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The Study of Evaluation for Stability of Serum Free PSA In Vitro
( Jum Gi Park ),( Kyung Woong Joo ) 대한임상검사과학회 2013 대한임상검사과학회지(KJCLS) Vol.45 No.1
In the specimen of free PSA in the low concentration, the result in % bias from our institution and comparable evaluation institution was -33.7% which is exceeded % bias ±20% ; however, it was the domestically allowable limit recommended by the laboratory accreditation commission for specimen at the low concentration. In this paper, the cause was accredited by instability of free PSA substance within the specimen, and the specimen stability test was performed according to CLSI documents GP29-A2. After the low and high concentration specimen were made, and rapidly cooled down in a deep freezer with -30oC, serum of two concentrations was measured for 10 consecutive days with 3 times a day by Architect i2000 and observed a change in the mean value. As the results of two groups, there were changes in the established target value, and a change level was evaluated by calculating it with % bias. The low concentration specimen had no significant reduction until the 4 day lapse in cold storage. However, % bias were reduced by -17.5% from the 5 day lapse, by 21.5% after the 7 day lapse, and by -26.9% after the 9 day lapse. The frozen specimen had only intra-day variation for 10 days. In the high concentration specimen, bias began to show as -12.2% from the 3 day lapse in cold storage. There was reduction by -28.9% from the 5 day lapse, by -39% after the 7 day lapse, and by -42.9% after the 9 day lapse. In the frozen specimen, there was only intra-day variation like the low concentration specimen in cold storage.
( Jum Gi Park ),( Kyeng Woong Joo ) 대한임상검사과학회 2011 대한임상검사과학회지(KJCLS) Vol.43 No.1
In clinical chemistry tests, the interfering substances such as hemoglobin, lipid, bilirubin, and drugs, etc. can cause the changes of test results performed by spectrophotometrical methods. We evaluated the effects of interfering substances on the test results by adding interfering substances on the samples in the 19 kinds of clinical chemistry tests such as aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, gamma-glutamyltransferase, total protein, albumin,glucose, total cholesterol, total bilirubin, triglyceride, uric acid, calcium, inorganic phosphours, high density lipoprotein cholesterol, low density lipoprotein cholesterol, creatinine, blood urea nitrogen, and C-reactive protein using newly implemented automatic chemical analyzer Toshiba TBA-C8000 under the direction of CLSI EP07-A guideline. Hemolytic samples show increased concentration of total protein, aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase and reduced concentration of total bilirubin, alkaline phosphatase by interfering effect. Hyperlipemic samples show increased concentration of total protein and alkaline phosphatase and reduced concentration of low density lipoprotein cholesterol. The samples with conjugated bilirubinemia show increased concentration of inorganic phosphours, otherwise the samples with unconjugated bilirubinemia show no interference or allowable range in the test result.
Park, Jum Gi,Joo, Kyeng Woong 대한임상검사과학회 2011 대한임상검사과학회지(KJCLS) Vol.43 No.1
In clinical chemistry tests, the interfering substances such as hemoglobin, lipid, bilirubin, and drugs, etc. can cause the changes of test results performed by spectrophotometrical methods. We evaluated the effects of interfering substances on the test results by adding interfering substances on the samples in the 19 kinds of clinical chemistry tests such as aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, gamma-glutamyltransferase, total protein, albumin, glucose, total cholesterol, total bilirubin, triglyceride, uric acid, calcium, inorganic phosphours, high density lipoprotein cholesterol, low density lipoprotein cholesterol, creatinine, blood urea nitrogen, and C-reactive protein using newly implemented automatic chemical analyzer Toshiba TBA-C8000 under the direction of CLSI EP07-A guideline. Hemolytic samples show increased concentration of total protein, aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase and reduced concentration of total bilirubin, alkaline phosphatase by interfering effect. Hyperlipemic samples show increased concentration of total protein and alkaline phosphatase and reduced concentration of low density lipoprotein cholesterol. The samples with conjugated bilirubinemia show increased concentration of inorganic phosphours, otherwise the samples with unconjugated bilirubinemia show no interference or allowable range in the test result.
The Study of Evaluation for Stability of Serum Free PSA In Vitro
Park, Jum Gi,Joo, Kyung Woong 대한임상검사과학회 2013 대한임상검사과학회지(KJCLS) Vol.45 No.1
In the specimen of free PSA in the low concentration, the result in % bias from our institution and comparable evaluation institution was -33.7% which is exceeded % bias ${\pm}20%$ ; however, it was the domestically allowable limit recommended by the laboratory accreditation commission for specimen at the low concentration. In this paper, the cause was accredited by instability of free PSA substance within the specimen, and the specimen stability test was performed according to CLSI documents GP29-A2. After the low and high concentration specimen were made, and rapidly cooled down in a deep freezer with $-30^{\circ}C$, serum of two concentrations was measured for 10 consecutive days with 3 times a day by Architect i2000 and observed a change in the mean value. As the results of two groups, there were changes in the established target value, and a change level was evaluated by calculating it with % bias. The low concentration specimen had no significant reduction until the 4 day lapse in cold storage. However, % bias were reduced by -17.5% from the 5 day lapse, by 21.5% after the 7 day lapse, and by -26.9% after the 9 day lapse. The frozen specimen had only intra-day variation for 10 days. In the high concentration specimen, bias began to show as -12.2% from the 3 day lapse in cold storage. There was reduction by -28.9% from the 5 day lapse, by -39% after the 7 day lapse, and by -42.9% after the 9 day lapse. In the frozen specimen, there was only intra-day variation like the low concentration specimen in cold storage.
박점기 ( Jum Gi Park ) 대한임상검사과학회 2004 대한임상검사과학회지(KJCLS) Vol.36 No.2
The lower limit of detection, precision, setting method of target value, reportable range determination, recovery, linearity, and comparison study with another equipment was evaluated for the Toshiba-120FR chemistry autoanalyzer which was newly introduced at the Daejeon Veteran Hospital in Dec. 2003. Nineteen kinds of test for AST, ALT, ALP, LDH, GGT, TP, ALB, GLU, T-cho, T-bil, TG, UA, CAL, IP, AMY, HDL-C, LDL-C, Cre and BUN were performed to evaluate the lower limit of detection, precision, setting method of target value, reportable range determination, recovery, linearity, and comparison study with other equipment according to the NCCLS guidelines(EP5-A, EP6-P, EP9-A). The Toshiba-120FR autochemical analyzer showed good precision for all tested items. The data concerning the lower limit of detection, precision(total CV 0.47%~3.65%), setting method of target value, reportable range determination, recovery(93%~111%), linearity(R2=0.997~0.999), and comparison study(r=0.977~0.999) with other equipment was acceptable for all tested items. The results of evaluation for the Toshiba-120FR autochemical analyzer showed that this equipment could be used as an alternative to other equipment.
Jum Soo Yoo,Gi Pyoung Kim 한국IT마케팅학회 2015 Journal of Information Technology and Management Vol.3 No.2
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