Head-to-head comparison of two transcription-mediated amplification assay versions for detection of hepatitis B virus, hepatitis C virus, and human immunodeficiency virus Type 1 in blood donors

Transfusion

Volumn 53, Issue 10 PART 2, 2013, Pages 2512-2524

  Grabarczyk, Piotr ^{a,b,c,d,e,f,g}   Van Drimmelen, Harry ^{a,b,c,d,e,f,g}   Kopacz, Aneta ^{a,b,c,d,e,f,g}   Gdowska, Jolanta ^{a,b,c,d,e,f,g}   Liszewski, Grzegorz ^{a,b,c,d,e,f,g}   Piotrowski, Dariusz ^{a,b,c,d,e,f,g}   Górska, Joanna ^{a,b,c,d,e,f,g}   Kuśmierczyk, Jolanta ^{a,b,c,d,e,f,g}   Candotti, Daniel ^{a,b,c,d,e,f,g}   Łȩtowska, Magdalena ^{a,b,c,d,e,f,g}   Lelie, Nico ^{a,b,c,d,e,f,g}   Brojer, Ewa ^{a,b,c,d,e,f,g}  

^a INSTITUTE OF HEMATOLOGY AND TRANSFUSION MEDICINE   (Poland)

^b DDL DIAGNOSTIC LABORATORY   (Netherlands)

^c Regional Blood Center   (Poland)

^d Regional Blood Transfusion Centre   (Poland)

^e Regional Blood Transfussion Center   (Poland)

^f NHS BLOOD AND TRANSPLANT   (United Kingdom)

^g Lelie Research   (France)

Author keywords

[No Author keywords available]

Indexed keywords

VIRUS DNA; VIRUS RNA;

ARTICLE; BLOOD; BLOOD DONOR; COMPARATIVE STUDY; EVALUATION STUDY; GENETIC TRANSCRIPTION; GENETICS; GENOTYPE; HEPATITIS B VIRUS; HEPATITIS C VIRUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; ISOLATION AND PURIFICATION; LIMIT OF DETECTION; MASS SCREENING; METHODOLOGY; NUCLEIC ACID AMPLIFICATION; SEROLOGY; STANDARD; STATISTICS; WORLD HEALTH ORGANIZATION; HEPACIVIRUS; PROCEDURES; STANDARDS; STATISTICS AND NUMERICAL DATA;

BLOOD DONORS; DNA, VIRAL; GENOTYPE; HEPACIVIRUS; HEPATITIS B VIRUS; HIV-1; HUMANS; LIMIT OF DETECTION; MASS SCREENING; NUCLEIC ACID AMPLIFICATION TECHNIQUES; RNA, VIRAL; SEROLOGIC TESTS; TRANSCRIPTION, GENETIC; WORLD HEALTH ORGANIZATION;

EID: 84888644373     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/trf.12190     Document Type: Article

References (31)

1. Brojer E, Gronowska A, Medynska J, Grabarczyk P, Mikulska M, Letowska M, Kryczka W, Gietka A. The hepatitis C virus genotype and subtype frequency in hepatitis C virus RNA-positive, hepatitis C virus antibody-negative blood donors identified in the nucleic acid test screening program in Poland. Transfusion 2004;44:1706-10.
2. Brojer E, Grabarczyk P, Liszewski G, Mikulska M, Allain JP, Letowska M; Polish Blood Transfusion Service Viral Study Group. Characterization of HBV DNA(+)/HBsAg(-) blood donors in Poland identified by triplex NAT. Hepatology 2006;44:1666-74.
3. Candotti D, Grabarczyk P, Ghiazza P, Roig R, Casamitjana N, Iudicone P, Schmidt M, Bird A, Crookes R, Brojer E, Miceli M, Amiri A, Li C, Allain JP. Characterization of occult hepatitis B virus from blood donors carrying genotype A2 or genotype D strains. J Hepatol 2008;49:537-47.
4. Brojer E, Grabarczyk P, Kopacz A, Liszewski G, Mikulska M, Łȩtowska M. Decade of viral nucleic acid testing (NAT) in Poland (2000-2010); methods and yields. The 21st Regional Congress of the ISBT, June 18-22 2011. Lisbon, Portugal: Vox Sanguinis, 2011, p. 313.
5. Glynn SA, Wright DJ, Kleinman SH, Hirschkorn D, Tu Y, Heldebrant C, Smith R, Giachetti C, Gallarda J, Busch MP. Dynamics of viremia in early hepatitis C virus infection. Transfusion 2005;45:994-1002.
6. Grabarczyk P, Gronowska A, Brojer E, Letowska M, Radziwon P. Sequence analysis confirmation of transfusiontransmitted hepatitis C by red blood cells that tested negative by minipool hepatitis C virus nucleic acid testing. Transfusion 2007;47:1102-4.
7. Kleinman SH, Lelie N, Busch MP. Infectivity of human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus and risk of transmission by transfusion. Transfusion 2009;49:2454-89.
8. Grabarczyk P, Letowska M, Kopacz A, Liszewski G, Sulkowska E, Brojer E; Polish Blood Transfusion Service. Effectiveness of various minipool nucleic acid test systems for hepatitis B virus detection in blood donors. Transfusion 2009;49:1494-5.
9. Liszewski G, Kopacz A, Grabarczyk P, Sulkowska E, Łetowska M, Brojer E. [Frequency of HBV DNA, HCV RNA and HIV RNA in blood donors-effectiveness of different screening systems.] XXIII PTHiT Congress.Wrocław: Acta Haematologica Polonica 2009, 2009, p. 36.
10. Assal A, Barlet V, Deschaseaux M, Dupont I, Gallian P, Guitton C, Morel P, van Drimmelen H, David B, Lelie N, De Micco P. Sensitivity of two hepatitis B virus, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) nucleic acid test systems relative to hepatitis B surface antigen, anti-HCV, anti-HIV, and p24/anti-HIV combination assays in seroconversion panels. Transfusion 2009;49: 301-10.
11. Assal A, Barlet V, Deschaseaux M, Dupont I, Gallian P, Guitton C, Morel P, David B, De Micco P. Comparison of the analytical and operational performance of two automated NAT blood screening systems: Procleix Tigris and cobas s 201. Transfusion 2009;49:289-300.
12. Margaritis AR, Brown SM, Seed CR, Kiely P, D'Agostino B, Keller AJ. Comparison of two automated nucleic acid testing systems for simultaneous detection of human immunodeficiency virus and hepatitis C virus RNA and hepatitis B virus DNA. Transfusion 2007;47: 1783-93.
13. Heermann KK, Gerlich WH, Chudy M, Schaefer S, Thomssen R. Quantitative detection of hepatitis B virus DNA in two international reference preparations. J Clin Microbiol 1999;37:68-73.
14. Pisani G, Marino F, Cristiano K, Bisso GM, Mele C, Luciani F, Wirz M, Gentili G; the National Collaborative Study Group. Collaborative study for the calibration of HCV RNA, HBV DNA and HIV RNA reference preparations against the relative international standards. Ann Ist Super Sanità 2007; 43:69-76.
15. Komiya Y, Katayama K, Yugi H, Mizui M, Matsukura H, Tomoguri T, Miyakawa Y, Tabuchi A, Tanaka J, Yoshizawa H. Minimum infectious dose of hepatitis B virus in chimpanzees and difference in the dynamics of viremia between genotype A and genotype C. Transfusion 2008;48: 286-94.
16. Katayama K, Kumagai J, Komyiya Y, Mizui M, Yugi H, Kishimoto S, Yamanaka R, Tamatsukuri S, Tomoguri T, Miyakawa Y, Tanaka J, Yoshizawa H. Titration of hepatitis C virus in chimpanzees for determining the copy number required for transmission. Intervirology 2004;47:57-64.
17. Biswas R, Tabor E, Hsia CC, Wright DJ, Laycock ME, Fiebig EW, Peddada L, Smith R, Schreiber GB, Epstein JS, Nemo GJ, Busch MP. Comparative sensitivity of HBV NATs and HBsAg assays for detection of acute HBV infection. Transfusion 2003;43:788-98.
18. Yoshikawa A, Gotanda Y, Itabashi M, Minegishi K, Kanemitsu K, Nishioka K; Japanese Red Cross NAT Screening Research Group. Hepatitis B NAT virus-positive blood donors in the early and late stages of HBV infection: analyses of the window period and kinetics of HBV DNA. Vox Sang 2005;88:77-86.
19. Collins ML, Zayati C, Detmer JJ, Daly B, Kolberg JA, Cha TA, Irvine BD, Tucker J, Urdea MS. Preparation and characterization of RNA standards for use in quantitative branched DNA hybridization assays. Anal Biochem 1995; 226:120-9.
20. Magdzik W, Czarkowski MP. [Coverage of vaccination against hepatitis B in Poland in 2004]. Przegl Epidemiol 2006;66:185-92.
21. De Maddalena C, Giambelli C, Tanzi E, Colzani D, Schiavini M, Milazzo L, Bernini F, Ebranati E, Cargnel A, Bruno R, Galli M, Zehender G. High level of genetic heterogeneity in S and P genes of genotype D hepatitis B virus. Virology 2007;365:113-24.
22. Grabarczyk P, Garmiri P, Liszewski G, Doucet D, Sulkowska E, Brojer E, Allain JP; Polish Blood Transfusion Centres Viral Study Group. Molecular and serological characterization of hepatitis B virus genotype A and D infected blood donors in Poland. J Viral Hepat 2010;17:444-52.
23. Grabarczyk P. Study on polymorphism of the transfusion transmitted viruses in Poland-hepatitis B virus (HBV) and parvovirus B19 (B19V). J Transfus Med 2011; 4:45-81.
24. Weusten J, Vermeulen M, van Drimmelen H, Lelie N. Refinement of a viral transmission risk model for blood donations in seroconversion window phase screened by nucleic acid testing in different pool sizes and repeat test algorithms. Transfusion 2011;51:203-15.
25. Tabuchi A, Tanaka J, Katayama K, Mizui M, Matsukura H, Yugi H, Shimada T, Miyakawa Y, Yoshizawa H. Titration of hepatitis B virus activity in the sera of pre-acute and late acute phases of HBV infection: transmission experiments to chimeric mice with human liver repopulated hepatocytes. J Med Virol 2008;80:2064-68.
26. Landers TA, Greenberg HB, Robinson WS. Structure of hepatitis B Dane particle DNA and nature of the endogenous DNA polymerase reaction. J Virol 1977;23:368-76.
27. Gerlich WH, Robinson WS. Hepatitis B virus contains protein attached to the 5' terminus of its complete DNA strand. Cell 1980;21:801-9.
28. Gerlich WH, Glebe D, Schuettler CG. Deficiencies in the standardization and sensitivity of diagnostic tests for hepatitis B virus. J Viral Hepat 2007;14:16-21.
29. Chudy M, Weber-Schehl M, Pichl L, Jork C, Kress J, Heiden M, Funk MB, Nübling CM. Blood screening nucleic acid amplification tests for human immunodeficiency virus Type 1 may require two different amplification targets. Transfusion 2012;52:431-9.
30. European Commission. Commission Decision of 3 February 2009 amending Decision 2002/364/EC on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2009) 565) (2009/108/EC); L 39/34 EN Official Journal of the European Union 10.2.2009.
31. Cable R, Lelie N, Bird A. Reduction of the risk of transfusion- transmitted viral infection by nucleic acid amplification testing in theWestern Cape of South Africa: a five year review. Vox Sang 2013;104:93-9.