BACKGROUND: The Coapresta 2000 (Sekisui Medical CO., LTD, Japan) is a fully automated random-access multiparameter hemostasis coagulation analyzer, which is equipped with a photo-optical clot detection unit and a cap-piercing system. It is able to perform clotting time assays as well as colorimetric assays (synthetic substrate method and latex turbidimetric method). In this study, we evaluated the analytical performance of the Coapresta 2000 for coagulation test items and compared with that of the ACL-TOP (Instrumentation Laboratory, Lexingtion, MA, USA) analyzer, which is currently used for routine coagulation test items in our hospital. METHODS: The Coapresta 2000 was evaluated with respect to its technical characteristics in the determination of 8 routine coagulation test items: prothrombin time, activated partial thromboplastin time, fibrinogen, fibrin-degradation product (FDP) antithrombin III, D-dimer, factors VIII and IX. Analyse-it (Analyse-it Software Ltd, UK) and SigmaStat (Systat Software, Inc., USA) were used for statistical analysis between items on the Coapresta 2000 and the ACL-TOP analyzer. RESULTS: The intra-assay and inter-assay coefficients of variation (CV) were below 5% for both groups of samples having values within the reference interval and outside the reference interval. Significant interference was observed with hemolytic and icteric samples. Carryover was not detected. The results obtained by Coapresta 2000 were well correlated with those obtained by the ACL-TOP analyzer (r2 in the range from 0.781 to 0.969). CONCLUSIONS: We concluded that Coapresta 2000 analyzer was well correlated with ACL-TOP analyzer for the routine coagulation test items tested.
Antithrombin III ; Fibrin Fibrinogen Degradation Products ; Fibrinogen ; Hemostasis ; Latex ; Partial Thromboplastin Time ; Prothrombin Time

Approximately 80-85% of D-negative (D-) persons produce anti-D antibodies after exposure to D-positive (D+) red blood cells (RBCs). Previously, anti-D was the most commonly detected Rh antibody, but its incidence has greatly decreased due to the prophylactic use of Rh immunoglobulin (RhIG). Anti-D antibody formation may occur following RhD-incompatible organ transplantation when D- recipients are exposed to D+ RBCs that originate from a donor organ. As a large volume of donor blood may be contained within the transplanted organ, the use of a large amount of RhIG is required in RhD-incompatible liver transplantation. Here, we describe the use of a large amount of RhIG to treat a patient following RhD-incompatible liver transplantation. This patient was a 71-yr-old woman with hepatitis C virus-related liver cirrhosis, who had an A/D- blood type. The donor was her grandson, whose blood type was O/D+. The recipient's preoperative anti-D antibody test was negative. One unit of O/D- irradiated leukoreduced RBCs and three units of A/D- fresh frozen plasma were transfused during liver transplantation. An equal amount (12,000 IU) of RhIG was infused intravenously, immediately after liver transplantation and a second time on post-operation day 1. The anti-D titer was 1:64 on the first post-operation day, and had increased to 1:128 by the following day. By 1 month after the surgery, the titer had decreased to 1:4. In this case of liver transplantation, RhIG was actively used to prevent RhD sensitization and the subsequent occurrence of adverse events associated with RhD-incompatible liver transplantation.
Antibodies ; Antibody Formation ; Erythrocytes ; Female ; Hepatitis C ; Humans ; Immunoglobulins* ; Incidence ; Liver Cirrhosis ; Liver Transplantation* ; Organ Transplantation ; Plasma ; Tissue Donors ; Transplants

BACKGROUND: ABO blood grouping reagent verification is essential to ascertain safe blood transfusions. However, the research use of donated blood products has been hampered in Korea by the blood transfusion law and management policies. In this study, we developed cryopreserved red blood cell (RBC) panels utilizing the high glycerol method to verify the ABO and D blood grouping reagents. In addition, we evaluated the stability of ABO and D antigenicity. METHODS: Fresh blood was frozen by the high glycerol method, aliquoted and cryopreserved in 2 mL cryotubes. Twenty-four vials of bloods with types A (n=5), B (n=5), AB (n=4) and O (n=10) for ABO RBC panels, and eleven vials of blood types D positive (n=5), D negative (n=5) and D weak (n=1) for D RBC panels were established. Potency, avidity and specificity tests were carried out with four different commercial ABO and D blood grouping reagents. RESULTS: The potency of cryopreserved RBCs after thawing showed no statistical difference compared with pre-freezing RBCs. Avidity time measurements were 5 seconds in ABO blood and 20 seconds in D positive blood. Specificity test uniformly showed 100% specificity. When thawed RBCs were stored at 4degrees C for 7 days, the potency test measured at intervals of 2 days showed no variation. CONCLUSION: Cryopreserved RBC panels produced by the high glycerol method showed excellent results in stability test with reagents produced by manufacturers in Korea. Therefore, these panels can be utilized as a reliable method of verifying blood grouping reagents.
Blood Grouping and Crossmatching ; Blood Transfusion ; Erythrocytes ; Glycerol ; Indicators and Reagents ; Jurisprudence ; Korea ; Sensitivity and Specificity

BACKGROUND: Lung cancer is the most lethal malignant neoplasm in the world. Serum cytokeratin fragment 21-1 (Cyfra 21-1) is a valuable tumor marker for detection of lung cancer, and it has good sensitivity and specificity. The aim of this study was to investigate the diagnostic value of Cyfra 21-1 levels in patients with lung cancer. METHODS: We retrospectively reviewed 814 samples from 169 patients with lung cancer, 124 patients with benign pulmonary diseases, and 521 normal controls from health check-up clinic. Serum Cyfra 21-1 levels were determined with Architect CYFRA 21-1 kit (Abbott, USA) using Architect i2000 analyzer. RESULTS: Median levels and interquartile ranges for Cyfra 21-1 in patients with lung cancer (non-small cell lung cancer: 3.16 [1.98, 9.00] ng/mL, small cell lung cancer: 3.32 [2.07, 5.20] ng/mL) were higher than those in patients with benign pulmonary diseases (1.50 [1.17, 2.17] ng/mL; P<0.01) and in normal controls (1.26 [0.93, 1.75] ng/mL; P<0.01). Sensitivity, specificity, positive predictive value, and negative predictive value for Cyfra 21-1 were 70.4%, 81.2%, 49.6%, and 91.3%, respectively. The area under the curve for Cyfra 21-1 was 0.839 (95% confidence interval, 0.802-0.877). CONCLUSIONS: We concluded that Cyfra 21-1 may be useful in the diagnosis of lung cancer.
Diagnosis ; Humans ; Keratins* ; Lung Diseases ; Lung Neoplasms* ; Retrospective Studies ; Sensitivity and Specificity ; Small Cell Lung Carcinoma

Background: Laboratory tests in blood banks vary with respect to methods,equipment, and quality control according to the hospital’s environment. Methods: We surveyed institutions that regularly participated in the Koreanassociation of external quality assessment using a web-based questionnairecomprising 79 questions regarding transfusion laboratory work. Results: A total of 84 institutions were surveyed including 17 senior generalhospitals, 43 general hospitals, 19 hospitals, four clinics, and one commerciallaboratory. ABO cell typing was performed by slide (63, 75.0%), tube (42,50.0%), automated column (19, 22.6%), and automated microplate (7, 8.3%)methods. ABO serum typing was performed by tube (75, 89.3%), automatedcolumn (19, 22.6%), automated microplate (7, 8.3%), and slide (7, 8.3%)methods. Irregular antibody screening test and identification test wasperformed by 58 (69.0%) and 36 (42.9%) institutions, respectively. Irregularantibody screening test and identification test was performed by the columnagglutination method in 34 (40.5%) and 26 (31.0%) institutions, respectively.Room temperature saline, albumin, and anti-globulin reagent crossmatchingtest (three-step method) was the most popular method (48, 57.1%). Theuse of anti-globulin reagent in the crossmatching test did not significantlyvary according to the size of the hospital. A daily quality control programfor ABO, Rh typing, and the crossmatching test was conducted in 58 (69.0%)institutions. Conclusions There were differences in transfusion-related laboratory testsamong the institutions. Although this survey included a limited number ofinstitutions, it can be helpful to evaluate the routine laboratory tests andtransfusion-related blood bank work in each institution.

BACKGROUND: The performance of Cell-Dyn Sapphire (Abbott Diagnostic, USA) was compared to the Bayer Advia 2120 (Bayer Diagnostics, USA), Sysmex XE-2100 (Sysmex Corporation, Japan), and reference microscopy. METHODS: Three hundred samples for routine CBC and WBC differentials were randomly chosen for a comparison analysis. The Cell-Dyn Sapphire system was evaluated according to the linearity, imprecision, inter-instrument correlations, and white blood cell differential. RESULTS: The CBC parameters (WBC, RBC, hemoglobin and platelet) showed a significant linearity with correlation coefficients greater than 0.99 (P<0.0001). Coefficients of variation (CV) for withinrun and differential count of WBC were less than 5% except for Total CV for monocytes, eosinophils, and basophils and within-run CV for low valued eosinophils. The correlation coefficients with manual count were lower in monocytes, eosinophils, and basophils than in neutrophils and lymphocytes. The correlation with other hematology anlayzers was significant exclusive of basophils. CONCLUSIONS: These results demonstrate that the Cell-Dyn Sapphire has a good linearity, an acceptable reproducibility, a minimal carryover, and a comparable performance with the sysmex XE-2100 and Advia 2120.
Analysis of Variance ; Autoanalysis ; Blood Cell Count/*instrumentation/methods ; Blood Specimen Collection ; Diagnostic Errors ; Humans ; Reproducibility of Results ; Sensitivity and Specificity

To evaluate the safety and efficacy of the computed tomography coronary angiography (CTCA) for evaluation of acute chest pain in real world population, we prospectively enrolled 296 patients with acute chest pain at emergency department (ED) from November 2005 to February 2007. The patients were grouped based on the clinical information and CTCA result. The patients with a low risk profile and no significant coronary stenosis (>50%) in CTCA were discharged immediately (Group 1, n=103). On the other hand, the patients with an intermediate risk profile without significant stenosis were observed in ED for 24 hr (Group 2, n=104). The patients with significant stenosis underwent further coronary evaluation and management accordingly (Group 3, n=89). While no false negative case was found in Group 1, seven cases (6.73%) were found in Group 2, mostly during the observation period. In Group 3, there were 54 (60.67%) cases of acute coronary syndrome including 10 myocardial infarctions. The overall accuracy of CTCA for acute coronary syndrome was 88.5% (sensitivity), 85.1% (specificity), 60.7% (positive predictive value) and 96.6% (negative predictive value). In conclusion, clinical decision based on CTCA is safe and effective for low risk patients. Further validation is needed in patients with intermediate risk profile.
Adult ; Aged ; *Chest Pain/diagnosis/etiology/radiography ; Coronary Angiography/*methods ; Coronary Stenosis/radiography ; Decision Making ; Emergency Service, Hospital ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Prospective Studies ; Risk Factors ; Sensitivity and Specificity ; Tomography, X-Ray Computed/*methods

BACKGROUND: This study was designed to characterize urinary isolates of Escherichia coli that produce extended-spectrum beta-lactamases (ESBLs) and to determine the prevalence of other antimicrobial resistance genes. METHODS: A total of 264 non-duplicate clinical isolates of E. coli were recovered from urine specimens in a tertiary-care hospital in Busan in 2005. Antimicrobial susceptibility was determined by disk diffusion and agar dilution methods, ESBL production was confirmed using the double-disk synergy (DDS) test, and antimicrobial resistance genes were detected by direct sequencing of PCR amplification products. E. coli isolates were classified into four phylogenetic biotypes according to the presence of chuA, yjaA, and TSPE4. RESULTS: DDS testing detected ESBLs in 27 (10.2%) of the 264 isolates. The most common type of ESBL was CTX-M-15 (N=14), followed by CTX-M-3 (N=8) and CTX-M-14 (N=6). All of the ESBL-producing isolates were resistant to ciprofloxacin. PCR experiments detected genes encoding DHA-1 and CMY-10 AmpC beta-lactamases in one and two isolates, respectively. Also isolated were 5 isolates harboring 16S rRNA methylases, 2 isolates harboring Qnr, and 19 isolates harboring AAC(6')-Ib-cr. Most ESBL-producing isolates clustered within phylogenetic groups B2 (N=14) and D (N=7). CONCLUSION: CTX-M enzymes were the dominant type of ESBLs in urinary isolates of E. coli, and ESBL-producing isolates frequently contained other antimicrobial resistance genes. More than half of the urinary E. coli isolates harboring CTX-M enzymes were within the phylogenetic group B2.
Bacterial Proteins/biosynthesis/*genetics ; Bacteriuria/microbiology ; Ciprofloxacin/pharmacology ; Disk Diffusion Antimicrobial Tests ; Drug Resistance, Multiple, Bacterial/*genetics ; Escherichia coli/*drug effects/enzymology/isolation & purification ; Humans ; Methyltransferases/genetics ; Phylogeny ; beta-Lactamases/biosynthesis/*genetics

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