Analysis of HCV Genotype with Low Titer of HCV RNA Using the Methods of Concentration / 대한수혈학회지

Analysis of HCV genotypes can help identify infection routes and the development of treatment methods. However, in some samples with a low titer of HCV RNA, it is difficult to analyze their genotypes. In our previous study about HCV genotyping, we could not identify 12 cases among the 175 HCV NAT reactive samples due to their low titer. In this study, we adopted three different kinds of virus concentration methods to identify the genotypes of the 12 unidentified cases and compared their efficacy. The three virus concentration methods were automatic nucleic acid extraction, polyethyleneimine-magnetic bead-based extraction, and sucrose cushion ultracentrifugation. After virus concentration using every three methods, we analyzed HCV RNA genotypes using the concentrated sample of the best efficacy. Among the 12 cases, six were identified as 1b, four as mixed types, and two were unidentified. Here we could validate that the sample concentration method is useful to identify the HCV genotypes, especially in samples with low HCV RNA titers. Furthermore, considering the convenience, high efficacy, and time-saving, automatic nucleic acid extraction is considered the most useful concentration method for samples with titer lower than 50 IU/mL.

Analysis of HCV Genotype with Low Titer of HCV RNA Using the Methods of Concentration / 대한수혈학회지

Analysis of HCV genotypes can help identify infection routes and the development of treatment methods. However, in some samples with a low titer of HCV RNA, it is difficult to analyze their genotypes. In our previous study about HCV genotyping, we could not identify 12 cases among the 175 HCV NAT reactive samples due to their low titer. In this study, we adopted three different kinds of virus concentration methods to identify the genotypes of the 12 unidentified cases and compared their efficacy. The three virus concentration methods were automatic nucleic acid extraction, polyethyleneimine-magnetic bead-based extraction, and sucrose cushion ultracentrifugation. After virus concentration using every three methods, we analyzed HCV RNA genotypes using the concentrated sample of the best efficacy. Among the 12 cases, six were identified as 1b, four as mixed types, and two were unidentified. Here we could validate that the sample concentration method is useful to identify the HCV genotypes, especially in samples with low HCV RNA titers. Furthermore, considering the convenience, high efficacy, and time-saving, automatic nucleic acid extraction is considered the most useful concentration method for samples with titer lower than 50 IU/mL.

Analysis of HIV RNA Genotypes and Quantitative Values of HIV NAT Reactive Blood Donations / 대한수혈학회지

Background@#The Korean Red Cross adopted HIV NAT for blood donor screening in 2005 using a minipool assay. In June 2012, the NAT system was replaced with the individual assay. This study examined the characteristics of HIV NAT reactive blood donors to determine if there was any difference in their features between 10 years ago and later. @*Methods@#This study analyzed the HIV RNA quantitative values and the distribution of HIV subtypes using 118 HIV NAT positive blood donations (37 in 2007, 20 in 2008, 32 in 2017 and 29 in 2018). @*Results@#No significant variations of the quantitative values of HIV RNA and the distribution of HIV subtypes 10 years ago and later were observed. This study failed to produce quantitative values of three samples due to the low titer. The mean titer of HIV RNA of the remaining 115 samples were 5.14×10 4 IU/mL. The dominant HIV subtype of the HIV NAT reactive donors was B showing 54.2% (64/118). Approximately 5.9% (7/118) of the samples showed the HIV subtype C. Forty-seven samples (39.8%) showed the circulating recombinant form (CRF). @*Conclusion@#The rate of HIV subtype B in this study (54.2%) has decreased compared to the results of the past study (95.2%). Some of the cases showing CRF were identified as B in the past study because CRF3, 8, 9, 14, and 15 are recombinant forms, including subtype B.

Unrelated Hematopoietic Stem Cell Donor Recruitment of the Korean Red Cross: 20 Years Experience / 대한수혈학회지

BACKGROUND: The National unrelated hematopoietic stem cell (HSC) donor program started in 1994. The Korean Red Cross (KRC) has participated in this program from the start as a recruiting organization. Results of 20 years of donor recruitment were analyzed to make suggestions to manage potential donors more effectively and improve retention rate. METHODS: Statistics on registration, deregistration, and donation of potential HSC donors registered in the Korean Network for Organ Sharing (KONOS) registry from 1994 to 2013 were analyzed. For donors recruited by the KRC, gender and age distribution, and reasons for self-withdrawal were also analyzed. RESULTS: As of 2013, a total of 265,307 potential HSC donors have been registered in the KONOS registry, among which 38.8% have been recruited by the KRC. Rate of self-withdrawal from the registry was lower for the KRC than the mean of all recruiting organizations (15.9% vs 21.8%). Reasons for withdrawal were objections by family members (34.9%), medical conditions (28.8%), change of donors' mind (21.7%), and other personal reasons (14.6%). The overall retention rate during the 20 year period for KRC was 63.7% which was higher than that of KONOS (58.1%). CONCLUSION: The lower self-withdrawal rate and higher retention rate of donors recruited by the KRC are the result of continuous education of donors to maintain their willingness to donate not only during recruitment but also after registration. This study will help to improve the retention rate and manage registered donors more effectively.

Pathogen Reduction for Platelets / 대한수혈학회지

Although application of multiple safety measures like donor screening and screening for infectious agents has made blood transfusion safer than ever, blood safety remains a hot topic in transfusion medicine. Emerging pathogens constantly threaten the safety of blood and current safety measures have their limitations in addressing these matters. Pathogen reduction technologies have been developed as a proactive approach to overcoming these limitations. This paper outlines the efficacy of pathogen reduction technologies that are currently applied for platelets for clinical use. Their clinical efficacy and safety issues and other effects are also reviewed.

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.

Application of a Grey Zone for HCV and HIV Immunoassays for Blood Donor Screening: Is It still Necessary? / 대한수혈학회지

BACKGROUND: When enzyme immunoassays (EIA) were implemented, considering the limited sensitivity of 1st generation EIAs, the Korean Red Cross (KRC) applied grey zones for detection of weak reactive samples that could lead to false negative results. Despite improved performance of assays, grey zone application is still in practice. We examined whether application of a grey zone to HCV and HIV EIAs is still necessary. METHODS: HCV and HIV EIA results, number of grey zone results, results of further testing done on grey zone samples, and NAT results from 2005 to 2012 were analyzed retrospectively using the Blood Information Management System of the KRC. RESULTS: Among 18,736,094 cases tested, 4,817 HCV (0.03%) and 5,108 HIV (0.05%) cases repeatedly had grey zone results. Twenty-eight (0.58%) HCV grey zone cases were positive on the recombinant immunoblot assay, but negative on NAT. For HIV, 3 cases were diagnosed as indeterminate by the Korea Centers for Disease Control and Prevention (KCDC). However these cases did not seroconvert after several years and were also negative on NAT. CONCLUSION: For HCV, since the grey zone led to detection of true anti-HCV positive cases, not detected by NAT, application of the grey zone should be continued. For HIV, since none of the grey zone cases has been diagnosed as HIV positive by the KCDC, further application of the grey zone is thought not to be necessary. Re-evaluation of the grey zone will save costs for testing, and prevent discard of blood components and loss of donors.

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.

Korean Red Cross HLA-Matched Platelet Donor Registry / 대한수혈학회지

BACKGROUND: Transfusion of HLA-matched platelets is required when development of platelet refractoriness occurs after repeated platelet transfusion. This study was conducted to establish a HLA-matched platelet donor registry to supply matched platelets to patients who develop platelet refractoriness. METHODS: HLA-matched platelet donors were recruited among plateletpheresis donors. HLA-A and HLA-B antigen types of recruited donors were tested using a polymerase chain reaction-sequence specific oligonucleotide probe method. RESULTS: A total of 1,029 plateletpheresis donors were recruited. HLA-A and HLA-B antigen frequencies of recruited donors were similar to those of previously reported HLA antigen frequencies of Koreans. During the study period, a patient with platelet refractoriness recovered after receiving six units of HLA-matched platelets. CONCLUSION: During this study 1,029 donors were registered as HLA-matched platelet donors and a patient with platelet refractoriness received HLA-matched platelets using this registry. Supply of HLA-matched platelets will be facilitated by continuous expansion of the number of registered HLA-matched platelet donors, development of a program for management and searching for HLA-matched donors, and establishment of a request-supply system between hospitals and the Korean Red Cross through further studies.

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.

Evaluation of Point-of-Care Testing Devices for Pre-donation Alanine Aminotransferase Test / 대한수혈학회지

BACKGROUND: In Korea, since 1990, in an effort to reduce the transmission of non-A, non-B hepatitis, all blood donations with alanine aminotransferase (ALT) levels above 65 IU/L are discarded. In 2012, 64.8% of the disposed blood units at the Korean Red Cross blood centers were due to high ALT levels. Pre-donation ALT testing might prevent unnecessary blood donation and save related expenses. We evaluated performance of point-of-care test (POCT) devices for pre-donation ALT screening. METHODS: ALT levels by four ALT POCT devices (Mission C100, Acon; Reflotron Plus, Roche; Labgeo PT10, Samsung; and FDC NX500, Fujifilm) were compared with venous blood results using laboratory chemistry analyzers (AU series, Beckman Coulter Inc.). Intraclass correlation coefficients (ICCs), sensitivity (ability to detect ALT > or =65 IU/L), and specificity (ability to detect <65 IU/L) for each method were calculated. RESULTS: Compared with the laboratory analyzers, the ICCs of ALT measurements by Mission C-100, Reflotron Plus, Labgeo PT10, and FDC NX500 were 0.96 (95% confidence interval (CI): 0.95~0.97), 0.99 (95% CI: 0.99~0.99), 0.98 (95% CI: 0.98~0.98), and 0.94 (95% CI: 0.91~0.96), respectively. The sensitivity was 80.95% for Mission C-100, 83.33% for Reflotron Plus, 78.57% for Labgeo PT10, and 97.62% for FDC NX500. The specificity was 99.13% for Mission C-100, 100.00% for Reflotron Plus, 99.78% for Labgeo PT10, and 98.26% for FDC NX500. CONCLUSION: The ALT POCT devices showed almost perfect agreement with the laboratory analyzers and could be useful for pre-donation ALT screening. However, before implementing ALT POCT devices, cost-effectiveness analyses should be performed.

In Remembrance of the 33rd International Congress ISBT Seoul 2014 / 대한수혈학회지

The 33rd International Congress of the ISBT was held in conjunction with the 33rd Congress of the Korean Society of Blood Transfusion (KSBT) and the 2014 Congress of the Korean Hematology Societies in Seoul. The idea to host an ISBT congress came to birth among KSBT members whilst attending the 18th Regional ISBT Congress held in Hanoi in 2007. Finally after 4 years, this idea became reality when Seoul was awarded to host the 2014 International Congress. After a short period of excitement, we soon had to realize that organising an international congress is a huge challenge with tremendous work involved! During the 3 years of preparation the ISBT headquarters and the local organising committee had several meetings that were not easy. But at the end, our concentrated and energetic discussions turned out to be most productive and made this congress a huge success. Highest appreciation again for their marvelous support goes to Peter Flanagan, ISBT President, and Judith Chapman, ISBT Executive Director. During the Korean day, three parallel sessions were held, attracting not only participants from the field of transfusion medicine but also many clinicians working in the field of hematology and transplantation. Martin Olsson, ISBT Scientific Secretary, and the local scientific committee did a great job in preparing an excellent scientific program that not only dealt with traditional topics of transfusion medicine but also hot topics like cellular therapy and clinical aspects of transfusion medicine. A total of 55 sessions were run in five tracks dealing with immunobiology of blood cells, blood safety, clinical aspects, donors & donation, and cellular therapies. 758 abstracts from 68 countries were submitted, among which 93 high quality abstracts were chosen for oral presentations and 603 for poster presentations. With 77 esteemed invited speakers presenting their cutting-edge research, all sessions were well attended and followed by lively discussions between speakers and the audience. Industry was also well presented and participants had the opportunity to exchange their experiences and take home information about the latest developments provided by the 74 exhibitors. But a congress isn't only about science! The opening ceremony started with the traditional presentation of the talking stick to the Congress President, Prof. Kyou-Sup Han. Afterwards, participants enjoyed the serenity and the flowing movements of Seoungmu, the Buddhist monk's dance, and Pungmulnori, a Korean folk music and dance tradition. All participants were greeted with a taste of Korean cuisine at the welcome reception. During the Speakers Dinner, guests had the chance to learn about the history of Korea and the Korean alphabet. The congress party, however, was the highlight of the social events. Since the congress took place in the middle of Gangnam, the southern part of Seoul, it was a must for everybody to learn dancing "Gangnam Style". Participants were invited onto stage to compete for the best dancer award and soon the stage was filled with joyously dancing participants and within seconds the party hall turned into a twilight zone. The party is over. It is time now to prepare calmly for the next stage. Hopefully ISBT Seoul 2014 will serve as a starting point to motivate many researchers working in the field of transfusion medicine and blood program to become more engaged at an international level.

Influence of Pathogen Inactivation on the Quality of Platelet Rich Plasma Derived Platelets / 대한수혈학회지

BACKGROUND: Pathogen inactivation (PI) is a proactive approach to overcome the limitations of the current testing system and donor questionnaires. Effect of PI on non-leukoreduced platelet rich plasma derived platelets (PRP-PLTs) suspended in plasma has not yet been evaluated. This study was conducted in order to evaluate the effect of PI on the quality of non-leukoreduced PRP-PLTs suspended in plasma. METHODS: PRP-PLTs treated with the Mirasol PRT System and the Intercept Blood System were tested for PLT count, blood gas, PLT activation, and apoptosis on days 3, 5, and 7 of storage. RESULTS: PLT number showed a decrease after PI. No difference in pH was observed until day 5. At day 7, PLTs treated with Mirasol had a lower pH value (6.5), however, it satisfied the quality control criteria. PLTs treated with Mirasol had a lower pO2 compared to pre-inactivation PLTs. pO2 during storage differed significantly between the two PI groups. pCO2 showed a decrease after inactivation and both groups showed a significant difference, compared with the control. PLTs treated with Mirasol had increased P-selectin expression after inactivation; however, difference of P-selectin during storage was not significant compared to the control. P-selectin of PLTs treated with Intercept was significantly different compared to those treated with Mirasol and control. Annexin V showed an increase after inactivation in Mirasol treated PLTs and difference during storage was significant compared to control and Intercept. CONCLUSION: As both PI systems showed satisfactory pH values, the criteria showing a high correlation with in vivo PLT viability and generally applied to monitor quality of PLTs, quality of PRP-PLTs after PI appears not to be negatively affected.

Platelet Additive Solutions / 대한수혈학회지

Storage of platelet concentrates in platelet additive solution (PAS) with plasma removal has many advantages, including reduction of allergic reactions, contributing to the available plasma pool for fractionation or transfusion, and employment of pathogen reduction technology. In order to decrease platelet activation for improvement of in vivo viability, PAS should be designed for optimization of aerobic metabolism using compounds such as glucose, acetate, citrate, phosphate, and electrolytes. After a thorough discussion, particularly on the efficacy and regulations, use of the buffy coat method as well as application of a new generation of PAS may likely be the future direction of platelet storage in Korea.

Evaluation of RF300 for Leukoreduction of Red Blood Cells / 대한수혈학회지

BACKGROUND: Use of universal leukoreduction for prevention of leukocyte associated transfusion reactions is common practice in many countries. This study was conducted in order to evaluate the performance of a newly developed leukoreduction filter for red blood cells (RBCs), the RF300 (Kolon Industries, Inc, Gumi, Korea). METHODS: Filtration time, RBC recovery, residual leukocyte count, and leukocyte removal rate were evaluated. To assess the quality of RBCs after filtration, percent hemolysis was monitored for a period of 21 days. Performance of the RF300 (N=78) was compared with that of the Bio-R O2 plus (Fresenius, Hamburg, Germany), the Pall Purecell RC (Pall Co., Washington, USA), and the Sepacell R-500N (Asahi, Tokyo, Japan). RESULTS: The shortest filtration time was observed using the RF300 (P<0.05). Using the RF300, recovery of RBC was 96.5%, which was higher than that of two filters (P<0.05). Mean residual leukocyte count was 0.26x10(6)/unit, with a leukocyte removal rate of 3 log. Using the RF300, mean percent hemolysis was 0.32% at day 21, which was comparable with that of two filters, but lower than that of one filter (P<0.05). CONCLUSION: The RF300 meets all established quality requirements for conduct of safe and effective leukoreduction of RBCs.

Development and Preliminary Evaluation of a Leukocyte Removal Aptamer Filter / 대한수혈학회지

BACKGROUND: Leukocyte reduction filters are widely used to prevent transfusion reactions caused by leukocytes in blood components. Commercial filters are not sufficient for removal of leukocytes for prevention of transfusion associated graft-versus-host disease; therefore, irradiation of blood components was performed using expensive equipment. Techniques using an aptamer substituted for antibody have been developed and are available in clinical areas. The purpose of this study is to develop the aptamer filter system and to evaluate its efficiency and the possibility of its clinical application. METHODS: Aptamers targeted to CD45 were selected by the Postech Aptamer Initiative. The aptamer filter in which aptamers attached to beads were bound to leukocytes and removed by magnetic field was developed. Filtration of 14 units of leukoreduction-red blood provided by Korean Red Cross Blood Services was performed using aptamer filters. Leukocyte removal rate and red cell recovery rate were evaluated and bacterial culture was performed. RESULTS: After filtration using the aptamer filters, 45.6% of leukocytes were additionally removed and the red cell recovery rate was 92.8%. No growth in the bacterial culture was observed. CONCLUSION: In order to apply the cell depletion technique utilizing an aptamer to blood filter system, we developed and evaluated the aptamer filter system. Through improvement of the binding efficiency of the aptamer and the filtering process, and application of the various aptamers for other different cells, we suggest that this technique can be applied in the clinical area, such as a substitution for the irradiation process for TAGVHD prevention.

Analysis of the Coagulation Factors of Donated Plasma for Effective Utilization / 대한수혈학회지

BACKGROUND: The aim of present study was to assess the effect of different freezing time after phlebotomy on the activity of coagulation factors in frozen plasma and to evaluate which source plasma for clotting factor fractionation is appropriate for use. METHODS: Blood plasma units rejected due to a high level of ALT were divided into four groups depending on freezing time after phlebotomy, and each unit of the four groups was assayed for six different clotting factors and blood type. SAS 9.2 was used for statistical analysis of data. RESULTS: A decrease was observed in the activities of FVIII of the plasmas, in the following order: PL-A>FFP>FP(8-24)approximatelyFP(24-72). Results of the assay also showed that the levels of FVIII were significantly higher in the AB type plasmas than in the O type plasmas. PL-A and FFP units met the current quality requirements of the Korean Red Cross, in which the FVIII activity should have more than 0.7 IU/mL in more than 75% of the source plasma, as 85.0% and 82.5%, respectively. On the other hand, FP24 met the Canadian (Quebec) requirements for the source plasma, in which the FVIII activity should have more than 0.52 IU/mL in more than 75% of the source plasma, as 82.6%. CONCLUSION: For use of plasma frozen within 24 hours after phlebotomy (FP24) and plasma of specific blood type, European Pharmacopeia and WHO guidelines on quality control should be adopted for production of plasma-derived coagulation factors in Korea.

Establishment of Plasma Working Standards for the Performance and Quality Assurance of NAT Screening Tests for HIV, HCV and HBV / 대한수혈학회지

BACKGROUND: Since Jan. 2012, for performance evaluation of viral reagents, analysis of domestic samples has been recommended in order to obtain approval from the KFDA when they are first introduced to Korea. This regulation requires the standard domestic materials driven from locally infected samples. We tried manufacturing the plasma working standards of HBV, HCV, and HIV NAT using a mixed titer of viral loads. METHODS: Forty three HBV DNA positive plasmas, 25 HCV RNA positive plasmas, and 26 HIV RNA positive plasmas were evaluated according to viral load and genotype. Several plasma units, which had high-titer viral loads and the common viral genotypes in Korea, were selected as the source materials for each viral standard. To adjust the appropriate concentration based on the detectable range of variable viral reagents, the source plasma was diluted to several concentrations, divided into small vials, and analyzed for quantification. RESULTS: The 13 plasma working standards, which had variable viral loads for the mixed titer performance panel of HIV, HCV, and HBV NAT, were produced. CONCLUSION: These national standard materials were first produced in order to supply the mixed titer performance panel for the viral NAT reagent of the level IV transfusion related high-risk group in Korea.

Analysis for Human Immunodeficiency Virus 1 Subtype in Korean Blood Donors / 대한수혈학회지

BACKGROUND: Genetic variants of virus appear to differ depending on the country, race, infection route, and so on. To characterize the main HIV subtype in infected blood donors and inquire about the route of HIV infection, we analyzed HIV subtype for samples that showed reactive results on the anti-HIV 1/2 and HIV-1 NAT test from September 2007 to February 2010. METHODS: To identify the HIV-1 subtype of the 90 samples that showed reactive results on the anti-HIV test and HIV-1 NAT, we performed HIV 1/2 Western blot assay, HIV RNA quantitative assay, HIV-1 nested PCR, and HIV-1 RNA sequencing. RESULTS: A total of 85 samples (94.4%) were confirmed to be HIV-1 subtypes. Among them, 82 samples (96.5%) were subtype B; and subtype A, C, and G was confirmed for one case each (1.2% for each case). We could not identify the subtype of the other five samples. One of them was amplified by nested PCR, but was not confirmed of the subtype, and four samples were not amplified even by nested PCR. CONCLUSION: The main HIV-1 subtype among the HIV-infected blood donors was confirmed to be subtype B. In addition, we identified one case each of HIV-1 subtype A, C, and G, which was not detected in blood donors in the past. It appeared that the route of HIV infection in Korea had become complicated. Therefore, we concluded that continuous research for HIV subtype analysis and efficient management of blood donors is needed.