1.Clinical Chemistry.
Journal of the Korean Medical Association 1997;40(2):197-202
No abstract available.
Chemistry, Clinical*
2.Comparison of Method Group Precision in Proficiency Testing of Clinical Chemistry Tests Before and After Two Major Changes: Reorganization of Proficiency Testing and Implementation of the Differential Benefit for the Quality of Laboratory Tests
Annals of Laboratory Medicine 2019;39(3):333-339
No abstract available.
Chemistry, Clinical
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Clinical Chemistry Tests
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Methods
3.Test for stupefacient
Journal of Medical and Pharmaceutical Information 1999;(12):13-18
The effective analysis of the stupefacient must be a sensitivity, specificity, and reliability, correct, prompt and easy to make. There are 2 kinds of stupefacient including natural and synthetic agents. The metabolism of the stupefacient and the collection of samples influenced on the results of analysis. The tests of the stupefacient are a test with the high sensitivity in the ligal aspect
Clinical Chemistry Tests
4.Clinical tests of theophylline tablets with release effect prepared by the Hanoi Pharmaceutical college
Pharmaceutical Journal 2003;9(6):26-29
The study conducted on bronchial asthmatic patients treated at Allergic Clinic in Bach Mai Hospital. The patients treated by theophylline pill acting within 12 hours, manufactured by Hanoi College of Pharmacy combined with Central Pharmaceutical Factory No. 2, used single-blind, controlled method. The patients used 200mg dose, twice in day (8 a.m and 8 p.m), separated from each other 12 hours. Results: The change of respiratory functions are good, both groups are more than 15 percentage
Theophylline
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Clinical Chemistry Tests
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Tablets
5.A Questionnaire Survey on General Status and Opinions about Clinical Mass Spectrometric Analysis in Korea (2018)
Sung Eun CHO ; Hyojin CHAE ; Hyung Doo PARK ; Sail CHUN ; Yong Wha LEE ; Yeo Min YUN ; Sang Hoon SONG ; Sang Guk LEE ; Kyunghoon LEE ; Junghan SONG ; Soo Youn LEE ;
Laboratory Medicine Online 2019;9(3):161-165
The Clinical Mass Spectrometry Research Committee (CMSRC), in affiliation with the Korean Society of Clinical Chemistry (KSCC), conducted a questionnaire survey on opinions about the general status of clinical mass spectrometric analysis in Korea. As a result, we understand that this field has passed through the introductory stage and is settled as a field of clinical laboratory testing in Korea, with the number of new laboratories performing mass spectrometric analysis being low. In spite of the many difficulties in introducing and operating clinical mass spectrometric analysis, there is a strong interest in this field, and even though further expansion is expected, there are still many issues to be resolved. In the future, it will be necessary to make concrete and thorough efforts to further develop the laboratory tests using clinical mass spectrometric analysis in Korea, centering on the CMSRC affiliated with the KSCC.
Chemistry, Clinical
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Korea
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Mass Spectrometry
6.Annual Report on the External Quality Assessment Scheme for Routine Clinical Chemistry in Korea (2016).
Yong Wha LEE ; Byung Ryul JEON ; Jeong Gwon KIM ; Sun Hee JUN ; Yeo Min YUN ; Sail CHUN ; Junghan SONG ; Won Ki MIN
Journal of Laboratory Medicine and Quality Assurance 2017;39(2):61-75
In 2016, the clinical chemistry proficiency-testing program consisted of 21 programs, including the general chemistry program of the Korean Association of External Quality Assessment Service. The general chemistry program consisted of 28 test items and was conducted using two level control materials four times per year. Based on the information and results for each test item entered by each institution, statistical analysis data according to test method, instrument, and reagent were reported. The report comprised a general statistics report showing the characteristics of all participating institutions and a separate institutional report showing the evaluation data of individual institutions. The statistics included the number of participating institutions and the mean, standard deviation, coefficient of variation, median, minimum, and maximum values for each group. Each report was composed of a table, histogram, and Levey-Jennings chart showing the statistics for each test item. The results of each institution and the statistics for each classification are presented in the table showing the statistics, and a standard deviation index is presented together with a method classification and a classification by reagent companies. A total of 14 items, including albumin, were evaluated by more than 1,000 institutions. There was no significant difference in the distribution of the measurement methods compared with those used in the previous year. The coefficient of variation showed a tendency to increase as the concentration of the level control material decreased and as the number of participating institutions decreased for each test item. Most of them showed a coefficient of variation within 10%. These statistical data will be useful when interpreting the survey results from the institutions and selecting a test method.
Chemistry
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Chemistry, Clinical*
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Classification
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Korea*
;
Methods
7.Quality control in Clinical Chemistry by "The Multi-Item Univariate Delta Check Method": The Multi-Item Univariate Delta Check Method.
Journal of Korean Society of Medical Informatics 1999;5(3):119-125
Difficulties in calculation that hindered the practice of the delta check in the past is now no longer a problem thanks to the development of computers. But, high false positive rates, which creates heavy burden of checking-work load, are still a problem in the practice of the delta check. We propose a new approach to the reduction of false positive rates, naming our method "the multi-item univariate delta check (MIUDC) method". By the multi-item univariate delta check method, we mean a method in which univariate delta checks are performed on multiple items and specimens with the positive univariate delta check in at least k items receive a detailed investigation. Using data collected in the Department of Clinical Pathology at Korea University Guro Hospital via the Korea University Laboratory Information System, our research found that if we put specimens with positive univariate delta check in at least four test items (k=4) under a detailed investigation, check-out volumes will be light and efficiency will be high. As for test items deserving of more interest, total cholesterol, albumin, and total protein are appropriate because the false positive rate associated with them in the MIUDC was zero in a simulation study.
Chemistry, Clinical*
;
Cholesterol
;
Clinical Laboratory Information Systems
;
Korea
;
Pathology, Clinical
;
Quality Control*
8.Performance Evaluation of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer.
So Young KIM ; Tae Dong JEONG ; Woochang LEE ; Sail CHUN ; Won Ki MIN
Laboratory Medicine Online 2014;4(3):132-139
BACKGROUND: Optimal operational efficiency requires specific technical solutions such as open, flexible, and adaptable space, suitable equipment requirements, and laboratory instrumentation that combine excellent analytical performance with a capacity for testing large panels in a high throughput manner, under rapid turnaround times. Thus, the aim of this study was to assess the analytical performance of the novel Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer. METHODS: Precision, linearity, carry over, detection limits, and comparison studies were performed with 31 routine clinical chemistry tests according to the CLSI guidelines. Commercial quality chemistry control material (Lyphochek, Bio-Rad, USA) and patient sera were used as the test specimens. Unicel DxC instrument (Beckman Coulter, USA) was used as a control analyzer to evaluate the correlation. RESULTS: The total coefficients of variations (CVs) of almost all the analytes were between 0.4 and 4.1%, except for CO2 and ammonia. Excellent linearities were observed in the performance ranges used (r>0.99, slope, 0.961-1.048). Correlations with analogous tests ran on the Unicel DxC instrument were good, correlation coefficients ranging between 0.921 and 1.000. The carryover ranged from -0.216 to 0.481%. CONCLUSIONS: The Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer showed satisfactory precision, linearity, carry over, detection limits, and high throughput capacity. The instrument performance correlated well with the Unicel DxC analyzer. We conclude that the balance of elevated throughput and optimal analytical performance should make Roche-Hitachi cobas c702 Chemistry Autoanalyzer suitable for very large clinical laboratories.
Ammonia
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Chemistry*
;
Clinical Chemistry Tests
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Humans
;
Limit of Detection
9.Evaluation of the MAS Quality Control Materials for Chemistry and Urinalysis.
Journal of Laboratory Medicine and Quality Assurance 2003;25(2):251-257
BACKGROUND: To evaluate the stability and the precision of quality control materials for clinical chemistry analytes, we compared liquid quality control materials, Moni-Trol H (MAS Inc., Camarillo, CA, USA) with lyophilized and other liquid quality control materials. For urinalysis, liquid MAS UA Controls were compared with analyte affixed-strip type quality control materials. METHODS: Using Hitachi-7600 (Hitachi, Tokyo, Japan), we analyzed lyophilized Seronorm & Pathonorm (SERO AS, Billingstad, Norway) and Moni-Trol H for 26 commonly measured chemistry analytes for 3~4 weeks. Using Synchron CX-7 (Beckman Coulter Inc., Fullerton, CA, USA), liquid Decision (Beckman Coulter) and Moni-Trol H were compared for 12 emergency chemistry analytes. For urinalysis, MAS UA Controls were compared with Chek-Stix (Bayer, Elkhart, IN, USA). We evaluate the stability of analyte by regression coefficient and the imprecision by coefficient of variation. RESULTS: Moni-Trol H was more stable than Seronorm & Pathonorm and Decision. The imprecision was more evident with Moni-Trol H than the others, but the CVs of Moni-Trol H were within 10%. In urinalysis, all the results were within two semi-quantity levels with both MAS UA Control and Chek-Stix. CONCLUSIONS: The MAS quality control materials for common chemistry analytes and urinalysis showed good stability and comparable precision. The materials were efficient for laboratory use due to the advantage of human source based liquid form and long-term stability after preparation.
Chemistry*
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Chemistry, Clinical
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Emergencies
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Humans
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Quality Control*
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Urinalysis*
10.Proposal of Modified HIL-indices for Determining Hemolysis, Icterus and Lipemia Interference on the Beckman Coulter AU5800 Automated Platform.
Laboratory Medicine Online 2017;7(2):66-72
BACKGROUND: The amount of interference due to hemolysis, bilirubin, and lipemia can be measured on the AU5800 autoanalyzer (Beckman Coulter, USA) by spectrophotometry. This is reported as semi-quantitative indices, specifically H-index, I-index, and L-index, respectively. In this study, we evaluated the impact of interference using chemistry assays and established the concentration of interfering substances and HIL-index above which analytically significant interference exists, according to CLSI guidelines C56-A and EP7-A2. METHODS: Pooled sera including different concentrations of analytes were prepared and mixed with hemoglobin, bilirubin, or Intralipid. These samples were then tested for 35 clinical chemistry analytes by AU5800 and the bias based on interferent concentrations was computed. The interferent concentration above which significant interference exists was calculated from the 50% within-subject biological variation (desirable analytic goal), and the corresponding index was assigned. RESULTS: Among 35 items evaluated, interference was detected for 12 analytes by hemoglobin, 7 analytes by bilirubin, and 12 analytes by Intralipid. We proposed HIL-index₁ and HIL-index₂ for each analyte according to 2 different medical decision levels. HIL-index₁ and HIL-index₂ were considered more reasonable criteria than the HIL-index from the manufacturer's technical document (HIL-index(TD)). This is because HIL-index(TD) was empirically set to 5% or 10%, and had a wide tolerance range, which was not sufficient to reflect the presence of interference, compared to HIL-index₁ and HIL-index₂. CONCLUSIONS: We have demonstrated hemoglobin, bilirubin, and Intralipid interferences according to CLSI guidelines using the desirable analytic goal. Our results provide applicable information for Beckman Coulter automated chemistry analyzers.
Bias (Epidemiology)
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Bilirubin
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Chemistry
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Chemistry, Clinical
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Hemolysis*
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Hyperlipidemias*
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Jaundice*
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Spectrophotometry