Performance of an algorithm for the reentry of volunteer blood donors deferred due to false-positive test results for antibody to hepatitis B core antigen

Transfusion

Volumn 48, Issue 11, 2008, Pages 2315-2322

  Katz, Louis ^a   Strong, D Michael ^b   Tegtmeier, Gary ^b   Stramer, Susan ^b  

^a Mississippi Valley Regional Blood Center   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

HEPATITIS B CORE ANTIBODY; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B VACCINE;

ALGORITHM; ARTICLE; BLOOD DONOR; CONTROLLED STUDY; DISEASE TRANSMISSION; DNA DETERMINATION; DNA REPLICATION; FALSE POSITIVE RESULT; FOOD AND DRUG ADMINISTRATION; HEPATITIS B; HUMAN; MAJOR CLINICAL STUDY; SENSITIVITY ANALYSIS;

ADULT; ALGORITHMS; BLOOD BANKS; BLOOD DONORS; DIAGNOSTIC ERRORS; DNA, VIRAL; FALSE POSITIVE REACTIONS; FEMALE; HEPATITIS B; HEPATITIS B ANTIBODIES; HEPATITIS B CORE ANTIGENS; HUMANS; MALE; MASS SCREENING; PRACTICE GUIDELINES AS TOPIC; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VOLUNTARY WORKERS;

EID: 55349141094     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/j.1537-2995.2008.01844.x     Document Type: Article

References (24)

1. Seeger C, Zoulim F, Mason W. Hepadnaviridae. In : Knipe DM, Howley PM, editors. Fields virology. 5th ed. Philadelphia (PA) : Lippincott Williams & Wilkins 2007. p. 2977 3029.
2. Alter HJ, Purcell RH, Shih JW, Melpolder JC, Houghton M, Choo QL, Kuo G. Detection of antibody to hepatitis C virus in prospectively followed transfusion recipients with acute and chronic non-A, non-B hepatitis. N Engl J Med 1989 321 : 1494 500.
3. Tegtmeier G, Henderson S, McNamara A, Kuhns M. Contribution of anti-HBc screening to blood safety at a regional blood center in the United States [Abstract S439 Transfusion 1997 37S 11S.
4. Food and Drug Administration. Recommendations concerning testing for antibody to hepatitis B core antigen (Anti-HBc). Rockville (MD) : Food and Drug Administration 1991 Sep 10 [cited 2008 Mar 17 Available from: http://www.fda.gov/CBER/bldmem/091091.pdf.
5. Infectious disease testing for blood transfusions. NIH Consensus Statement 1995 13 : 1 29.
6. Mosely J, Stevens C, Aach R, Hollinger FB, Mimms LT, Solomon LR, Barbosa LH, Nemo GJ. Donor screening for antibody to hepatitis B core antigen and hepatitis B virus infection in transfusion recipients. Transfusion 1995 35 : 5 12.
7. Kleinman SH, Kuhns MC, Todd DS, Glynn SA, McNamara A, DiMarco A, Busch MP for REDS. Frequency of HBV DNA detection in US blood donors testing positive for the presence of anti-HBc: implications for transfusion transmission and donor screening. Transfusion 2003 43 : 696 704.
8. Allain J-P. Occult hepatitis B virus infection: implications in transfusion. Vox Sang 2004 86 : 83 91.
9. Busch MP. Should HBV DNA NAT replace HBsAg and/or anti-HBc screening of blood donors? Transfus Clin Biol 2004 11 : 26 32.
10. Reesink HW, Engelfriet CP, Henn G, Mayr WR, Delage G, Bernier F, Krusius T, Assal A, Gallian P, Corbi C, Morel P, David B, De Micco P, Murokawa H, Yugi H, Hino S, Tadokoro K, Flesland O, Brojer E, Letowska M, Olim G, Nascimento F, Gonçalves H, Castro L, Morais M, Stezinar SL, Alvarez M, Sauleda S, González R, Niederhauser C, Stolz M, Allain JP, Owusu-Ofori S, Eglin R, Stramer S, Busch M, Strong DM, Epstein J, Biswas R. Occult hepatitis B infection in blood donors. Vox Sang 2008 94 : 153 66.
11. Stramer SL, Foster GA, Notari EP. HBV DNA PCR positive rates of antibody to hepatitis B core (anti-HBc) repeat reactive (RR) donors; implications for reentry protocols [abstract Transfusion 2006 46 9S 21A.
12. Roth WK, Weber M, Petersen D, Drosten C, Buhr S, Sireis W, Weichert W, Hedges D, Seifried E. NAT for HBV and anti-HBc testing increase blood safety. Transfusion 2002 42 : 869 75.
13. Satake M, Taira R, Yugi H, Hino S, Kanemitsu K, Ikeda H, Tadokoro K. Infectivity of blood components with low hepatitis B virus DNA levels identified in a lookback program. Transfusion 2007 47 : 1197 205.
14. Busch MP, Dodd RY, Lackritz EM, AuBuchon JP, Birkmeyer JD, Petersen LR. Value and cost-effectiveness of screening blood donors for antibody to hepatitis B core antigen as a way of detecting window-phase human immunodeficiency virus type 1 infections. The HIV Blood Donor Study Group. Transfusion 1997 37 : 1003 11.
15. Food and Drug Administration. Blood Products Advisory Committee. FDA's current thinking on reentry of donors deferred for repeated detection of antibody to hepatitis B core antigen: Blood Products Advisory Committee. Rockville (MD) : Food and Drug Administration 2004 Oct 21 [2007 July 5 Available from: http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4074b1.htm.
16. Kleinman SH, Kuhns MC, Todd DS, Glynn SA, McNamara A, DiMarco A, Busch MP Retrovirus Epidemiology Donors Study. Frequency of HBV DNA detection in US blood donors testing positive for the presence of anti-HBc: implications for transfusion transmission and donor screening. Transfusion 2003 43 : 696 704.
17. Food and Drug Administration. Recommendations for the quarantine and disposition of units from prior collections from donors with repeatedly reactive screening tests for hepatitis B virus (HBV), hepatitis C virus (HCV) and human T-lymphotropic virus type I (HTLV-I). Rockville (MD) : Food and Drug Administration 1996 Jul 19 cited 2007 July 5]. Available from http://www.fda.gov/cber/gdlns/htlv-ii.txt
18. Aoki S, Finegold D, Kuramoto IK, Douville C, Richards C, Randell R, Fernando L, Holland PV, Zeldis JB. Significance of antibody to hepatitis B core antigen in blood donors as determined by their serologic response to hepatitis B vaccine. Transfusion 1993 33 : 362 7.
19. Schmidt M, Nubling CM, Chudy M, Walch CH, Seifried E, Hourfar MK. Anti-HBc screening of blood donors: a comparison of nine anti-HBc tests. Vox Sang 2006 91 : 237 43.
20. Cheng Y, Dubovoy N, Hayes-Rogers ME, Stewart J, Shah D. Detection of IgM to hepatitis B core antigen in a reductant containing, chemiluminescence assay. J Immunol Methods 1999 230 : 29 35.
21. Kleinman S, Strong DM, Tegtmeier G, Gorlin J, Holland PV, Cousins C, Chiacchierini RP, Pietrelli L. HBV DNA screening of blood donation in minipools using the COBAS AmpliScreen™ HBV test. Transfusion 2005 45 : 1247 57.
22. Food and Drug Administration. Product approval information - licensing action. Rockville (MD) : Food and Drug Administration 2005 Apr 21 [cited 2008 Mar 17 Available from: http://www.fda.gov/cber/approvltr/hbvroc042105L.htm.
23. Food and Drug Administration. Guidance for industry, November 2007. Adequate and appropriate donor screening tests for hepatitis B; hepatitis B surface antigen (HBsAg) assays used to test donors of whole blood and blood components, including source plasma and source leukocytes. Rockville (MD) : Food and Drug Administration 2007 [cited 2008 Mar 17 Available from: http://www.fda.gov/cber/gdlns/hbslotrel.htm.
24. Gallarda JL, Yang Y, Tegtmeier G. HBV DNA testing and reinstatement of donors deferred for anti-HBc [Abstract S88 Transfusion 2003 43S 26A.