• Journal of The Korean Society of Inherited Metabolic disease
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• v.14 no.2
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• pp.150-155
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• 2014

The measurement of $17{\alpha}$-hydroxyprogesterone ($17{\alpha}$-OHP) in a dried blood spot on filter paper is an important for screening of congenital adrenal hyperplasia (CAH). Since high levels of $17{\alpha}$-OHP are frequently observed in premature infants without congenital adrenal hyperplasia, we evaluated cuts-off based on birth weight and performed validation. Birth weight and $17{\alpha}$-OHP concentration data of 292,204 newborn screening subjects in Greencross labopratories were analyzed. The cut-off values based on birth weight were newly evaluated and validated with the original data. The mean $17{\alpha}$-OHP concentration were 7.25 ng/mL in very low birth weight (VLBW) group, 4.02 ng/mL in low birth weight (LBW) group, 2.53 g/mL in normal birth weight (NBW) group, and 2.24 ng/mL in heavy birth weight (HBW) group. The cut-offs for CAH were decided as follows: 21.12 ng/mL for VLBW and LBW groups and 11.14 ng/mL for NBW and HBW groups. When applied new cut-offs for original data, positive rates in VLBW and LBW groups were decreased and positive rates in NBW and HBW groups were increased. The cut-offs based on birth weight should be used in the screening for CAH. We believe that our new cut-off reduce the false positive rate and false negative rate and our experience for cut-off set up and validation will be helpful for other laboratories doing newborn screening test.

• Korean Journal of Clinical Laboratory Science
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• v.36 no.2
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• pp.127-130
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• 2004

Analytical sensitivity on TDM test is the lowest concentration that can be distinguished from background noise. The aim of study was to evaluate analytical sensitivity that is also referred to as the lower limit of detection(LLD) about difference between zero calibrator and isotonic saline sample. We tested for 10 days with zero calibrators and 0.85% saline samples while running trilevel control samples under control. Raw data divided by two groups calculated mean and standard deviation from two sample populations and analytical sensitivity by ${\bar{X}}+2SD$. In comparison with isotonic saline samples and zero calibrators, there were significant differences in phenytoin, phenobarbital and vancomycin, etc. Especially analytical sensitivity on phenytoin is at the same level as the upper limit of analytical measurement range with $40{\mu}g/mL$. We think the cause of this is matrix interference. In conclusion, we were sure that standard protocol for analytical sensitivity as lower limit of analytical measurement range on TDM test must be measured with zero standard rather than an isotonic saline sample and type 1 reagent DW for reducing matrix effects within interactions between different materials in a mixture.

• Korean Journal of Clinical Laboratory Science
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• v.36 no.2
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• pp.121-126
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• 2004

The primary goal of six sigma is to improve patient satisfaction, and thereby profitability, by reducing and eliminating defects. Defects may be related to any aspect of customer satisfaction: high product quality, schedule adherence, cost minimization, process capability indices, defects per unit, and yield. Many six sigma metrics can be mathematically related to the others. Literally, six means six standard deviations from the mean or median value. As applied to quality metrics, the term indicates that failures are at least six standard deviations from the mean or norm. This would mean about 3.4 failures per million opportunities for failure. The objective of six sigma quality is to reduce process output variation so that on a long term basis, which is the customer's aggregate experience with our process over time, this will result in no more than 3.4 defect Parts Per Million(PPM) opportunities (or 3.4 Defects Per Million Opportunities. For a process with only one specification limit (upper or lower), this results in six process standard deviations between the mean of the process and the customer's specification limit (hence, 6 Sigma). The results of applicative six sigma experiment studied on 18 items TP, ALB, T.B, ALP, AST, ALT, CL, CK, LD, K, Na, CRE, BUN, T.C, GLU, AML, CA tests in clinical chemistry were follows. Assessment of process performance fits within six sigma tolerance limits were TP, ALB, T.B, ALP, AST, ALT, CL, CK, LD, K, Na, CRE, BUN, T.C, GLU, AML, CA with 72.2%, items that fit within five sigma limits were total bilirubin, chloride and sodium were 3 sigma. We were sure that the goal of six sigma would reduce test variation in the process.

• Journal of the Korean Recycled Construction Resources Institute
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• v.9 no.2
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• pp.117-126
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• 2021

An experimental study was carried out to investigate the applicability of cement-based materials for green soil which is a soil for promoting plant growth. The results show that the shear strength of the green soil mixed with gypsum cement (No.3) was low, but the hardness (23.6mm) and pH value (7.4) was most suitable for the vegetation environment. In addition, the initial vegetation germination of green soil, which improved performance by adding a moisturizer, was slower than that of general green soil, and the conductivity value tended to be slightly higher. On the other hand, the slope adhesion of advanced green soil was high, and it was found that the plant growth rate and the regeneration capacity were superior after time passed.

• Korean Journal of Clinical Laboratory Science
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• v.37 no.1
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• pp.1-7
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• 2005

The purpose of this study was to verify (i) a consistent calibration verification for the assessment of method linearity and (ii) calibration agreement with calibration settings. We validated calibration verification through method linearity with different lot number of individual calibrators that span the working range for 9 tests except salicylate with control sample in test. We evaluated that it covered broad analyte range to assay from near zero to the top of the measuring range with 5 or 6 points every three times for 10 analytes in TDM test. Target values were plotted on X-axis with assigned or observed values on the Y-axis. Working range were as follows. Calibration verification of the measuring range (maximum to minimum values) has been validated asetaminophen 0.1 to $304.6_{\mu}g/mL$, salicylate 0 to $1005_{\mu}g/mL$, valproic acid 3.2 to $154.19_{\mu}g/mL$, digoxin 0.17 to 5.65 ng/mL, vancomycine 1.3 to $80.51_{\mu}g/mL$, carbarmazepine 0.1 to $22.3_{\mu}g/mL$, phenytonin 0.6 to $40.21_{\mu}g/mL$, theophyline 0.2 to $40.21_{\mu}g/mL$, primidone 0 to $24.07_{\mu}g/mL$, phenobarbital 0.6 to $60.0_{\mu}g/mL$. Drawing a straight line through five or six points of these data showed good linearity. We are sure that it is important to assess the calibration verification of a test method to ascertain the lowest and highest test results that are reliable.

• KIEAE Journal
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• v.12 no.5
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• pp.43-52
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• 2012

This study aims to analyze the green strategies of laboratory buildings in the U.S. developed by LABS21 and LEED of USGBC. To achieve this goal, the paper analyzed the design process of green laboratories and the sustainable planning strategies. Laboratories, as a building type, have specific requirments stipulated by NIH. Chemical restive measures and biosafety level measures needed to be met in laboratory buildings prior to meeting green measures. Obama Admistration's Executive Order 13514 in mind, the paper has mainly focused on the five areas of green planning strategies in the laboratory buildings; site, energy, water, indoor environment, and materials. The study informed that the current green certification program needs to expand into the particular building types in order to; first, provide more realistic energy-saving benchmarking data, and second, provide building-type-specific green strategies.

• The Korean journal of internal medicine
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• v.33 no.6
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• pp.1119-1128
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• 2018

Background/Aims: In multicenter clinical trials, laboratory tests are performed in the laboratory of each center, mostly using different measuring methodologies. The purpose of this study was to evaluate coefficients of variation (CVs) of laboratory results produced by various measuring methods and to determine whether mathematical data adjustment could achieve harmonization between the methods. Methods: We chose 10 clinical laboratories, including Green Cross Laboratories (GC Labs), the central laboratory, for the measurement of total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), serum triglycerides, creatinine, and glucose. The serum panels made with patient samples referred to GC Labs were sent to the other laboratories. Twenty serum samples for each analyte were prepared, sent frozen, and analyzed by each participating laboratory. Results: All methods used by participating laboratories for the six analytes had traceability by reference materials and methods. When the results from the nine laboratories were compared with those from GC Labs, the mean CVs for total cholesterol, HDL-C, LDL-C, and glucose analyzed using the same method were 1.7%, 3.7%, 4.3%, and 1.7%, respectively; and those for triglycerides and creatinine analyzed using two different methods were 4.5% and 4.48%, respectively. After adjusting data using Deming regression, the mean CV were 0.7%, 1.4%, 1.8%, 1.4%, 1.6%, and 0.8% for total cholesterol, HDL-C, LDL-C, triglyceride, creatinine, and glucose, respectively. Conclusions: We found that more comparable results can be produced by laboratory data harmonization using commutable samples. Therefore, harmonization efforts should be undertaken in multicenter trials for accurate data analysis (CRIS number; KCT0001235).

• Korean Journal of Clinical Laboratory Science
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• v.39 no.1
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• pp.31-36
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• 2007

The purpose of the clinically reportable range (CRR) in clinical chemistry is to estimate linearity in working range. The reportable range includes all results that may be reliably reported, and embraces two types of ranges: the analytical measurement range (AMR) is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment not part of the usual assay process. CAP and JCAHO require linearity on analyzers every six months. The clinically reportable range is the range of analyte values that a method can measure, allowing for specimen dilution, concentration, or other pretreatment used to extend the direct analytical measurement range. The AMR cannot exceed the manufacturer's limits. Establishing AMR is easily accomplished with Calibration Verification Assessment and experimental Linearity. For example: The manufacturer states that the limits of the AST on their instrument are 0-1100. The lowest level that could be verified is 2. The upper level is 1241. The verified AMR of the instrument is 2-1241. The lower limit of the range is 2, because that is the lowest level that could be verified by the laboratory. The laboratory could not use the manufacturer's lower limit of 2 because they have not proven that the instrument values below 2 are valid. The upper limit of the range is 1241, because although the lab has shown that the instrument is linear to 1241, the manufacturer does not make that claim. The laboratory needs to demonstrate the accuracy and precision of the analyzer, as well the validation of the patient AMR. Linearity requirements have been eliminated from the CLIA regulations and from the CAP inspection criteria, however, many inspectors continue to feel that linearity studies are a part of good lab practice and should be encouraged. If a lab chooses to continue linearity studies, these studies must fully comply with the calibration/calibration verification requirements of CLIA and/or CAP. The results of lower limit and upper limit of clinically reportable range were total protein (2.1 - 79.9), albumin (1.3 - 39), total bilirubin (0.2 - 106.2), alkaline phosphatase (13 - 6928.2), aspartate aminotransferase (24 - 7446), alanine aminotransferase (13 - 6724.2), gamma glutamyl transpeptidase (16.64 - 9904.2), creatine kinase (15.26 - 4723.8), lactate dehydrogenase (127.66 - 13231.8), creatinine (0.4 - 129.6), blood urea nitrogen (8.67 - 925.8), uric acid (1.6 - 151.2), total cholesterol (48.52 - 3162), triglycerides (36.91 - 3367.8), glucose (31 - 4218), amylase (21 - 6694.2), calcium (3.1 - 118.2), inorganic phosphorus (1.11 - 108), HDL (11.74 - 666), NA (58.3 - 1800), K (1.0 - 69.6), CL (38 - 1230).

• Korean Journal of Clinical Laboratory Science
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• v.38 no.2
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• pp.117-124
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• 2006

The analytical measurement range (AMR) is the range of analyte values that a method can directly measure on a specimen without any dilution, concentration, or other pretreatment not part of the usual assay process. The linearity of the AMR is its ability to obtain test results which are directly proportional to the concentration of analyte in the sample from the upper and lower limit of the AMR. The AMR validation is the process of confirming that the assay system will correctly recover the concentration or activity of the analyte over the AMR. The test specimen must have analyte values which, at a minimum, are near the low, midpoint, and high values of the AMR. The AMR must be revalidated at least every six months, at changes in major system components, and when a complete change in reagents for a procesure is introduced; unless the laboratory can demonstrate that changing the reagent lot number does not affect the range used to report patient test results. The AMR linearity was total protein (0-16.6), albumin (0-8.1), total bilirubin (0-18.1), alkaline phosphatase (0-1244.3), aspartate aminotransferase (0-1527.9), alanine aminotransferase (0-1107.9), gamma glutamyl transpeptidase (0-1527.7), creatine kinase (0-1666.6), lactate dehydrogenase (0-1342), high density lipoprotein cholesterol (0.3-154.3), sodium (35.4-309), creatinine (0-19.2), blood urea nitrogen (0.5-206.2), uric acid (0-23.9), total cholesterol (-0.3-510), triglycerides (0.7-539.6), glucose (0-672.7), amylase (0-1595.3), calcium (0-23.9), inorganic phosphorus (0.03-17.0), potassium (0.1-116.5), chloride (3.3-278.7). We are sure that materials for the AMR affect the evaluation of the upper limit of the AMR in the process system.

• 한국정보디스플레이학회:학술대회논문집
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• 2003.07a
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• pp.339-342
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• 2003

Main PDP panel efficacy improvement factors are discussed. A large panel efficacy improvement can be obtained through a combination of discharge efficiency improvement and phosphor improvement. Important design elements are a high Xe-content gas mixture, the application of a $TiO_2-layer$, and a new green phosphor with little saturation at high VUV-load. In a 4-inch color test panel with a conventional stripe-type cell configuration a white efficacy of 4.4 lm/W and a luminance of 5000 $cd/m^2$ is obtained for sustaining at 250V in addressed condition.