Blood is an essential medical resource for treating diseases and trauma of people, but a limited biological resource for which no artificial production is possible. Therefore, systematic and rational management of its supply and use must be carried out under the national responsibility. On the other hand, the low birthrate and aging population have raised the problem of blood shortages in Korea. To help solve this problem, this study examined proposals for the development of a blood management system in Korea. In addition, the works of blood management bodies were analyzed based on the operation subjects and types of blood projects in the United States, the United Kingdom, France, Germany, the Netherlands, Canada, Australia, Singapore, and Japan. Based on these data, this paper proposes a new organization that can best enhance the specialization of national blood services and strengthen its capacity under the current blood supply system in Korea.

BACKGROUND: Screening for healthy blood donors through donor interviews is essential to the safety of donors and blood resources. Our goal was to suggest educational material for donor interviewers and donors, as well as supplemental material for interview sites, which will help provide an effective interview process. METHODS: We conducted surveys regarding experiences in donor interviews from donor interviewers and cognitive interviews about difficulties during interview from blood donors between September and October of 2015. We additionally conducted a post-survey about provided educational and supplemental materials between December 2015 and January 2016. RESULTS: The possibility of an incorrect answer in the donor history questionnaire (DHQ) was high for questions about sexual contact, imprisonment, or medication, and the reasons were incorrect memories, ignorance about donor interview, or protection of privacy. Cognitive interviews of donors revealed questions and terminology that are difficult to understand. Donor interviewers could obtain improved understanding of the DHQ through educational materials, which were found to be useful for new interviewers or donors. Use of a supplemental flip book for the interview process was found to be useful, especially for blood centers with small blood donations. CONCLUSION: This study investigated difficulties in the donor interview from the perspective of donor interviewers and donors and suggested educational and supplemental materials to address these difficulties. These materials will induce correct and honest answers from blood donors through education and guidance about the donor interview process and help secure the safety of blood products.
Blood Donors* ; Cognition ; Education ; Humans ; Mass Screening ; Privacy ; Tissue Donors*

As Immunoserology Subcommittee of the Korean Association of External Quality Assessment Service, we organized two trials on the external quality assessment of viral markers and serological tests for syphilis (STS) in 2014. For this purpose, we delivered three kinds of pooled sera specimens for external proficiency testing to 1,060 and 1,064 institutions for the first and second trials, respectively. Pooled sera were checked for their homogeneity and stability by using more than three other methods between the day of their manufacture and 3 days after despatching. The numbers of participating laboratories were 1,053 (99.3%) and 1,046 (99.3%) in the first and second trials, respectively. The most commonly tested items were hepatitis B surface antigen, followed by antibody to hepatitis B surface antigen, anti-human immunodeficiency virus, anti-hepatitis C virus, STS, and anti-hepatitis B core. The most frequently used methods for detecting viral markers were the chemiluminescence immunoassay (CLIA) and the electrochemiluminescence immunoassay, which generated few false positive results. In contrast, false negative results were frequently found through the immunochromatography assay, the use of which for detecting viral markers has been steadily increasing in recent years. Furthermore, the use of turbidoimmunoassay and CLIA, which are new tests recently introduced for the measurement of non-treponemal and treponemal antibodies, is also increasing.
Antibodies ; Biomarkers* ; Hepatitis B ; Hepatitis B Surface Antigens ; Hepatitis C ; HIV ; Immunoassay ; Immunochromatography ; Korea* ; Laboratory Proficiency Testing ; Luminescence ; Serologic Tests* ; Syphilis*

BACKGROUND: Establishment of a national reference panel for syphilis antibodies is necessary to evaluate the performance of in-vitro diagnostic tests for syphilis and to verify test quality. This study aimed to establish a national reference panel for syphilis antibodies, to assess the suitability of a panel for non-treponemal and treponemal testing, and to assess the reactivity of the various tests currently in use. METHODS: Treponemal pallidum particle agglutination (TPPA)-positive and -negative fresh frozen plasma samples were obtained. After the fresh frozen plasma was converted to serum by defibrination, the samples were pooled. Two candidate reference standards containing no syphilis antibodies and 10 candidate reference standards containing syphilis antibodies were prepared on the basis of reactivity in the TPPA assay. Candidate reference standards were tested by three laboratories using five non-treponemal tests and four treponemal tests. RESULTS: All three laboratories reported positive non-treponemal test results for the mixed-titer performance panel (MP)/6-MP/12. MP/1, MP/2, and MP/3 were negative for non-treponemal tests. MP/4 and MP/5 were reported either as positive or negative according to the laboratories. All laboratories reported positive TPPA results for MP/3-MP/12 and negative results for MP/1 and MP/2. No significant difference was detected among the treponemal testing results in three laboratories. CONCLUSIONS: We established 12 candidate national reference standards containing various concentrations of syphilis antibodies. A collaborative study using nine tests demonstrated that 12 candidate national reference standards presented consistent results, except a few assays with low sensitivity, and thus could be used as a national reference panel for syphilis antibody testing.
Agglutination ; Antibodies* ; Diagnostic Tests, Routine ; Korea* ; Plasma ; Syphilis*

BACKGROUND: The Hb levels of prospective blood donors are usually determined using a finger prick test. A new noninvasive Hb device has the advantage of not causing any sampling pain. The purpose of this study was to evaluate the accuracy of the noninvasive Hb sensor and to compare its measurements with those of a currently used portable hemoglobinometer. METHODS: Hb was measured using a noninvasive Hb sensor (NBM-200; OrSense, Israel), a portable hemoglobinometer (HemoCue; HemoCue AB, Sweden), and an automated hematology analyzer (LH500; Beckman Coulter, USA). The correlations between Hb measurements taken by the NBM-200 and HemoCue with those by an automated hematology analyzer were assessed using intraclass correlation coefficients (ICCs). Hb measurements were compared among 3 different Hb level groups. RESULTS: The mean Hb values of 506 blood donors were 14.1 g/dL by the NBM-200, 14.0 g/dL by the LH500, and 14.3 g/dL by the HemoCue. The correlation between the LH500 and the NBM-200 was substantial (ICC=0.69), while that between the LH500 and the HemoCue agreed almost perfectly (ICC=0.86). CONCLUSIONS: The possibility to judge to be eligible for donors who are ineligible to donate was substantial when using NBM-200. Even though the NBM-200 has the apparent advantage of noninvasiveness, its use in pre-screening should be given meticulous attention. Since pre-donation testing is crucial to protecting donors' health, complete evaluation of the instrument should be performed prior to use.
Automation ; Biosensing Techniques/*instrumentation ; Blood Chemical Analysis/*instrumentation ; Blood Donors ; Donor Selection/*methods ; Female ; Hemoglobins/*analysis ; Humans ; Male ; Sensitivity and Specificity

BACKGROUND: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). METHODS: Clinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid, rheumatoid factor, multipara, and several viral infections. RESULTS: The clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%), respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors. CONCLUSIONS: The clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings.
Cross Reactions ; Hepacivirus/*immunology ; Hepatitis C/blood/*diagnosis ; Hepatitis C Antibodies/*blood ; Humans ; Immunoassay ; Reagent Kits, Diagnostic ; Saliva/immunology/virology ; Sensitivity and Specificity

BACKGROUND: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). METHODS: Clinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid, rheumatoid factor, multipara, and several viral infections. RESULTS: The clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%), respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors. CONCLUSIONS: The clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings.
Cross Reactions ; Hepacivirus/*immunology ; Hepatitis C/blood/*diagnosis ; Hepatitis C Antibodies/*blood ; Humans ; Immunoassay ; Reagent Kits, Diagnostic ; Saliva/immunology/virology ; Sensitivity and Specificity

BACKGROUND: An objective and standardized interview process is important when screening for healthy blood donors. Our aims were to gather opinions of the interviewing nurses at blood centers on the current donor interview and to suggest improvements to the interview. METHODS: We conducted an anonymous survey consisting of five questions regarding the donor health questionnaire, which can be found on the reverse side of the donation record card. The survey targeted the interviewing nurses with more than 1 year of experience at collection sites of the Korean Red Cross and the Hanmaum blood centers. The survey was sent out and gathered via mail, fax or email between September and October of 2010. RESULTS: The average self-deferral rate of donors prior to interview was 7.4%, and 66.7% of the interviewing nurses considered 'taking medicine' as the most common reason for donor self-deferral. The past and current history of disorders was the hardest question for nurses to determine the eligibility of the donors. Having a history of blood transfusion, surgery, tattoo or a piercing procedure, etc. within a year was the most unacceptable reason for deferred donors. The nurses strongly recommended revision of redundant questions as well as re-examining the unsolvable dilemma of questions concerning malaria. CONCLUSION: According to the survey, this study outlines the perspectives of interviewing nurses at blood centers regarding the rate and reasons for self-deferral of blood donors, the difficulties and the suggestions for improving the current donor interview. The results will be helpful in the future when proposing modifications to the donor interview.
Anonyms and Pseudonyms ; Blood Donors ; Blood Transfusion ; Electronic Mail ; Humans ; Mass Screening ; Postal Service ; Red Cross ; Tissue Donors ; Surveys and Questionnaires

BACKGROUND: The sensitivity of the blood screening test is crucial to ensure blood safety. Generally the test methods with greater sensitivity tend to have lower specificity. Therefore, secondary confirmatory tests are required to solve this problem. Since the confirmatory test for hepatitis B virus surface antigen (HBsAg) has not been routinely applied yet in Korea for blood donors, the true positive rate of HBsAg is unknown. This study was intended to determine the true seroprevalence of the hepatitis B virus (HBV) among Korean blood donors. METHODS: A total of 906 blood donor samples found to be positive for HBsAg with Prism qualitative assay from November 2010 to April 2011 at Korean Red Cross blood centers were tested with Architect HBsAg qualitative assay and confirmatory assay. Blood samples with negative results using Architect HBsAg qualitative assay were tested with Prism HBsAg confirmatory test. RESULTS: Of the 906 samples positive by Prism HBsAg qualitative assay, 793 were confirmed as positives. The positive predictive value of Prism HBsAg qualitative assay was 87.5%, and the true seroprevalence of HBV among Korean blood donors was 8 out of 100,000. The sample-to-cut-off ratio (S/CO) value of one true positive sample was lower than 1. CONCLUSION: The positive predictive value of HBsAg by Prism was higher than expected. Baseline data for estimation of residual risk of HBV as well as the cost-effectiveness analysis for lookback policy were drawn. Finally, the current cut-off level for repeat assay looked reasonable and it should be maintained at least until the nucleic acid amplification test is implemented as a routine screening method.
Antigens, Surface ; Blood Donors ; Blood Safety ; Dietary Sucrose ; Hepatitis ; Hepatitis B ; Hepatitis B Surface Antigens ; Hepatitis B virus ; Humans ; Korea ; Mass Screening ; Nucleic Acid Amplification Techniques ; Prevalence ; Red Cross ; Sensitivity and Specificity ; Seroepidemiologic Studies

BACKGROUND: The current donor selection criteria need to be revised to ensure a reliable blood supply and for donor protection. This study was conducted to analyze the distribution of hemoglobin (Hb) levels of blood donors and to estimate the change of eligible donors when using the revised Hb criterion. METHODS: The Hb levels of all the blood donors who visited the Korean Red Cross Blood Center (KRCBC) between November 9th, 2010 and November 15th, 2010 were measured with a portable hemoglobinometer (HemoCue). The Hb levels of all the eligible donors and some of the deferred donors who visited the Hanmaeum Blood Center (HBC) from April 26th, 2010 to April 30th, 2010 and from November 9th, 2010 to November 15th, 2010 were measured with a portable hemoglobinometer (Hemo_Control). RESULTS: A total of 7,521 donors (6,500 eligible donors and 1,021 deferred donors) were enrolled. The donation eligibility rate at the KRCBC, which is where all the donors were examined, was 84.2% (3,409/4,049) and the deferral rate was 15.8% (640/4,049). The percent of blood donors whose Hb level was less than 12.5 g/dL was 2.1% of the men (44/2,145) and 34.9% of the women (664/1,904), respectively. The percent of female deferred donors with a Hb level of 12.0~12.4 g/dL was 19.3% (109/564) and the percent of male eligible donors with a Hb level of 12.5~12.9 g/dL was 2.6% (54/2,069). At the HBC, and with some deferred donors being excluded, the deferral rate of males and females was 2.0% (36/1,799) and 20.6% (345/1,673), respectively. CONCLUSION: About 20% of the female deferred donors could be expected to participate when a less strict Hb criterion (> or =12.0 g/dL) is applied. This study is thought to be helpful in order to determine the number of donors according to the Hb criteria and to create improved criteria.
Blood Donors ; Dietary Sucrose ; Donor Selection ; Female ; Hemoglobins ; Humans ; Male ; Red Cross ; Tissue Donors