• Journal of Korean Medical Science
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• 제33권51호
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• pp.340.1-340.14
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• 2018

Background: Various pneumococcal vaccines have been evaluated for immunogenicity by opsonophagocytic assay (OPA). A multiplexed OPA (MOPA) for 13 pneumococcal serotypes was developed by Nahm and Burton, and expanded to 26 serotypes in 2012. The development of new conjugate vaccines with increased valence has necessitated expanded MOPAs to include these additional serotypes. In this study, we validated this expanded MOPA platform and applied to measure antibodies against 11 additional serotypes (2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F) in human sera. Methods: All materials, including serum, complement, bacterial master stocks, and HL-60 cells, were evaluated for assay optimization. Following optimization, the assay was validated for accuracy, specificity, and intra- and inter-assay precision with sera from adult donors following standard protocols. The assay was applied to evaluate functional antibodies of 42 sera immunized with 23-valent pneumococcal polysaccharide vaccine (PPV23). Results: The expanded MOPA platform was specific for all serotypes, with the exception of serotype 20. The assay results were highly correlated with those obtained from single-serotype OPA, indicating acceptable accuracy. The coefficients of variation were 7%-24% and 13%-39% in tests of intra- and inter-assay precision, respectively, using three quality-control samples. A MOPA that included 11 additional serotypes in the PPV23 was established and validated with respect to accuracy, specificity, and precision. The opsonic indices of immune sera were obtained using this validated assay. Conclusion: The expanded MOPA will be useful for evaluation of the immunogenicity of PPV23 and future conjugate vaccine formulations.

• 대한상부위장관⦁헬리코박터학회지
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• 제18권3호
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• pp.150-156
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• 2018

Precision medicine stands for 4Ps - precise, preventive, participatory, and personal; in which "precision" is important because the current modern medicine starts from "trial and error," and "one does not fit all". Current targeted therapies for cancer have changed treatment approaches and led the precision medicine; however, clinical use of liquid biopsy, using blood or other liquid specimens to characterize circulating tumor cells (CTC) or tumor genes instead of biopsies of tumor tissues, still awaits availability of more information regarding non-invasive cancer detection and characterization, prediction of treatment response, monitoring the disease course and relapse possibilities, identification of mechanisms of drug resistance, and newer pathogenesis. In this review, we will introduce the basic concept of CTC, circulating cell free DNA, and exosomes and their possible application for gastric cancer relevant with Helicobacter pylori infection.

• Genomics & Informatics
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• 제15권4호
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• pp.136-141
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• 2017

Accurate detection of genomic alterations, especially druggable hotspot mutations in tumors, has become an essential part of precision medicine. With targeted sequencing, we can obtain deeper coverage of reads and handle data more easily with a relatively lower cost and less time than whole-exome or whole-genome sequencing. Recently, we designed a customized gene panel for targeted sequencing of major solid cancers. In this study, we aimed to validate its performance. The cancer panel targets 95 cancer-related genes. In terms of the limit of detection, more than 86% of target mutations with a mutant allele frequency (MAF) <1% can be identified, and any mutation with >3% MAF can be detected. When we applied this system for the analysis of Acrometrix Oncology Hotspot Control DNA, which contains more than 500 COSMIC mutations across 53 genes, 99% of the expected mutations were robustly detected. We also confirmed the high reproducibility of the detection of mutations in multiple independent analyses. When we explored copy number alterations (CNAs), the expected CNAs were successfully detected, and this result was confirmed by target-specific genomic quantitative polymerase chain reaction. Taken together, these results support the reliability and accuracy of our cancer panel in detecting mutations. This panel could be useful for key mutation profiling research in solid tumors and clinical translation.

• 한국의학물리학회:학술대회논문집
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• 한국의학물리학회 2006년도 제33회 추계학술대회 발표논문집
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• pp.41-41
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• 2006

• Natural Product Sciences
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• 제18권3호
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• pp.158-165
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• 2012

A UPLC method for the simultaneous determination of seven compounds was established for the quality control in H. cordata. The UPLC was performed on a $C_{18}$ HSS T3 $2.1{\times}100$ mm, 1.8 ${\mu}m$ column during a 13 minute gradient elution of 0.2% aqueous acetic acid and acetonitrile with the flow rate of 0.2 mL/min at $30^{\circ}C$. The UPLC method was validated according to the ICH guideline of analytical procedures with respect to precision, accuracy, and linearity. The limit of determination and quantitation for the seven compounds were 0.01-0.09 and 0.03-0.28 ${\mu}g/mL$, respectively. The calibration curves of all seven compounds showed good linearity ($r^2$ > 0.999). The intra-day and inter-day the RSD values used to evaluate the precision of analysis were less than 0.9%. The recoveries of quantified compounds ranged from 98.63 to 103.85%. The developed UPLC method was found to be effective, convenient and sensitivity for quantitative analysis of seven compounds in H. cordata. This work could be provided a baseline source for quality control of H. cordata.

• 대한본초학회지
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• 제29권1호
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• pp.13-18
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• 2014

Objectives : Iridoid glycoside, swertiamarin is a well known bioactive component found in Swertia japonica Makino (SJ). In this study, we tried to optimize a suitable method which would extract swertiamarin effectively. Methods : Extraction of SJ was carried out by various conditions of time (5 - 60 min), temperature ($30-70^{\circ}C$), solvent (from non-polar to polar), and ratio of solvnet / sample (10 : 1 - 40 : 1) using ultrasonic extractor. Swertiamarin in SJ extracts was quantified by high performance liquid chromatography - Phtodiode array detector (HPLC-PDA) using C18 column and the analytical procedure was validated by evaluation of specificity, range, linearity, accuracy (recovery), precision (intra- and inter day variability), limit of detection (LOD), and limit of quantification (LOQ). Results : An efficient extraction condition for swertiamarin in SJ was optimized using sonicator extraction (temperature $40^{\circ}C$, solvent 20% methanol, solvent / sample (20 : 1), and time 10 min. Analytical procedure was optimized by HPLC-PDA using isocratic solvent system of acetonitrile and water (9 : 91), and the method was validated in regard to linearity (correlation coefficient, $R^2$ > 0.9999), range ($50-1000{\mu}g/mL$), intra- and inter-precision (RSD < 5.0 %), and recovery (99 -103 %). LOD and LOQ were 0.051 and $0.155{\mu}g/mL$, respectively. Conclusion : An optimized method of extraction for swertiamarin in SJ was established through conditions of diverse extraction and the validation result indicated that the method is suited for the determination of swertiamarin in SJ.

• 핵의학기술
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• 제19권1호
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• pp.72-80
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• 2015

Estradiol($E_2$)은 월경 주기와 배란유도 및 불임 및 폐경을 진단하는데 유용한 지표이다. 따라서 정도인증 평가 지표인 정밀도(precision), 회수율(accuracy), 예민도(sensitivity) 및 타 키트와의 상관성(comparison) 비교를 통하여 우수한 키트를 선정하여 사용함으로서 핵의학검사실 표준화와 질 향상을 도모하고자 본 연구를 시행하였다. 핵의학검사실에서 사용하고 있는 방사면역측정법(Radioimmunoassay; RIA)으로 SIEMENS (Coat-A-Count Estradiol, USA), DIAsource (Immunoassays S.A.. Belgium), AMP (As bach Medical Products GMBH, Germany), BECKMAN COULTER (IMMUNOTECH s.r.o. Czech Republic), Beckman Coulter Ultra Sensitive Estradiol (IMMUNOTECH s.r.o. Czech Republic), CIS Bio (France), MP (ICN Biomedicals, Germany) 7개 키트와 화학발광면역측정법으로 검사하는 E170 (Roche Diagnostics, Germany), Architect (ABBOTT, USA) 2종류의 자동화장비로 측정하였다. 측정 내 정밀도는 키트별로 농도에 따라 다르게 측정 되었으며, 측정값이 낮은 저농도에서는 10.9~13.6% 변이계수를 보였으며, 중, 고농도에서는 모든 키트가 10% 이내의 결과를 보였다. 키트간 상관성 평가를 위한 ANOVA 분석에서 저농도, 중농도, 고농도 검체 각각에 대하여 대부분 키트 간에 유의한 상관관계를 보였으나 일부 키트에서는 유의하지 않은 결과를 보이기도 하였다. 측정 간 정밀도는 측정값이 낮은 저(Low) 농도에서는 10.8~12.3% 변이계수를 보였으며, 중(Medium), 고(High)농도에서는 모든 키트가 10% 이내의 결과를 보였다. 회수율은 IEMENS $92.7{\pm}12.4%$, DIAsou rce $101.4{\pm}18.4%$, AMP $95.1{\pm}11.5%$, BECKMAN COULTER $108.4{\pm}18.5%$, BECKMAN COULTER Ultra Sensitive $104.2.{\pm}13.5%$, CIS Bio $101.3{\pm}11.6%$, MP $93.1{\pm}13.2%$ 이다. 예민도(pg/mL)는 SIEMENS 7.5, DIAsource 6.2, AMP 5.7, BECKMAN COULTER 6.2, BECKMAN COULTER Ultra Sensitive 5.3, CIS Bio 4.5, MP 5.5 이다. 상관성에서는 저농도에서는 MP 키트가 타 키트에 비해 다소 높게 측정되었으며, 중, 고농도에서는 E170 장비가 다소 높게 측정되었다. 외부정도관리 숙련도 시료를 이용한 측정값에서는 타 키트에 비하여 SIEMENS 키트는 낮은 경향을 보였으며, E170, Architect, MP 키트들은 다소 높은 경향을 보였다. $E_2$ 검사 측정 키트 및 방법들은 전체적으로 정밀도, 회수율, 민감도 등의 지표에서 검사에 이용하는 데 무리가 없으나, 키트 변경 시에는 검사의 일관성 유지를 위하여 상호 상관성을 고려하여야 할 것이다.

• 대한약침학회지
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• 제12권4호
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• pp.33-50
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• 2009

Objectives : This study was conducted to confirm validation and stability of concentration analysis method of pure melittin (Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration. Methods : All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Standard solutions of melittin (SIGMA, USA) and test substances were dispensed and were analyzed with HPLC for Sweet BV to secure the validation of analysis. Results : 1. Measurement of system suitability of Sweet BV satisfied criterion of below 3%. 2. Confirming Linearity of Sweet BV in 10-200${\mu}g/m\ell$ solution yielded correlation coefficient (r) of 0.995 and accuracy of 85-115% which satisfy criterion. 3. Measurement of Specificity of Sweet BV didn't yield any substance affecting the peak of test substances, but detected at 21.22min verified as the test substance. 4. Confirming Intra-day of Sweet BV, accuracy and precision of 0.1, 100${\mu}g/m\ell$ were 105.70, 95.81 and 0.66, 0.73, respectively, satisfying both criteria of accuracy (85-115%) and precision (within 10%). 5. To measure Stability in autosampler, all samples used in Intra-day reproducibility sat in the autosampler for five hours and were re-analyzed. Both variability and precision satisfied the criteria. 6. Homogeneity of Sweet BV (0.1, 100${\mu}g/m\ell$) at upper, middle, and lower layers all satisfied the accuracy and precision criteria. 7. Stability of Sweet BV (0.1, 100${\mu}g/m\ell$) at room temperature for four hours and refrigerated for 7 days all satisfied the criterion. 8. For the measurement of Quality control, QC samples measured on the first and eighth day all satisfied accuracy and precision criteria. Conclusion : Above experiment data satisfies validation and stability of concentration analysis method of Sweet BV.

• Journal of Genetic Medicine
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• 제18권1호
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• pp.8-15
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• 2021

Recent genetic advances allow for identification of the genetic etiologies of epilepsy within individual patients earlier and more frequently than ever. Specific targeted treatments have emerged from improvements in understanding of the underlying epileptogenic pathophysiology. These targeted treatment strategies include modifications of ion channels or other cellular receptors and their function, mechanistic target of rapamycin signaling pathways, and substitutive therapies in hereditary metabolic epilepsies. In this review, we explore targeted treatments based on underlying pathophysiologic mechanisms in specific genetic epilepsies.

• 한국근적외분광분석학회:학술대회논문집
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• 한국근적외분광분석학회 2001년도 NIR-2001
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• pp.4103-4103
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• 2001

The aim of this study was to examine whether near infrared spectroscopy (NIRS) is an acceptable tool to determine cholesterol and collagen in human atherosclerotic plaque without destruction of the analyzed areas and without danger the endothelial cells - three preconditions for the development of a NIR-heart-catheter. The questions were: Can the cholesterol and collagen content of the arterial intima be estimated with acceptable precision in vitro by NIRS despite the matrix inhomogeneity of the plaques and their anatomic variability\ulcorner How deep can such NIR radiation penetrate into arterial tissue without danger for endothelial cells\ulcorner Is this penetration sufficient for information on the lipid and collagen accumulation\ulcorner Using NIRS, cholesterol and collagen can be determined with acceptable precision in model mixtures and human aortic specimens (r=0,896 to 0,957). The chemical reference method was HPLC. The energy dose was 71 mW/$cm^{-2}$ using a fiber optic strand with a length of 1.5m and an optical window of d=4mm. This dose appears to be not dangerous for endothelial cells, It will be attenuated to 50% by a arterial tissue of about 170-$200\mu\textrm{m}$ thickness. The results are also acceptable using a thin coronary catheter-like fiber optic strand (d=1mm).