Necessity of Anti-HBc and Anti-HBs Screening in Korean Blood Donation Program: Study using LG Anti-HBc and LG Anti-HBs ELISA Kit and HBV Nucleic Acid Amplification Test / 대한수혈학회지

ABSTRACT

BACKGROUND: Post-transfusion hepatitis B remains a risk for recipients of HBsAg negative bloods in Korea. The usefulness of anti-HBc screening for blood donors to reduce the risk of HBV transmission was evaluated in this study using LG Anti-HBc and LG Anti-HBs ELISA (LG Chemicals, Seoul, Korea) and HBV nucleic acid amplification test. METHOD: Sera from 2,274 HBsAg-negative blood donors were tested of anti-HBc and anti-HBs by LG Anti-HBc and LG Anti-HBs ELISA, respectively. Using 260 samples from HBsAg-negative blood donors and 62 FANA-positive samples, reactivity to LG Anti-HBc ELISA were compared with COBAS CORE Anti-HBc EIA (Roche Diagnostics, Basel, Switzerland). The precision of LG Anti-HBc was also tested. The nucleic acid amplification of 97 primary pools prepared from 2,274 samples was carried out, and then HBV presence was confirmed in individual samples. RESULT: Of 2,274 HBsAg-negative blood donors, 531 (23.4%) were positive for anti-HBc and 32 (1.4%) were anti-HBc positive/ anti-HBs negative. The concordance rate of LG Anti-HBc ELISA and COBAS was 97.8% (315/322). The intra-run and inter-run coefficient of variation was 4.7-10.2% and 2.5-11.4%, respectively. Thirteen pools showed initial positive in HBV PCR, but seven pools (53.8%) were finally found to be false positive. Of six true positive pools, seven samples were confirmed to have HBV DNA. The HBV detection rate was 6.3% (2/32) among donors whose results were anti-HBc positive/ anti-HBs negative. CONCLUSION: Among screen-negative blood donors, 6.3% of donors whose seroreactivity was anti-HBc positive/ anti-HBs negative were positive for HBV by nucleic acid amplification test, while donors showing such seroreactivity were only 1.4%. It is suggested that an introduction of anti-HBc and anti-HBs testing in Korean Blood Donation program be efficient to attain safety from HBV transmission.