• Journal of the Korean Society of Radiology
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• v.83 no.2
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• pp.265-283
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• 2022

To develop Korean coronavirus disease (COVID-19) chest imaging justification guidelines, eight key questions were selected and the following recommendations were made with the evidence-based clinical imaging guideline adaptation methodology. It is appropriate not to use chest imaging tests (chest radiograph or CT) for the diagnosis of COVID-19 in asymptomatic patients. If reverse transcription-polymerase chain reaction testing is not available or if results are delayed or are initially negative in the presence of symptoms suggestive of COVID-19, chest imaging tests may be considered. In addition to clinical evaluations and laboratory tests, chest imaging may be contemplated to determine hospital admission for asymptomatic or mildly symptomatic un-hospitalized patients with confirmed COVID-19. In hospitalized patients with confirmed COVID-19, chest imaging may be advised to determine or modify treatment alternatives. CT angiography may be considered if hemoptysis or pulmonary embolism is clinically suspected in a patient with confirmed COVID-19. For COVID-19 patients with improved symptoms, chest imaging is not recommended to make decisions regarding hospital discharge. For patients with functional impairment after recovery from COVID-19, chest imaging may be considered to distinguish a potentially treatable disease.

• Korean Journal of Clinical Laboratory Science
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• v.56 no.2
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• pp.147-155
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• 2024

Gallium-68-prostate-specific membrane antigen-11 (⁶⁸Ga-PSMA-11) is a positron emission tomography radiopharmaceutical that labels a Glu-urea-Lys-based ligand with ⁶⁸Ga, binding specifically to the PSMA. It is used widely for imaging recurrent prostate cancer and metastases. On the other hand, the preparation and quality control testing of ⁶⁸Ga-PSMA-11 in medical institutions takes over 60 minutes, limiting the daily capacity of ⁶⁸Ge/⁶⁸Ga generators. While the generator provides 1,110 MBq (30 mCi) nominally, its activity decreases over time, and the labeling yield declines irregularly. Consequently, additional preparations are needed, increasing radiation exposure for medical technicians, prolonging patient wait times, and necessitating production schedule adjustments. This study aimed to reduce the ⁶⁸Ga-PSMA-11 preparation time and optimize the automated synthesis system. By shortening the reaction time between ⁶⁸Ga and the PSMA-11 precursor and adjusting the number of purification steps, a faster and more cost-effective method was tested while maintaining quality. The final synthesis time was reduced from 30 to 20 minutes, meeting the standards for the HEPES content, residual solvent EtOH content, and radiochemical purity. This optimized procedure minimizes radiation exposure for medical technicians, reduces patient wait times, and maintains consistent production schedules, making it suitable for clinical application.

• Journal of Life Science
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• v.34 no.5
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• pp.339-355
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• 2024

The pulmonary system is a highly complex system that can only be understood by integrating its functional and structural aspects. Hence, in vivo animal models are generally used for pathological studies of pulmonary diseases and the evaluation of inhalation toxicity. However, to reduce the number of animals used in experimentation and with the consideration of animal welfare, alternative methods have been extensively developed. Notably, the Organization for Economic Co-operation and Development (OECD) and the United States Environmental Protection Agency (USEPA) have agreed to prohibit animal testing after 2030. Therefore, the latest advances in biotechnology are revolutionizing the approach to developing in vitro inhalation models. For example, lung organ-on-a-chip (OoC) and organoid models have been intensively studied alongside advancements in three-dimensional (3D) bioprinting and microfluidic systems. These modeling systems can more precisely imitate the complex biological environment compared to traditional in vivo animal experiments. This review paper addresses multiple aspects of the recent in vitro modeling systems of lung OoC and organoids. It includes discussions on the use of endothelial cells, epithelial cells, and fibroblasts composed of lung alveoli generated from pluripotent stem cells or cancer cells. Moreover, it covers lung air-liquid interface (ALI) systems, transwell membrane materials, and in silico models using artificial intelligence (AI) for the establishment and evaluation of in vitro pulmonary systems.

• Clinical and Experimental Pediatrics
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• v.49 no.4
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• pp.381-387
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• 2006

Purpose : Neonatal lupus is characterized by congenital complete heart block(CCHB), cutaneous rash, and laboratory abnormalities in infants born to mothers with systemic lupus erythematosus(SLE). This study aims to examine the incidence of CCHB and clinical outcome in neonates born to mothers with SLE. Methods : The study group consisted of 49 neonates, born from 57 pregnancies of 55 women with SLE, diagnosed at Hanyang University Hospital for the period between January 1997 and January 2005. Clinical and laboratory data were retrospectively identified from medical record. Results : There were 5(8.8 percent) spontaneous abortions and one(1.8 percent) still births among 57 pregnancies of 55 mothers. Of 49 live births, 15(26.3 percent) were premature and eight(12.3 percent) were small for their gestational age. There was one(1.8 percent) CCHB suspected during pregnancy on fetal echocardiograpy in a fetus of mother with systemic lupus erythematosus and the fetus was not born by artificial abortion because of mother. There was no CCHB among EKG findings of 49 newborns. Laboratory testing showed hematologic abnormalities among 25.6 percent(10/39) of the babies. 5.1 percent(2/39) and 7.7 percent(3/39) of them were diagnosed as neutropenia, and thrombocytopenia was seen respectively. Anti-SSA(Ro) and antiphospholipid antibodies were predictive factors for prematurity(P=0.003, P=0.049). Anticardiolipin antibodies were predictive factors for ventilatory care(P=0.018). Conclusion : The incidence of CCHB among neonates born to mothers with SLE, which was measured in this study, was lower than that in earlier studies. A high incidence of hematologic abnormalities was found in our study. It is suggested that careful examination should be made of skin for the diagnosis of neonatal lupus.

• The Journal of KAIRB
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• v.1 no.2
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• The Korean Journal of Nuclear Medicine Technology
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• v.19 no.1
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• pp.44-50
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• 2015

Purpose Quality control used in laboratory help to sustain precision and accuracy consistently to ensure the Diagnostic and treatment for medical employee. To perform an evaluation in statistical manner, it is recommended to use different quality control material than calibrator from manufacturer, quality control material must include analyzed concentration perimeter, must use more than two different concentration materials and recommended to use materials to indicate the concentration in clinical use. However, currently used quality control material has limit of evaluation due to unconsidered concentration or improperly used to get clinical importance data. Therefore, we compared the value of quality control, DIACON Hormone Level 1, 2, 3 (Scantibodies, USA) and DIACON Tumor Level 1, 2, 3 which applied to clinical concentration range. Materials and Methods DIACON Hormone Level 1, 2, 3 (Scantibodies, USA) and DIACON Tumor Level 1, 2, 3 (Scantibodies, USA) that used materials and methods test to compare the result from five RIA testing institution and one institution that used Elecsys (ROCHE) and Architect (ABOTT) for each level. The reagent RIA kit that used in this experiment is followed by Table 2 and 3. Test has performed by instruction itself and follow by instruction. Results Among DIACON hormone result of twenty four items, level 1 have three items, level 2 have four items and level 3 have five items were out of manufacturer set up range based on the average value. Among DIACON tumor result of thirteen items, level 1 have three items, level 2 have four items and level 3 have five items were out of manufacturer set up range. Other result were inside of manufacturer range. Conclusion For quality control material, it is widely available in market, but it is limited for normal range which is only concerned in improper clinical value and difficult to evaluate important concentration area in terms of clinical analyze. In this experiment, we evaluate Hormone twenty three items and Tumor thirteen items with DIACON Hormone and Tumor (Scantibodies, USA) to resolve this limit and we could observe that it ca be substituted and used.

• Journal of the Korea Convergence Society
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• v.12 no.5
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• pp.93-99
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• 2021

Recently, the miniaturization and digitalization for the inspection devices of point-of-care testing (POCT) are rapidly evolving. In the urine test, a lot of researches on index paper technology are being conducted because people can be self-diagnosed through visual color comparison using a urine test paper, Dipsick. The purpose of this study is to analyze the RGB values from the color changes on Dipstick Pad, which isused for urine test, using a smartphone camera. To this end, the primary, analytes in urine wasdiabetes-related parameters such as glucose, ketone body and pH, which is the most frequently tested elements, and we pursuited to quantify the changes in dipstick color caused from artificial urine containing different ranges of sugar, ketone body, and pH. In this experiment, changes in RGB values under bright and dark illuminances were compared, and changes in RGB value were monitored as a function of concentration of analytes under the ambient illumination of laboratory. As a result, color separation at the bright luminance region was good, but it did not appearat the low luminance region, and the changed profiles in RGB value under different illuminances was suggested to correct the problem of the color separation algorithm.

• Obstetrics & gynecology science
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• v.61 no.6
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• pp.662-668
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• 2018

Objective This study was to identify the risk factors for cytological progression in women with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesions (LSIL). Methods We analyzed data from women infected with the human papillomavirus (HPV) who participated in the Korean HPV cohort study. The cohort recruited women aged 20-60 years with abnormal cervical cytology (ASC-US or LSIL) from April 2010. All women were followed-up at every 6-month intervals with cervical cytology and HPV DNA testing. Results Of the 1,158 women included, 654 (56.5%) and 504 (43.5%) women showed ASC-US and LSIL, respectively. At the time of enrollment, 143 women tested positive for HPV 16 (85 single and 58 multiple infections). Cervical cytology performed in the HPV 16-positive women showed progression in 27%, no change in 23%, and regression in 50% of the women at the six-month follow-up. The progression rate associated with HPV 16 infection was higher than that with infection caused by other HPV types (relative risk [RR], 1.75; 95% confidence interval [CI], 1.08-2.84; P=0.028). The cytological progression rate in women with persistent HPV 16 infection was higher than that in women with incidental or cleared infections (P<0.001). Logistic regression analysis showed a significant relationship between cigarette smoking and cytological progression (RR, 4.15; 95% CI, 1.01-17.00). Conclusion The cytological progression rate in HPV 16-positive women with ASC-US or LSIL is higher than that in women infected with other HPV types. Additionally, cigarette smoking may play a role in cytological progression.

• Journal of Genetic Medicine
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• v.7 no.2
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• pp.125-132
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• 2010

Purpose: Preimplantation genetic diagnosis (PGD), also known as embryo screening, is a pre-pregnancy technique used to identify genetic defects in embryos created through in vitro fertilization. PGD is considered a means of prenatal diagnosis of genetic abnormalities. PGD is used when one or both genetic parents has a known genetic abnormality; testing is performed on an embryo to determine if it also carries the genetic abnormality. The main advantage of PGD is the avoidance of selective pregnancy termination as it imparts a high likelihood that the baby will be free of the disease under consideration. The application of PGD to genetic practices, reproductive medicine, and genetic counseling is becoming the key component of fertility practice because of the need to develop a custom PGD design for each couple. Materials and Methods: In this study, a survey on the contents of genetic counseling in PGD was carried out via direct contact or e-mail with the patients and specialists who had experienced PGD during the three months from February to April 2010. Results: A total of 91 persons including 60 patients, 49 of whom had a chromosomal disorder and 11 of whom had a single gene disorder, and 31 PGD specialists responded to the survey. Analysis of the survey results revealed that all respondents were well aware of the importance of genetic counseling in all steps of PGD including planning, operation, and follow-up. The patient group responded that the possibility of unexpected results (51.7%), genetic risk assessment and recurrence risk (46.7%), the reproduction options (46.7%), the procedure and limitation of PGD (43.3%) and the information of PGD technology (35.0%) should be included as a genetic counseling information. In detail, 51.7% of patients wanted to be counseled for the possibility of unexpected results and the recurrence risk, while 46.7% wanted to know their reproduction options (46.7%). Approximately 96.7% of specialists replied that a non-M.D. genetic counselor is necessary for effective and systematic genetic counseling in PGD because it is difficult for physicians to offer satisfying information to patients due to lack of counseling time and specific knowledge of the disorders. Conclusions: The information from the survey provides important insight into the overall present situation of genetic counseling for PGD in Korea. The survey results demonstrated that there is a general awareness that genetic counseling is essential for PGD, suggesting that appropriate genetic counseling may play a important role in the success of PGD. The establishment of genetic counseling guidelines for PGD may contribute to better planning and management strategies for PGD.

• Korean Journal of Clinical Laboratory Science
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• v.49 no.2
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• pp.79-87
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• 2017

GenesWell$^{TM}$ BCT is a 12-gene test suggesting the prognostic risk score (BCT Score) for distant metastasis within the first 10 years in early breast cancer patients with hormone receptor-positive, HER2-negative, and pN0~1 tumors. In this study, we validated the analytical performance of GenesWell$^{TM}$ BCT. Gene expression values were measured by a one-step, real-time qPCR, using RNA extracted from FFPE specimens of early breast cancer patients. Limit of Blank, Limit of Detection, and dynamic range for each of the 12 genes were assessed by serially diluted RNA pools. The analytical precision and specificity were evaluated by three different RNA samples representing low risk group, high risk group, and near-cutoff group in accordance with their BCT Scores. GenesWell$^{TM}$ BCT could detect gene expression of each of the 12 genes from less than $1ng/{\mu}L$ of RNA. Repeatability and reproducibility across multiple testing sites resulted in 100% and 98.3% consistencies of risk classification, respectively. Moreover, it was confirmed that the potential interference substances does not affect the risk classification of the test. The findings demonstrate that GenesWell$^{TM}$ BCT have high analytical performance with over 95% consistency for risk classification.