• Title/Summary/Keyword: Test Validation

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Introduction on the Products and the Quality Management Plans for GOCI-II (천리안 해양위성 2호 산출물 및 품질관리 계획)

  • Lee, Sun-Ju;Lee, Kyeong-Sang;Han, Tae Hyun;Moon, Jeong-Eon;Bae, Sujung;Choi, Jong-kuk
    • Korean Journal of Remote Sensing
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    • v.37 no.5_2
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    • pp.1245-1257
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    • 2021
  • GOCI-II, succeeding the mission of GOCI, was launched in February 2020 and has been in regular operation since October 2020. Korea Institute of Ocean Science and Technology (KIOST) processes and produces in real time Level-1B and 26 Level-2 outputs, which then are provided by Korea Hydrographic and Oceanographic Agency (KHOA). We introduced current status of regular GOCI-II operation and showed future improvement. Basic GOCI-II products including chlorophyll-a, total suspended materials, and colored dissolved organic matter concentration, are induced by OC4 and YOC algorithms, which were described in detail. For the full disk (FD), imaging schedule was established considering solar zenith angle and sun glint during the in-orbital test, but improved by further considering satellite zenith angle. The number of slots satisfying the condition 'Best Ocean' significantly increased from 15 to 78. GOCI-II calibration requirements were presented based on that by European Space Agency (ESA) and candidate fixed locations for calibrating local observation area were. The quality management of FD uses research ships and overseas bases of KIOST, but it is necessary to establish an international calibration/validation network. These results are expected to enhance the understanding of users for output processing and help establish detailed plans for future quality management tasks.

A Study on the Establishment and Operation of a Regulatory Response Framework in connection with the Regulatory Strength of the Licensing Policy for New Medical Devices -Focusing on the Application of FMEA- (의료기기 신제품의 인허가정책 규제강도에 연계한 규제대응 프레임워크 수립 및 운영에 관한 연구 - FMEA 적용을 중심으로 -)

  • Kim, Gyosu;Ru, Gyuha;Kim, Yeonhee
    • Journal of Technology Innovation
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    • v.28 no.4
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    • pp.1-26
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    • 2020
  • Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

Optimization of Analytical Method for Annatto Pigment in Foods (식품 중 안나토색소 분석법 최적화 연구)

  • Lee, Jiyeon;Park, Juhee;Lee, Jihyun;Suh, Hee-Jae;Lee, Chan
    • Journal of Food Hygiene and Safety
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    • v.36 no.4
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    • pp.298-309
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    • 2021
  • In this study we sought to develop a simultaneous analysis method for cis-bixin and cis-norbixin, the main components, to detect annatto pigment in food. To establish the optimal test method, the HPLC analysis methods of the European Food Safety Authority (EFSA), Japan's Ministry of Health, Labor and Welfare (MHLW), and National Institute of Food and Drug Safety Evaluation (NIFDS) were compared and reviewed. In addition, a new pretreatment method applicable to various foods was developed after selecting conditions for simultaneous high-performance liquid chromatography (HPLC) analysis in consideration of linearity, limit of detection (LOD), limit of quantification (LOQ), and analysis time. The HPLC analysis method of NIFDS showed the best linearity (R2 ≥ 0.999), exhibiting low detection and quantification limits for cis-norbixin and cis-bixin as 0.03, 0.05 ㎍/mL, and 0.097, 0.16 ㎍/mL, respectively. All previously reported pretreatment methods had limitations in various food applications. However, the new pretreatment method showed a high recovery rate for all three main food groups of fish meat and meat products, processed cheese and beverages. This method showed an excellent simultaneous recovery rate of 98% or more for cis-bixin and cis-norbixin. The HPLC analysis method with a new pretreatment method showed high linearity with a coefficient of determination (R2) of 1 for both substances, and the accuracy (recovery rate) and precision (%RSD) were 98% and between 0.4-7.9, respectively. From this result, the optimized analytical method was considered to be very suitable for the simultaneous analysis of cis-bixin and cis-norbixin, two main components of annatto pigment in food.

A Development and Validation Study of the Web-based Korean Version of the Eating Disorder Diagnostic Scale DSM-5 (웹 기반 한국판 섭식장애진단척도 DSM-5의 개발 및 타당화 연구)

  • Lee, Hye Rin;Kwag, Kyung Hwa;Lee, You Kyung;Han, Soo Wan;Kim, Youl-Ri
    • Korean Journal of Psychosomatic Medicine
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    • v.28 no.2
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    • pp.185-193
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    • 2020
  • Objectives : The aim of this study was to develop and to verify the Korean version of the Eating Disorder Diagnosis Scale DSM-5 (K-EDDS) as a web-based diagnostic system, which enables rapid diagnosis of patients for early intervention. Methods : A total of 119 persons participated in the study, including patients with eating disorders (n=38) and college students (n=81). Along with the paper-and-pencil SCOFF, all participants completed the web-based K-EDDS, the Eating Disorder Examination-Questionaire (EDE-Q), and the Clinical Impairment Assessment Questionnaire (CIA). The semi-structured interview using the Eating Disorder Examination Interview (EDE) was conducted for participants with two or more SCOFF scores. Within two weeks, the web-based K-EDDS, the EDE-Q, and the CIA were re-tested. Results : In the exploratory factor analysis, four factors were extracted : body dissatisfaction, binge behaviors, binge frequency and compensatory behaviors. The four subscales of the web-based K-EDDS had significant correlation with each of the four subscales of the EDE-Q. The internal consistency of the web-based K-EDDS was highly satisfactory (Cronbach's alpha=0.93). The diagnostic agreement between the web-based K-EDDS and the EDE was excellent (96.83%), and the web-based K-EDDS's test-retest diagnostic agreement was fairly good (92.86%). The web-based K-EDDS and the CIA also showed significant differences between patients and general population, supporting discriminant validity. Conclusions : This study suggested that the web-based K-EDDS is a valid tool for assisting diagnosis of eating disorders based on DSM-5 in clinical and research fields.

Development of Method using LC-ESI-MS/MS and KASP for Identification of Gymnema sylvestre in Food (식품에서 당살초 판별을 위한 LC-ESI-MS/MS 분석법과 KASP 마커 개발)

  • Park, Boreum;Lee, Sun Hee;Eom, Kwonyong;Noh, Eunyoung;Moon Han, Kyoung;Hwang, Jinwoo;Kim, Hyungil;Baek, Sun Young
    • Journal of Food Hygiene and Safety
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    • v.37 no.2
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    • pp.46-54
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    • 2022
  • Known for its effectiveness in weight loss and diabetes prevention, Gymnema sylvestre products can be found in the US, Japanese, and Indian markets. However, the recommended dosage or safety of these products has not yet been proven. Therefore, development of an analytical method for detecting the content of Gymnema sylvestre in food products is required. Accordingly, this study proposes an analysis method that can examine Gymnema sylvestre in food using LC-ESI-MS/MS and KASP (Kompetitive Allele-Specific PCR) markers. In LC-ESI-MS/MS, a simultaneous analysis method for gymnemic acid and deacylgymnemic acid was optimized using negative ionization mode, and its validation test was completed for solid and liquid samples. In addition, KASP markers were prepared by finding the specific SNP of G. sylvestre in ITS2 and matK through DNA barcodes. The two KASP markers returned positive FAM fluorescence result when combined with G. sylvestre, and this aspect was confirmed in raw G. sylvestre as well. The applicability of the method was tested on 21 different food and healthy functional products containing G. sylvestre purchased on the internet. As a result, although there was a difference in the ratios of gymnemic acid and deacylgymnemic acid in LC-ESI-MS/MS, the index component was detected in all 21 products samples. In the KASP analysis, 9 products returned positive FAM result, and the rest of the products were found to be containing G. sylvestre extract. This study is the first study to use the dual system of LC-ESI-MS/MS and KASP for the analysis of G. sylvestre. The study has confirmed that these two methods are applicable to the examine G. sylvestre content in food products.

Development and Validation of the 'Food Safety and Health' Workbook for High School (고등학교 「식품안전과 건강」 워크북 개발 및 타당도 검증)

  • Park, Mi Jeong;Jung, Lan-Hee;Yu, Nan Sook;Choi, Seong-Youn
    • Journal of Korean Home Economics Education Association
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    • v.34 no.1
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    • pp.59-80
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    • 2022
  • The purpose of this study was to develop a workbook that can support the class and evaluation of the subject, 「Food safety and health」 and to verify its validity. The development direction of the workbook was set by analyzing the 「Food safety and health」 curriculum, dietary education materials, and previous studies related to the workbook, and the overall structure was designed by deriving the activity ideas for each area. Based on this, the draft was developed, and the draft went through several rounds of cross-review by the authors and the examination and revision by the Ministry of Food and Drug Safety, before the final edited version was developed. The workbook was finalized with corrections and enhancements based on the advice of 9 experts and 44 home economics teachers. The workbook consists of 4 areas: the 'food selection' area, with 10 learning topics and 36 lessons, the 'food poisoning and food management' area, with 10 learning topics and 36 lessons, the 'cooking' area, with 11 learning topics and 43 lessons, and the 'healthy eating' area, with 11 learning topics and 55 lessons, resulting in a total of 42 learning topics, 170 lessons. The workbook was designed to evenly cultivate practical problem-solving competency, self-reliance capacity, creative thinking capacity, and community capacity. In-depth inquiry-learning is conducted on the content, and the context is structured so that self-diagnosis can be made through evaluation. According to the validity test of the workbook, it was evaluated to be very appropriate for encouraging student-participatory classes and evaluations, and to create a class atmosphere that promotes inquiry by strengthening experiments and practices. In the current situation where the high school credit system is implemented and individual students' learning options are emphasized, the results of this study is expected to help expand the scope of home economics-based elective courses and contribute to realizing student-led classrooms with a focus on inquiry.

Comparison between Uncertainties of Cultivar Parameter Estimates Obtained Using Error Calculation Methods for Forage Rice Cultivars (오차 계산 방식에 따른 사료용 벼 품종의 품종모수 추정치 불확도 비교)

  • Young Sang Joh;Shinwoo Hyun;Kwang Soo Kim
    • Korean Journal of Agricultural and Forest Meteorology
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    • v.25 no.3
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    • pp.129-141
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    • 2023
  • Crop models have been used to predict yield under diverse environmental and cultivation conditions, which can be used to support decisions on the management of forage crop. Cultivar parameters are one of required inputs to crop models in order to represent genetic properties for a given forage cultivar. The objectives of this study were to compare calibration and ensemble approaches in order to minimize the uncertainty of crop yield estimates using the SIMPLE crop model. Cultivar parameters were calibrated using Log-likelihood (LL) and Generic Composite Similarity Measure (GCSM) as an objective function for Metropolis-Hastings (MH) algorithm. In total, 20 sets of cultivar parameters were generated for each method. Two types of ensemble approach. First type of ensemble approach was the average of model outputs (Eem), using individual parameters. The second ensemble approach was model output (Epm) of cultivar parameter obtained by averaging given 20 sets of parameters. Comparison was done for each cultivar and for each error calculation methods. 'Jowoo' and 'Yeongwoo', which are forage rice cultivars used in Korea, were subject to the parameter calibration. Yield data were obtained from experiment fields at Suwon, Jeonju, Naju and I ksan. Data for 2013, 2014 and 2016 were used for parameter calibration. For validation, yield data reported from 2016 to 2018 at Suwon was used. Initial calibration indicated that genetic coefficients obtained by LL were distributed in a narrower range than coefficients obtained by GCSM. A two-sample t-test was performed to compare between different methods of ensemble approaches and no significant difference was found between them. Uncertainty of GCSM can be neutralized by adjusting the acceptance probability. The other ensemble method (Epm) indicates that the uncertainty can be reduced with less computation using ensemble approach.

Vitamin D analysis in the Korean total diet study and UV/sun light irradiated mushrooms (한국형 총식이조사 및 UV/태양광 조사 버섯에서의 비타민 D 분석)

  • Min-Jeong Seo;In-Hwa Roh;Jee-Yeon Lee;Sung-Ok Kwon;Cho-Il Kim;Gae-Ho Lee
    • Food Science and Preservation
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    • v.30 no.1
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    • pp.109-121
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    • 2023
  • This study was conducted to evaluate vitamin D intake of Koreans in a total diet study (TDS) and to determine the effect of irradiation on vitamin D synthesis in mushrooms. For analysis, sample were saponified and extracted with hexane, and vitamin D was quantified by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Based on the validation results, the recovery of the National Institute of Standards and Technology (NIST) standard reference sample (SRM) 1849a was 96.7% and the z-score of -1.6 was obtained by the Food Analysis Performance Assessment Scheme (FAPAS) proficiency test (PT) 21115. Vitamin D2 was not detected in any samples, and the highest level of vitamin D3 was detected in mackerel and anchovies ranging from 24.2 to 120.2 ㎍/kg. The mean daily intake of vitamin D was 0.99 ㎍/day, as estimated from the vitamin D contents of the analyzed foods and their corresponding intake. The adequate intake (AI) of vitamin D based on the Dietary reference intakes for Koreans provided by the Ministry of Health and Welfare is 5-15 ㎍/day for Koreans aged 6 to 75 years. Compared with this AI, vitamin D intake of Koreans estimated in this study was inadequate. For that, the increased vitamin D content in ultraviolet (UV)/sun light irradiated mushrooms warrants further research to increase vitamin D intake of Koreans through diet.

A Hybrid Recommender System based on Collaborative Filtering with Selective Use of Overall and Multicriteria Ratings (종합 평점과 다기준 평점을 선택적으로 활용하는 협업필터링 기반 하이브리드 추천 시스템)

  • Ku, Min Jung;Ahn, Hyunchul
    • Journal of Intelligence and Information Systems
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    • v.24 no.2
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    • pp.85-109
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    • 2018
  • Recommender system recommends the items expected to be purchased by a customer in the future according to his or her previous purchase behaviors. It has been served as a tool for realizing one-to-one personalization for an e-commerce service company. Traditional recommender systems, especially the recommender systems based on collaborative filtering (CF), which is the most popular recommendation algorithm in both academy and industry, are designed to generate the items list for recommendation by using 'overall rating' - a single criterion. However, it has critical limitations in understanding the customers' preferences in detail. Recently, to mitigate these limitations, some leading e-commerce companies have begun to get feedback from their customers in a form of 'multicritera ratings'. Multicriteria ratings enable the companies to understand their customers' preferences from the multidimensional viewpoints. Moreover, it is easy to handle and analyze the multidimensional ratings because they are quantitative. But, the recommendation using multicritera ratings also has limitation that it may omit detail information on a user's preference because it only considers three-to-five predetermined criteria in most cases. Under this background, this study proposes a novel hybrid recommendation system, which selectively uses the results from 'traditional CF' and 'CF using multicriteria ratings'. Our proposed system is based on the premise that some people have holistic preference scheme, whereas others have composite preference scheme. Thus, our system is designed to use traditional CF using overall rating for the users with holistic preference, and to use CF using multicriteria ratings for the users with composite preference. To validate the usefulness of the proposed system, we applied it to a real-world dataset regarding the recommendation for POI (point-of-interests). Providing personalized POI recommendation is getting more attentions as the popularity of the location-based services such as Yelp and Foursquare increases. The dataset was collected from university students via a Web-based online survey system. Using the survey system, we collected the overall ratings as well as the ratings for each criterion for 48 POIs that are located near K university in Seoul, South Korea. The criteria include 'food or taste', 'price' and 'service or mood'. As a result, we obtain 2,878 valid ratings from 112 users. Among 48 items, 38 items (80%) are used as training dataset, and the remaining 10 items (20%) are used as validation dataset. To examine the effectiveness of the proposed system (i.e. hybrid selective model), we compared its performance to the performances of two comparison models - the traditional CF and the CF with multicriteria ratings. The performances of recommender systems were evaluated by using two metrics - average MAE(mean absolute error) and precision-in-top-N. Precision-in-top-N represents the percentage of truly high overall ratings among those that the model predicted would be the N most relevant items for each user. The experimental system was developed using Microsoft Visual Basic for Applications (VBA). The experimental results showed that our proposed system (avg. MAE = 0.584) outperformed traditional CF (avg. MAE = 0.591) as well as multicriteria CF (avg. AVE = 0.608). We also found that multicriteria CF showed worse performance compared to traditional CF in our data set, which is contradictory to the results in the most previous studies. This result supports the premise of our study that people have two different types of preference schemes - holistic and composite. Besides MAE, the proposed system outperformed all the comparison models in precision-in-top-3, precision-in-top-5, and precision-in-top-7. The results from the paired samples t-test presented that our proposed system outperformed traditional CF with 10% statistical significance level, and multicriteria CF with 1% statistical significance level from the perspective of average MAE. The proposed system sheds light on how to understand and utilize user's preference schemes in recommender systems domain.

The Influence Evaluation of $^{201}Tl$ Myocardial Perfusion SPECT Image According to the Elapsed Time Difference after the Whole Body Bone Scan (전신 뼈 스캔 후 경과 시간 차이에 따른 $^{201}Tl$ 심근관류 SPECT 영상의 영향 평가)

  • Kim, Dong-Seok;Yoo, Hee-Jae;Ryu, Jae-Kwang;Yoo, Jae-Sook
    • The Korean Journal of Nuclear Medicine Technology
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    • v.14 no.1
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    • pp.67-72
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    • 2010
  • Purpose: In Asan Medical Center we perform myocardial perfusion SPECT to evaluate cardiac event risk level for non-cardiac surgery patients. In case of patients with cancer, we check tumor metastasis using whole body bone scan and whole body PET scan and then perform myocardial perfusion SPECT to reduce unnecessary exam. In case of short term in patients, we perform $^{201}Tl$ myocardial perfusion SPECT after whole body bone scan a minimum 16 hours in order to reduce hospitalization period but it is still the actual condition in which the evaluation about the affect of the crosstalk contamination due to the each other dissimilar isotope administration doesn't properly realize. So in our experiments, we try to evaluate crosstalk contamination influence on $^{201}Tl$ myocardial perfusion SPECT using anthropomorphic torso phantom and patient's data. Materials and Methods: From 2009 August to September, we analyzed 87 patients with $^{201}Tl$ myocardial perfusion SPECT. According to $^{201}Tl$ myocardial perfusion SPECT yesterday whole body bone scan possibility of carrying out, a patient was classified. The image data are obtained by using the dual energy window in $^{201}Tl$ myocardial perfusion SPECT. We analyzed $^{201}Tl$ and $^{99m}Tc$ counts ratio in each patients groups obtained image data. We utilized anthropomorphic torso phantom in our experiment and administrated $^{201}Tl$ 14.8 MBq (0.4 mCi) at myocardium and $^{99m}Tc$ 44.4 MBq (1.2 mCi) at extracardiac region. We obtained image by $^{201}Tl$ myocardial perfusion SPECT without gate method application and analyzed spatial resolution using Xeleris ver 2.0551. Results: In case of $^{201}Tl$ window and the counts rate comparison result yesterday whole body bone scan of being counted in $^{99m}Tc$ window, the difference in which a rate to 24 hours exponential-functionally notes in 1:0.114 with Ventri (GE Healthcare, Wisconsin, USA), 1:0.249 after the bone tracer injection in 12 hours in 1:0.411 with 1:0.79 with Infinia (GE healthcare, Wisconsin, USA) according to a reduction a time-out was shown (Ventri p=0.001, Infinia p=0.001). Moreover, the rate of the case in which it doesn't perform the whole body bone scan showed up as the average 1:$0.067{\pm}0.6$ of Ventri, and 1:$0.063{\pm}0.7$ of Infinia. According to the phantom after experiment spatial resolution measurement result, and an addition or no and time-out of $^{99m}Tc$ administrated, it doesn't note any change of FWHM (p=0.134). Conclusion: Through the experiments using anthropomorphic torso phantom and patients data, we found that $^{201}Tl$ myocardium perfusion SPECT image later carried out after the bone tracer injection with 16 hours this confirmed that it doesn't receive notable influence in spatial resolution by $^{99m}Tc$. But this investigation is only aimed to image quality, so it needs more investigation in patient's radiation dose and exam accuracy and precision. The exact guideline presentation about the exam interval should be made of the validation test which is exact and in which it is standardized about the affect of the crosstalk contamination according to the isotope use in which it is different later on.

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