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Performance Evaluation of In Vitro Diagnostic Reagents for Mycobacterium tuberculosis and Non-tuberculous Mycobacteria by FDA Approval (미국 FDA 허가사례를 통해 본 결핵균 및 비결핵 항산균 체외진단용 시약의 성능평가)

  • Kim, Yeun;Park, Sunyoung;Kim, Jungho;Chang, Yunhee;Ha, Sunmok;Choi, Yeonim;Lee, Hyeyoung
    • Korean Journal of Clinical Laboratory Science
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    • v.50 no.1
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    • pp.20-28
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    • 2018
  • Tuberculosis (TB) is a bacterial infection disease caused by members of the species Mycobacterium tuberculosis (MTB) complex. Approximately one third of the world's population is infected with TB. In Korea, approximately 40,000 new patients are identified each year. Moreover, infections from non-tuberculous mycobacteria (NTM) have also increased. In the diagnosis of TB and NTM, traditional bacterial cultures are required for 3 to 4 weeks. Therefore, rapid and accurate diagnostic tests for TB and NTM are needed. To distinguish between TB and NTM, a range of diagnostic methods have been developed worldwide. In vitro diagnostic assays are constantly being developed to meet the increasing need for the rapid and accurate identification for TB and NTM. On the other hand, the performance evaluations of in vitro diagnostic reagents for TB and NTM are lacking. Recently, the Korea Food and Drug Administration (KFDA) issued a guideline for in vitro diagnostic reagents for MTB and NTM. Here, this study analyzed the performance of currently developed in vitro diagnostic reagents for TB and NTM in the US FDA. This analysis of US FDA approved molecular assays could serve as a useful reference for an evaluation of the reagent performance of TB and NTM.

Structural analysis of an 38 feet diffusion style for high-speed catamaran yacht (38피트급 보급형 고속 카타마란 요트의 구조해석)

  • Park, Joo-Shin;Ko, Jae-Yong;Lee, Kyoung-Woo;Oh, Woo-Jun
    • Journal of Navigation and Port Research
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    • v.33 no.3
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    • pp.167-174
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    • 2009
  • Recently, design technology of has been required such as catamaran yacht with high-speed according to expand a marine leisure industry. The domestic technical development for design and production of yacht is not actively than Canada, USA, Japan etc. However, with further development of yacht design & technology, it is need to develop a key technology related to increase the value of catamaran yacht. In the present paper, new guideline is suggest for catamaran yacht as like kinds of marine leisure ship in order for fundamental structure design and structural analysis for twin-hulled ship yacht and techniques for structural analysis as sea leisure ship in this research. The class of society has not been proposed formally about regulation and methodology for estimation of strength of small hight-speed craft with satisfying two conditions as noted; length less than 50meters, ratio of length to breadth less than 12. In the present study, we were adopted DNV (Yachts, Design Principles, Design Loads, Hull Structural Design) Rule and KR (FRP rule application guide) for scantling of structural members. Furthermore, ABS rule is used for structural calculation about application of loading conditions for catamaran yacht. This study can be available feedback role to manufacture of 38ft diffusion style for catamaran yacht. It is expected that this study will be a good reference in order to design of catamaran yacht with high-speed.

Elementary Teachers' Perception in Using Smart-Technology in STEAM Class : Focus on Application Type, Difficulties and Support Required (STEAM 수업에서 스마트테크놀로지 적용에 대한 초등교사의 인식 -적용 유형과 어려움 및 지원을 중심으로-)

  • Han, Areum;Na, Jiyeon
    • Journal of The Korean Association For Science Education
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    • v.39 no.6
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    • pp.777-790
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    • 2019
  • The purpose of this study is to investigate the experience of teachers who apply Smart-technology in elementary school STEAM class and the reasons, difficulties when applying the technology and required support. Semi-structured in-depth interviews were conducted with six elementary school teachers with specialized knowledge in STEAM education who have experienced STEAM lessons several times before. The research findings are as follows: First, research participants utilized a variety of Smart-technology in STEAM class, most of which were experiential or interactive technology. Among the STEAM learning criteria, the Smart-technology in 'Creative Design' course was most often applied. Second, they adopted Smart Technology in STEAM class to encourage students to feel interested, actively participate in the class, enjoy indirect experience, and nurture interest in state-of-the-art technology. They used it to prepare for future societies and organize classes that are suitable for STEAM learning criteria. They also used Smart-technology because it was easy to use. Third, they found it difficult to find, secure, and use suitable Smart-technology when applying Smart-technology in the STEAM class. They also had trouble restructuring the curriculum. In addition, there were difficulties in using Smart-technology in the class such as lack of class hours, increased level of activity, insufficient physical environment and unexpected malfunction of Smart-technology, thus interrupted the class. After the class, it was hard to manage Smart-technology and also, there were difficulties in assessment, record, and negative awareness of surrounding people. Fourth, they mentioned that's suggesting education guidelines, develop, and distribute educational materials are required to enable 'Creative Design,' reduce educational content, provide training, secure Smart-technology equipment and provide Wi-Fi, support teacher's club and communities and create an atmosphere to emotionally support teachers in order to activate using Smart-technology in STEAM class.

Foundation Methods for the Soft Ground Reinforcement of Lightweight Greenhouse on Reclaimed Land: A review (간척지 온실 기초 연약지반 보강 방법에 대한 고찰)

  • Lee, Haksung;Kang, Bang Hun;Lee, Su Hwan
    • Journal of Bio-Environment Control
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    • v.29 no.4
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    • pp.440-447
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    • 2020
  • The demand for large-scale horticultural complexes utilizing reclaimed lands is increasing, and one of the pending issues for the construction of large-scale facilities is to establish foundation design criteria. In this paper, we tried to review previous studies on the method of reinforcing the foundation of soft ground. Target construction methods are spiral piles, wood piles, crushed stone piles and PF (point foundation) method. In order to evaluate the performance according to the basic construction method, pull-out resistance, bearing capacity, and settlement amount were measured. At the same diameter, pull-out resistance increased with increasing penetration depth. Simplified comparison is difficult due to the difference in reinforcement method, diameter, and penetration depth, but it showed high bearing capacity in the order of crushed stone pile, PF method, and wood pile foundation. In the case of wood piles, the increase in uplift resistance was different depending on the slenderness ratio. Wood, crushed stone pile and PF construction methods, which are foundation reinforcement works with a bearing capacity of 105 kN/㎡ to 826 kN/㎡, are considered sufficient methods to be applied to the greenhouse foundation. There was a limitation in grasping the consistent trend of each foundation reinforcement method through existing studies. If these data are supplemented through additional empirical tests, it is judged that a basic design guideline that can satisfy the structure and economic efficiency of the greenhouse can be presented.

Factors influencing the axes of anterior teeth during SWA on masse sliding retraction with orthodontic mini-implant anchorage: a finite element study (교정용 미니 임플랜트 고정원과 SWA on masse sliding retraction 시 전치부 치축 조절 요인에 관한 유한요소해석)

  • Jeong, Hye-Sim;Moon, Yoon-Shik;Cho, Young-Soo;Lim, Seung-Min;Sung, Sang-Jin
    • The korean journal of orthodontics
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    • v.36 no.5
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    • pp.339-348
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    • 2006
  • Objective: With development of the skeletal anchorage system, orthodontic mini-implant (OMI) assisted on masse sliding retraction has become part of general orthodontic treatment. But compared to the emphasis on successful anchorage preparation, the control of anterior teeth axis has not been emphasized enough. Methods: A 3-D finite element Base model of maxillary dental arch and a Lingual tipping model with lingually inclined anterior teeth were constructed. To evaluate factors influencing the axis of anterior teeth when OMI was used as anchorage, models were simulated with 2 mm or 5 mm retraction hooks and/or by the addition of 4 mm of compensating curve (CC) on the main archwire. The stress distribution on the roots and a 25000 times enlarged axis graph were evaluated. Results: Intrusive component of retraction force directed postero-superiorly from the 2 mm height hook did not reduce the lingual tipping of anterior teeth. When hook height was increased to 5 mm, lateral incisor showed crown-labial and root-lingual torque and uncontrolled tipping of the canine was increased.4 mm of CC added to the main archwire also induced crown-labial and root-lingual torque of the lateral incisor but uncontrolled tipping of the canine was decreased. Lingual tipping model showed very similar results compared with the Base model. Conclusion: The results of this study showed that height of the hook and compensating curve on the main archwire can influence the axis of anterior teeth. These data can be used as guidelines for clinical application.

Investigation of Varied MR Spectra by TE and Metabolite Amount in the Localized Voxel using the MR Cone-shape Phantom (자기공명분광법에서 TE와 Voxel 내의 대사물질 양에 따른 스펙트럼 변화 평가에 관한 연구)

  • Woo, Dong-Cheol;Kim, Sang-Soo;Rhim, Hyang-Shuk;Jahng, Geon-Ho;Choe, Bo-Young
    • Progress in Medical Physics
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    • v.18 no.3
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    • pp.179-185
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    • 2007
  • The purpose of this study is to investigate the spectra of a magnetic resonance spectroscopy (MRS) in accordance with the variance of TE and the volumes of metabolites in a localized voxel for the quality assurance using a designed single voxel spectroscopy QA phantom. Because a cone-shade phantom is designed as the volume of metabolite in a localized voxel is changeable, we try to analyze the peaks of each metabolite (NAA, Cr, Cho, Lac, etc.) in accordance with metabolite volume in a localized voxel as well as echo time (TE). All data were obtained using a 3T MRI/MRS machine and analyzed using $jMRUI^{(R)}$. The results of this study show that TE is in inverse proportion to the noise of MRS and the longer TE and the less metabolite volume in the localized voxel, the peak intensities of each metabolite decrease. In case of the lactate, its peak was observed on the all TE only if the greatest metabolite is included in the localized voxel. Then, the intensity of a metabolite is more sensitive to the metabolite volume in the localized voxel than the TE. These obtained in vitro MRS data is provide the guideline that is important for in vivo metabolite quantification. But, in the edge of cone-shape vial air bubbles were observed and spectrum could not obtained. Therefore our cone-shape MRS phantom needs to be modified in order to solve these problems.

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Pain Reduction Effects of Lidocaine Gel for Urethral Catheterization : A Systematic Review and Meta-Analysis (요도 카테터 삽입술에서 리도카인 윤활제의 통증 감소 효과 : 체계적 문헌고찰과 메타분석)

  • Hong, Hyun-Jung;Kim, Ga-Eun;Lee, Ha-Nee;Lee, A-Reum
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.18 no.6
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    • pp.438-448
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    • 2017
  • This study was a systematic review and meta-analysis that evaluated the results of research on the pain reduction effects of lidocaine gel for urethral catheterization in adults. A literature search was conducted using seven electronic databases, gray literature and other resources based on the guidelines of Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA). A Risk of Bias (RoB) tool was applied to assess the quality of selected studies. Data were analyzed using the RevMan 5.3.-program. Sixteen randomized controlled trials involving 1904 adults were included. RoB was not observed in the funnel plot. Overall, lidocaine gel was effective for pain reduction during urethral catheterization (Standard Mean Difference[SMD] -0.96;95% CI: -1.43, -0.49). To explore the cause of heterogeneity (I2=95%, p<.001), subgroup analysis was conducted according to three catheter types (urinary catheter, flexible cystoscopy, and rigid cystoscopy) and the SMDs were -0.88 (95% CI:-1.51, -0.26), -0.31 (95% CI:-0.63, 0.01), and -1.93 (95% CI:-2.88, -0.97), respectively. A significant pain reduction effect was observed regardless of gender in urinary catheterization. However, in rigid cystoscopy, a significant pain reduction effect was observed only in male subjects. Pain reduction effects were observed when 10~11ml lidocaine gel was used during rigid cystoscopy and when lubrication was used during urinary catheterization, irrespective of application time. These findings suggest that lidocaine gel is a useful anesthetic lubricant for urinary catheterization and rigid cystoscopy in male adults.

Evaluation of Patient Radiation Doses Using DAP Meter in Interventional Radiology Procedures (인터벤션 시술 시 면적선량계를 이용한 환자 방사선 선량 평가)

  • Kang, Byung-Sam;Yoon, Yong-Su
    • Journal of radiological science and technology
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    • v.40 no.1
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    • pp.27-34
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    • 2017
  • The author investigated interventional radiology patient doses in several other countries, assessed accuracy of DAP meters embedded in intervention equipments in domestic country, conducted measurement of patient doses for 13 major interventional procedures with use of Dose Area Product(DAP) meters from 23 hospitals in Korea, and referred to 8,415 cases of domestic data related to interventional procedures by radiation exposure after evaluation the actual effectives of dose reduction variables through phantom test. Finally, dose reference level for major interventional procedures was suggested. In this study, guidelines for patient doses were $237.7Gy{\cdot}cm^2$ in TACE, $17.3Gy{\cdot}cm^2$ in AVF, $114.1Gy{\cdot}cm^2$ in LE PTA & STENT, $188.5Gy{\cdot}cm^2$ in TFCA, $383.5Gy{\cdot}cm^2$ in Aneurysm Coil, $64.6Gy{\cdot}cm^2$ in PTBD, $64.6Gy{\cdot}cm^2$ in Biliary Stent, $22.4Gy{\cdot}cm^2$ in PCN, $4.3Gy{\cdot}cm^2$ in Hickman, $2.8Gy{\cdot}cm^2$ in Chemo-port, $4.4Gy{\cdot}cm^2$ in Perm-Cather, $17.1Gy{\cdot}cm^2$ in PCD, and $357.9Gy{\cdot}cm^2$ in Vis, EMB. Dose referenece level acquired in this study is considered to be able to use as minimal guidelines for reducing patient dose in the interventional radiology procedures. For the changes and advances of materials and development of equipments and procedures in the interventional radiology procedures, further studies and monitorings are needed on dose reference level Korean DAP dose conversion factor for the domestic procedures.

Deriving Key Risk Sub-Clauses of General Conditions of FIDIC White Book - Based on FIDIC Client/Consultant Model Services Agreement, 5th edition 2017 - (FIDIC White Book 일반조건 핵심 리스크 세부조항 도출 - 피딕 클라이언트/컨설턴트 모델 서비스 계약, 2017년 5판 기준으로 -)

  • Jei, Jaeyong;Hong, Seongyeoll;Seo, Sungchul;Park, Hyungkeun
    • Korean Journal of Construction Engineering and Management
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    • v.24 no.2
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    • pp.59-69
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    • 2023
  • FIDIC White Book is a Model Services Agreement between the Client and the Consultant. This study aimed to derive the Key Risk Sub-Clauses out of 63 Sub-Clauses of General Conditions of the FIDIC White Book by using the Delphi technique. A panel of 40 experts with more than 10 years of experience and expertise in overseas construction services agreements and FIDIC White Book was formed, and the reliability was improved in the direction of increasing the consensus of experts through a total of three Delphi survey processes. In the first Delphi survey, a closed-type survey was conducted on the impact of risk among 63 Sub-Clauses of General Conditions on a Likert 5-point scale, and 26 main risk Sub-Clauses were derived. The Content Validity of the results of the first Delphi survey was verified with the CVR value. In the 2nd and 3rd Delphi surveys, a closed-type survey was conducted on a Likert 10-point scale for 26 main risk Sub-Clauses and the risk possibility and impact of each main risk Sub-Clause were evaluated. The reliability of the 3rd Delphi survey result was verified with the COV value. Total 14 Key Risk Sub-Clauses were derived by applying the average risk possibility and impact of each of the 26 main risk Sub-Clauses to the PI Risk Matrix. The results of deriving Key Risk Sub-Clauses showed that agreement on specific scope of service, delay management, and change management were the most important. As a result of this study, from a practical point of view, consultants of consulting companies provide guidelines that should be reviewed to minimize contractual risks when signing service contracts with clients. From an academic point of view, the direction of research on deriving key risks related to service contracts for consultants participating in overseas construction is presented.