• Title/Summary/Keyword: Non-clinical testing

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A Normative Review on Non-Invasive Prenatal Diagnosis (NIPD): Focusing on the German Discussion on PrenaTest®

  • Kim, Na-Kyoung
    • Development and Reproduction
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    • v.25 no.2
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    • pp.113-121
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    • 2021
  • This article aims to introduce German discussion on the approval of the non-invasive prenatal diagnosis (NIPD), which started with the development of PrenaTest® by LifeCodexx AG. The discussion started with the concern that the non-invasive nature of NIPD, such as PrenaTest®, may rapidly expand the use and scope of similar tests, thus leading to a new era of eugenics. Based on this concern, the need for clear clinical guidelines on specific indications for NIPD has been suggested. Along the same line, it was discussed whether PrenaTest® is against the Basic Law prohibiting discrimination on grounds of disability and whether the test is outside the scope of the purpose of gene testing limited by Genetic Diagnosis Act. Through such discussion, the Federal Ministry of Health of Germany established the preconditions for inclusion of NIPD in the German public health insurance system. For this, the German motherhood guideline was amended and the information for the insured persons provided to pregnant women was included in the amended guideline. Such discussion made in Germany provides insight on which points should be considered when various gene testings are accepted in Korea, in which genetic communication has not been systematized yet. In particular, German counseling system for pregnant women will provide valuable insights for Korea where the direction for regulations on abortion has not been established even after the ruling by the Constitutional Court that charges for abortion are against the constitution.

Clinical Significance of Upregulation of mir-196a-5p in Gastric Cancer and Enriched KEGG Pathway Analysis of Target Genes

  • Li, Hai-Long;Xie, Shou-Pin;Yang, Ya-Li;Cheng, Ying-Xia;Zhang, Ying;Wang, Jing;Wang, Yong;Liu, Da-Long;Chen, Zhao-Feng;Zhou, Yong-Ning;Wu, Hong-Yan
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.5
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    • pp.1781-1787
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    • 2015
  • Background: miRNAs are relatively recently discovered cancer biomarkers which have important implications for cancer early diagnosis, treatment and estimation of prognosis. Here we focussed on expression of mir-196a-5p in gastric cancer tissues and cell lines so as to analyse its significance for clinicopathologic characteristics and generate enriched KEGG pathways clustered by target genes for exploring its potential roles as a biomarker in gastric cancer. Materials and Methods: The expression of mir-196a-5p in poorly, moderate and well differentiated gastric cancer cell lines compared with GES-1 was detected by RT-qPCR, and the expression of mir-196a-5p in gastric cancer tissues comparing with adjacent non cancer tissues of 58 cases were also assessed by RT-qPCR. Subsequently, an analysis of clinical significance of mir-196a-5p in gastric cancer and enriched KEGG pathways was executed based on the miRWalk prediction database combined with bioinformatics tools DAVID 6.7 and Mirfocus 3.0. Results: RT-qPCR showed that mir-196a-5p was up-regulated in 6 poorly and moderate differentiated gastric cancer cell lines SGC-7901, MKN-45, MKN-28, MGC-803, BGC-823, HGC-27 compared with GES-1, but down-regulated in the highly differentiated gastric cancer cell line AGS. Clinical data indicated mir-196a-5p to beup-regulated in gastric cancer tissues (47/58). Overexpression of mir-196a-5p was associated with more extensive degree of lymph node metastasis and clinical stage (P < 0.05; x2 test). Enriched KEGG pathway analyses of predicted and validated targets in miRWalk combined with DAVID 6.7 and Mirfocus 3.0 showed that the targeted genes regulated by mir-196a-5p were involved in malignancy associated biology. Conclusions: Overexpression of mir-196a-5p is associated with lymph node metastasis and clinical stage, and enriched KEGG pathway analyses showed that targeted genes regulated by mir-196a-5p may contribute to tumorgenesis, suggesting roles as an oncogenic miRNA biomarker in gastric cancer.

Guidelines for Manufacturing and Application of Organoids: Heart

  • Hyang-Ae Lee;Dong-Hun Woo;Do-Sun Lim;Jisun Oh;C-Yoon Kim;Ok-Nam Bae;Sun-Ju Ahn
    • International Journal of Stem Cells
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    • v.17 no.2
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    • pp.130-140
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    • 2024
  • Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function. This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments. This guideline addresses this need, catering to regulatory requirements, and describes common standards for organoid quality and toxicity assessment methodologies, commensurate with current technological capabilities. While acknowledging the dynamic nature of technological progress and the potential for future comparative studies, this guideline serves as a foundational framework. It offers a comprehensive approach to standardized cardiac organoid testing, ensuring scientific rigor, reproducibility, and ethical integrity in investigations of cardiotoxicity, particularly through the utilization of human pluripotent stem cell-derived cardiac organoids.

Clinical Application of Ultrasound-Guided Thyroid Fine Needle Aspiration Biopsy and Thinprep Cytology Test in Diagnosis of Thyroid Disease

  • Wei, Ying;Lu, Yao;Li, Chenxi
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.10
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    • pp.4689-4692
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    • 2016
  • Purpose: To study the clinical application value of ultrasound guided thyroid fine needle aspiration biopsy and thinprep cytology testing in diagnosis of thyroid disease. Methods: A total of 78 patients with thyroid nodules were enrolled, 34 males and 44 females, aged 33-64 years old with mean age of 47.6 years. All underwent thyroid module fine needle puncture after surgery to assess cell pathology and histopathological features. Results: Sufficient specimens were obtained from all of 78 patients, the cytological results of 73 cases (93.6 %) being consistent with pathological results. While 20 cases (25.6 %) were malignant tumors, 44 (56.4 %) were benign and 9 (11.5 %) were non-tumor lesions. The sensitivity of benign and malignant thyroid nodule by thyroid fine needle puncture was 90.9 %, specificity was 98.1 % and the positive predictive value was 96.3 %. Conclusions: It is demonstrated that ultrasound-guided thyroid fine needle aspiration biopsy and thinprep cytology testing have diagnostic value in clinical application for thyroid disease,showing good diagnostic coincidence rates with histopathological examination. They can thus be regarded as safe and effective for preoperative diagnosis and providing an appropriate basis for selection of surgery.

High Resolution Melting Analysis for Epidermal Growth Factor Receptor Mutations in Formalin-fixed Paraffin-embedded Tissue and Plasma Free DNA from Non-small Cell Lung Cancer Patients

  • Jing, Chang-Wen;Wang, Zhuo;Cao, Hai-Xia;Ma, Rong;Wu, Jian-Zhong
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.11
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    • pp.6619-6623
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    • 2013
  • Background:The aim of the research was to explore a cost effective, fast, easy to perform, and sensitive method for epidermal growth factor receptor (EGFR) mutation testing. Methods: High resolution melting analysis (HRM) was introduced to evaluate the efficacy of the analysis for dectecting EGFR mutations in exons 18 to 21 using formalin-fixed paraffin-embedded (FFPE) tissues and plasma free DNA from 120 patients. Results: The total EGFR mutation rate was 37.5% (45/120) detected by direct sequencing. There were 48 mutations in 120 FFPE tissues assessed by HRM. For plasma free DNA, the EGFR mutation rate was 25.8% (31/120). The sensitivity of HRM assays in FFPE samples was 100% by HRM. There was a low false-positive mutation rate but a high false-negative rate in plasma free DNA detected by HRM. Conclusions: Our results show that HRM analysis has the advantage of small tumor sample need. HRM applied with plasma free DNA showed a high false-negative rate but a low false-positive rate. Further research into appropriate methods and analysis needs to be performed before HRM for plasma free DNA could be accepted as an option in diagnostic or screening settings.

Study on the Fourth Industrial Revolution and Clinical Laboratory Science Techniques (4차 산업혁명과 임상검사과학기술에 관한 연구)

  • Sung, Hyun Ho;Choi, Kwang-Mo;Jung, You Hyun;Cho, Eun Kyung
    • Korean Journal of Clinical Laboratory Science
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    • v.51 no.3
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    • pp.386-395
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    • 2019
  • The aim of this study was to introduce clinical laboratory science techniques with the core technology of the 4th Industrial Revolution. Among the core technologies of the 4th Industrial Revolution, AI, IOT, block-chain, robotics, and nanotechnology were analyzed and linked by themes. The scope of the job of clinical laboratory technologists (also known as medical laboratory technologists and medical technologists) is laboratory medicine testing, pathology testing, and clinical physiology testing. Through a number of previous papers, 73 linkages in the laboratory medicine area, 27 linkages in the pathology area, and 47 linkages in the clinical physiology area were examined. In the 4th industrial revolution and clinical laboratory science techniques, AI (4), IOT (3), block-chain (4), robotics (3) and nanotechnology (15) sectors were surveyed. The limitation of this study was the limitation in collecting and analyzing all the data and non-clinical areas were not analyzed. In addition, there was no validity test and no similar study. In conclusion, the core technologies of the 4th industrial revolution and clinical laboratory science techniques are closely related. Therefore, further research on the future and social benefits of clinical laboratory science techniques is needed.

Correlation of single leg vertical jump, single leg hop, and single leg squat distances in healthy persons

  • Shin, Seung-Ho;Woo, Hyunjae
    • Physical Therapy Rehabilitation Science
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    • v.2 no.1
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    • pp.57-61
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    • 2013
  • Objective: To determine the correlation among three functional tests: single leg vertical jump (SLVJ), single leg hop for distance (SLHD), and single leg squat (SLSQ). Design: Cross sectional study. Methods: Twenty healthy men (n=10) and women (n=10) with no history of lower extremity dysfucntion participated in this study and performed in university research laboratory. The procedures consisted of a general warm-up, a task-specific warm-up, actual testing, and a cool down. All participants performed the three tests in random order. Each test was performed three times for the dominant and non-dominant lower extremity (LE). SLVJ, SLHD, SLSQ were measured using a standard tape measure. Results: Statistically significant difference was presented between dominant LE and non-dominant LE in each function test (p<0.05). The strongest correlation was between SLVJ and SLSQ, 0.939 and 0.883 for dominant and non-dominant LE, respectively (p<0.05). The weakest correlation was between SLVJ and SLHD, 0.713 for dominant (p<0.05) and between SLSQ and SLHD, 0.739 for non-dominant (p<0.05). Conclusions: There is a strong correlation between SLVJ and SLSQ, suggesting that each test measures similar constructs of function and can be substitutive, while weak correlation between SLSQ and SLHD suggest these two tests do not measure the same functional components and could be paired as outcome measures for the clinical assessment of LE function. It will provide physical therapist with scientific evidence for effective test combination of LE function assessment in clinical practice.

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Clinical outcomes of preimplantation genetic testing for aneuploidy in high-risk patients: A retrospective cohort study

  • Jun Woo Kim;So Young Lee;Chang Young Hur;Jin Ho Lim;Choon Keun Park
    • Clinical and Experimental Reproductive Medicine
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    • v.51 no.1
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    • pp.75-84
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    • 2024
  • Objective: The purpose of this study was to evaluate the impact of preimplantation genetic testing for aneuploidy (PGT-A) on clinical outcomes among high-risk patients. Methods: This retrospective study involved 1,368 patients and the same number of cycles, including 520 cycles with PGT-A and 848 cycles without PGT-A. The study participants comprised women of advanced maternal age (AMA) and those affected by recurrent implantation failure (RIF), recurrent pregnancy loss (RPL), or severe male factor infertility (SMF). Results: PGT-A was associated with significant improvements in the implantation rate (IR) and the ongoing pregnancy rate/live birth rate (OPR/LBR) per embryo transfer cycle in the AMA (39.3% vs. 16.2% [p<0.001] and 42.0% vs. 21.8% [p<0.001], respectively), RIF (41.7% vs. 22.0% [p<0.001] and 47.0% vs. 28.6% [p<0.001], respectively), and RPL (45.6% vs. 19.5% [p<0.001] and 49.1% vs. 24.2% [p<0.001], respectively) groups, as well as the IR in the SMF group (43.3% vs. 26.5%, p=0.011). Additionally, PGT-A was associated with lower overall incidence rates of early pregnancy loss in the AMA (16.7% vs. 34.3%, p=0.001) and RPL (16.7% vs. 50.0%, p<0.001) groups. However, the OPR/LBR per total cycle across all PGT-A groups did not significantly exceed that for the non-PGT-A groups. Conclusion: PGT-A demonstrated beneficial effects in high-risk patients. However, our findings indicate that these benefits are more pronounced in carefully selected candidates than in the entire high-risk patient population.

A STUDY ON THE BOND STRENGTH OF REPAIRED GLASS IONOMER CEMENTS (Repaired glass ionomer cement의 결합강도에 관한 연구)

  • Seo, Su-Jeong;Kim, Shin
    • Journal of the korean academy of Pediatric Dentistry
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    • v.23 no.2
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    • pp.347-355
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    • 1996
  • The purpose of this study was to compare the bond strengths of different kinds of glass ionomer cements (GIC), which is recently increasing the clinical application in the field of pediatric dentistry and measure the repaired bond strengths in order to examine the clinical applicabilty of partial repaired cases. By using one kind of the light cured type GIC and three kinds of the chemical cured type GIC, the bond strengths of the followings were compared : unrepaired group as control, repaired conditioning group, which was treated the repaired surface using 25% polyacrylic acid and repaired non-conditioning group without surface treatment. Three point bending test was performed under Universal Testing Machine in order to measure the compressive bond strengths. The results were as follows : 1. Light cured GIC had higher bond strength than chemical cured type GIC in both of repaired and unrepaired groups. 2. In repaired cases, all of the materials decreased the bond strength when compared to the control group. In the light cured type, the bond strength of repaired conditioning group decreased 31.6%, repaired non-conditioning group decreased 40.8%. In chemical cured types, the bond strength of repaired conditining group decreased 11.8%, repaired non-conditioning group decreased 20.9%. 3. All the materials, in the case of the chemical treatment on the repaired surface using 25% polyacrylic acid had higher bond strength than untreated but, lower than control group.

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Acute Hepatotoxicity and Toxicokinetics of Acetaminophen in Mice (마우스에서 아세트아미노펜의 급성간독성과 독물동태학)

  • 서경원;류정상;김효정
    • Toxicological Research
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    • v.13 no.3
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    • pp.237-245
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    • 1997
  • As the development of a pharmaceutical product is a dynamic process which involves continuousfeed-back between non-clinical and clinical studies, the integration of pharmacokinetics into toxicity testing became increasingly important in recent years. Toxicokinetic measurements in the toxicity studies is considered to be an important scientific approach in the interpretation of the toxicology findings and the promotion of rational study design development. Primarily this research project was conducted to determine the systemic exposure achieved in acute toxicity test and its relationship to dose level and the time course of the toxicity study. Acute hepatotoxicity study and its relevant toxicokinetic study in mice were performed using acetarninophen (AA) as a model compound. The correlation between acute hepatotoxicity indices and toxicokinetic parameters following intraperitoneally administration of various dosages of AA in mice was evaluated and discussed minutely in the text. Based on these studies, single-dose toxicity testing of AA including kinetic studies was evaluated in ICR mice for 7 days and interpreted in the text. Our results from the integration of toxicokinetic monitoring into single-dose toxicity study enable to elucidate the relation of the exposure achieved in toxicity study to toxicological findings and assist in the selection of appropriate dose levels for use in repeated-dose toxicity or later studies.

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