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      • KCI등재후보

        메디컬시험기관에서 ISO 15189 도입의 필요성과 시행의 효용성

        양만길 ( Man Gil Yang ),이원호 ( Won Ho Lee ),전진현 ( Jin Hyun Jun ) 대한임상검사과학회 2016 대한임상검사과학회지(KJCLS) Vol.48 No.2

        다양한 분야에 대한 품질표준들 중에서 메디컬시험기관에 대한 품질 및 적격성에 대한 요구사항인 ISO 15189는 ISO 9001; 품질경영시스템-요구사항과 ISO/IEC 17025; 시험기관 및 교정기관의 능력에 관한 일반요구사항인 두 표준을 바탕으로 메디컬시험기관에 요구되는 사항들을 충족하도록 제정되어 있다. 이 ISO 15189에서는 메디컬시험기관 검사에 관여하는 실무자의 자격 및 지속적인역량, 시험기관 규모, 장비, 시약 및 소모품, 분석전 및 분석인자, 품질보증을 위한 고려사항 및 분석 후 인자 등이 기술되어 있다. 인정과정에서는 업무와 관련된 범주에 전문성을 갖춘 전문가 및 임상 평가사들은 다음의 사항을 포함하여 시험데이터 산출에 영향을 미치는 시험기관에서의 모든 요인에 대한 철저한 평가를 수행한다. 메디컬시험기관의 품질경영시스템은 임상의 또는 환자의 니즈 및 요구사항을 충족시켜야 한다. 품질경영시스템을 기획할 때는 요구사항을 준수하고 품질목표를 충족시켜야 하며 변경하고자 하는 경우에는 품질경영시스템의 통합성을 유지시켜야 한다. 품질경영시스템의 통합성은 목표 달성을 위한 세부 요소들의 상호작용 즉, Plan-Do-Check-Act (P-D-C-A) cycle이 서로 유기적으로 작용하여 지속적인 개선(improvement)이 이루어짐을 의미한다. 메디컬시험기관 ISO 15189 인정제도는 법률 또는 국제기준에 적합한 인정기구가 전문적인 자격을 갖춘 평가사로 하여금 메디컬시험기관의 품질 시스템과 기술능력을 평가하도록 하여 메디컬시험분야에 대한 시험능력이 있다는 것을 공식적으로 인정하는 제도로 우리나라에서는 한국인정기구(KOLAS)가 담당하고 있다. 정부의 2010년 무렵의 KS P ISO 15189 도입 계획은 다소 지연되어, 2016년 4월 1일 기준으로 한국인정기구(KOLAS)를 통해 인정 받은 메디컬시험기관은 공공기관 2곳(한국원자력의학원 생물학적선량 평가실, 서울대학교병원 핵의학과)과 민간기관이 3곳(삼성서울병원 핵의학과, 서울아산병원 핵의학과, 서울아산병원 병리과)뿐이지만, ISO 15189 도입의 궁극적인 목적인 메디컬 서비스의 질적 수준의 향상과 국제적인 경쟁력 강화에 대한 사회적인 요구를 반영하기 위해, 각 기관에서는 적극적인 자세로 도입에 노력해야 할 것으로 생각된다. The requirements for medical laboratories ISO 15189 is examined in organization and a quality management system, stressing the importance of evidence, document control, and control of records and clinical material. Medical services are provided from the areas of resource management, and pre-examination, examination and post-examination processes. The main goal of ISO 15189 accreditation is to improve the quality of laboratory services provided for patients and clinical users not only through compliance with consensually developed and harmonized requirements but also by adopting the philosophy of continual improvement using the Plan-Do-Check-Act cycle. Laboratory quality should be evaluated and improved in all steps of the testing process as the state-of-the art indicates that the pre- and post-analytical phases are more vulnerable to errors than the intra-analytical phase. The Korea Laboratory Accreditation Scheme (KOLAS), a national accreditation body, provides medical laboratory accreditations for appropriate approaches to evaluating the competence of a medical laboratory in providing effective services to its customers and clinical users. Adoption of ISO 15189 in 2010s as a government policy has been delayed, and only 5 laboratories have been accredited to date in Korea. The medical laboratories should seek the adoption of ISO 15189 with a positive attitude for quality improvement and strengthening of international competitiveness.

      • Dip-slide(URICULT)법에 관한 고찰

        고영진,양만길,정재원,박정오,장기봉 대한임상병리사협회 1985 대한임상병리사회지 Vol.17 No.1

        The bacterial culture was performed as described by Naylor and Guttmann(1967): immediately after taking the specimen the urine was poured on a dip-slide coated with CLED(cystine-Lactose-electrolyte-Deficient) on one side and with MacConkey agar on the other(Uricult). The dip-slides were kept in an incubator overnight and read the following day. We performed a comparative study of standard loop and dip-slide methods. The results obtained from 659 cases of urines were as follows; 1) Standard loop methods. 18hrs at 37℃-Negative 87.1%, doubtful 10.9% and positive 2.0%. 2) Dip-slide URICULT, 18hrs at 15∼20℃-Negative 88.5%, doubtful 9.5% and positive 2.0%. 3) Dip-slide URICULT, 18hrs at l5∼20hrs℃ and 24hrs at 37℃-Negative 88.5%, doubtful 9.5% and positive 2.0%.

      • KCI등재

        경쟁적 ELISA를 이용한 도파민과 세로토닌의 검출

        남궁수민,최정수,박지향,양만길,이민우,김성욱,Namkung, Su Min,Choi, Jeong Su,Park, Ji Hyang,Yang, Man Gil,Lee, Min Woo,Kim, Suhng Wook 대한임상검사과학회 2017 대한임상검사과학회지(KJCLS) Vol.49 No.3

        Dopamine (DA) and serotonin (5-Hydroxytryptamine, 5-HT) are neurotransmitters and hormones that exist in small amounts but have important role in the body. Serum and 24-hour urine are used as specimens, and are usually examined by HPLC-MS. In this study, we tried to detect DA and 5-HT by competitive ELISA using antigen-antibody (Ab) reaction. After immobilizing $5{\mu}g/mL$ BSA conjugate on a 96-well surface, hormone and primary Ab, which are respectively diluted to different concentrations, were treated. Then, HRP-conjugated secondary Ab and TMB were added to measure absorbance. The regression equation and $R^2$ value were calculated based on absorbance, and sensitivity of Ab to hormone as well as the correlation between hormone concentration and absorbance were determined. In DA ELISA, $R^2$, the correlation between the concentration of hormone and absorbance, was the highest by 0.91 when anti-dopamine Ab was diluted 6,000 times and 7,000 times. In 5-HT ELISA, $R^2$ was bigger than 0.90 in every concentration except 3,000 times and 6,000 times. Both DA and 5-HT were not effectively detected at low concentrations (less than $1.0{\times}10^{-7}M$); and because reference value of serum DA is lower than this, HPLC-MS was required to detect serum DA. However, competitive ELISA may be effective in detecting 24-hour urine DA, serum, and 24-hour 5-HT. Further studies are needed to detect hormones more accurately at lower concentrations.

      • KCI등재
      • KCI등재

        Proteomic Profiling of Serum from Patients with Tuberculosis

        송상훈,한민제,최양선,단기순,양만길,송정한,박성섭,이재호 대한진단검사의학회 2014 Annals of Laboratory Medicine Vol.34 No.5

        Background: Effective treatment and monitoring of tuberculosis (TB) requires biomarkers that can be easily evaluated in blood samples. The aim of this study was to analyze the serum proteome of patients with TB and to identify protein biomarkers for TB. Methods: Serum samples from 26 TB patients and 31 controls were analyzed by using nano-flow ultra-performance liquid chromatography coupled to quadrupole time-of-flight mass spectrometry in data-independent mode, and protein and peptide amounts were calculated by using a label-free quantitative approach. The generated data were analyzed by using principal component analysis and partial least squares discriminant analysis, a multivariate statistical method. Results: Of more than 500 proteins identified, alpha-1-antitrypsin was the most discrimina- tive, which was 4.4 times higher in TB patients than in controls. Peptides from alpha-1-an- titrypsin and antithrombin III increased in TB patients and showed a high variable impor- tance in the projection scores and coefficient in partial least square discriminant analysis. Conclusions: Sera from patients with TB had higher alpha-1-antitrypsin levels than sera from control participants. Alpha-1-antitrypsin levels may aid in the diagnosis of TB.

      • KCI등재

        Growth Inhibition of Hepatocellular Carcinoma Huh7 Cells by Lactobacillus casei Extract

        한대종,김종빈,박서영,양만길,김현철 연세대학교의과대학 2013 Yonsei medical journal Vol.54 No.5

        Purpose: Lactobacillus casei (L. casei) is known to exert anti-proliferation effects on many types of cancer cells. However, the effect of L. casei on liver cancer has not been reported. Accordingly, the aim of this study was to determine the anti-cancer effect of L. casei extract on Huh7 cells. Materials and Methods: L. casei ATCC393 extract was prepared and purified. After the treatment of L. casei extract on Huh7 cells, cell viability, cell cycle arrest and cell death were analyzed by flow cytometry. The expression levels of tumor necrosis factor-α receptor 1 (TNFR1) and death receptor 3 (DR3) mRNA related with extrinsic apoptosis were assessed by reverse transcription polymerase chain reaction. Additionally, P21 and P27 cell cycle proteins as well as Caspase-3, -8, -9, phospho-Bad and Bcl-2 apoptosis proteins were analyzed by western blot analysis. To determine the effect of L. casei extract on cancer stem-like cells, we analyzed changes in side population fraction through flow cytometry. Results: The cell viability of Huh7 cells treated with L. casei extract was decreased by 77%, potentially owing to increases in the rates of Huh7 cells arrested in the G2/M phase (3% increase) and that underwent apoptosis (6% increase). The expression levels of TNFR1 and DR3 mRNA, as well as P21 and P27 cell cycle proteins, were increased. Meanwhile, the expressions of caspase-8, -9, phospho-Bad and Bcl-2 proteins decreased. However, in the case of side population cells, no remarkable changes were observed. Conclusion: L. casei extract exerts a potent anti-tumor effect on the viability of liver cancer cells, although not on cancer stem-like cells.

      • KCI등재

        대한임상검사과학회지 50년사: 명칭과 KCI 등재에 대하여

        구본경,성호중,이기종,양병선,주세익,최승구,장인호,양만길,Koo, Bon-Kyeong,Sung, Ho Joong,Rhee, Ki-Jong,Yang, Byoung-Seon,Joo, Sei Ick,Choi, Seung-Gu,Jang, In-Ho,Yang, Man-Gil 대한임상검사과학회 2017 대한임상검사과학회지(KJCLS) Vol.49 No.3

        The Korean Society for Clinical Laboratory Science publishes the Korean Journal of Clinical Laboratory Science (KJCLS) as the official journal for the Korean Association of Medical Technologists. This year, 2017, marks the 50th anniversary of KJCLS. The original name was "the Korean Journal of Medical Technologists" (Volume 1, 1967~Volume 26, 1994), which was replaced with the "Korean Journal of the Clinical Laboratory Science" (Volume 27, 1995~Volume 35, 2003) and "the Korean Journal of Clinical Laboratory Science" (Volume 26, 2004~Present). The purpose of this study was to provide a framework for further development of KJCLS. In 1998, the National Research Foundation of Korea began the journal assessment service. The major domestic databases are KCI, KOFST, and KAMJE; the major international databases are SCI Index; SCI Core, SCI-Extended), SCOPUS, MEDLINE, and PUBMED. KJCLS has been registered with KCI of the National Research Foundation of Korea since 2014. More than 1,300 articles have been published, which all have made tremendous contributions to the field. To index KJCLS in the journal databases, we measured the value to understand the vocational level and social position. KJCLS is faced with a great challenge; immense effort will be needed to accomplish the original goal of KJCLS to become an internationally recognized journal. Ultimately, the goal of the Korean Society for Clinical Laboratory Science and the Korean Association of Medical Technologists should be to register KJCLS in databases such as KCI and SCOPUS.

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