Frequency of HBV DNA detection in US blood donors testing positive for the presence of anti-HBc: implications for transfusion transmission and donor screening
Article first published online: 21 MAY 2003
Volume 43, Issue 6, pages 696–704, June 2003
How to Cite
Kleinman, Steven H., Kuhns, Mary C., Todd, Deborah S., Glynn, Simone A., McNamara, A., DiMarco, A. and For The Retrovirus Epidemiology Donor Study, Michael P. Busch. (2003), 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, 43: 696–704. doi: 10.1046/j.1537-2995.2003.00391.x
ARC = American Red Cross; BCP = Blood Centers of the Pacific; ID = individual donation; MP = minipool; NGI = National Genetics Institute.
This work was supported by NHLBI Contracts N01-HB-97077 (superseded by N01-HB-47114), -9708, -97079, -97080, -97081, and -97082.
- Issue published online: 21 MAY 2003
- Article first published online: 21 MAY 2003
- Received for publication September 12, 2002; revision received December 20, 2002, and accepted January 17, 2003.
BACKGROUND: An estimate of the rate of HBV DNA-positive, anti-HBc-positive units is important for evaluating the need for anti-HBc donor screening, especially in the context of HBV NAT.
STUDY DESIGN AND METHODS: HBsAg EIA-nonreactive, anti-HBc-reactive (Corzyme, Abbott Laboratories) specimens were retrieved from a repository and were retested for anti-HBc (with PRISM HBcore, Abbott Laboratories, currently under FDA review) and anti-HBs (with PRISM Ausab, Abbott Laboratories, research assay). HBV DNA testing using a PCR assay with a greater than 95 percent detection rate of less than 50 copies per mL was performed on a subset of specimens that were PRISM HBcore-reactive and were anti-HBs- negative or reactive at less than 100 IU per L.
RESULTS: A total of 395 of 1231 specimens eligible by our serologic criteria were tested by PCR. Four anti-HBs-negative specimens were PCR-positive with estimated HBV DNA copy numbers of 10 per 30 copies per mL in two specimens and 50 to 100 copies per mL in two others. The HBV DNA detection rate in anti-HBs-negative specimens was 3.7 percent, and the projected rate among all Corzyme-reactive specimens was 0.24 percent, leading to an estimated yield of 1 HBV DNA-positive, anti-HBc-positive unit in 49,000 units that were otherwise eligible for transfusion (95% CI, 1 in 16,600-1 in 152,600).
CONCLUSIONS: Anti-HBc screening detects HBsAg EIA-negative, HBV-infected donors at a rate comparable to the estimated residual risk for HBV window-period infections. The low viral load in the HBV DNA-positive samples suggests that minipool NAT will not detect most potentially infectious units from anti-HBc-positive donors.