Current Status of Irradiated Blood Components and Blood Irradiators in Korean Medical Institutes / 대한수혈학회지

BACKGROUND: Gamma or X-ray irradiation of blood components is used to prevent transfusion associated graft-versus-host disease (TA-GVHD). In this study, we assessed the current status of irradiated blood components and blood irradiators in Korean medical institutes. METHODS: We surveyed 306 medical institutes in Korea by a questionnaire, between August 2015 and October 2015. Institutions were asked to answer 9~16 questions, including whether they had facilities for irradiation of blood, type of irradiators used, dose of irradiation used, and if they did not have irradiation facilities, they were asked whether their blood components were irradiated. RESULTS: One-hundred and ninety-seven (64.4%) out of 306 questionnaires were returned and analyzed: 96 institutions provide irradiated blood, and 101 institutions do not use irradiated blood components. Forty-eight institutions have on site facilities with gamma blood irradiator for the irradiation of blood components and uses a dose of 20 to 50 Gy. Of the 48 institutions without facilities that use irradiated blood components, 38 (79.2%) have their blood components by referral to Korean Red Cross Blood Centers and 9 (18.8%) refer to other medical institutes for their irradiation needs. The survey showed that there is lot of regional variation in the supply and demand of irradiated blood components in Korea. CONCLUSION: Our survey does suggest that the establishment of the supply system for irradiated blood component by nation-wide blood establishments may provide national nuclear safety and stability of irradiated blood supply. It may also alleviate some regional disparity for the transfusion service of irradiated blood in Korea.

A Case of Primary Anti-D Alloimmunization by RHD (c.1227G>A) DEL Red Blood Cell Transfusion / 대한수혈학회지

The Rh blood group D antigen is the most immunogenic of all antigens, next to ABO antigens. Anti-D immunization is clinically important since it may cause clinical problems, such as severe hemolytic transfusion reactions and hemolytic disease of the newborn. DEL is an extremely weak D variant that cannot be detected by basic serologic typing and is typed as D-negative without the absorption-elution techniques and RHD genotyping. Of the DEL phenotype, RHD (c.1227G>A) allelic variant is the most common in Korea. The DEL phenotype has been considered to carry only a few D antigens to induce anti-D immunization, but a few cases have reported that this allelic variant is capable of inducing anti-D immunization in a D-negative recipient, for which it is clinical significant. Herein, we present a case of primary anti-D alloimmunization in a RhD negative patient after receiving RHD (c.1227G>A) DEL red cell transfusion identified by serological and molecular tests, including RHD genotyping.

Consideration of Discontinuance of Malaria Antibody Test for Blood Donor Screening / 대한수혈학회지

BACKGROUND: Since 2001, the Korean Red Cross has performed malaria antibody test for blood donors in malaria-risk areas to prevent transfusion-transmitted malaria. However, due to insufficient sensitivity and specificity the malaria antibody assay is not considered an efficient screening method. Therefore, we have considered discontinuing malaria antibody testing for blood donors. METHODS: We analyzed the results of malaria antibody test from 2001 to 2014 utilizing data from the Blood Information Management System of the Korean Red Cross. RESULTS: Among 16,650,812 donations tested from 2001 to 2014, 50,143 donations (0.30%) showed positive results. However, there was no truly infected case at the time of donation. The positive rate among blood donations was between 34 and 39 per 10,000 in 2001, but between 9 and 10 per 10,000 in 2014. There was no interregional disparity in the positive rate of blood donations. CONCLUSION: Korea is in a malaria elimination phase and malaria antibody testing in limited areas is not effective, therefore we propose discontinuing the malaria antibody test.

Analysis of the Reasons for Donor Deferral after Introduction of the Electronic Donor Health Questionnaire Program / 대한수혈학회지

BACKGROUND: Electronic Donor Health Questionnaire (e-DHQ) could prevent omissions in filling in the questionnaire. Compared with the paper Donor Health Questionnaire (p-DHQ), it can expect honest answers from donors to the questions relating to high risk behaviors. The aim of this study is to evaluate the effect of e-DHQ on the answers from donors by analyzing variations of the reasons for deferral after the introduction of e-DHQ to the Korean Red Cross (KRC). METHODS: The reasons for deferral determined by p-DHQ in 2008~2011 and by e-DHQ in 2011~2014, which have been accumulated in the database of the Blood Information Management System in KRC, were analyzed and compared. RESULTS: The results showed that the deferral rates for the general health status and medication taken were 0.47% (P=0.0100) and 0.16% (P=0.0103) higher in e-DHQ than in p-DHQ. In particular, for questions including hunger, lack of sleep, fatigue, endoscopy, dental treatment, surgery, tattoo, and acupuncture, the proportion of answers was higher in e-DHQ than in p-DHQ. CONCLUSION: The deferral rates for general health status and medication taken increased after the implementation of e-DHQ. The rate of deferral by some details of general health status, medical treatment for recent one month, and history for recent one year also increased because e-DHQ induced donors to give straightforward answers. e-DHQ is expected to contribute to the strengthening of health protection of blood donors and recipients. However the questions relating to high risk behaviors should be reformed so that honest answers can be induced from donors.

In vitro Quality Evaluation of Apheresis Platelets in Four Kinds of Platelet Additive Solutions / 대한수혈학회지

BACKGROUND: Platelets (PLTs) stored in platelet additive solution (PAS) presents potential benefits in clinical use by reducing the risk of several plasma-associated adverse transfusion reactions and more plasma may be recovered for fractionation. In this study, we compared in vitro characteristics of apheresis PLTs stored in CompoSol PS (Fenwal, Lake Zurich, IL, USA), InterSol (Fenwal, Lake Zurich, IL, USA), SSP+ (MacoPharma, Tourcoing, France), T-PAS+ (Terumo BCT, Lakewood, CO, USA), or plasma to evaluate the effectiveness of PAS. METHODS: PLTs were collected two times by apheresis from 12 healthy volunteers in a study comparing four kinds of PASs with 35% autologous plasma and 100% plasma-stored apheresis PLTs. The parameters of PLTs, including PLT counts, pH, PLT activation markers, blood gases, and metabolic variables were assessed up to 7-day. RESULTS: The results of in vitro assay including PLT concentration, mean PLT volume, pH, and blood gases for PLTs in four kinds of PASs were similar to those in 100% plasma PLTs. All units had Day 5 pH greater than 6.2. In vitro quality rating results, PLTs in T-PAS+ had a rating of 5, 4 for CompoSol PS, 2 for SSP+, 1 for InterSol, and 2 for plasma on Day 5. CONCLUSION: Partial replacement of plasma with CompoSol PS, SSP+, or T-PAS+ in PLTs showed better or equivalent quality and preservability of PLTs compared to PLTs in 100% plasma. The use of PAS for storage of PLTs in clinical practice may have an advantage as PAS-stored PLTs have a reduced volume of plasma.

Emerging Infectious Disease and Safety of Blood Components / 대한수혈학회지

Recently, the emergency of Middle East Respiratory Syndrome in Korea raised public concern regarding emerging infectious disease (EID) and affected the strategy for blood safety. Although some cases of EID such as West Nile virus in the United States and hepatitis E virus in Japan emerged in a restricted area, the emergence can rapidly affect the situation in other countries in a globalized society with advancements in transportation and international exchange. Because the risk of transfusion-mediated infection may occur by the agent of EID which can be transmitted through blood, the strategy for safety must be considered for agents that were not tested in the stage of blood donor screening. We reviewed the characteristics of transfusion-transmissible EIDs raising concerns worldwide and the strategies which had been adopted.

Evaluation of Two Noninvasive Hemoglobin Testing Devices / 대한수혈학회지

BACKGROUND: Determination of the hemoglobin (Hb) levels of prospective blood donors has been performed on capillary blood obtained by finger prick using a gravimetric CuSO4 method. Noninvasive Hb testing devices based on pulse oximetry technology have recently been developed. This study was conducted to evaluate the performance of two noninvasive Hb testing devices, NBM 200 and Pronto-7 as a predonation Hb screening test. METHODS: Hb levels of 993 blood donors (727 males, 266 females) were measured using five methods: two noninvasive methods, CuSO4 method, HemoCue, and hematology analyzer (Sysmex KX-21N). The hematology analyzer was considered as the reference method. RESULTS: Compared with Hb levels of the hematology analyzer, the bias was 0.7 g/dL for NBM 200, 0.1 g/dL for Prtonto-7, and 0.4 g/dL for HemoCue. The intraclass correlation coefficients of Hb measurements compared to the hematology analyzer were 0.57 (95% CI: 0.25~0.73) for NBM 200, 0.73 (95% CI: 0.69~0.75) for Pronto-7, and 0.87 (95% CI: 0.69~0.93) for HemoCue. The ability to detect Hb or =12.5 g/dL was 16.4% and 99.2% for NBM 200, 55.8% and 95.9% for Pronto-7, 60.0% and 98.6% for HemoCue and 81.8% and 95.2% for the CuSO4 method, respectively. CONCLUSION: Unsatisfactory results were obtained using the noninvasive Hb testing devices for a predonation Hb screening test, although they have the apparent advantage of reducing pain and stress in donors thereby increasing donor satisfaction. However, for application in the blood donation setting, performance of these devices should be improved.

Assessment of Serum Ferritin Levels in Plateletpheresis Donors / 대한수혈학회지

BACKGROUND: While plateletpheresis donation results in less red blood cell loss and therefore less depletion of storage iron, repeated plateletpheresis can also lead to iron depletion. To determine the safety of regular plateletpheresis donations, this study estimated donor's iron status according to age, gender, number of donations, and donation interval. METHODS: The study population included 5,109 plateletpheresis donors (4,824 males, 285 females), who passed the hemoglobin (Hb) criteria for plateletpheresis donation of 12.0 g/dL or more in an inclusion period (September 2013~November 2013). During donor screening, serum ferritin levels were measured for assessment of iron status of plateletpheresis donors. RESULTS: Mean age of donors was 30.4 years (range: 17~59). Donors with a history of donation of more than 3 years accounted for 89.3% and 74.0% in males and females, respectively. Mean donation interval and annual donation number in male (female) donors was 11.9 (7.2) weeks and 4.2 (8.7) times, respectively. Approximately 37.8% of male donors and 64.2% of female donors had a serum ferritin level of less than 15 ng/mL. Serum ferritin levels showed correlation with donation interval, as the percentage of donors with a low ferritin level decreased with increase in donation interval (rho: 0.191~0.438, P<0.001). Serum ferritin levels also showed correlation with annual plateletpheresis number (rho: -0.261~-0.411, P<0.001). CONCLUSION: Depleted iron store was observed in nearly 40% of donors who had acceptable Hb levels for plateletpheresis donation. Hb pre-donation screening is not sufficient to reduce the risk of iron deficiency in regular plateletpheresis donors.

Consideration of the Improvement of the Confirmatory Assay for the Anti-HTLV Positive Blood Donation / 대한수혈학회지

BACKGROUND: In the Korean Red Cross, anti-HTLV (Human T-cell lymphotropic virus)-1/2 screening assay has been performed in all donated blood except plasmapheresis since April 2009. For anti-HTLV-1/2 positive donors, both Western blot (WB) and nucleic acid amplification test (NAT) are performed as confirmatory assays. In this study, we evalutated the efficiency of the current confirmatory assay scheme to improve the confirmatory assay scheme for anti-HTLV1/2. METHODS: The results of the HTLV confirmatory assay from April 15th 2009 to April 14th 2015 were analyzed using the Blood Information Management System of the Korean Red Cross. We also investigated the current situation in other countries. RESULTS: Of 12,923,854 donations, 3,483 (0.027%) showed positive results in anti-HTLV-1/2. Of the 3,483 donations, 499 (14.3%) showed positive results in WB or NAT or both. The number of positive cases in both was 461. Therefore, the concordance rate was 92.4%. In the cases of positive results only in NAT, the WB results were all indeterminate (ID). Most countries are using immunoblot assay as a confirmatory assay for anti-HTLV positive blood donors. In the results, there were no cases of positive result in only NAT with a negative result in immunoblot assay. CONCLUSION: It was considered that the accomplishment of only WB as a confirmatory assay for anti-HTLV-1/2 positive donors may be sufficient in the aspect of safety and economics. However, in the case of WB ID result, it may be better to perform NAT as a supplemental test.

Establishment and Multicenter Evaluation of a National Reference Panel for Syphilis Antibodies in Korea

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.

Prevalence of Hepatitis C Virus Infections and Distribution of Hepatitis C Virus Genotypes among Korean Blood Donors

BACKGROUND: Hepatitis C virus (HCV) remains a worldwide health-care burden. Prevalence rates vary and the distribution of genotypes depends on geographical location. Here, the recent prevalence of HCV infections and distribution of HCV genotypes among Korean blood donors were studied. METHODS: Between February 2005 and December 2009, a total of 11,064,532 donors were screened for anti-HCV and 11,412,690 donors were screened for HCV RNA. HCV genotyping was conducted for 748 blood donors with HCV RNA by using the line probe assay (VERSANT HCV Genotype 2.0 Assay, Bayer Healthcare, USA) after amplification of the 5'-untranslated and core regions of the genome. RESULTS: The anti-HCV prevalence was 0.16% (17,250/11,064,532). HCV RNA was detected in 959 out of the 11,412,690 donors (8.4/100,000). HCV RNA was more prevalent among women, donors who resided at harbor sites, and first-time donors. In addition, the prevalence of HCV RNA increased with age. The genotypes of 740 out of the 748 tested donors (98.9%) were identified. HCV genotype 1b (47.7%) and 2a/2c (35.0%) were dominant. Genotypes 2 (7.6%), 2b (2.3%), 3a (1.6%), 1a (1.3%), 1 (0.9%), 2v (0.5%), 1v (0.1%), and 3 (0.1%) were also identified. Genotype 4a/4c/4d (0.1%) was detected for the first time in one Korean blood donor. CONCLUSIONS: The distribution of HCV genotypes in Korea has not changed remarkably, with the exception of genotype 4a/4c/4d. A periodic study to monitor the prevalence of HCV infections and the distribution of HCV genotypes is required to identify emerging genotypes in Korea.

Analysis of the Effectiveness of Blotting Assays for Donor Blood Screening / 대한수혈학회지

BACKGROUND: Immunoblot assays (IBAs) have been widely used to confirm the reactivity of immunoassay. However, indeterminate (ID) results have shown the limits for interpreting IBAs. There is some debate about the benefit of these assays. We assessed the actual status of the IBAs for the donor screening process and we proposed more available algorithms. METHODS: We analyzed the data from the blood information management system of the Korean Red Cross. This study was approved by the Institutional Review Board of the KRC. The analyzed data included the present condition of various utilities and the results of the IBAs in the world. RESULTS: The infectivity of the ID results in IBAs seemed not to be high, but the safety could not be assured. IBA for HTLV was used as a confirmatory test in many countries. Most of the eligible blood donors could be saved by IBAs. CONCLUSION: IBAs seem to be valuable methods as supplemental and follow up tests for ID results. Furthermore, IBAs were useful to distinguish eligible blood donors. When donors show positive results on an immunoassay and NAT (HIV and HCV) concurrently, then IBA does not seem to be required. Only a RIBA for HCV is recommended for the donors showing a S/CO ratio above 2.0 on immunoassay. The additional alternative immunoassay would be effective in the HTLV screening algorithm.

Establishment of Reference Range of Serum Ferritin by Turbidimetric Immunoassay in Korean First Time Blood Donors / 대한수혈학회지

BACKGROUND: Regular blood donation can lead to iron deficiency. Serum ferritin is sensitive indicator of body iron depletion. The aim of this study is to evaluate serum ferritin reagents using the turbidimetric immunoassay (TIA) and to establish a reference range in first time blood donors in Korea. METHODS: The study was prospectively conducted, between Feb. 2011 and Apr. 2011, on 120 male and 120 female blood donors at five blood centers. Serum ferritin was determined by TIA using two brands of reagents (Beckman Coulter Inc., USA; HBi, South Korea) and two automated chemistry analyzers (AU640, Beckman Coulter Inc.; Hitachi7180, Hitachi High-Technologies Corp., Japan). Precision, linearity, limit of detection, analytical measurement range and correlation with chemiluminescent immunoassay (CLIA) were evaluated. A reference range for serum ferritin in first time donors was established. RESULTS: The coefficients of variation of precision were less than 4%. Linearity was observed up to 312.7~450 microg/L depending on which reagent used. Both reagents had good correlation with CLIA results. Serum ferritin levels for first time donors showed left skewed distribution. The reference ranges for males and females were 34.1~385.9 microg/L and 6.8~121 microg/L using Beckman Coulter (AU) reagent, and 18.7~271.3 microg/L and 4~83.7 microg/L using HBi (AU) reagent, and 15.2~274.7 microg/L and 6~84 microg/L using HBi (Hitachi) reagent. CONCLUSION: A reference range for serum ferritin in first time donors in Korea was established using automated chemistry analyzers with inexpensive TIA reagents.

Evaluation of the Virus-elimination Efficacy of Nanofiltration (Viresolve NFP) for the Parvovirus B19 and Hepatitis A Virus / 대한진단검사의학회지

BACKGROUND: The safety of plasma derivatives has been reinforced since 1980s by variable pathogen inactivation or elimination techniques. Nucleic acid amplification test (NAT) for the source plasma has also been implemented worldwide. Recently nanofiltration has been used in some country for ensuring safety of plasma derivatives to eliminate non-enveloped viruses such as parvovirus B19 (B19V) and hepatitis A virus (HAV). We evaluated the efficacy of nanofiltration for the elimination of B19V and HAV. METHODS: To verify the efficacy of nanofiltration, we adopted a 20 nm Viresolve NFP (Millipore, USA) in the scaling down (1:1,370) model of the antithrombin III production. As virus stock solutions, we used B19V reactive plasma and porcine parvovirus (PPV) and HAV obtained from cell culture. And 50% tissue culture infectious dose was consumed as infectious dose. The methods used to evaluate the virus-elimination efficacy were reverse-transcriptase polymerase chain reaction for B19V and the cytopathic effect calculation after filtration for PPV and HAV. RESULTS: B19V was not detected by RT-PCR in the filtered antithrombin III solutions with initial viral load of 6.42x10(5) IU/mL and 1.42x10(5) IU/mL before filtration. The virus-elimination efficacy of nanofiltration for PPV and HAV were > or =10(3.32) and > or =10(3.31), respectively. CONCLUSIONS: Nanofiltration would be an effective method for the elimination of B19V and HAV. It may be used as a substitute for NAT screening of these viruses in source plasma to ensure safety of plasma derivatives in Korea.

Investigation of the Prevalence of Human Parvovirus B19 DNA in Korean Plasmapheresis Donors / 대한진단검사의학회지

BACKGROUND: To ensure the safety of plasma derivatives, some countries have been screening for the human parvovirus B19 (B19V) antigen or DNA in blood donors. We investigated the prevalence of B19V DNA and anti-B19V antibodies in Korean plasmapheresis donors to evaluate the necessity of B19V DNA screening test. METHODS: Plasma samples were collected between March and July 2008 from 10,032 plasmapheresis donors. The B19V DNA test was performed using the LightCycler 2.0 (Roche, Germany) with quantification kits. Anti-B19V IgM and IgG were tested in 928 randomly selected samples from the 10,032 donors using recomWell Parvovirus B19 ELISA IgM, IgG assay (Mikrogen, Germany). RecomLine Parvovirus B19 LIA IgG, IgM assay (Mikrogen, Germany) was used to analyze the epitopes of antibodies in donors showing positive results for B19V DNA and anti-B19V antibodies. DNA sequencing was performed to identify the genotypes. RESULTS: The prevalence of B19V DNA was 0.1% (10/10,032). Virus titers in B19V DNA positive donors were less than 10(5) IU/mL (range: 2.7x10(1)-3.2x10(4) IU/mL) except for 1 donor (1.33x10(8) IU/mL). All the isolated B19V DNAs from 6 donors were identified as genotype I. Nine out of 10 B19V DNA positive donors also possessed anti-B19V IgG only or IgG and IgM. The prevalence of anti-B19V IgG was 60.1% (558/928). CONCLUSIONS: The prevalence of B19V DNA in Korean blood donors was not high and most donors also possessed neutralizing anti-B19V antibodies. Thus, the implementation of a B19V screening test for Korean blood donors does not appear to be imperative.

The Frequency and Distribution of the ABO Subgroups in Korean Blood Donors / 대한수혈학회지

BACKGROUND: ABO subgroups are obstacles in blood typing and cross matching in the process of pre-transfusion. Correct ABO typing is important for ensuring safety of a transfusion. The ABO subgroups contain a lesser amount of antigen on red cells and this is a common cause of discrepancy between the results of cell and serum tests. This study was performed to analyze the frequency and distribution of the ABO subgroups in Korean blood donors. METHODS: ABO blood grouping was performed by an automated analyzer (PK7200/7300, Olympus, Japan) for the 3,397,983 donors from January 2007 to December 2009. The 1,868 donor samples that were suspected to have ABO subgroups were tested with adsorption/elution techniques. The results of the tests were analyzed and we received approval of the Institutional Review Board of the Korean Red Cross to publish this study. RESULTS: 1,771 donors out of the 1,868 donors who underwent the tests were finally identified as having ABO subgroups. The kinds of identified ABO subgroups were as follows; 118 donors with the A subgroup (A2, A3, Ax, Am, Ael), 237 donors with the B subgroup (B3, Bx, Bm, Bel) and 1,416 donors with the AB subgroup (A2B, A2B3, A1B3, AmB, A1Bm, A1Bel, AxB, A1Bx). The most frequently observed subgroups were A2B (496/1,868, 26.55%) and then A2B3 (457/1,868, 24.46%). The subgroups of 97 donors (5.19%) were not identified. CONCLUSION: This study was meaningful to provide data on the frequency and distribution of the ABO subgroups of Korean blood donors. A more sensitive technique such as genotyping could be useful to resolve cases with an unidentified subgroup.

Analysis of the Reentry Test Results of the Deferred Donors with Hepatitis B Surface Antigen Reactivity / 대한수혈학회지

BACKGROUND: Since 2004, the donors showing hepatitis B surface antigen (HBsAg) reactive results have been registered in the donor deferral registry (DDR). Some of them can donate blood as eligible donors by passing the reentry tests. We evaluated the results of the reentry tests during 1 year. METHODS: We tested the samples from 2,230 deferred donors with HBsAg reactivity and 1,668 samples from donors who had a past history of hepatitis B and all these patients required reentry tests. Hepatitis B surface antigen, hepatitis B core antibody and hepatitis B surface antibody were tested for by using ARCHITECT HBsAg (Abbott, Wiesbaden, Germany), ARCHITECT anti-HBc (Abbott), and ARCHITECT anti-HBs (Abbott) and using an ARCHITECT i2000SR (Abbott). Hepatitis B virus DNA was tested for by performing HBV Polymerase Chain Reaction (PCR) with a COBAS AMPLICOR HBV MONITOR TEST (Roche Molecular Systems Inc., Branchburg, USA) and using a COBAS AMPLICOR (Roche Diagnostics, Basel, Switzerland). RESULTS: 894 (40.1%) of 2,230 the deferred donors and 880 (52.8%) of 1,668 donors who had a past history of hepatitis B were reentered as eligible donors. 1,171 (30.0%) of the 3,898 tested donors couldn't be released due to positive results on the anti-HBc test and 81.5% of them were also anti-HBs positive. CONCLUSION: The reentry test seems to be necessary to restore blood donors. But it was considered that the donor showing a reactive result for anti-HBc and a nonreactive result for HBsAg and HBV PCR can be released as eligible donors if the anti-HBs titer is higher than the reference value.

Analysis of the Reentry Test Results of the HCV Deferred Donors / 대한수혈학회지

BACKGROUND: The donor deferral registry (DDR) program has been operating since 2004. The donors who registered in the DDR are prohibited from donating blood. But some of them can enter the eligible donor group if they pass a reentry test. We analyzed the results of the reentry tests for the HCV deferred donors. METHODS: A total of 587 donor samples were tested during 18 months (July. 2007~December. 2008). Anti-HCV (ARCHITECT HCV, Abbott, Wiesbaden, Germany), RIBA (LG HCD confirm, LG Life Sciences, Daejeon, Korea), and HCV RNA (PCR with COBAS AMPLICOR HCV, Roche, Molecular Systems, Inc. Branchburg, USA) were used for detection. The donors showing negativity for all the test items were released from the DDR. RESULTS: Among the 587 subjects, 466 (79.4%) of the donors who showed negative results on the tests were released from DDR. The donors who showed variable positive results for the tests were not released. Only 15 donors of 121 donors showed positive or indeterminate (ID) results according to the anti-HCV, RIBA and the PCR results. CONCLUSION: Those people with RIBA ID with negative results in anti-HCV and PCR results were unnecessarily kept on the retained in DDR unnecessarily. The algorithm of the reentry test for HCV deferred donors seems to needs to be reevaluated to for the saveing eligible donors.

A Study to Verify the Stability of Currently Stored Blood Donor Samples (A First Year Study) / 대한수혈학회지

BACKGROUND: The Korean Red Cross (KRC) has stored blood donor samples for 10 years under -20degrees C since 2004. These samples have been used for investigating transfusion related infections and for Look-back studies. We designed an experimental scheme to verify the stability of stored blood samples. METHODS: We collected and prepared samples such as blood donor samples (HBV, HCV, HIV nucleic acid positive; n=90), the HIV infected patient samples (n=20), the WHO nucleic acid international standards serologic positive samples (HBsAg, anti-HCV, anti-HIV; n=120) and the negative samples (n=20). The samples were aliquoted in cryo tubes with volumes of 0.5~5 mL and they were stored at -20~-30degrees C and -70~-80degrees C. We used enzyme immunoassay, chemiluminescence immunoassay and quantitative PCR for the base line and the follow up studies. The linear mixed statistical model using SAS 9.1 for windows was used for statistical analysis. RESULTS: The results of the baseline test of the stored samples showed a variable range of viral load (10(1)~10(7) IU/mL or copies/mL) and optical density (S/CO 3.0~500). The results of the stored samples after 6 month (n=82) did not show any significant differences compared to the baseline data for the viral loads (P>0.05) and the qualitative serologic tests. CONCLUSION: We established an experimental scheme to verify the stability of the stored blood donor samples. From now on, the stability of the stored samples is going to be monitored by every 6 month for 10 years.

A Nationwide Survey Report on the Blood Transfusion Services in Korea / 대한수혈학회지

BACKGROUND: Inspecting thestatus of blood banks has been done for the larger Korean hospitals, but it has never been done for the smaller ones on a nationwide scale in Korea. Here, we analyzed the status of the blood banks for their transfusion services and equipment, and especially for the smaller hospitals. METHODS: The subjects were all the hospitals that were provided more than one unit of blood by the Korea Red Cross (KRC) in 2006. We divided the hospitals to a big-hospital group and a small-hospital group that received over or under 5,000 units of blood, respectively, from the Korea Red Cross in 2006. The questionnaires were delivered by mail. RESULTS: The number of total hospitals was 2,488 and the number of hospitals in the small-hospital group was 2,381, and this accounted for 95.7% of the total hospitals. The response rate was 23.1%. Among the small-hospital group, 35% had no working manual, 61% were not involved in certification programs and 17% had no refrigerators that were exclusively used for blood. Furthermore, 31% performed only cell typing as ABO typing, 69% didn't test for antibody detection, and 7% used a slide method for crossmatching tests. Only 6% used a blood information sharing system and only 28.4% of the hospitals shipped blood by blood transport containers. The mean amount of discarded blood was 16.8 units and the main component was RBC. CONCLUSION: The level of management and services showed a great difference between the two groups of Korean hospitals. The small-hospital group is thought to need more support and attention from the government. This study will supply essential data for understanding the current state of blood transfusion services and establishing government policies for safe transfusion.