ABSTRACT
The Republic of Korea has been using malaria antibody assays to screen blood donors and reduce the risk of transfusion-transmitted malaria (TTM). This study examined the effectiveness of the current malaria antibody test for screening blood donors and calculated the positive predictive value (PPV) with the real-time polymerase chain reaction (RT-PCR) as the reference. The reactive rate and PPV of the malaria antibody screening assay during particular period from 2020 to 2021 were 0.82% (248/30,309) and 0.40% (1/248), respectively. The low PPV of current malaria antibody screening in blood donors suggests that the effectiveness of this test is limited in terms of balancing blood safety and supply in low-prevalence situations.
ABSTRACT
There were 10 cases of transfusion-transmitted P. vivax malaria from 1990 to 2021. The Korean Centers for Disease Control and Prevention (KCDC) designated the areas showing a high frequency of malaria as a malaria-endemic area and has restricted whole blood donation from these areas. While the number of malaria infections has declined in recent years, the blood inventory has declined sharply due to the COVID-19 pandemic. Accordingly, the Ministry of Health and Welfare temporarily approved the donation of whole blood from malaria-endemic areas to secure the supply of blood products. In the present study, an anti-malaria screening and nucleic acid amplification test (NAT) was performed on samples collected from the malaria-endemic areas from May 20 to June 30, 2020. A total of 14,741 samples were collected and tested. NAT was performed for 1096 runs to test all the collected samples. The 117 (0.79%) samples showed initial reactive results due to the contamination of abnormal PCR results. Negative results were obtained for the samples showing initial reactive results using a duplicated re-test. From the NAT tests, no sample showed a true positive result. The results of the malaria antibody screening test were reactive in 10 out of the 14,741 samples. The malaria antibody screening needs to be reviewed through further study because of its insufficient sensitivity and specificity. According to this study, excluding the 10 reactive malaria antibodies, additional blood components could be secured from 14,731 blood donors for a stable blood supply.
ABSTRACT
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.
ABSTRACT
There were 10 cases of transfusion-transmitted P. vivax malaria from 1990 to 2021. The Korean Centers for Disease Control and Prevention (KCDC) designated the areas showing a high frequency of malaria as a malaria-endemic area and has restricted whole blood donation from these areas. While the number of malaria infections has declined in recent years, the blood inventory has declined sharply due to the COVID-19 pandemic. Accordingly, the Ministry of Health and Welfare temporarily approved the donation of whole blood from malaria-endemic areas to secure the supply of blood products. In the present study, an anti-malaria screening and nucleic acid amplification test (NAT) was performed on samples collected from the malaria-endemic areas from May 20 to June 30, 2020. A total of 14,741 samples were collected and tested. NAT was performed for 1096 runs to test all the collected samples. The 117 (0.79%) samples showed initial reactive results due to the contamination of abnormal PCR results. Negative results were obtained for the samples showing initial reactive results using a duplicated re-test. From the NAT tests, no sample showed a true positive result. The results of the malaria antibody screening test were reactive in 10 out of the 14,741 samples. The malaria antibody screening needs to be reviewed through further study because of its insufficient sensitivity and specificity. According to this study, excluding the 10 reactive malaria antibodies, additional blood components could be secured from 14,731 blood donors for a stable blood supply.
ABSTRACT
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.
ABSTRACT
Background@#Dengue fever is considered one of the transfusion-transmissible emerging infectious diseases. Dengue fever has been reported every year by the Korea Disease Control and Prevention Agency (KDCA). Because a blood donor screening assay to detect the dengue virus (DENV) as an agent of dengue fever is not performed, the risk of transfusion-transmitted DENV infection needs to be assessed. @*Methods@#This study collected the data of DENV infected cases from the Infectious Disease Portal of the KDCA, the data of blood donors and blood components from the Blood Information Management System of the Korean Red Cross, and the data of travelers to major dengue outbreak countries from the Korean Tourism Organization.All data were from 2016 to 2018. A risk assessment was performed using European Up-Front Risk Assessment Tool (EUFRAT). @*Results@#The risk of DENV-infected red cells and platelet concentrate was higher than that of plasma and apheresis platelet. Nevertheless, the risk of the DENV infected blood component was shown to be less than one case per year for all kinds of blood components. @*Conclusion@#All the DENV infected cases in Korea were overseas travelers. Therefore, the risk of transfusiontransmissible DENV infection is very low. On the other hand, continuous observation and monitoring are required because Aedes albopictus as a vector of DENV is found in Korea, and the increase in reported cases may lead to domestic infections.
ABSTRACT
Background@#Dengue fever is considered one of the transfusion-transmissible emerging infectious diseases. Dengue fever has been reported every year by the Korea Disease Control and Prevention Agency (KDCA). Because a blood donor screening assay to detect the dengue virus (DENV) as an agent of dengue fever is not performed, the risk of transfusion-transmitted DENV infection needs to be assessed. @*Methods@#This study collected the data of DENV infected cases from the Infectious Disease Portal of the KDCA, the data of blood donors and blood components from the Blood Information Management System of the Korean Red Cross, and the data of travelers to major dengue outbreak countries from the Korean Tourism Organization.All data were from 2016 to 2018. A risk assessment was performed using European Up-Front Risk Assessment Tool (EUFRAT). @*Results@#The risk of DENV-infected red cells and platelet concentrate was higher than that of plasma and apheresis platelet. Nevertheless, the risk of the DENV infected blood component was shown to be less than one case per year for all kinds of blood components. @*Conclusion@#All the DENV infected cases in Korea were overseas travelers. Therefore, the risk of transfusiontransmissible DENV infection is very low. On the other hand, continuous observation and monitoring are required because Aedes albopictus as a vector of DENV is found in Korea, and the increase in reported cases may lead to domestic infections.
ABSTRACT
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.
ABSTRACT
BACKGROUND: The risk of transfusion-transmissible infections (TTIs) of HBV, HCV, and HIV in Korea has been reduced significantly by strengthening the blood safety policies. On the other hand, the risk of TTI still exists due to the diagnostic window period or viral variants. METHODS: The residual risks of TTI of HBV, HCV, and HIV were calculated from July 1, 2012 to June 30, 2018 by dividing the data into two year sets. The residual risk was conducted by separating the donors who donated only once and those who donated more than once during each period. RESULTS: In the first two years, the residual risks of HBV, HCV, and HIV were calculated to be 17.54/106, 0.42/106, and 0.30/106 respectively. The residual risk of HBV and HCV over the last two years was calculated to be 9.41/106 and 0.27/106, showing a tendency to decrease with time. On the other hand, the residual risk of HIV over the last two years was calculated to be 0.29/106, showing no significant difference. The residual risk in the donors who donated only once was higher than that in the donors who donated more than once during each period. CONCLUSION: The real transfusion-transmitted infection can be different from the estimated residual risk in this study because this study was based on the thesis that all NAT-reactive blood components cause infection. Because the residual risk of HBV is higher than HCV and HIV, it was considered that the safety measures for the HBV need to be improved continuously.
Subject(s)
Humans , Blood Safety , Hand , HIV , Korea , Tissue DonorsABSTRACT
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.
Subject(s)
Humans , Blood Donors , HIV , Mass Screening , Nucleic Acid Amplification Techniques , Tissue DonorsABSTRACT
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.
Subject(s)
Humans , Blood Donors , Follow-Up Studies , Mass Screening , Nucleic Acid Amplification Techniques , Tissue DonorsABSTRACT
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.
Subject(s)
Humans , Antigens, Surface , Blood Safety , Hand , Hepatitis B Surface Antigens , Immunoassay , Information Management , Mass Screening , Red Cross , Tissue DonorsABSTRACT
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.
Subject(s)
Humans , Blotting, Western , DNA , Methods , Nucleic Acid Amplification Techniques , Plasmids , Polymerase Chain Reaction , T-Lymphocytes , Tissue DonorsABSTRACT
BACKGROUND: Because of a lack of substances for platelet (PLT) metabolism and preservation, normal saline (NS) washed PLTs can only be stored for short lengths of time. However, the use of platelet additive solutions (PAS) could help solve this problem. In this study, the in vitro quality of NS washed platelets (wPLTs) stored in two types of PAS were compared with those of wPLTs stored in NS. METHODS: Five units of NS washed apheresis platelets were pooled aseptically and separated into five aliquots for storage in NS only as well as T-PAS+ (Terumo BCT, Lakewood, CO, USA) and CompoSol PS (Fenwal, Lake Zurich, IL, USA) with or without 15 mM glucose. The parameters of wPLTs quality were assessed up to 48 hrs after washing and the whole experiment was repeated 10 times independently. RESULTS: wPLTs in two kinds of PAS had better quality than wPLTs in NS, and wPLTs in T-PAS+ showed better quality than those in CompoSol PS. PAS-stored wPLTs with added glucose maintained stable CD62P and Annexin V expression during storage, but exhibited increased lactate accumulation. Evaluation of in vitro quality revealed that all wPLTs had a rating of 4 immediately after washing. However, only T-PAS+-stored wPLTs with glucose maintained a rating of 4 up to 48 hrs of post-washing. CONCLUSION: Using PAS storage for wPLTs may be beneficial compared to NS. The results presented herein suggest that T-PAS+ containing glucose has the potential to extend storage time by up to 48-hours.
Subject(s)
Annexin A5 , Blood Component Removal , Blood Platelets , Blood Preservation , Glucose , In Vitro Techniques , Lactic Acid , Lakes , MetabolismABSTRACT
BACKGROUND: Transfusion transmissible emerging infectious diseases (EIDs) is a potential risk to the safety of blood transfusions due to the lack of donor screening assays. To prevent the spread of EIDs through blood transfusions, we attempted to predict the possibility of blood donations from people with EIDs using a public database. METHODS: We used the Disease Web Statistics System of the Korean Centers for Disease Control and Prevention and Korean Statistical Information Service. We estimated the possibility of blood donations from people with EIDs using the public database combined with the database made available by the Blood Information Management System of the Korean Red Cross. RESULTS: Among the transfusion transmissible EIDs, Babesiosis, Leishmaniasis, West Nile fever, Chikungunya, and Dengue fever were reported in Korea. All of them were cases imported from abroad. Although the number of reported cases of Babesiosis, Leishmaniasis, West Nile fever, and Chikungunya were less than 10 per year until 2016, the reported cases of Dengue fever gradually increased from 2001, and there were 318 cases of Dengue fever in 2016. CONCLUSION: The possibility of blood donation from people with transfusion-transmissible EIDs was low because all reported transfusion-transmissible EIDs in Korea were from foreigners and blood donation from Koreans who returned from abroad was restricted for a period of a month. Nonetheless, preventive strategy for donation from people is necessary given the recent increase in Dengue fever.
Subject(s)
Animals , Humans , Babesiosis , Blood Donors , Blood Transfusion , Communicable Diseases, Emerging , Dengue , Disease Outbreaks , Donor Selection , Emigrants and Immigrants , Information Management , Information Services , Korea , Leishmaniasis , Red Cross , West Nile FeverABSTRACT
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.