1.Performance Evaluation of Elecsys Vitamin D Total II Assay Using Roche Modular Analytics E170.
Eun Jung CHO ; Hyunjung KIM ; Jeongho PARK ; Dongsik KIM ; Youngjong CHA ; Hae Kyung LEE
Journal of Laboratory Medicine and Quality Assurance 2018;40(2):109-111
We evaluated the performance of a recently developed immunoassay, Elecsys vitamin D total II assay (Roche Diagnostics GmbH, Germany). Precision, linearity, and comparison studies were performed according to the Clinical and Laboratory Standards Institute guidelines. Control materials, linearity materials, and patient samples were used for the evaluation. For the correlation study, liquid chromatography-tandem mass spectrometry was used as the comparative method. Total coefficients of variations of the analyte were between 5.1% and 9.6%. The results of linearity evaluation were also acceptable for the range tested. Correlations with comparative methods were good; however, the mean values of the Elecsys vitamin D assay were higher than those of liquid chromatography-tandem mass spectrometry. The overall analytical performance of the Elecsys vitamin D total II assay is acceptable for the immunology analyzer. Therefore, the Elecsys vitamin D total II assay is expected to be widely used.
Allergy and Immunology
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Humans
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Immunoassay
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Mass Spectrometry
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Methods
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Statistics as Topic
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Vitamin D*
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Vitamins*
2.Performance Evaluation of ADVIA Centaur XPT.
Eun Jung CHO ; Kyoung Jin PARK ; Woochang LEE ; Sail CHUN ; Won Ki MIN
Journal of Laboratory Medicine and Quality Assurance 2017;39(1):47-51
We have evaluated the performance of a recently developed immunoassay analyzer, ADVIA Centaur XPT (Siemens, Germany). Precision, linearity, and comparison studies were performed according to the CLSI guidelines. The test items evaluated were ferritin, folate, human epidermal growth factor receptor 2/neu, homocysteine, vitamin B₁₂, B-type natriuretic peptide, creatine kinase–myocardial band, myoglobin, procalcitonin, troponin I. Bio-Rad control materials, linearity materials, and patients' samples were used for the evaluation. For the correlation study, ADVIA Centaur XP (Siemens) were used as comparative methods. The total coefficients of variations (CVs) of the analytes were between 2.5% and 7.0%. The results of linearity evaluation were also acceptable for the range tested. Correlations with comparative methods were good. The overall analytical performance of ADVIA Centaur XPT is acceptable for the immunology analyzer. Therefore, ADVIA Centaur XPT is expected to be widely used.
Allergy and Immunology
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Creatine
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Ferritins
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Folic Acid
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Homocysteine
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Humans
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Immunoassay
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Myoglobin
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Natriuretic Peptide, Brain
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Receptor, Epidermal Growth Factor
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Statistics as Topic
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Troponin I
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Vitamins
3.Performance Evaluation of the VISTA 500.
Dae Hyun KO ; Eun Jung CHO ; Woochang LEE ; Sail CHUN ; Won Ki MIN
Journal of Laboratory Medicine and Quality Assurance 2016;38(1):52-57
In this study, we evaluated the performance of a recently developed immunoassay analyser, the VISTA 500 (Siemens, Germany). Precision, linearity, and comparison studies were performed according to the Clinical and Laboratory Standards Institute guidelines. The test items evaluated included IgG, IgA, IgM, C3, C4, ceruloplasmin, prealbumin, transferrin, haptoglobin, rheumatoid factor, anti-streptolysin O, and cystatin C. Commercial control materials (BioRad Laboratories, USA), commercial linearity validation materials (Maine Standards, USA), and patient samples were used for the evaluation. For the correlation study, analysis with a BN-II nephelometer (Siemens) was used as a comparative method. Total coefficients of variation of analytes were found to be between 1.9% and 5.5%. Results of the linearity evaluation were also acceptable for the range tested. Correlations with comparative methods were acceptable. The VISTA 500 analyser showed satisfactory analytical performance with respect to precision, linearity, and comparison. We conclude that the VISTA 500 is likely a good candidate as an immunology analyser.
Allergy and Immunology
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Ceruloplasmin
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Cystatin C
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Evaluation Studies as Topic
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Haptoglobins
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Humans
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Immunoassay
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Immunoglobulin A
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Immunoglobulin G
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Immunoglobulin M
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Prealbumin
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Rheumatoid Factor
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Statistics as Topic
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Transferrin
4.The Current Practice of Skin Testing for Antibiotics in Korean Hospitals.
So Hee LEE ; Heung Woo PARK ; Sae Hoon KIM ; Yoon Seok CHANG ; Sun Sin KIM ; Sang Heon CHO ; Kyung Up MIN ; You Young KIM
The Korean Journal of Internal Medicine 2010;25(2):207-212
BACKGROUND/AIMS: Antibiotic skin testing is a useful procedure for identifying patients with IgE-mediated hypersensitivity to antibiotics. The procedures, however, have not been standardized, and the testing is performed with diverse protocols in Korean hospitals wards. Thus, we examined the current practice of antibiotic skin testing in Korea. METHODS: We sent questionnaires to 12 allergists working in secondary or tertiary referral hospitals and collected them by e-mail or fax. The questionnaire included items such as the types and concentrations of the tested antibiotics, the methods of antibiotic skin testing, and the interpretation of the results. RESULTS: All hospitals responded to the questionnaire. The antibiotic skin testing protocols were variable, inconsistent, and differed with regard to the type and concentrations of antibiotics, the volume injected, and the interpretation of the results. Moreover, the protocols differed from the commonly recommended procedures in the medical literature. CONCLUSIONS: Standardized guidelines for antibiotic skin testing are needed for the safe and effective use of antibiotics in Korea.
Allergy and Immunology/*statistics & numerical data
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Anti-Bacterial Agents/*adverse effects
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Drug Hypersensitivity/*diagnosis
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*Health Care Surveys
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Humans
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Medical Staff, Hospital/statistics & numerical data
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Professional Practice/statistics & numerical data
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Questionnaires
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Republic of Korea
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Skin Tests/*utilization
5.The Effect of Asthma Clinical Guideline for Adults on Inhaled Corticosteroids PrescriptionTrend: A Quasi-Experimental Study.
Sang Hyuck KIM ; Be Long CHO ; Dong Wook SHIN ; Seung Sik HWANG ; Hyejin LEE ; Eun Mi AHN ; Jae Moon YUN ; Yun Hee CHUNG ; You Seon NAM
Journal of Korean Medical Science 2015;30(8):1048-1054
In order to increase inhaled corticosteroid (ICS) use and to reduce hospitalization, emergency department visits and ultimately the economic burden of asthma, "Korean Asthma Management Guideline for Adults 2007" was developed. To assess the guideline effects on physician's ICS prescription for asthma, we conducted segmented regression and multilevel logistic regression using National Health Insurance claims database of outpatient visits from 2003 to 2010. We set each quarter of a year as a time unit and compared ICS prescription between before and after guideline dissemination. A total of 624,309 quarterly visits for asthma was observed. The ICS prescription rate before and after guideline dissemination was 13.3% and 16.4% respectively (P < 0.001). In the segmented regression, there was no significant guideline effect on overall ICS prescription rate. In multilevel logistic regression analyses, the effect of guideline on overall ICS prescription was not significant (odds ratio, 1.03; 95% CI, 1.00-1.06). In subgroup analysis, ICS prescription increased in secondary care hospitals (odds ratio, 1.15; 95% CI, 1.02-1.30) and in general hospitals (odds ratio, 1.10; 95% CI, 1.04-1.16). However, in primary clinics, which covered 81.7% of asthma cases, there was no significant change (odds ratio, 0.98; 95% CI, 0.94-1.02). From the in-depth interview, we could identify that the reimbursement criteria of the Health Insurance Review and Assessment Service and patient's preference for oral drug were barriers for the ICS prescription. The domestic asthma clinical guideline have no significant effect on ICS prescription, especially in primary clinics.
Administration, Inhalation
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Adrenal Cortex Hormones/*administration & dosage
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Allergy and Immunology/standards
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Anti-Inflammatory Agents/administration & dosage
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Asthma/*drug therapy/*epidemiology
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Drug Prescriptions/*statistics & numerical data
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Guideline Adherence/*utilization
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Humans
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*Practice Guidelines as Topic
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Prevalence
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Pulmonary Medicine/standards
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Republic of Korea/epidemiology
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Treatment Outcome
6.Epidemiology and Clinical Outcomes in Children with Aplastic Anemia in Korea: Retrospective Study.
Dae Chul JEONG ; Im Joo KANG ; Hong Hoe KOO ; Hoon KOOK ; Sun Young KIM ; Soon Ki KIM ; Hwang Min KIM ; Heung Sik KIM ; Kyung Duk PARK ; Kyeong Bae PARK ; Young Sil PARK ; Sang Kyu PARK ; Jae Sun PARK ; Jun Eun PARK ; Hyeon Jin PARK ; Jong Jin SEO ; Won Suk SUH ; Ki Woong SUNG ; Hee Young SHIN ; Hyo Seop AHN ; Chang Hyun YANG ; Keon Hee YOO ; Kyung Ha RYU ; Eun Sun YOO ; Chuhl Joo LYU ; Kun Soo LEE ; Kwang Chul LEE ; Soon Yong LEE ; Young Tak LIM ; Pil Sang JANG ; Nak Gyun CHUNG ; Hye Lim JUNG ; Bin CHO ; Yong Mook CHOI ; Jeong Ok HAH ; Tai Ju HWANG
Korean Journal of Pediatric Hematology-Oncology 2004;11(2):137-152
PURPOSE: The annual incidence of aplastic anemia (AA) in Asian countries is higher than in Western countries. The pathogenesis in AA has been investigated in hematopoiesis and immunology. Recently, the survival rate and the quality of life of the patients with AA have been steadily improved by the development of a variety of treatments such as the immunosuppressive therapy (IST), and hematopoietic stem cell transplantation (HSCT). The Korean Society of Pediatric Hematology-oncology retrospectively investigated the incidence, treatment strategies, survival rate, and time to become independent from transfusion in patients with AA, who were diagnosed from January 1st, 1991 to December 31st, 2000 in Korea. METHODS: All the questionnaires were sent to a group of training hospitals, and we collected about 600 questionnaire forms from 27 hospitals. However, 493 reports were available for data analysis. RESULTS: The male and female ratio in AA is 1.1 (259 males vs. 234 female). The median age at diagnosis is 9 years old (range; 0.8~16 years old). The annual incidence of children with AA in Korea is 4.5 per million on the basis of Korean pediatric population. In etiology, there are 20 cases (4.1%) in congenital and others in acquired AA. In acquired AA, the cause of illness was not identifiable for most of the patients, but 1 patient had hepatitis-associated AA, and 3 patients developed the illness after medication. According to the initial laboratory data at diagnosis, the peripheral blood findings showed that hemoglobin is 7.1+/-2.4 g/dL, white blood cell 3, 200/microL (200~16, 550), absolute neutrophil counts 670/microL (0~12, 487), platelets 19, 000/microL (1, 000~500, 000), and corrected reticulocytes 0.18% (0.0~4.7). The bone marrow examination revealed that cellularity was below 25% in 348 patients, and over 25% in 105 patients. In the available data, 269 patients (54.6%) were diagnosed of severe aplastic anemia (SAA) and 224 patients of non-SAA (NSAA). HSCT were done for 96 patients (19.5%) and others received another treatments such as the IST. The anti-thymocyte globulin (ATG) or anti-lymphocyte globulin (ALG) treatment was done for 263 cases, corticosteroids for 259, cyclosporine A (CSA) for 215, and anabolic steroids for 138. The combination IST including ATG or ALG plus corticosteroid plus CSA were applied to 154 children with AA, and transfusion only in 37, as conservative care. In case of those patients with HSCT, the time from diagnosis to transplantation was 12 months (1~144 months) and the sources of stem cells were bone marrow in 82 cases, growth factor mobilized peripheral blood in five, and cord blood in six. There were 57 patients transfused below 40 units of blood products before HSC transplantation. Graft rejection was identified from 16 patients, and booster transplantations were done for 12 patients among them. In complications of HSCT, the graft versus host disease was developed in 20 patients and viral diseases in 12 cases including the CMV, herpetic infection, and hepatitis. Also, one patient suffered from veno-occlusive disease. The overall survival rate in children with AA is 64.3%. The survival rate in HSCT is better than that IST (76.9% vs. 62.6%, P< 0.05). In IST, overall survival rate in very SAA showed lower than SAA and NSAA, and in SAA lower than NSAA in case of absolute neutrophil count below 200/microL (P< 0.05). There was no significant difference in terms of the sex, age at beginning of treatment. In HSCT, transfusion was not related to the survival rate. However, overall survival rate is better in short interval between diagnosis and HSCT than in long interval (P< 0.05). There was no significant difference in the probability of transfusion independence according to treatment strategies, even though it was 71.0% in HSCT and 12.8% in immunosuppressive therapy at the end point of survey (P=0.47). The response pattern was as follows. There were 155 cases of complete response, 110 of partial response and 120 of no response in spite of various treatments. The relapse after treatment was found in 11 patients after IST, of which 6 patients experienced more than 2nd relapse. The median time between the end of treatment and relapse was 16 months (6~84 months). Only three cases developed into other diseases (1 case into acute myeloid leukemia and 2 cases into myelodysplastic syndrome). The median time from diagnosis to the end of treatment was 62 months (0.5~174 months). In fatal cases, the median time between diagnosis and death was 29 months (0~144 months) despite several therapeutic strategies. CONCLUSION: In Korea, the annual incidence of children with AA is 4.5 per million. This result is similar to the ones reported in other Asian countries, but higher than those in Western countries. Although a lot of children with AA received various therapies including IST or HSCT, new treatment strategies have to be developed to improve the survival rate and the quality of life of children with AA
Adrenal Cortex Hormones
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Allergy and Immunology
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Anemia, Aplastic*
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Antilymphocyte Serum
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Asian Continental Ancestry Group
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Bone Marrow
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Bone Marrow Examination
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Child*
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Cyclosporine
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Diagnosis
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Epidemiology*
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Female
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Fetal Blood
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Graft Rejection
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Graft vs Host Disease
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Hematopoiesis
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Hematopoietic Stem Cell Transplantation
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Hepatitis
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Humans
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Incidence
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Korea*
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Leukemia, Myeloid, Acute
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Leukocytes
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Male
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Neutrophils
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Quality of Life
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Surveys and Questionnaires
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Recurrence
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Reticulocytes
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Retrospective Studies*
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Statistics as Topic
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Stem Cells
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Steroids
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Survival Rate
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Virus Diseases