• 대한의용생체공학회:의공학회지
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• 제43권4호
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• pp.199-213
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• 2022

EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.

• 의료법학
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• 제9권2호
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• pp.209-229
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• 2008

When we are totalizing the lawsrelated to the medical, as the Laboratory medical testing is a kind of the medical act, it is the regulation that the medical technologist can analyze the specimen using in vitro diagnostic devices and diagnosticdrugs under the guidance of doctor or dentist from a corresponding medical institution and can report through verification and interpretation. However, in real medical fields, 'the guidance of doctor' is seriously in-sufficient or even the person who is not the medical technologist is executing. Furthermore the cases that produce inspection results with devices or reagents which are not validated nor approved have been frequently occurred. The result of Laboratory medical testing derived from this procedure can become the important information for the disease control of a country, and also can be decisive to the definite diagnosis and the prognostic monitoring about the patient disease. In spite of its significant medical act to be applicable to an unique proof with the related expert appraisal result in the medical mal-practice lawsuit, our reality in which the quality control is not properly working due by the costs and the labor shortage related to the Laboratory medical testing is quietly in bad condition. Even from now, the government should recognize the significance of the Laboratory medical testing and must achieve more strict administrative management as well as the law maintenance.

• 한국의학물리학회지:의학물리
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• 제9권2호
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• pp.115-121
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• 1998

본 연구는 암을 조기진단을 위한 장치개발의 기초 연구로서, 질병(암)을 검출할수 있는 광 특성의 존재를 결정하기 위하여 12개 생체조직의 계층별 시료와 인체의 혈액에서 광 특성을 측정하였다. 실험은 동물의 지방 및 근육 조직과 인체 혈액 HCT의 27.3%, 35.4%, 45.6%과 59.1%을 대상으로, 광파장이 630nm, 660nm, 780nm, 880nm, 940nm 에서 흡수 계수, $\mu$$_{\alpha}$를 측정하였다. 측정된 흡수계수는 일정하고 특이한 변화를 보여 주었다. 본 연구의 결과에 의하면 생체조직의 계층별과 광파장의 특정 파장대에서 분명한 차이를 구분할 수 있었다. 차이를 구분할 수 있었다.

• 대한기관윤리심의기구협의회지
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• 제4권2호
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• pp.30-35
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• 2022

The Human Research Protection Program (HRPP) includes all subject protection activities and entities involved in the process of planning, reviewing, and conducting clinical research and it ultimately aims that research can be conducted ethically and scientifically while protecting the rights and welfare of research subjects. At the beginning of its introduction in Korea, it was settled down by adopting the United States HRPP, especially the form of AAHRPP element and regulations. However, regulations and operating forms of HRPP have been changed according to the Korean domestic research environment. Actually, all the Korean institutions are adopted the Korean HRPP guidelines that have been officially announced by the Ministry of Food and Drug Safety in Korea. Recently, Korean domestic laws such as the "Advanced Regenerative Biology Act" or "In Vitro Diagnostic Medical Device Act" have been dramatically innovated and our research environment becomes to be more complicated. Therefore, the development of a suitable Korean HRPP model considering the Korean research environment is strongly demanded. For the early settle down of the Korean HRPP model, the positive incentive method should be applied, when the HRPP is operated and/ or properly operated. These improvements in the Korean HRPP environment will eventually lead to the appropriate protection of subjects who are participating in human clinical research and the quality improvement of clinical research.

• Asian Pacific Journal of Cancer Prevention
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• 제14권5호
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• pp.2983-2986
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• 2013

MicroRNAs (miRNAs) are small, non-coding RNAs (18-25 nucleotides) that post-transcriptionally modulate gene expression by negatively regulating the stability or translational efficiency of their target mRNAs. In this context, the present study aimed to evaluate the in vitro effects of miR-153 inhibition in the breast carcinoma cell line MDA-MB-231. Forty-eight hours after MDA-MB-231 cells were transfected with the miR-153 inhibitor, an MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay was utilized to determine the effects of miR-153 on cell viability. Flow cytometry analysis and assessment of caspase 3/7 activity were adopted to determine whether miR-153 affects the proliferation rates and apoptosis levels of MDA-MB-231 cells. Our results showed that silencing of miR-153 significantly inhibited growth when compared to controls at 48 hours, reducing proliferation by 37.6%, and inducing apoptosis. Further studies are necessary to corroborate our findings and examine the potential use of this microRNA in future diagnostic and therapeutic interventions.

• Asian Pacific Journal of Cancer Prevention
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• 제17권7호
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• pp.3025-3033
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• 2016

Chronic myeloid leukaemia (CML) is a clonal myeloproliferative hematopoietic stem cell disorder. Deregulated BCR-ABL fusion tyrosine kinase activity is the main cause of CML disease pathogenesis, making BCR-ABL an ideal target for inhibition. Current tyrosine kinase inhibitors (TKIs) designed to inhibit BCR-ABL oncoprotein activity, have completely transformed the prognosis of CML. Interruption of TKI treatment leads to minimal residual disease reside (MRD), thought to reside in TKI-insensitive leukaemia stem cells which remain a potential reservoir for disease relapse. This highlights the need to develop new therapeutic strategies for CML either as small molecule master TKIs or phytopharmaceuticals derived from nature to achieve chronic molecular remission. This review outlines the past, present and future therapeutic approaches for CML including coverage of relevant mechanisms, whether ABL dependent or independent, and epigenetic factors responsible for developing resistance against TKIs. Appearance of mutant clones along the course of therapy either pre-existing or induced due to therapy is still a challenge for the clinician. A proposed in-vitro model of generating colony forming units from CML stem cells derived from diagnostic samples seems to be achievable in the era of high throughput technology which can take care of single cell genomic profiling.

• BLOOD RESEARCH
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• 제53권4호
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• pp.299-306
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• 2018

Background IgG-mediated anaphylaxis occurs after infusion of certain monoclonal antibody-based therapeutics. New in vitro tests are urgently needed to diagnose such reactions. We investigated whether allergens trigger neutrophil oxidative burst (OB) and if neutrophil OB occurs due to allergen-specific IgG (sIgG). Methods Neutrophil OB was measured by dihydrorhodamine 123 flow cytometry using a leukocyte suspension spiked with a very small patch of the allergen crude extract, Dermatophagoides farinae (Der f). The mean fluorescence intensity ratio of stimulated to unstimulated samples was calculated as the neutrophil oxidative index (NOI). Results The Der f-specific NOI (Der f-sNOI) showed a time-dependent increase after Der f extract addition. At 15 min activation, higher Der f-sIgG levels were associated with lower Der f-sNOI values in 31 subjects (P<0.05). This inverse relationship occurs due to the initial blocking effect of free Der f-sIgG. Additionally, neutrophil OB was nearly absent (Der f-sNOI of -1) in two cases: a subject with undetectable Der f-sIgG levels and washed leukocyte suspensions deprived of Der f-sIgG. Conclusion Allergens can trigger neutrophil OB via preexisting allergen-sIgG. Neutrophil OB can be easily measured in a leukocyte suspension spiked with the allergen. This assay can be used to diagnose IgG-mediated anaphylaxis.

• Clinical and Experimental Reproductive Medicine
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• 제16권1호
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• pp.15-21
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• 1989

An in vitro fertilization assay employing zona-free hamster embryos was used to investigate human spermatozoal fertilitzing ability. Yanaghimarchi et al.(1976) first introduced this cross species fertilzation technique, with its application as a diagnostic tool for male infertility. Human spermatozoa were preincubated for 3 to 4 hrs in B W W medium at concentration of $4{\times}10^6$ sperm/ml prior to the addition to zona-free hamster embryos. After 3 hrs, human sperm was evaluated for fertilizing potential by the presence of swelling or decondencing sperm head in the cytoplasm. The results of penetration rates for sperm were as follow : 1. The average penetration rate of a 7 fertile donor group was $47.8{\pm}27.67%$(Range 14.3-98.0%) 2. The average penetration rate of 12 infertile patients with normal semen analysis was $21.7{\pm}26.9%$(Range 0-38.8%) 3. The average penetration rate of 10 infertile patients with semen abnormalities was $6.1{\pm}8.1%$(Range 0-25%)

• 대한소아치과학회지
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• 제33권2호
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• pp.207-220
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• 2006

새로 개발된 조기 진단 장비들로는 laser fluorescence device(LFD), 초음파 진단 시스템, confocal laser scanning microscopy(CLSM), quantitative light-induced fluorescence(QLF) 시스템 그리고 digital imaging fiber-optic trans-illumination(DIFOTI) 시스템 등이 있다. 본 연구는 임상에서 사용되고 있는 DIFOTI시스템과 LFD를 이용하여 유치 교환 시기에 있는 환아 21명, 25개의 유치를 대상으로 각 치아당 $1{\sim}3$점을 선정하여 구강내에서 초기 우식법랑질에 대한 DIFOTI 이미지 촬영 결과와 LFD 계측값을 3회 측정하고 그 평균을 대표값으로 한 결과를 CLSM과 비교하여 진단 능력을 평가하였다. 실험실 연구에서는 인공우식 용액을 이용하여 수거된 40개의 유치를 협설면에 $2{\times}3mm$ 크기의 창을 형성하고 4, 8, 12, 16일간 탈회시키면서 그 변화를 DIFOTI 시스템과 LFD를 이용하여 측정하고 이를 CLSM과 비교 분석하여 다음과 같은 결론을 얻었다. 1. 구강내에서 촬영된 DIFOTI의 민감도는 88.2%이었고, 특이도는 76.9%이었다. 2. 구강내에서 측정된 LDD의 민감도는 76.5%이었고, 특이도는 69.2%이었다. 3. 실험실 연구에서 유치 법랑질의 탈회 기간에 따른 DIFOTI 광투과율의 회귀 분석한 결과, 탈회 시간에 따라 광투과율은 감소하였다(r=-0.96, p<0.05). 4. 실험실에서 탈회 기간에 따른 LFD의 측정값의 회귀 분석 결과 통계적 유의성을 보이지 않았다(p>0.05). 5. DIFOTI 이미지의 광투과율과 CLMS의 병소 깊이에 대한 상관 계수는 -0.688이었으나(p<0.05), LFD의 측정값은 유의성을 보이지 않았다.

• 한국미생물·생명공학회지
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• 제45권2호
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• pp.87-92
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• 2017

첫 번째 에볼라 출혈열 발발은 1976년 콩고 민주 공화국과 수단에서 발생했으며, 이후 2014년서 아프리카에서 27,741건, 11,284건의 사망자가 발생했다. 발열은 Filoviridae 계열에 속하며 ssRNA 게놈을 가진 에볼라 바이러스에 의해 발생했다. 바이러스의 알려진 아형은 Bundibugyo ebolavirus, Reston ebolavirus, Sudan ebolavirus, Tai Forest ebolavirus 및 Zaire ebolavirus이다. 역사적으로 에볼라의 주요 발생 지역은 동부 및 중부 아프리카 열대 지방에서 발생했다. 서아프리카에서의 발발로 인해 전세계 사회에서 수많은 사망과 공포가 확산되었다. 효과적인 치료와 백신이 없는 상황에서 전염병을 관리하고 통제하는 가장 중요한 방법은 정확한 진단을 통해서이다. WHO(세계 보건기구)는 체외진단(IVD) 검사에서 에볼라의 선택과 사용에 관한 긴급 지침을 발표했다. RealStar Ebolavirus Screen RT-PCR 키트 1.0 (Altona), Liferiver-Ebola Virus (EBOV) 실시간 RT-PCR 키트, Xpert 에볼라 검사 및 ReEBOV 항원 검사를 통해 수많은 회사 및 연구 기관에서 진단을 받고 4가지 WHO 조달 승인 진단을 확인했다. 또한, 신속한 검사 키트 Rapid Diagnosis Test (RDT)와 같은 새로운 진단법이 현재 연구 중이다.