• Title/Summary/Keyword: food and drug

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Laboratory Diagnosis of Coronavirus Disease 19 (COVID-19) in Korea: Current Status, Limitation, and Challenges (국내 중증 급성 호흡기 증후군 코로나 바이러스의 검사실 내 진단: 현재, 한계점 그리고 직면한 과제)

  • Song, Gi Seon;Lee, You-Rim;Kim, Sungmin;Kim, Wontae;Choi, Jungwon;Yoo, Dahyeon;Yoo, Jungyoung;Jang, Kyung-Tae;Lee, Jaewang;Jun, Jin Hyun
    • Korean Journal of Clinical Laboratory Science
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    • v.52 no.3
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    • pp.284-295
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    • 2020
  • In December 2019, the first coronavirus disease- 2019 (COVID-19) patient was reported in Wuhan, Hubei Province, China. Since then, the number of patients who suffered severe acute respiratory syndrome caused by the novel Coronavirus (SARS-CoV-2 or 2019-nCoV) has increased dramatically in Korea. This new variant virus induces pulmonary diseases, including cough, sore throat, rhinorrhea, dyspnea, and pneumonia. Because SARS-CoV-2 is an RNA virus, real-time reverse-transcriptase PCR has been used widely to diagnose COVID-19. As the Korea Centers for Disease Prevention and Control (KCDC) and Ministry of Food & Drug Safety (MFDS) approved emergency use authorization, clinical specimens collected from COVID-19 patients and even healthy people have been clinically diagnosed by laboratory medicine. Based on a literature search, this paper reviews the epidemiology, symptoms, molecular diagnostics approved by KCDC, a current diagnosis of COVID-19 in the laboratories, the difference between molecular and serological diagnosis, and guidelines for clinical specimens. In addition, the Korean guidelines of biosafety for clinical laboratory scientists are evaluated to prevent healthcare-associated infection. The author's experience and lessons as clinical laboratory scientists will provide valuable insights to protect the domestic and international health community in this COVID-19 pandemic around the world.

Analytical method study for cephalexin with high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) applicable for residue studies in the whiteleg shrimp Litopenaeus vannamei (흰다리새우(Litopenaeus vannamei)에서 cephalexin의 잔류농도 연구를 위한 LC-MS/MS 분석법 연구)

  • Yang, Chan Yeong;Bae, Jun Sung;Lee, Chae Won;Jeong, Eun Ha;Lee, Ji-Hoon;Bak, Su-Jin;Choi, Sang-Hoon;Park, Kwan Ha
    • Journal of fish pathology
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    • v.34 no.1
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    • pp.71-80
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    • 2021
  • Cephalexin, a semi-synthetic cephalosporin antibiotic, has long been used in fish aquaculture in various countries under legal authorization. The drug is thus widely available for use in other aquatic species except fishes like the crustacean whiteleg shrimp. This study aims to develop a sensitive method for laboratory residue studies to adopt in withdrawal period determinations. Through repeated trials from the existing methods developed for other food animal tissues, it was possible to achieve a sensitive high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. The results showed that at a concentration of 0.1 mg/kg, the recovery rate was 81.79%, and C.V. value was 8.2%, which meet the recovery rate and C.V. recommended by Codex guideline. After satisfactory validation of analytical procedures, applicability to the shrimp tissue was confirmed in experimentally cephalexin-treated whiteleg shrimp. As a result, most muscle samples were detected below the limit of quantification (0.05 mg/kg) after day 3, and most hepatopancreas samples were detected below the limit of quantification after day 14. In particular, the limit of quantification 0.05 ppm with the presently developed method suggests sufficient sensitive over the current legal maximum residue limit of 0.2 mg/kg set for fishes.

Entrance Skin Dose According to Age and Body Size for Pediatric Chest Radiography (소아 흉부촬영 시 나이와 체격에 따른 입사피부선량)

  • Shin, Gwi-Soon;Min, Ki-Yeul;Kim, Doo-Han;Lee, Kwang-Jae;Park, Ji-Hwan;Lee, Gui-Won
    • Journal of radiological science and technology
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    • v.33 no.4
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    • pp.327-334
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    • 2010
  • Exposure during childhood results in higher risk for certain detrimental cancers than exposure during adulthood. We measured entrance skin dose (ESD) under 7-year children undergoing chest imaging and compared the relationship between ESD and age, height, weight, chest thickness. Though it is important to measure chest thickness for setting up the exposure condition of chest examination, it is difficult to measure chest thickness of children. We set up exposure parameters according to age because chest thickness of children has correlation with age. In the exposure parameters, for chest A-P examination under 2 year-children, tube voltage (kVp) in hospital A was higher than that in hospital B while tube current (mAs) was higher in hospital B, thus the ESD values were about 1.7 times higher in hospital B. However, for chest P-A examination over 4 year-children, the tube voltage was 7 kVp higher in hospital B, the tube current were same in all two systems, and focus to image receptor distance (FID) in hospital B (180 cm) was longer than that in hospital A (130 cm), thus the ESD values were 1.4 times higher in hospital A. For same ages, the ESD values for chest A-P examinations were higher than those for chest P-A examinations. Comparing ESD according to age, ESD values were $154{\mu}Gy$, $194{\mu}Gy$ and $138{\mu}Gy$ for children under 1 year, 1 to under 4 years and 4 to under 7 years of age, respectively. These values were lower than reference level ($200{\mu}Gy$) recommended in JART (japan association of radiological technologists), however these were higher than reference values recommended by EC (european commission), NRPB (national radiological protection board) and NIFDS (national institute of food & drug safety evaluation). In conclusion, the values of ESD were affected by exposure parameters from radiographer's past experience more than x-ray system. ESD values for older children were not always higher than those for younger children. Therefore we need to establish our own DRLs (diagnostic reference levels) according to age of the children in order to optimize pediatric patient protection.

A Survey on Radiation Exposure of Patient in Mammography (유방 X선촬영 시 피폭선량에 대한 조사 연구)

  • Kim, Hyung-Chul;Cho, Pyung-Gon;Kim, Sung-Soo;Choi, Jong-Hak;Kim, You-Hyun
    • Journal of radiological science and technology
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    • v.27 no.4
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    • pp.55-60
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    • 2004
  • The purpose of this study was to examine both patient exposure dose during mammography and the utility status of mammograpy equipments. The data of this study were collected through questionnaire survey for 278 medical facilities registered at Korean Hospital Association and finally 161 medical facilities's data were analyzed. According to data analysis, medical facilities of 14.9% used the average glandular dose of less than 0.5 mGy, $0.51{\sim}1.0\;mGy$ 8.6%, $1.01{\sim}1.5\;mGy$ 14.9%, $1.51{\sim}2.0\;mGy$ 11.1%, $2.01{\sim}2.5\;mGy$ 9.8%, $2.51{\sim}3.0\;mGy$ 33.3%, and 7.4% more than 3.01 mGy. It was found that medical facilities of 92.6% used less than 3 mGy, showing that this figure is similar to the limit value of 3 mGy recommended by Korea Food & Drug Administration(KFDA). Recently, international organizations such as ICRP associated with radiation protection suggests that less than 3 mGy of average mammary gland dose be used during mammography in case of using Mo target+Mo filter, film/screen system and craniocaudal projection with the breast pressed to 4.2 cm. The standard dose is being strictly observed and that of the limits is going down to 2 mGy or 1.5 mGy. The major results of this study indicate that interests and a counterplan to reduce patient dose during mammography should be considered. Based on this study, the authors of this study will continue to measure exposure dose to set a new standard for patient exposure dose during mammography.

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Residual Pattern of Pesticide, Chlorfluazuron in Perilla Leaves Under Plastic House (들깻잎 재배 중 chlorfluazuron의 잔류량 변화 및 잔류분석법 시험)

  • Lee, Min-Ho;Kim, Seok-Ho;Park, Young-Guin;Jo, Gyeong-Yeon;Shin, Byung-Gon;Kim, Jong-Han;Kwon, Chan-Hyeok;Sohn, Jae-Keun;Kim, Jang-Eok
    • The Korean Journal of Pesticide Science
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    • v.11 no.2
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    • pp.106-116
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    • 2007
  • Pesticide, chlorfluazuron was subjected to determine the safety of terminal residues at the harvesting date of perilla leaves cultivated in plastic house. After the pesticide applied on a foliar spray in 2005 and 2006, leaf persistence of its residue was analysed for 10 days before leaf harvest. The degradation rate of chlorfluazuron in the leaf was 32.3 %(standard application), 43.6 %(double application) and 78.0 %(standard), 80.4 %(double) at second and tenth day, respectively, under analysis of GC/ECD in 2005. The degradation rate of chlorfluazuron in the leaf was 33.1 %(GC/ECD analyze), 34.0 %(HPLC/UVD analyze) and 77.9 %(GC/ECD), 78.4 %(HPLC/UVD) at second and tenth day, respectively, under the standard level of pesticide in 2006. The biological half-life of the chlorfluazuron residue was estimated by the regression equation calculated from daily dissipation of pesticide in the perilla leaves. The longest half-life of the chlorfluazuron residue in perilla leaves was 5.5 days. The maximum residual limit(MRL) for chlorfluazuron based on the longest half-life was estimated 2.0ppm at harvesting day, 2.5ppm at second day and 7.1ppm at tenth day before leaf harvesting of perilla.

Analysis of stress distribution of tooth restored with metal-ceramic crown covering abfraction lesion according to its finish line location under occlusal load (금속도재관으로 수복된 Abfraction lesion이 있는 치아에 가해지는 교합력의 응력 분포 분석)

  • Kim, Jee-Hwan;Yoon, Chol-Wook;Kim, Taehyeon;Kim, Han-Sung;Woo, Dae-Gon;Lee, Keun-Woo;Shim, June-Sung
    • The Journal of Korean Academy of Prosthodontics
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    • v.52 no.4
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    • pp.305-311
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    • 2014
  • Purpose: When the full veneer crown was treated in the tooth with abfraction lesion due to various causes, the prognosis of it may be compromised according to the location of the finish line, but there is few study about the location of its buccal finish line. The purpose of this study was to investigate the effect of location of the finish line of the full veneer crown on stress distribution of the tooth with abfraction lesion. Materials and methods: The two dimensional finite element model was developed to express tooth, surrounding tissue and full veneer crown. The stress distribution under eccentric 144 N occlusal load was analyzed using finite element analysis. The location of finish line was set just at the lower border of the lesion (Group 0), 1 mm (Group 1) and 2 mm (Group 2) below the lower border of the lesion. Results: In the Group 0, von Mises stress was concentrated at the finish line and the apex of the lesion. Also, the stress at the bucal finish line propagated to the lingual side. In the Group 1 and Group 2, stress distribution was similar each other. Stress was concentrated at the apex of lesion, but the stress at the buccal finish line did not propagate to the lingual side. That implied decrease of the possibility of horizontal crown fracture. Conclusion: Full veneer crown alleviated the stress concentrated at the apex of the abfraction lesion, when the finish line of full veneer crown was set below the lower border of abfraction lesion.

Production Medium Optimization for Monascus Biomass Containing High Content of Monacolin-K by Using Soybean Flour Substrates (기능성 원료를 기질로 이용하는 Monacolin-K 고함유 모나스커스 균주의 생산배지 최적화)

  • Lee, Sun-Kyu;Chun, Gie-Taek;Jeong, Yong-Seob
    • KSBB Journal
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    • v.23 no.6
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    • pp.463-469
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    • 2008
  • During the last decade, monacolin-K biosynthesized by fermentation of red yeast rice (Monascus strains) was proved to have an efficient cholesterol lowering capability, leading to rapid increase in the market demand for the functional red yeast rice. In this study, the production medium composition and components were optimized on a shake flask scale for monacolin-K production by Monascus pilosus (KCCM 60160). The effect of three different soybean flours on the monacolin-K production were studied in order to replace the nitrogen sources of basic production medium (yeast extract, malt extract and beef extract). Among the several experiments, the production medium with dietary soybean flour to replace a half of yeast extract was very good for monacolin-K production. Plackett-Burman experimental design was used to determine the key factors which are critical to produce the biological products in the fermentation. According to the result of Plackett-Burman experimental design, a second order response surface design was applied using yeast extract, beef extract and $(NH_4)_2SO_4$ as factors. Applying this model, the optimum concentration of the three variables was obtained. The maximum monacolin-K production (369.6 mg/L) predicted by model agrees well with the experimental value (418 mg/L) obtained from the experimental verification at the optimal medium. The yield of monacolin-K was increased by 67% as compared to that obtained with basic production medium in shake flasks.

One-stop Evaluation Protocol of Ischemic Heart Disease: Myocardial Fusion PET Study (허혈성 심장 질환의 One-stop Evaluation Protocol: Myocardial Fusion PET Study)

  • Kim, Kyong-Mok;Lee, Byung-Wook;Lee, Dong-Wook;Kim, Jeong-Su;Jang, Yeong-Do;Bang, Chan-Seok;Baek, Jong-Hun;Lee, In-Su
    • The Korean Journal of Nuclear Medicine Technology
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    • v.14 no.2
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    • pp.33-37
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    • 2010
  • Purpose: In the early stage of using PET/CT, it was used to damper revision but recently shows that CT with MDCT is commonly used and works well for an anatomical diagnosis. This hospital makes the accuracy and convenience more higher in the diagnosis and evaluate of coronary heart disease through concurrently running myocardial perfusion SPECT examination, myocardial PET examination with FDG, and CT coronary artery CT angiography(coronary CTA) used PET/CT with 64-slice. This report shows protocol and image based on results from about 400 coronary heart disease examinations since having 64 channels PET/CT in July 2007. Materials and Methods: An Equipment for this examination is 64-slice CT and Discovery VCT (DVCT) that is consisted of PET with BGO ($Bi_4Ge_3O_{12}$) scintillation crystal by GE health care. First myocardial perfusion SPECT with pharmacologic stress test to reduce waiting time of a patient and get a quick diagnosis and evaluation, and right after it, myocardial FDG PET examination and coronary CTA run without a break. One-stop evaluation protocol of ischemic heart disease is as follows. 1)Myocardial perfusion SPECT with pharmacologic stress: A patient is injected with $^{99m}Tc$-MIBI 10 mCi and does not have any fatty food for myocardial PET examination and drink natural water with ursodeoxcholic acid 100 mg and we get SPECT image in an hour. 2)Myocardial FDG PET: To reduce blood fatty content and to increase uptake of FDG, we used creative oral glucose load using insulin and Acipimox to according to blood acid content. A patient is injected with $^{18}F$-FDG 5 mCi for reduction of his radiation exposure and we get a gated image an hour later and get delay image when we need. 3) Coronary CTA: The most important point is to control heart rate and to get cooperation of patient's breath. In order to reduce a heart rate of him or her below 65 beats, let him or her take beta blocker 50 mg ~ 200 mg after a consultation with a doctor about it and have breath-practices then have the examination. Right before the examination, we spray isosorbide dinitrate 3 to 5 times to lower tension of bessel wall and to extension a blood wall of a patient. It makes to get better the shape of an anatomy. At filming, a patient is injected CT contrast with high pressure and have enough practices before the examination in order to have no problem. For reduction of his radiation exposure, we have to do ECG-triggered X-ray tube modulation exposure. Results: We evaluate coronary artery stenosis through coronary CTA and study correlation (culprit vessel check) of a decline between stenosis and perfusion from the myocardial perfusion SPECT with pharmacologic stress, coronary CTA, and can check viability of infarction or hibernating myocardium by FDG PET. Conclusion: The examination makes us to set up a direction of remedy (drug treatment, PCI, CABG) because we can estimate of effect from remedy, lesion site and severity. In addition, we have an advantage that it takes just 3 hours and one-stop in that all of process of examinations run in succession and at the same time. Therefore it shows that the method is useful in one stop evaluation of ischemic heart disease.

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Analysis of Patient Effective Dose in PET/CT; Using CT Dosimetry Programs (CT 선량 측정 프로그램을 이용한 PET/CT 검사 환자의 예측 유효 선량의 분석)

  • Kim, Jung-Sun;Jung, Woo-Young;Park, Seung-Yong
    • The Korean Journal of Nuclear Medicine Technology
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    • v.14 no.2
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    • pp.77-82
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    • 2010
  • Purpose: As PET/CT come into wide use, it caused increasing of expose in clinical use. Therefore, Korea Food and Drug Administration issued Patient DRL (Diagnostic Reference Level) in CT scan. In this study, to build the basis of patient dose reduction, we analyzed effective dose in transmission scan with CT scan. Materials and Methods: From February, 2010 to March 180 patients (age: $55{\pm}16$, weight: $61.0{\pm}10.4$ kg) who examined $^{18}F$-FDG PET/CT in Asan Medical Center. Biograph Truepoint 40 (SIEMENS, GERMANY), Biograph Sensation 16 (SIEMENS, GERMANY) and Discovery STe8 (GE healthcare, USA) were used in this study. Per each male and female average of 30 patients doses were analyzed by one. Automatic exposure control system for controlling the dose can affect the largest by a patient's body weight less than 50 kg, 50-60 kg less, 60 kg more than the average of the three groups were divided doses. We compared that measured value of CT-expo v1.7 and ImPACT v1.0. The relationship between body weight and the effective dose were analyzed. Results: When using CT-Expo V1.7, effective dose with BIO40, BIO16 and DSTe8 respectably were $6.46{\pm}1.18$ mSv, $9.36{\pm}1.96 $mSv and $9.36{\pm}1.96$ mSv for 30 male patients respectably $6.29{\pm}0.97$ mSv, $10.02{\pm}2.42$ mSv and $9.05{\pm}2.27$ mSv for 30 female patients respectably. When using ImPACT v1.0, effective dose with BIO40, BIO16 and DSTe8 respectably were $6.54{\pm}1.21$ mSv, $8.36{\pm}1.69$ mSv and $9.74{\pm}2.55$Sv for 30 male patients respectably $5.87{\pm}1.09$ mSv, $8.43{\pm}1.89$ mSv and $9.19{\pm}2.29$ mSv for female patients respectably. When divided three groups which were under 50 kg, 50~60 kg and over 60 kg respectably were 6.27 mSv, 7.67 mSv and 9.33 mSv respectably using CT-Expo V1.7, 5.62 mSv, 7.22 mSv and 8.91 mSv respectably using ImPACT v1.0. Weight and the effective dose coefficient analysis showed a very strong positive correlation(r=743, r=0.693). Conclusion: Using such a dose evaluation programs, easier to predict and evaluate the effective dose possible without performing phantom study and such dose evaluation programs could be used to collect basic data for CT dose management.

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Dosimetric Evaluation of a Small Intraoral X-ray Tube for Dental Imaging (치과용 초소형 X-선 튜브의 선량평가)

  • Ji, Yunseo;Kim, YeonWoo;Lee, Rena
    • Progress in Medical Physics
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    • v.26 no.3
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    • pp.160-167
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    • 2015
  • Radiation exposure from medical diagnostic imaging procedures to patients is one of the most significant interests in diagnostic x-ray system. A miniature x-ray intraoral tube was developed for the first time in the world which can be inserted into the mouth for imaging. Dose evaluation should be carried out in order to utilize such an imaging device for clinical use. In this study, dose evaluation of the new x-ray unit was performed by 1) using a custom made in vivo Pig phantom, 2) determining exposure condition for the clinical use, and 3) measuring patient dose of the new system. On the basis of DRLs (Diagnostic Reference Level) recommended by KDFA (Korea Food & Drug Administration), the ESD (Entrance Skin Dose) and DAP (Dose Area Product) measurements for the new x-ray imaging device were designed and measured. The maximum voltage and current of the x-ray tubes used in this study were 55 kVp, and 300 mA. The active area of the detector was $72{\times}72mm$ with pixel size of $48{\mu}m$. To obtain the operating condition of the new system, pig jaw phantom images showing major tooth-associated tissues, such as clown, pulp cavity were acquired at 1 frame/sec. Changing the beam currents 20 to $80{\mu}A$, x-ray images of 50 frames were obtained for one beam current with optimum x-ray exposure setting. Pig jaw phantom images were acquired from two commercial x-ray imaging units and compared to the new x-ray device: CS 2100, Carestream Dental LLC and EXARO, HIOSSEN, Inc. Their exposure conditions were 60 kV, 7 mA, and 60 kV, 2 mA, respectively. Comparing the new x-ray device and conventional x-ray imaging units, images of the new x-ray device around teeth and their neighboring tissues turn out to be better in spite of its small x-ray field size. ESD of the new x-ray device was measured 1.369 mGy on the beam condition for the best image quality, 0.051 mAs, which is much less than DRLs recommended by IAEA (International Atomic Energy Agency) and KDFA, both. Its dose distribution in the x-ray field size was observed to be uniform with standard deviation of 5~10 %. DAP of the new x-ray device was $82.4mGy*cm^2$ less than DRL established by KDFA even though its x-ray field size was small. This study shows that the new x-ray imaging device offers better in image quality and lower radiation dose compared to the conventional intraoral units. In additions, methods and know-how for studies in x-ray features could be accumulated from this work.