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Lack of correlation between HBsAg and HBV DNA levels in blood donors who test positive for HBsAg and anti-HBc: implications for future HBV screening policy

Authors

  • Mary C. Kuhns,

    1. From Abbott Laboratories, Abbott Park, Illinois; Westat, Rockville, Maryland; and Blood Systems Research Institute, San Francisco, California.
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  • Steven H. Kleinman,

    1. From Abbott Laboratories, Abbott Park, Illinois; Westat, Rockville, Maryland; and Blood Systems Research Institute, San Francisco, California.
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  • Anne L. McNamara,

    1. From Abbott Laboratories, Abbott Park, Illinois; Westat, Rockville, Maryland; and Blood Systems Research Institute, San Francisco, California.
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  • Bhupat Rawal,

    1. From Abbott Laboratories, Abbott Park, Illinois; Westat, Rockville, Maryland; and Blood Systems Research Institute, San Francisco, California.
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  • Simone Glynn,

    1. From Abbott Laboratories, Abbott Park, Illinois; Westat, Rockville, Maryland; and Blood Systems Research Institute, San Francisco, California.
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  • Michael P. Busch

    1. From Abbott Laboratories, Abbott Park, Illinois; Westat, Rockville, Maryland; and Blood Systems Research Institute, San Francisco, California.
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  • This study was funded in part by the National Heart, Lung and Blood Institute through support to the Retrovirus Epidemiology Donor Study (contracts N01-HB-97077 (superseded by N01-HB-47114), -97078, -97079, -97080, -97081, and -97082). This included partial salary support for three authors (SK, SG, and MB) and support for performance of Amplicor Monitor testing (reagents contributed by Roche Molecular Systems) and data analysis. No funding was given to Abbott Laboratories for the efforts of the Abbott authors (MCK, ALM)) or performance of HBV serologic assays or ultrasensitive HBV DNA PCR assays.

  • TRANSFUSION 2004;44:1332-1339.

Mary C. Kuhns, PhD, Department 9C9, Bldg. AP20, Abbott Laboratories, Abbott Park, IL 60064; e-mail: Mary.Kuhns@abbott.com.

Abstract

BACKGROUND:  Studies showing a significant correlation between hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels have focused on the HBV seroconversion window period.

STUDY DESIGN AND METHODS:  HBsAg levels relative to HBV DNA results in 200 HBsAg-positive, anti-hepatitis B core antigen (HBc)–reactive blood donations were analyzed using quantitative polymerase chain reaction (PCR) (detection limit 400 copies/mL), two research PCR assays with increasing sensitivities (65 copies/mL and 1.3 copies/mL, respectively), and a quantitative HBsAg assay; HBsAg and HBV DNA levels were correlated with HBV serologic profiles; and the potential for replacing HBsAg screening with nucleic acid testing (NAT) was analyzed.

RESULTS:  Serologic profiles for over 90 percent of the donor samples were consistent with chronic HBV infection. Correlation between HBsAg and HBV DNA concentrations was weak (correlation coefficient = 0.33). Thirty-six percent (72/200) of donor samples had DNA levels under 400 copies per mL. Retesting of the 72 samples by more sensitive PCR assays showed that 60 out of 200 (30%) were positive by PCR with sensitivity of 65 copies per mL, whereas 6 out of 200 (3%) required PCR sensitivity of 1.3 copies per mL for positivity. Three percent (6/200) were negative by all three NAT assays.

CONCLUSIONS:  HBV DNA levels in HBsAg-positive, anti-HBc–reactive blood donations can be extremely low. About 6 percent of donations would be negative by current minipool HBV NAT methods. About 3 percent of donations would remain undetected by sensitive single-donor NAT. These results indicate caution in any consideration of dropping HBsAg screening.

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