Background: We aimed to examine the status of Korean blood services from 2015 to 2022, including the coronavirus disease-2019 (COVID-19) pandemic period. Methods: We referred to the Korean Red Cross Blood Services Statistics Yearbooks from 2015 to 2022 and analyzed the data. Results: The actual number of blood donors decreased by 20.4% in the period 2015∼2022. During this period, the number of blood donations decreased by 14.1%, and the number of teenage blood donations decreased by 55.9%.Nevertheless, the supply of patient-appropriate blood products such as leukocyte-reduced red blood cells, specific antigen-negative blood cells, and apheresis platelets steadily increased. The plasma self-sufficiency rate for manufacturing of plasma derived medicinal product decreased yearly, from 95% in 2015 to 43.9% in 2022. Among the reasons for being ineligible for blood donations, the rate of hemoglobin levels not meeting the standard is slightly increasing. The positive rates of blood donor screening tests have decreased by 1% since 2019. The yearly differences in the number of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), and human T-lymphotropic virus type 1 antibody (HTLV Ab) positive cases between 2017 and 2022, are noticeable. Conclusion To secure an adequate supply of blood and ensure a stable supply of efficient blood products, we must utilize registered blood donors, including middle-aged people, and should also attempt the donation of multi-unit component blood products to increase blood donation efficiency.

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.
Antibodies ; Blood Donors ; Blood Safety ; Hepacivirus* ; Hepatitis C* ; Hepatitis* ; HIV ; Humans ; Incidence ; Information Management ; Korea* ; Mass Screening ; Prevalence ; Red Cross ; RNA ; RNA, Viral ; Tissue Donors

BACKGROUND: A nucleic acid amplification test was adopted to detect transfusion-transmitted infectious agents. In the case of HTLV, however, there was no internal control (IC) because the laboratory developed polymerase chain reaction (laboratory-developed PCR) was used. In this study, noncompetitive IC was constructed for the laboratory-developed PCR of HTLV and the effectiveness was compared with the competitive test that was constructed in a previous study. METHODS: As a competitive IC, plasmid DNA, including the primer recognition sequence for the amplification of the HTLV pX region, was constructed. As a noncompetitive IC, an additional primer was constructed for the amplification of the housekeeping gene, the glyceraldehyde 3-phosphate dehydrogenase (GAPDH) gene. The performance of the competitive and noncompetitive IC was verified and compared using 10 HTLV positive samples and 10 negative samples. In addition, the detection limits in the assay adopting competitive IC and noncompetitive IC were compared. RESULTS: In the case of competitive IC applications, all 10 positive samples were positive and all 10 negative samples were negative. In the case of noncompetitive IC applications, however, one positive sample was not detected. The detection limit of the assay using competitive IC was 100 pg and that of the assay using noncompetitive IC was 1 ng. CONCLUSION: Although the manufacturing processes is not required using noncompetitive IC, the adoption of competitive IC is more effective to ensure the assay results because the ability of detection of the assay adopting competitive IC was better than that using noncompetitive IC.
DNA ; Genes, Essential ; Glyceraldehyde 3-Phosphate ; Limit of Detection ; Nucleic Acid Amplification Techniques ; Oxidoreductases ; Plasmids ; Polymerase Chain Reaction

Corrections of author names are needed.

HBV core antibody and surface antibody test are currently conducted for those donors showing non-discriminated reactive (NDR) results on a nucleic acid amplification test (NAT) as a blood donor screening assay. It is necessary to investigate the relationship with HCV or HIV in the donors showing NDR results. From June 12th, 2012 to December 31st, 2018, 0.05% (9,020/17,798,461) donors showed NDR results on a NAT. Among the donors showing NDR results, 17 and 18 donors showed positive results on serological assay of HCV and HIV, respectively. 23 donors with NDR results showed positive results on the serological assay or NAT for HCV or HIV on the following donation. Further study and more accumulated data are required because it may be difficult to find the cause of NDR results by the current serological assay that is used for screening blood donors.
Blood Donors ; HIV ; Humans ; Mass Screening ; Nucleic Acid Amplification Techniques ; Tissue Donors

BACKGROUND: For donor samples showing reactive results in a human T-cell lymphotropic virus (HTLV) antibody test along with indeterminate results in Western blot assay, HTLV nucleic acid amplification test using laboratory-developed polymerase chain reaction (PCR) was performed. It is necessary to construct an adequate internal control (IC) to evaluate the accuracy of the results since we did not use an IC in the laboratory-developed PCR. METHODS: As a competitive IC, plasmid DNA containing the primer recognition sequence for amplification of the HTLV pX region was constructed. We determined the adequate concentration of the IC, which was added to the samples to evaluate the accuracy of the test results. RESULTS: When the plasmid DNA was added to the HTLV-positive samples, the amplified product of IC (400 bp) was detected with the HTLV gene (230 bp). The adequate concentration of plasmid DNA added as an IC was 1 pg. CONCLUSION: The construction of plasmid DNA as a competitive IC is an efficient method to evaluate accuracy of the test results. However, the production process for the competitive IC must be further developed. Therefore, it is necessary to compare with the performance of a non-competitive IC.
Blotting, Western ; DNA ; Humans ; Methods ; Nucleic Acid Amplification Techniques ; Plasmids ; Polymerase Chain Reaction* ; T-Lymphocytes ; Tissue Donors

Purpose: Presently, Korea is facing new challenges associated with an imbalance in blood supply and demand. The purpose ofthis study was to examine trends in blood supply and demand in Korea over the past 10 years through 2018 and to propose whatto prepare in the future. Materials and Methods: Age demographics in Korea were analyzed using data from the Statistics Korea. Blood donation andblood supply data were analyzed using Blood Services Statistics 2018 by the Korean Red Cross. Blood transfusion data from hospitalsin 2018 were obtained from the Health Insurance Review and Assessment Service. Results: In 2018, 2883270 whole blood and apheresis units were collected in Korea. The Korean Red Cross supplied 4277762 bloodcomponents to 2491 hospitals. The overall blood donation rate was 5.6%, and the most frequent donors were young male donors.Leukoreduced red blood cells (RBCs) constituted 25% of all RBCs used, and 40% of all platelets were supplied by single-donorplatelets. The self-sufficiency rate of domestic plasma with which to produce plasma-derived medicinal products was 68.7% in2018. Blood use was the most frequent among patients aged 70–79 years. Conclusion Blood management in Korea is changing rapidly due to a low birth rate, rapid aging, and an increase in severely illpatients who require most of the blood supply. Therefore, future plans to promote donation at a national level and optimal use ofblood in hospitals is necessary.

BACKGROUND: If donors who were deferred due to the reactivity or grey zone in HBV surface antigen (HBsAg) assay want to donate blood again, they need to pass reentry tests. On the other hand, approximately half of the donors who are subject to the reentry tests cannot be reentered. This study examined the association between the sample to cutoff (S/Co) value of the HBsAg assay and the final results of the reentry test. METHODS: This study analyzed the S/Co values of the HBsAg assay and the final results of the reentry tests for the 3,947 donors from January 2008 to December 2017 using the database of Blood Information Management System of the Korean Red Cross. RESULTS: 1,767 donors (44.8%) were not reentered among 3,947 deferred donors. Among 1,585 donors showing ≥10 of the S/Co value in the HBsAg screening test, 1,542 donors (97.3%) were not reentered. The additional reentry tests were performed on 120 donors who were not reentered in the first reentry test; 98 donors (81.7%) were still not reentered. Overall, 4.6% of the donors showing a grey zone in the HBsAg assay were not reentered. CONCLUSION: The reentry test needs to be restricted for the deferred donors showing a more than 10 S/Co value. The application of the grey zone of current HBsAg assay will need to be continued to enhance the HBV-related blood safety.
Antigens, Surface* ; Blood Safety ; Hand ; Hepatitis B Surface Antigens ; Humans ; Immunoassay* ; Information Management ; Mass Screening ; Red Cross ; Tissue Donors*

BACKGROUND: Since December 15 2017, donors showing a non-discriminated reactive (NDR) result in the nucleic acid amplification test (NAT) have been temporarily deferred and anti-HBc and anti-HBs assays as additional tests were performed. Donors with an anti-HBc reactive result and less than 100 IU/L of anti-HBs could not be released and can request a reentry test after more than six months. This study considered the effects of additional tests for NDR donors by analyzing the reentry test results in donors not released in the additional test. METHODS: This study examined the results of the additional test for NDR donors from January 2017 to September 2018 and the reentry test of the donors not released in the additional test. RESULTS: NAT was conducted on 4,706,051 blood donors over the period and 2,545 (0.05%) of them showed NDR. A total of 656 (25.8%) of the NDR donors were not released in the additional test. Among them, 246 donors requested a reentry test; 222 (90.2%) donors were not reentered, and 23 (10.4%) showed HBV NAT reactive results in the reentry test. Among the remaining 24 reentered donors, 2 donors (8.3%) showed anti-HBc nonreactive results in the reentry test and 22 donors (91.7%) showed higher than 100 IU/L of anti-HBs. CONCLUSION: The follow-up of NDR donors may be significant because some donors showed different results between screening test and reentry test. In addition the effectiveness of the introduction of additional tests for the NDR donors has been proved to be effective.
Blood Donors ; Follow-Up Studies ; Humans ; Mass Screening ; Nucleic Acid Amplification Techniques ; Tissue Donors

BACKGROUND: Ever since the Korean Red Cross adopted HCV NAT for blood donor screening in 2005, HCV NAT reactive donors have been identified every year. The identification of the clinical features for these HCV NAT reactive donors may be helpful for the treatment and prevention of HCV infection. METHODS: We analyzed HCV NAT reactive samples to examine the distribution of HCV RNA genotypes and the quantitative values of 128 and 47 HCV NAT reactive samples in 2007 and 2017, respectively. RESULTS: The dominant genotype of the HCV NAT reactive donors was 1b showing 50.0% (64/128) in 2007 and 44.7% (21/47) in 2017. The genotype 2a was the second most dominant at 40.6% (52/128) in 2007 and 40.4% (19/47) in 2017. The mean titers of HCV RNA were 3.17×106 IU/mL in 2007 and 2.61×106 IU/mL in 2017. More than 90% of the donors showed a range of more than 1,000 IU/mL for the HCV RNA titer. There was no difference of quantitative values in the different genotypes. CONCLUSION In this study, the distribution of HCV RNA genotypes in Korean blood donors showed a similar pattern compared to that of the general population. There was no correlation between the quantitative values and genotypes in the HCV NAT reactive blood donors, and there was no significant variation in the distribution of HCV RNA genotypes of the HCV NAT reactive donors between 2007 and 2017. Yet it is thought that the characteristics of HCV NAT reactive samples in other years have to be analyzed to achieve more significant results.