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Background@#In Korea, there were issues regarding the use of immunoassays for anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies to detect infection. So, we compared antibody results of eight kinds of commercial immunoassays using clinical remnant specimens. @*Methods@#We compared the results of several immunoassay kits tested on 40 serum samples from 15 confirmed patients and 86 remnant serum samples from clinical laboratory.Eight kinds of IVD kits—four enzyme-linked immunosorbent assay, two lateral flow rapid immunochromatographic assays, and two chemiluminescent immunoassays with one RUO kit were tested. @*Results@#Among 40 serum samples from 15 coronavirus disease 2019 (COVID-19) patients, 35 yielded at least one positive result for detecting antibodies in the combined assessment. There were inconsistent results in 12 (28%) samples by single immunoassay. Forty samples collected in 2019 before the first COVID-19 Korean case showed negative results except for one equivocal result. @*Conclusion@#The discrepant results obtained with different immunoassay kits in this study show that serological assessment of SARS-CoV-2 by a single immunoassay requires caution not only in detecting infection but also in assessing immunologic status.
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Background@#In Korea, there were issues regarding the use of immunoassays for anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies to detect infection. So, we compared antibody results of eight kinds of commercial immunoassays using clinical remnant specimens. @*Methods@#We compared the results of several immunoassay kits tested on 40 serum samples from 15 confirmed patients and 86 remnant serum samples from clinical laboratory.Eight kinds of IVD kits—four enzyme-linked immunosorbent assay, two lateral flow rapid immunochromatographic assays, and two chemiluminescent immunoassays with one RUO kit were tested. @*Results@#Among 40 serum samples from 15 coronavirus disease 2019 (COVID-19) patients, 35 yielded at least one positive result for detecting antibodies in the combined assessment. There were inconsistent results in 12 (28%) samples by single immunoassay. Forty samples collected in 2019 before the first COVID-19 Korean case showed negative results except for one equivocal result. @*Conclusion@#The discrepant results obtained with different immunoassay kits in this study show that serological assessment of SARS-CoV-2 by a single immunoassay requires caution not only in detecting infection but also in assessing immunologic status.
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Background@#We recently introduced the Barricor (BD, Franklin Lakes, NJ, USA) plasma separation tube, which uses a mechanical separator instead of a gel. We evaluated the effects of using the Barricor tube in a stat (statin) laboratory on the results and turnaround time (TAT) of routine chemical tests. We verified the impact of Barricor tube on reducing TAT and providing results similar to those obtained using serum separator tubes (SSTs). @*Methods@#We collected venous blood samples from 166 outpatients in Barricor tubes and SSTs and measured 28 routine analytes using an AU5800 instrument (Beckman Coulter, Brea, CA, USA). TAT indexes were compared before and after using Barricor tube. @*Results@#Mean percent differences were 60 minutes decreased from 7.84% to 2.66%, which was approximately one-third of that for SST. The reduction in TAT was attributable to a decrease in centrifugation time. Incomplete clotting and repeated centrifugation, which occurred frequently when using SST, also decreased after using the Barricor tubes. @*Conclusions@#The Barricor tube is an alternative to SST for routine chemical tests in institutions aiming to reduce TAT, with clinically allowable differences in test results.
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Background@#Patients with ongoing or expected bleeding require platelet (PLT) transfusions; however, owing to the testing required after a blood donation, manufacturing PLT products may take 1.5–2.0 days after a request is made. This supply-demand mismatch leads clinicians to retain spare PLTs for transfusions, leading to increased PLT discard rates. We developed a PLT inventory management program to supply PLTs more efficiently to patients requiring PLT transfusions within the expiration date, while reducing PLT discard rates. @*Methods@#PLT concentrates (58,863 and 58,357 units) and apheresis products (7,905 and 8,441 units) were analyzed from May 2015 to November 2017 and from December 2017 to January 2020, respectively. We developed a program to manage total PLT inventories and prospective PLT transfusion patients based on blood type, blood product, and remaining period of efficacy; the program facilitates PLT preparation transfer to non-designated patients within the remaining period of efficacy. @*Results@#The overall PLT concentrate discard rate was 3,254 (2.78%): 1,811 (3.07%) units before and 1,443 units (2.41%) after program application (P < 0.001). The discard rate owing to expiration was reduced from 69 units (3.81%) before to two units (0.14%) after program application (P < 0.001). @*Conclusions@#This program can guide the allocation of PLT preparations based on the remaining period of efficacy, enabling PLT products to be used before their expiration date and reducing PLT product discard rate.
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Minimal residual disease (MRD) monitoring has proven to be one of the fundamental independent prognostic factors for patients with acute lymphoblastic leukemia (ALL). Sequential monitoring of MRD using sensitive and specific methods, such as real-time quantitative polymerase chain reaction (qPCR) or flow cytometry (FCM), has improved the assessment of treatment response and is currently used for therapeutic stratification and early detection. Although both FCM and qPCR yield highly consistent results with sensitivities of 10‒4, each method has several limitations. For example, qPCR is time-consuming and laborious: designing primers that correspond to the immunoglobulin (IG) and T-cell receptor (TCR) gene rearrangements at diagnosis can take 3‒4 weeks. In addition, the evolution of additional clones beyond the first or index clone during therapy cannot be detected, which might lead to false-negative results. FCM requires experienced technicians and sometimes does not achieve a sensitivity of 10‒4. Accordingly, a next generation sequencing (NGS)-based method has been developed in an attempt to overcome these limitations. With the advent of high-throughput NGS technologies, a more in-depth analysis of IG and/or TCR gene rearrangements is now within reach, which impacts all applications of IG/TR analysis. However, standardization, quality control, and validation of this new technology are warranted prior to its incorporation into routine practice.
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Subject(s)
Classification , Consensus , Diagnosis , Hematologic Neoplasms , Hematology , Lymphoid TissueABSTRACT
BACKGROUND@#Blood transfusion poses high risks and has a high probability of error because of the complexity and involvement of several people in the process. The purpose of this study was to share our experience in classifying reports related to blood transfusions. We included patient safety reports that were prepared over a 10-year period that began from the opening of the hospital. We then analyzed the causes and the corrective actions.@*METHODS@#We analyzed 125 reports related to blood transfusions, and these reports were included in the patient safety reports received from November 2008 to December 2018. The events were categorized as sampling error, inspection error, testing error, issue error, disposal error, transfusing blood components error, or others error, depending on the stage of the blood transfusion process. Regardless of the cause, the event that led to an inappropriate transfusion was classified as a transfusion incident.@*RESULTS@#The number of blood transfusions per year increased, and the rate of blood transfusion accidents ranged from 0.00% to 0.05% per year. A total of 125 reports were prepared over a 10-year period, and these included 8 blood sampling errors, 11 testing errors, 2 issuing errors, 94 disposal errors, 3 others errors, and 7 errors associated with the transfusing of blood components. After the transfusion incident, PDA was applied as a solution. Transfusing the wrong blood components did not occur, and the incidence of taking blood from the wrong patients was decreased.@*CONCLUSION@#We applied corrective actions according to the cause of the event and we confirmed that the blood transfusion incidents decreased.
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BACKGROUND: Genetic variants and haplotypes of the interleukin-10 (IL10) gene have been shown to affect clinical outcomes, including the incidence of opportunistic infections (OIs), in HIV-infected patients. This study investigated the effect of IL10 gene variants on susceptibility to OIs in HIV-infected Korean patients in the era of highly active antiretroviral therapy (HAART). METHODS: Eighty-five HIV-infected patients receiving HAART were enrolled in the study. OIs were diagnosed based on the published criteria of the Korean Society for AIDS. Three promoter SNPs and four haplotype-tagging SNPs (htSNPs) of IL10 were selected and genotyped. The haplotypes were reconstructed according to the genotyping data and linkage disequilibrium (LD) status of these SNPs. RESULTS: During the study, 38 OIs developed in 23 of the 85 patients (27.1%), at a rate of 1.7 episodes/patient. Carrying the minor alleles at the rs1518111, rs3024490, and rs1800871 SNPs had a protective effect against OIs (adjusted P=0.035). Among the seven assessed variants, only three possible haplotypes were observed. The second most common haplotype, which was composed of the rs1518111 minor allele and the rs3021094 major allele showed a protective effect against OIs (P=0.0153). CONCLUSION: This study demonstrated that some IL10 genetic variants and haplotypes are associated with protective effects against OIs in the era of HAART. These data suggest the potential of two htSNPs, rs1518111 and rs3021094, as markers revealing the genetic association of IL10 in Koreans. This is the first report on the association of IL10 with OIs in HIV-infected Korean patients in the era of HAART.
Subject(s)
Humans , Alleles , Antiretroviral Therapy, Highly Active , Haplotypes , HIV , Incidence , Interleukin-10 , Korea , Linkage Disequilibrium , Opportunistic Infections , Polymorphism, Single NucleotideABSTRACT
BACKGROUND: In pregnant women, the frequency of irregular antibodies that cause hemolytic disease of the fetus and newborn (HDFN) vary between study populations. The clinical manifestations of HDFN differ according to the specificities and degree of irregular antibodies. This study examined the frequency and nature of maternal alloimmunization and neonatal outcomes. METHODS: Pregnant women, who underwent irregular antibody screening for prenatal testing at an obstetrics clinic in a single center, were enrolled. Those who screened positive for irregular antibodies were selected as the test group, and age- and obstetrics history-matched pregnant women were selected as the control group to evaluate the pregnancy outcomes according to irregular antibodies. RESULTS: The prevalence of irregular antibodies was 2.78% (42/1,508). With the exception of an unidentified antibody, anti-D was the most frequently identified antibody, followed in order by anti-E and anti-Le(a). The rate of fetal death was higher in the test group (6/37, 16.2%) than in the control group (1/37, 2.7%) (P=0.047). Eight pregnant women had anti-C or anti-D, one woman had a stillbirth, and four living neonates developed hyperbilirubinemia. Of six pregnant women with anti-E alone or with other alloantibodies, three experienced a spontaneous abortion or stillbirth. Among the six newborns with maternal anti-Le(a) and anti-Jk(a), four developed hyperbilirubinemia, but their mothers did not experience a spontaneous abortion or stillbirth. CONCLUSION: The prevalence of unexpected antibodies among pregnant Korean women was 2.78%. A significant difference in neonatal outcomes was observed, including the death rate, prematurity, and hyperbilirubinemia, depending on the specificity of the unexpected antibody.
Subject(s)
Female , Humans , Infant, Newborn , Pregnancy , Abortion, Spontaneous , Antibodies , Fetal Death , Fetus , Hyperbilirubinemia , Isoantibodies , Mass Screening , Mortality , Mothers , Obstetrics , Pregnancy Outcome , Pregnant Women , Prevalence , Sensitivity and Specificity , StillbirthABSTRACT
BACKGROUND: Disasters themselves can increase the blood transfusion requirements due to an increase in injuries, and can lead to deficiencies in the blood transport system. To prepare for a disaster, it is important to know the actual blood requirements at the time of the disaster and the changes in blood supply according to the type of disaster. METHODS: From March 2018 to May 2018, all RBC transfusion cases at Pusan National University Yangsan Hospital were analyzed retrospectively. The patients were divided into Categories 1 to 3 according to the urgency of transfusion by disease. Priority one was defined as having only a category 1 patient receiving a transfusion, and priority two was defined as an emergency situation where only category 1 and 2 patients could receive transfusions. RESULTS: The amount of RBC concentrates used in this hospital was 53.1 units per day, which was 19.4%, 42.2%, and 38.4% in category 1, 2, and 3, respectively. The results of simulating the number of blood products that can be used according to the priorities when having a blood product inventory held by the blood banks are as follows: 2.45 days (normal), 12.64 days (P1), and 3.97 days (P2) can be used. CONCLUSION: The simulation showed the time of blood transfusion without additional blood supply in the event of a crisis, and will help establish the transfusion countermeasures in the event of a disaster.
Subject(s)
Humans , Blood Banks , Blood Transfusion , Disaster Planning , Disasters , Emergencies , Korea , Retrospective Studies , Tertiary HealthcareABSTRACT
BACKGROUND: There are few commercial quality-control (QC) materials for internal QC of flow cytometric analysis, especially for leukemia/lymphoma immunophenotyping. The purpose of this study was to investigate the current QC status of flow cytometry in Korea through a questionnaire survey, and develop new QC materials using cultured cell lines for markers which QC materials are unavailable. METHODS: The current state of internal QC of flow cytometry in Korea was investigated via a questionnaire survey. Cell lines to be used as QC materials were cultured and produced as QC materials. Cell viability and the expression of markers on the cultured cell lines were tested by flow cytometry to confirm the stability of the QC materials. Simulated quality assessment results for the cultured cell line QC materials were sent to laboratories for external proficiency testing (PT). RESULTS: Seventeen medical institutions completed the questionnaire survey. Hematopoietic stem cell count (CD34) and lymphocyte subset panel items in most of these institutions were managed using commercialized QC materials. The markers that could not be managed by QC materials were CD117, MPO (myeloperoxidase), TdT (terminal deoxynucleotidyl transferase), CD20, CD10, CD64, CD79α, FMC7, cytoCD22, CD23, CD34, and CD61. Five cell lines expressing these markers were selected and sent as QC materials. PT results for most of the markers were in concordance, except those for FMC7 and CD64. CONCLUSIONS: For the QC control of flow cytometry without commercialized QC materials, cultured cell lines are useful and can be used as an alternative for management of reagents used in flow cytometric analysis.
Subject(s)
Cell Line , Cell Survival , Cells, Cultured , Flow Cytometry , Hematopoietic Stem Cells , Immunophenotyping , Indicators and Reagents , Korea , Laboratory Proficiency Testing , Lymphocyte Subsets , Quality ControlABSTRACT
BACKGROUND: Blood transfusion is important when treating patients with anemia or bleeding; thus, supply of blood components should be stable prior to transfusion. To recruit donors, blood donation sites should be conveniently located. This study evaluated factors responsible for increased donation rates in hospitals and the characteristics of the donors in hospital blood banks without a fixed blood collection site nearby. METHODS: We retrospectively reviewed 687 blood donations at a blood donation center in Pusan National University Yangsan Hospital (PNUYH) from March 2011 to June 2016. A total of 3,053,695 blood donors listed in the 2014 Korean Red Cross Annual Report were compared to donors in PNUYH. We analyzed the age distribution of donor at blood donation centers from Korean Red Cross according to presence and number of high school and college. RESULTS: Comparison with total blood donors in Korea revealed that there were more blood donors in their thirties, office workers and business owners at PNUYH (P<0.001). The percentage of younger donors in their twenties differed significantly according to the presence of a college within a 4 km radius of the blood donation center (P=0.03). The presence of a high school did not affect the proportion of teenage donors (P=0.833). CONCLUSION: The blood donation rate at our medical institution without fixed blood collection sites nearby increased. A regional hospital may be used as a blood collection site to recruit donors in areas in which there are no fixed blood donation centers.
Subject(s)
Humans , Age Distribution , Anemia , Blood Banks , Blood Donors , Blood Transfusion , Commerce , Hemorrhage , Korea , Radius , Red Cross , Retrospective Studies , Tertiary Healthcare , Tissue DonorsABSTRACT
BACKGROUND: Blood transfusions are complicated procedures, and are highly sensitive to mistakes that could seriously endanger the life of patients. The failure mode and effect analysis (FMEA) can be used to inspect and improve high risk processes. Here, we aimed to identify the risk factors of a blood transfusion process and to improve its safety by optimizing the process. METHODS: We conducted a weekly meeting from March to April 2014. We investigated the frequency of events for 2013 (before FMEA) and 2015 (after FMEA). The FMEA process was performed in eight steps and the improvement priorities were determined in accordance with the magnitude of calculated fatalities (multiplied by severity, occurrence, and detection scores). RESULTS: The whole process of blood transfusion was analyzed by detailed steps: Decision of blood transfusion, blood transfusion request, pre-transfusion test, blood product discharge, delivery, and administration process. Then, we identified the types of failures and likelihood of occurrence, discovery, and severity. Based on the calculated risk priority number, strategies to improve the highest failure modes were developed. Eleven transfusion-related events occurred before FMEA, and three events occurred after FMEA. CONCLUSION: In this study, we analyzed the failure modes that may occur during a transfusion procedure. The FMEA was a useful tool for analyzing and reducing the risks associated with a blood transfusion procedure. Continuous efforts to improve the failure modes would be helpful to further improve the safety of patients undergoing blood transfusion.
Subject(s)
Humans , Blood Transfusion , Healthcare Failure Mode and Effect Analysis , Hematologic Tests , Patient Safety , Risk Factors , Transfusion MedicineABSTRACT
Delayed hemolytic transfusion reaction is difficult to prevent using an unexpected antibody test performed prior to transfusion, and unlike acute hemolytic transfusion reaction, it occurs a few days after blood transfusion. Hence, determining the reason for delayed hemolytic transfusion reaction may be a tim-consuming task for clinicians Here, we report our experience of two cases of delayed hemolytic transfusion reaction as a result of the unexpected antibody production to Rh blood group antigens after transfusion. The first patient with a history of transfusion during admission was identified as having anti-E and anti-C antibodies according to the antibody identification test at the time of re-admission. The second patient who had chronic blood transfusion due to cancer treatment was found to have anti-C antibody. Both patients received transfusion of Rh antigen-compatible RBC units only after unexpected antibody development. However, like both cases, patients receiving continuous blood transfusion should be considered for a routine Rh phenotype test.
Subject(s)
Humans , Antibodies , Antibody Formation , Blood Group Antigens , Blood Transfusion , Phenotype , Transfusion ReactionABSTRACT
No abstract available.
Subject(s)
Budd-Chiari Syndrome , Complement System Proteins , Hemoglobinuria, Paroxysmal , KoreaABSTRACT
Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.
Subject(s)
Anticoagulants/therapeutic use , Antidepressive Agents/therapeutic use , Antimetabolites, Antineoplastic/therapeutic use , Antitubercular Agents/therapeutic use , Arylamine N-Acetyltransferase/genetics , Coronary Artery Disease/drug therapy , Cytochrome P-450 CYP2C19/genetics , Cytochrome P-450 CYP2C9/genetics , Cytochrome P-450 CYP2D6/genetics , Depressive Disorder/drug therapy , Genotype , Isoniazid/therapeutic use , Laboratories, Hospital/standards , Methyltransferases/genetics , Pharmacogenomic Testing/methods , Platelet Aggregation Inhibitors/therapeutic use , Pulmonary Embolism/drug therapy , Ticlopidine/analogs & derivatives , Tuberculosis/drug therapy , Vitamin K Epoxide Reductases/genetics , Warfarin/therapeutic useABSTRACT
BACKGROUND: The aims of this study were to investigate the parameters of thromboelastography (TEG) for evaluating coagulopathy and to reveal an association with disease severity and/or transfusion requirement in patients with chronic liver disease (CLD) in a clinical laboratory setting. METHODS: We enrolled two groups of adult patients with cirrhotic (N=123) and non-cirrhotic liver disease (N=52), as well as 84 healthy controls. Reaction time (R), kinetic time (K), α-angle (α), maximal amplitude (MA), and coagulation index (CI) were measured with kaolin-activated citrated blood with the TEG 5000 system (Haemonetics Corporation, USA). Platelet count, prothrombin time international normalized ratio (PT INR), albumin, bilirubin, and creatinine were simultaneously measured. The CLD severity was calculated by using the Child-Pugh (C-P) and Model for End-stage Liver Disease (MELD) scores. Transfusion history was also reviewed. RESULTS: All TEG parameters, PT INR, and platelet count in the cirrhotic group showed significant differences from those in other groups. At least one or more abnormal TEG parameters were identified in 17.3% and 44.7% of patients in the non-cirrhotic and cirrhotic group, respectively. Patients with cirrhotic disease had hypocoagulability. A weak correlation between R and PT INR (r=0.173) was noted. The TEG parameters could not predict CLD severity using the C-P and MELD scores. Patients with normal TEG parameters did not receive transfusion. CONCLUSIONS: Clinical application of TEG measurements in CLD can be informative for investigating coagulopathy or predicting the risk of bleeding. Further studies are warranted.
Subject(s)
Adult , Humans , Bilirubin , Creatinine , Hemorrhage , International Normalized Ratio , Liver Diseases , Liver , Platelet Count , Prothrombin Time , Reaction Time , ThrombelastographyABSTRACT
No abstract available.
Subject(s)
Humans , Drug Therapy , Leukemia, Myelogenous, Chronic, BCR-ABL Positive , Leukocytosis , Lymphoma, B-CellABSTRACT
No abstract available.
Subject(s)
Female , Humans , Middle Aged , Bone Marrow/pathology , Chromosomes, Human, Pair 3 , Chromosomes, Human, Pair 6 , In Situ Hybridization, Fluorescence , Karyotyping , Lymphoma, Large B-Cell, Diffuse/diagnosis , Proto-Oncogene Proteins c-bcl-6/genetics , Tomography, X-Ray Computed , Translocation, GeneticABSTRACT
Pharmacogenetics is a rapidly evolving field and the number of pharmacogenetic tests for clinical use is steadily increasing. However, incorrect or inadequate implementation of pharmacogenetic tests in clinical practice may result in a rise in medical costs and adverse outcomes in patients. This document suggests guidelines for the clinical application, interpretation, and reporting of pharmacogenetic test results based on a literature review and the collection of evidence-based expert opinions. The clinical laboratory practice guidelines encompass the clinical pharmacogenetic tests covered by public medical insurance in Korea. Technical, ethical, and regulatory issues related to clinical pharmacogenetic tests have also been addressed. In particular, this document comprises the following pharmacogenetic tests: CYP2C9 and VKORC1 for warfarin, CYP2C19 for clopidogrel, CYP2D6 for tricyclic antidepressants, codeine, tamoxifen, and atomoxetine, NAT2 for isoniazid, UGT1A1 for irinotecan, TPMT for thiopurines, EGFR for tyrosine kinase inhibitors, ERBB2 (HER2) for erb-b2 receptor tyrosine kinase 2-targeted therapy, and KRAS for anti-epidermal growth factor receptor drugs. These guidelines would help improve the usefulness of pharmacogenetic tests in routine clinical settings.