Residual Risk of Transfusion-Transmitted Infection with Hepatitis C Virus since the Introduction of Nucleic Acid Testing in Korea / 대한수혈학회지

BACKGROUND: In 2005, the Korean Red cross introduced mini-pool nucleic acid testing (NAT) for human immunodeficiency virus (HIV) and hepatitis C virus (HCV), which upgraded to individual donation (ID) NAT including HBV in 2012. In this study, we analyzed the trend of HCV infection among blood donors after introduction of NAT by estimating the residual risk (RR) of transfusion transmitted infection (TTI) of HCV. METHODS: Donation data from 2003 to 2014 were analyzed using the Blood Information Management System (BIMS). Each donation was tested for antibodies and viral RNA for HCV. Prevalence and incidence rate (IR) among repeat donors were determined. RR was determined using the incidence rate/window period model. RESULTS: During the 12-year period, a total of 29,058,436 donations were screened with 34 HCV NAT yield donations. Calculated RR per million donations for HCV was significantly reduced from 13.41 in the pre-NAT period (2003~2004) to 0.52 in the post NAT period (2006~2007) (P<0.001). Most recently (2013~2014), RR for HCV with TTI was estimated by 0.16 per million donations (1:6,289,308). CONCLUSION: RR of TTI with HCV was remarkably decreased since introduction of NAT. However, the prevalence and IR of HCV RNA among first time donors was still high and yield cases were more frequent among repeat donors. Therefore, establishment of a sensitive and accurate screening system and measures for maintaining healthy donors should be considered in order to ensure blood safety.

The Past, Present and Future of the Blood Pre-Deposit System in Korea / 대한수혈학회지

The certificate of blood donation was introduced in 1975. Blood donor receives the certificate after donation. The person who has this certificate can receive one unit of blood component transfusion without charge in the hospital when he needs transfusion. The donor can use it for himself or anyone else whom it may concern, if necessary. This blood pre-deposit system in Korea is regulated by Transfusion Law. The government health insurance budget and pre-deposit foundation budget support the reimbursement fee for blood. Whenever blood centers collect blood from donors, they deposit 2,500 KRW into the pre-deposit foundation budget. The return rate of certificates was 15-28% and recently showed a gradual decrease to 13% due to the extension of coverage by government insurance for cancer patients, who are the main transfusion candidates. This system has contributed to the shift from paid donation to voluntary donation for the past 40 years. However, because this certificate imposes financial incentives for donors, the spirit of voluntary non-remunerated donation can be abused. If the transfusion fee is fully covered by government budget, it might be possible to discontinue the use of the certificate in order to implement true voluntary donation.

Repeat Blood Donors and Iron Deficiency Anemia / 대한수혈학회지

Recently, there is a growing concern for loss of iron among repeat blood donors. We evaluated the effects of blood donation to iron deficiency in several studies and propose following measures to prevent iron depletion among repeat blood donors. We reviewed and analyzed comprehensively results of several domestic and foreign studies and cited Korean blood donor's statistics data. There is a high prevalence of iron depletion in repeat blood donors. Predictors of iron depletion (serum ferritin <12~15 ng/mL) included a high frequency of blood donation, short donation interval, and female gender regardless of blood donation type. Taking iron supplements reduced the risk of iron depletion for repeat blood donors. We would like to propose the following preventive measures for repeat blood donors. 1) Test for serum ferritin for repeat donors who donate at least three times per year. If the donors show low serum ferritin level which is below 15 ng/mL, 2) Increase the donation interval or limit of blood donation frequency and 3) Recommend iron supplement for a certain period.

Establishment of a Korean Hepatitis B Surface Antigen Low Titer Performance Panel for Performance Validation of Hepatitis B Surface Antigen Immunoassays / 대한수혈학회지

BACKGROUND: A range of well characterized materials are needed for validating the performance of hepatitis B surface antigen (HBsAg) immunoassays. These materials are purchased currently from overseas manufacturers at a high cost and with limited quantity. This study was conducted to establish an HBsAg low titer performance panel for use as a national standard for validation of HBsAg immunoassays in Korea. METHODS: 476 plasma units reactive on blood donor screening were collected HBsAg was tested using 3 enzyme immunoassays (EIA) and 1 chemiluminescence immunoassay (CIA). Units reactive on the CIA assay or on 2 or more immunoassays were subjected to hepatitis B virus (HBV) DNA quantification, HBV genotyping and subtyping. Units reactive on HBV DNA quantification were confirmed for HBsAg by neutralization. Candidates for the panel were subjected to a collaborative study performed at 7 laboratories using 7 immunoassays. RESULTS: Eleven HBsAg positive units were selected for the low titer performance panel based on HBsAg immunoassay, HBV DNA quantification, HBV genotyping and subtyping results. The range of the HBsAg concentration of the panel members was 0.05~1.28 IU/mL. Two HBsAg negative units were also included as negative controls. CONCLUSION: As a result of this study, a low titer performance panel [KFDA standard (08/028); HBsAg low titer performance panel (BTRL HBV/LP)] for validation of HBsAg immunoassays has been established as a Korean national standard. Use of this panel will improve performance assessment of HBsAg immunoassays. Because the performance of immunoassays cannot be assessed properly with a limited number of panels, continuous efforts are needed to develop a range of performance panels.