCLEIX HIV-1/HCV assay: ISBT VII European Congress (abstract P122). Transfus Clin Biol 2001;8(Suppl 1):93s.
37. Caglioti S, McAuley J, Morgan L, et al. Evaluation of nonreproducible NAT results from blood donor screening laboratory (abstract SP198). Transfusion 2000;40(Suppl 10):92s.
38. Waldman KJ, Perks C, Brodsky JP, Stramer S. Impact of the inclusion of seroreactives in a nucleic acid testing (NAT) program (abstract SP199). Transfusion 2000;40(Suppl 10):92s.
39. Cardoso MS, Koerner K, Kubanek B. Screening of blood donations by NAT in Baden-Wurttemberg: the cumulative data. ISBT VII European Congress (abstract P099). Transfus Clin Biol 2001;8(Suppl 1):87s.
40. Calosso L, Ghiazza P, Trive M, et al. Testing of minipools for HCV RNA reducing the residual risk of transfusion-transmitted HCV infection. ISBT VII European Congress (abstract P116). Transfus Clin Biol 2001;8(Suppl 1):92s.
41. Mison LM, Bolton W, Brown S, et al. Nucleic acid testing at the Australian red cross blood service-pooled vs single donation testing (abstract S27-030E). Transfusion 2000;40(Suppl 10):9s.
42. Pinho L, Dias F, Leal J, Monteiro R, Benvindo J. Experience of a Portuguese blood service. ISBT VII European Congress (abstract P114). Transfus Clin Biol 2001;8(Suppl. 1):91S.
43. Gonzalez R, Barea L, Bueno JL, Rodriguez P, Castro E. Implementation of nucleic acid testing (NAT) on single donation in a 40 000 donations a year blood center. ISBT VII European Congress (abstract P120). Transfus Clin Biol 2001;8(Suppl 1):93s.
44. Montcharmont P, Degottex J, Rigal D. Simultaneous screening of human immunodeficiency virus and hepatitis C virus genomes in transfusion. Vox Sang 2000;78(Suppl 1):424.
45. Gammon RR, Everett S, Simmonds-Brown P, et al. NAT testing: the first year's experience (abstract SP181). Transfusion 2000;40(Suppl 10):88s.
46. Montcharmont P, Degottex J, Monneron P, Rigal D. Single testing of human immunodeficiency virus and hepatitis C virus genomes on a high throughput semi-automated system: practice and efficiency (abstract SP188). Transfusion 2000; 40(Suppl 10):89s.
47. Ludicone P, Testi M, Moscetti A, et al. Evaluation of two nucleic acid amplification assays for HCV-RNA screening of blood donations (abstract SP186). Transfusion 2000;40(Suppl 10):89S.
48. Frank C, Mohamed MK, Strickland GT, et al. The role of parenteral antischistosomal therapy in the spread of hepatitis C virus in Egypt. Lancet 2000;355:887-91.
49. Surveillance UNAIDS/WHO. Report on the Global HIV/AIDS Epidemic-December UNAIDS. Geneva; UNAIDS/WHO; 1997.
50. Williamson LM, Heptonstall J, Soldan KA. A SHOT in the arm for safer blood transfusion. BMJ 1996;313:1221-2.
51. Soldan K, Barbara JA, Heptonstall J. Incidence of seroconversion to positivity for hepatitis C antibody in repeat blood donors in England, 1993-5. BMJ 1998;316:1413-7.