Blood Transfusion Status Based on the Literature of the 1920s in Korea / 대한수혈학회지

The ABO blood type was discovered by Karl Landsteiner in 1901. The frequency of occurrence of the ABO blood type in Korea was reported in the journal of the Joseon Medical Association in 1922. The status of 54 transfusions at one medical clinic in 1924 was reported at a medical congress in 1925. Many direct transfusion cases in Korea were identified by a literature search for articles published during the 1920s.

Analysis of Results of Donor Blood Screening Tests of Hanmaeum Blood Center (2011~2020) / 대한수혈학회지

Background@#According to blood management law, serology and nucleic acid testing (NAT) are performed for HIV, HBV, HCV, and others as blood screening tests in Korea. The blood screening tests for HIV, HBV, and HCV have substantially improved transfusion safety. The blood screening results of one blood center were investigated because there is little domestic data available on screening tests. @*Methods@#The blood donation records and screening tests results of a supplying blood center were analyzed retrospectively from January 2011 to December 2020 in Korea. Annual first-time donation numbers, sex, and age distribution of donors were investigated during 10 years. The positivity of ALT, HBsAg, anti-HCV, and anti-HIV antibody testing and the positive cases of HIV, HCV, and HBV NAT were inquired. @*Results@#For 10 years, the blood center has collected 1,896,392 units of blood, and male donation was 1,239,873 units, which was 65.38% of total blood donation. ALT abnormal blood units were 2.06% in 2011, 2.14% in 2013, and 0.81% in 2019. The donor screening test showed HBsAg 0.03%, anti-HCV 0.02%, and anti-HIV 0.06% positivity at 2020. NAT yield cases were three with HIV, two with HCV, and 260 with HBV for 10 years. @*Conclusion@#The positivity of serology screening tests of the Hanmaeum blood center showed a decreasing trend, and the transfusion of nucleic acid positive but serologically negative blood could be prevented by performing NAT.

How Does COVID19 Affect Blood Transfusion and Blood Management? / 대한수혈학회지

The scientific interest in transfusion medicine as related to COVID19 can be summarized in three important points. 1) How can we identify asymptomatic COVID19 infected potential blood donors from healthy donors, and if the asymptomatic COVID19 infected person has donated blood and it has been transfused, how will it affect the transfused patient? 2) What affect will COVID19 have on blood establishments and medical institutions that use blood? 3) How will convalescent plasma from recovered COVID-19 patients be collected and then be used for patients in need of it? Since COVID19 has a negative effect on blood transfusion and blood management, well developed lines of communication and cooperation from blood establishments, medical institutions, government agencies, and people are urgently needed to overcome the impact of this negative effect.

Suggestions for Specialization and Enhancing Capacity in National Blood Services / 대한수혈학회지

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.

The Effect and Development of a Simulation Learning Module based on Schizophrenic Patients Care of Nursing Students / 정신간호학회지

Purpose@#The purpose of this study was to develop and examine the effects of a simulation learning module based on schizophrenic patients care on the knowledge of schizophrenic patients care, learning self-efficacy, and nursing skill performance of nursing students. @*Methods@#Junior nursing students with no mental health nursing experience from two different colleges in G city participated. A total of 64 participants were classified into the experimental group (31) and the control group (33). This study was conducted based on the Jeffries simulation model, and the simulation learning module based on schizophrenic patient care was developed based on the Instructional System Design simulation learning module based on schizophrenic patients care comprising the module I lecture, the module II case-based team learning, and the module III standardized patient-based simulation learning. @*Results@#There were significant increases in the knowledge of schizophrenic patients care (t=2.85, p=.006), learning self-efficacy (t=3.42, p=.001) and nursing skill performance (t=16.69, p<.001) in the experimental group compared to the control group @*Conclusion@#The simulation learning module based on schizophrenic patients care can be useful in the educational and clinical environment as effective strategies in contributing to nursing education and clinical changes.

Estimation of the Residual Risk of Transfusion-Transmissible Infectious Agents in Korea / 대한수혈학회지

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.

Development of HLA-A, -B and -DR Typing Method Using Next-Generation Sequencing / 대한수혈학회지

BACKGROUND: Research on next-generation sequencing (NGS)-based HLA typing is active. To resolve the phase ambiguity and long turn-around-time of conventional high resolution HLA typing, this study developed a NGS-based high resolution HLA typing method that can handle large-scale samples within an efficient testing time. METHODS: For HLA NGS, the condition of nucleic acid extraction, library construction, PCR mechanism, and HLA typing with bioinformatics were developed. To confirm the accuracy of the NGS-based HLA typing method, the results of 192 samples HLA typed by SSOP and 28 samples typed by SBT compared to NGS-based HLA-A, -B and -DR typing. RESULTS: DNA library construction through two-step PCR, NGS sequencing with MiSeq (Illumina Inc., San Diego, USA), and the data analysis platform were established. NGS-based HLA typing results were compatible with known HLA types from 220 blood samples. CONCLUSION: The NSG-based HLA typing method could handle large volume samples with high-throughput. Therefore, it would be useful for HLA typing of bone marrow donation volunteers.

Development of External Quality Controls for Human Immunodeficiency Virus Antigen/Antibody Tests in Korea

BACKGROUND: Quality control is important for accurate diagnosis of human immunodeficiency virus (HIV) infection, and proficiency testing with external quality controls is an important part of quality control. This study intended to develop and supply customized external quality controls for HIV antigen/antibody testing fitted with currently used reagents for standardization of HIV infection diagnosis and evaluation of HIV testing competency of laboratories in Korea. METHODS: Serological tests and inactivation were performed on the obtained HIV antibody positive plasma. To manufacture quality controls having the required antibody titers, dilution ratio was searched using VIDAS (bioMérieux, France), Architect (Abbott Laboratories, USA), and Cobas 8000 (Roche Diagnostics, Germany) analyzers. Diluted source plasma was divided into aliquots after filtering. Homogeneity and stability of the produced external quality controls were evaluated. RESULTS: The collected HIV antibody positive plasma was confirmed by Western blot. Dilution ratios for source plasma were produced for each analyzer showing signal-to-cut-off 2–3, 5–7, and 15–16 reactivity. Diluted plasma was made to 1 mL aliquots and total set of 1,500 external quality controls for HIV antigen/antibody were manufactured. Produced controls satisfied the required criteria of homogeneity and showed less than 10% coefficient of variation for stability except negative controls. CONCLUSIONS: Customized external quality controls were developed and qualified for HIV testing reagents used in Korea. Continuous external quality control assessment for HIV tests with controls would be required.

Clinical Usefulness of a DNA Microarray-based Assay for the Diagnosis of Sexually Transmitted Infections

BACKGROUND: Many molecular diagnostic methods have been developed to detect sexually transmitted infections (STI). The STDetect Chip (LabGenomics, Korea) which is a DNA microarray-based tool, newly developed for STI diagnosis in vitro, and the real-time PCR-based Anyplex STI-7 (Seegene, Korea) in clinical use were evaluated using ATCC DNA and clinical samples to determine the clinical usefulness of the STDetect Chip. METHODS: The two methods were compared for consistency, sensitivity, and specificity for 6 pathogens in 300 prospectively selected clinical samples. Analytical sensitivity for ATCC Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma hominis and Trichomonas vaginalis DNA and the effect of mixing bacterial DNA were studied. RESULTS: The consistency of the two methods for clinical samples was superior at more than 0.92 kappa value. The sensitivity and specificity of the STDetect Chip compared with Anyplex STI-7 were 90.5-98.8%, and 95.6-99.6%, respectively. With similar analytical performance for ATCC DNA, the STDetect Chip detected 10(-5) ng/µL of N. gonorrhoeae, 10(-4) ng/µL of C. trachomatis, 10(-6) ng/µL of M. hominis, and 10(-3) ng/µL of T. vaginalis. For the mixture of three bacterial DNAs, less sensitive detection level was observed for T. vaginalis. CONCLUSIONS: The STDetect Chip showed good agreement with the Anyplex STI-7 test and it is considered clinically useful for detecting sexually transmitted pathogens.

Analysis of Recent Four Years' Cross-Matching Tests of One Commercial Laboratory

The cross-matching test, an essential pre-transfusion test, is usually performed using only a segment of a blood bag and a recipient's blood sample at a commercial laboratory. We analyzed cross-matching test results obtained at LabGenomics laboratory, client of which were mainly small- and medium-sized medical clinics. Data for a total of 12,902 cross-matching tests referred from January 2012 to December 2015 were analyzed for incompatibility in the results and trends based on the distribution of medical clinics. Medical clinics were categorized as nursing home, obstetrics and gynecology, plastic surgery, dental clinic, orthopedic surgery, and others. Incompatible results were observed for 35 cases (1.09%) in 2012, 22 cases (0.68%) in 2013, 31 cases (1.02%) in 2014, and 41 cases (1.20%) in 2015. Overall, 55.4% of referrals came from a nursing home, 6.4% from obstetrics and gynecology, 4.4% from plastic surgery, 20.0% from dental clinic, 5.9 % from orthopedic surgery, and 7.9% from others. Further studies are required to evaluate the efficacy of cross-matching test results and its relationship with transfusion requirements.

Performance Evaluation of the DxH 800 Hematology Analyzer

In this study, the performance of a hematology analyzer, DxH 800 (Beckman Coulter, USA) was evaluated. The precision, carry-over, linearity, and comparison studies were performed according to the Clinical Laboratory Standards Institute guidelines. The test items were white blood cell, red blood cell, hemoglobin, red blood cell index, platelet, and reticulocyte counts. The 6C control and Retic-X cell control (Beckman Coulter) were used for precision evaluation. For the correlation study, the test results were compared with those obtained from the ADVIA 2120i (Siemens, USA) using 120 blood samples. The results of precision and carry-over evaluations were within acceptable range. The coefficient of determination (R 2) for linearity was good, being more than 0.99. The correlation coefficient (R) ranged from 0.945 to 0.996. DxH 800 was evaluated as an acceptable hematology analyzer for the automation of large volume of laboratory samples.

Neonatal Screening Tests for Inherited Metabolic Disorders using Tandem Mass Spectrometry: Experience of a Clinical Laboratory in Korea

BACKGROUND: The purpose of this study is to investigate the positive rates of screening tests for inherited metabolic disorders, set cutoff values, and report the actual status of internal quality controls in LabGenomics Clinical Laboratories by using LC-MS/MS system. METHODS: We use Agilent 1260 Infinity HPLC System (Agilent Technologies, USA) for liquid chromatography, and API 2000 (AB Sciex, Canada) for MS/MS system. We set up screening tests for 55 diseases, which include metabolic disorders of 25 amino acids, 16 organic acids, and 14 fatty acids. RESULTS: We determined the analyte cutoff values as 99.9 or 0.1 percentiles in 15,000 newborn samples. The total number of samples tested from January 2012 to September 2014 was 119,948; of these, 6,681 were repeated. Of the repeated samples, 713 were presumed to be positive in the screening tests. Repeat screening with newly obtained dried blood spot specimens was recommended for these 713 samples and 600 specimens were obtained. Thus, the recall rate was 0.5% (600/119,948) for all samples and 84.2% (600/713) for the samples presumed to be positive in the screening tests. About 70 samples, that is, 0.06% of the total samples and 11.7% of the "reobtained" samples, again tested positive; we recommended confirmatory tests for these samples. CONCLUSIONS: We have presented data on the status of neonatal screening tests for inherited metabolic disorders using LC-MS/MS, including positive rates and recall rates of screening tests, set up cutoff values and reported the actual status of internal quality controls in a clinical laboratory in Korea.

An Experience of Using the Harmony Test for Genomics-Based Non-Invasive Prenatal Testing / 임상검사와정도관리

Serological prenatal screening tests are widely used to detect fetal chromosomal abnormalities such as Down and Edward syndromes. Amniocentesis is conducted as a confirmatory test in the screening-positive case. After discovering of presence of fetal cell-free DNA in maternal blood, non-invasive prenatal test (NIPT) coupled with next generation sequencing are performed in abroad. Results of genomics-based NIPT results supplied to Labgenomics laborotory from June, 2013 to August, 2014 were analyzed. Maternal blood samples were collected into specific Cell-Free DNA BCT tube and were transported. The samples were then delivered to Ariosa Diagnostics by FEDEX. Fetal cell-free DNA samples were analyzed using the Harmony test with sequencing of relevant chromosomes and by using the FORTE (fetal-fraction optimized risk of trisomy evaluation) algorism at Ariosa Diagnostics. In all, 149 cases from 28 medical clinics were analyzed. Six subjects were required recollection of samples because of a low fetal DNA fraction in the initially obtained samples. Of these 6 subjects, no sample could be collected from one. Of the remaining 148 cases, 144 had a low risk of trisomy, and 4 had a high risk for Down syndrome, thus providing a positivity percentage of 2.7%. Fetal DNA fraction in the maternal blood samples ranged from 4.2% to 23.7% with a mean value of 12.0%. We have experienced cases with a high risk for Down syndrome with genomics-based NIPT referred to abroad.

Clinical Study of Non-Invasive Prenatal Testing Using Next-Generation Sequencing

BACKGROUND: Serological prenatal screening tests are widely used to detect fetal chromosomal abnormalities such as Down and Edward syndromes. After determining the presence of fetal cell-free DNA in maternal blood, the non-invasive prenatal test (NIPT) coupled with next-generation sequencing has been performed in other countries, therefore, we developed a domestic NIPT technology. METHODS: The results of genomics-based NIPT performed between April and May, 2015 were analyzed. Maternal blood samples were collected in a specific Cell-Free DNA BCT tube. The samples were then massively sequenced using MiSeq and NextSeq 500 (Illumina Inc., USA) using LabGenomics laboratory-developed libraries. Chromosomal abnormalities were analyzed using a bioinfomatics algorithm. RESULTS: A total of 464 cases were analyzed. The samples of 12 subjects had to be collected again because of a low fetal DNA fraction in the initially obtained samples. Among the 456 cases for which fetal genome results were obtained, 436 had a low risk of trisomy, 12 had a high risk for Down syndrome, two had a high risk for Edward syndrome, and four had sex chromosomal aneuploidy, showing that the positive percentage of chromosomal abnormalities was 4.4%. All 12 cases with high risk for Down syndrome were confirmed as having trisomy 21 by amniocentesis. CONCLUSIONS: Our laboratory-developed genomics-based NIPT showed high positive predictive value, therefore, NIPT may be replaced by our own developed method.

Evaluation of Centaur Syphilis, Immulite Syphilis, and Mediace TPLA for Detecting Treponemal Antibodies

BACKGROUND: We evaluated the efficacy of two chemiluminescence immunoassays that detect treponemal antibodies, Centaur Syphilis and Immulite Syphilis, in comparison with Mediace Treponema pallidum latex agglutination (TPLA). METHODS: The study was conducted in two phases. In the first phase, we tested 1,147 serum samples that were sequentially submitted for routine syphilis serology. In the second phase, we tested a panel of 119 frozen serum samples that had previously tested positive by Mediace RPR. The kappa value, total agreement percentage, and sensitivity and specificity were analyzed. RESULTS: Of the 1,147 random samples, 24 (2.09%) tested positive with Centaur Syphilis, 16 (1.39%) with Immulite Syphilis, and 19 (1.66%) with Mediace TPLA. Of the 119 Mediace RPR-positive samples, 103 (86.6%) tested positive with Centaur Syphilis, 101 (84.9%%) with Immulite Syphilis, and 105 (88.2%) with Mediace TPLA. The percent agreements (kappa values) were 98.8% (0.934) between Centaur Syphilis and Mediace TPLA, 99.0% (0.94) between Immulite Syphilis and Mediace TPLA, and 99.2% (0.955) between Centaur Syphilis and Immulite Syphilis. To measure the sensitivity and specificity of each treponemal test, samples showing agreement in three or four of the tests (three treponemal tests and Mediace-RPR) were regarded as true positive (n=117) or true negative (n=1,142). The respective values for sensitivity and specificity were 100% and 99.6% for Centaur Syphilis, 98.3% and 100% for Immulite Syphilis, and 99.2% and 99.7% for Mediace TPLA. CONCLUSIONS: Results from the three treponemal assays were in good agreement. Greater sensitivity of Centaur Syphilis and greater specificity of Immulite Syphilis were suggested.

Evaluation of Centaur Syphilis, Immulite Syphilis, and Mediace TPLA for Detecting Treponemal Antibodies

BACKGROUND: We evaluated the efficacy of two chemiluminescence immunoassays that detect treponemal antibodies, Centaur Syphilis and Immulite Syphilis, in comparison with Mediace Treponema pallidum latex agglutination (TPLA). METHODS: The study was conducted in two phases. In the first phase, we tested 1,147 serum samples that were sequentially submitted for routine syphilis serology. In the second phase, we tested a panel of 119 frozen serum samples that had previously tested positive by Mediace RPR. The kappa value, total agreement percentage, and sensitivity and specificity were analyzed. RESULTS: Of the 1,147 random samples, 24 (2.09%) tested positive with Centaur Syphilis, 16 (1.39%) with Immulite Syphilis, and 19 (1.66%) with Mediace TPLA. Of the 119 Mediace RPR-positive samples, 103 (86.6%) tested positive with Centaur Syphilis, 101 (84.9%%) with Immulite Syphilis, and 105 (88.2%) with Mediace TPLA. The percent agreements (kappa values) were 98.8% (0.934) between Centaur Syphilis and Mediace TPLA, 99.0% (0.94) between Immulite Syphilis and Mediace TPLA, and 99.2% (0.955) between Centaur Syphilis and Immulite Syphilis. To measure the sensitivity and specificity of each treponemal test, samples showing agreement in three or four of the tests (three treponemal tests and Mediace-RPR) were regarded as true positive (n=117) or true negative (n=1,142). The respective values for sensitivity and specificity were 100% and 99.6% for Centaur Syphilis, 98.3% and 100% for Immulite Syphilis, and 99.2% and 99.7% for Mediace TPLA. CONCLUSIONS: Results from the three treponemal assays were in good agreement. Greater sensitivity of Centaur Syphilis and greater specificity of Immulite Syphilis were suggested.

Evaluating the results of the Momguard noninvasive prenatal test

PURPOSE: To evaluate the performance of the Momguard noninvasive prenatal test by tracing the 'screen positive' results based on preliminary samples from Korean cohorts. MATERIALS AND METHODS: This preliminary study is based on data collected by the LabGenomics Clinical Laboratory (Seongnam, Korea) with informed consent. Only pregnant women who underwent both the Momguard test and karyotyping were included in this study. Momguard test results were compared with those of the karyotyping analysis. RESULTS: Among the 38 cases with 'screen positive' results by Momguard, 30 cases also had karyotyping results available. In three trisomy (T) 18 and three T13 cases, the Momguard results were concordant with the karyotyping results. For the T21 cases, except for one case belonging to the mid-risk zone, Momguard results from 23 out of 24 cases matched the karyotyping results. CONCLUSION: Momguard is a highly reliable screening tool for detecting T13, T18, and T21 cases in independent Korean cohort samples.

The Past, Present and Future of the Blood Pre-Deposit System in Korea / 대한수혈학회지

The certificate of blood donation was introduced in 1975. Blood donor receives the certificate after donation. The person who has this certificate can receive one unit of blood component transfusion without charge in the hospital when he needs transfusion. The donor can use it for himself or anyone else whom it may concern, if necessary. This blood pre-deposit system in Korea is regulated by Transfusion Law. The government health insurance budget and pre-deposit foundation budget support the reimbursement fee for blood. Whenever blood centers collect blood from donors, they deposit 2,500 KRW into the pre-deposit foundation budget. The return rate of certificates was 15-28% and recently showed a gradual decrease to 13% due to the extension of coverage by government insurance for cancer patients, who are the main transfusion candidates. This system has contributed to the shift from paid donation to voluntary donation for the past 40 years. However, because this certificate imposes financial incentives for donors, the spirit of voluntary non-remunerated donation can be abused. If the transfusion fee is fully covered by government budget, it might be possible to discontinue the use of the certificate in order to implement true voluntary donation.

History of the Korean Society of Blood Transfusion and Blood Services in Korea / 대한수혈학회지

The Korean Society of Blood Transfusion (KSBT) was established in Seoul in 1982 by a group of physicians of clinical pathology (currently laboratory medicine), internal medicine, paediatrics, anaesthesiology, and surgery, who were members of the Korean Society of Hematology, in which they had been actively engaged as transfusion specialists. However, these physicians were dissatisfied with the lack of public recognition of blood transfusion and the unrealistic blood service system and therefore attempted to build an influential organization for improvement of blood services and transfusion medicine. The mission of the KSBT is to advance the science and practice of transfusion medicine. The KSBT advocates for education and research in the fields of transfusion medicine and for safe blood in blood services. The inaugural KSBT conference, with approximately 50 participants, was held in November, 1982; since then, annual conferences and educational workshops have been held regularly once or twice a year. Currently, the KSBT has approximately 800 members, who are practitioners of blood transfusion (holders of M.D.) or staff members of blood services (holders of other professional degrees). The Society also publishes the Korean Journal of Blood Transfusion (first issue published in 1990) and guidelines for blood services. A Society web site (http://www.transfusion.or.kr) was started in 2001, with the hope of increasingly providing information and feedback to members on a real-time basis. The KSBT has been an active participant in international activities. In 1995, the KSBT hosted the Sixth ISBT Western Pacific Regional Congress in Seoul and will host the 33rd ISBT Congress in Seoul in 2014. Since its inauguration, the KSBT has had key roles not only in education and research in the fields of transfusion medicine but also in development of safe-blood services during the last 30 years.

Study on the Promotion of HLA-matched Platelet Supply in Korea / 대한수혈학회지

BACKGROUND: Platelet transfusion refractoriness can develop in patients after multiple transfusions of platelets. Once patients develop platelet refractoriness caused by immunological factors, HLA-matched platelet transfusion is required. However, there is no system to supply HLA-matched platelets in Korea. This study was performed to find way to promote the HLA-matched platelet supply in Korea. METHODS: The status of platelets supply in Korea and the frequency of platelet refractoriness in four university hospitals during 2005 were analyzed. It was obtained that the number of ordered and positive cases for the anti-platelet antibody, HLA antibody screening, and Panel Reactive Antibody test among inpatients of hematological malignancies. And the means to use the HLA-A, B data of unrelated bone marrow donors was searched. RESULTS: Platelet supply increased annually and totally 1,558,395 units were supplied in 2005, from Korean Red Cross blood centers. The frequency of platelet transfusion refractoriness was 12.4%, among them 10.4% showed anti-platelet or anti-HLA antibodies positive. A revision of the related law was required to use the HLA data of unrelated bone marrow donors. CONCLUSION: Immunological factors were observed in about 10% of patients with platelet transfusion refractoriness. HLA-matched platelet could be widely available if the HLA-typed donor registry is established in the Korean Red Cross after the revision of the related law.