• Title/Summary/Keyword: 검체 관리

검색결과 102건 처리시간 0.023초

The Evaluation of Radioimmunoassay kits for Insulin (Insulin 측정용 방사면역측정법 시약의 평가)

  • Shin, Yong Hwan;Kim, Yun Hyun;Lee, Il Kyu;Kim, Ji Young;Seok, Jae Dong;Shin, Suk Hee
    • The Korean Journal of Nuclear Medicine Technology
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    • 제16권2호
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    • pp.149-155
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    • 2012
  • Purpose : Serum insulin levels are useful indicator which of reflecting the function of insulin secretion in pancreatic ${\beta}$ cell and diagnosis of diabetes, differentiating the cause of impaired glucose tolerance. Insulin measurement kits have shown some differences in many ways such as test methods as well as quality control. The purpose of this study was to evaluate the diagnostic performance of seven manufacturing companies commercial kits. Materials and Methods : The values of insulin measured by three manufacturing companies (Biosource, Siemens, TFB) with 59 samples in August 2009 were compared with those measured by four manufacturing companies (Immunotech, Izotope, BNIBT, Cisbio) with 68 samples in December 2011. We evaluated precision, recovery rate, dilution test and correlation of serum insulin measurement using seven manufacturing company kits. Statistical program SPSS 12.0 was used for the verification of results. Results : The coefficients variation of the precision on all seven different kits were showed within 5.0%. Recovery rate of Biosource, Siemens, TFB kits on three different levels showed 94.2~103.7%, 99.0~104.6%, 99.7~107.6% respectively. Immunotech, Izotope, BNIBT, Cisbio were 93.5~99.1%, 91.4~99.1%, 99.2~131.0%, 84.8~102.3% respectively. There was strong correlation between the measurement of insulin by Biosource kit and that by two commercial kits, Siemens (R2=0.96), TFB (R2=0.99). There was good correlation between the measurement of insulin by TFB kit and that by three commercial kits, Immunotech (R2=0.97), Izotope (R2=0.96), Cisbio (R2=0.97). In the dilution test performed with more than 200 ${\mu}IU/ml$ high concentration samples, samples with diabetes correctly was measured in all seven manufacturing kits. However, as measured with insulinoma samples TFB, Siemens, Izotope, Cisbio kits were correctly measured, but Biosource and Immunotech kits were measured 47.4 ${\mu}IU/ml$, 72.3 ${\mu}IU/ml$, respectively. Conclusion : Serum Insulin radioimmunoassay kits were showed excellent precision, correlation and good recovery rate. However, some kits were not measured correctly in the high concentration insulin values. when selecting a kit should be considered many factors that cost effectiveness, compatible for automation equipment, high performance kit, the environment for each laboratory such as reaction time and reporting time.

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Chemical Preservation Methods of Urine Sediment for Quality Control (정도관리를 위한 요침사의 화학적 보존방법)

  • Cho, Soung Suck;Kim, Myong Soo;Shin, Kyung-A
    • Korean Journal of Clinical Laboratory Science
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    • 제49권4호
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    • pp.359-365
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    • 2017
  • There is greater standardization of quality control for microscopic examination of urine than for physicochemical test. In this study, we investigated whether it is possible to control the sediment accuracy by microscopic examination through the real thing by preserving the essential sediment with glutaraldehyde, which is required for the rationality of sediment quality control. A urine specimen was prepared using 2.5% glutaraldehyde as a preservation solution. Samples treated with urine preservatives confirmed the morphological deformation of the cells for four weeks at intervals of one week and confirmed whether they should be preserved for 4 weeks thereafter. After preparing the required sediment slide, two more slides were produced; one was stored in a refrigerator for, and the other was stored at room temperature. The morphological deformation of the specimen was confirmed. Glutaraldehyde has the effect of preserving the refrigerated essential sediments and storing them for up to 8 weeks, refrigerated storage after slide production, stabilized by 3 days. Moreover, after treatment with preservatives, the production of the slide and comparison between the measured values between the laboratories and examiners showed a low consistency. In conclusion, we showed that the urine sediment components can be preserved, and it can be used for quality control and education through real objects.

Establishment of Plasma Working Standards for the Performance and Quality Assurance of NAT Screening Tests for HIV, HCV and HBV (HIV, HCV와 HBV 유전자 분석시약의 성능 및 품질관리용 Plasma Working Standards 제조에 관한 연구)

  • Kim, Myung Han;Cho, Youn Jung;Kwon, So-Yong;Cho, Nam Sun
    • The Korean Journal of Blood Transfusion
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    • 제23권2호
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    • pp.152-161
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    • 2012
  • Background: Since Jan. 2012, for performance evaluation of viral reagents, analysis of domestic samples has been recommended in order to obtain approval from the KFDA when they are first introduced to Korea. This regulation requires the standard domestic materials driven from locally infected samples. We tried manufacturing the plasma working standards of HBV, HCV, and HIV NAT using a mixed titer of viral loads. Methods: Forty three HBV DNA positive plasmas, 25 HCV RNA positive plasmas, and 26 HIV RNA positive plasmas were evaluated according to viral load and genotype. Several plasma units, which had high-titer viral loads and the common viral genotypes in Korea, were selected as the source materials for each viral standard. To adjust the appropriate concentration based on the detectable range of variable viral reagents, the source plasma was diluted to several concentrations, divided into small vials, and analyzed for quantification. Results: The 13 plasma working standards, which had variable viral loads for the mixed titer performance panel of HIV, HCV, and HBV NAT, were produced. Conclusion: These national standard materials were first produced in order to supply the mixed titer performance panel for the viral NAT reagent of the level IV transfusion related high-risk group in Korea.

Application of Westgard Multi-Rules for Improving Nuclear Medicine Blood Test Quality Control (핵의학 검체검사 정도관리의 개선을 위한 Westgard Multi-Rules의 적용)

  • Jung, Heung-Soo;Bae, Jin-Soo;Shin, Yong-Hwan;Kim, Ji-Young;Seok, Jae-Dong
    • The Korean Journal of Nuclear Medicine Technology
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    • 제16권1호
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    • pp.115-118
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    • 2012
  • Purpose: The Levey-Jennings chart controlled measurement values that deviated from the tolerance value (mean ${\pm}2SD$ or ${\pm}3SD$). On the other hand, the upgraded Westgard Multi-Rules are actively recommended as a more efficient, specialized form of hospital certification in relation to Internal Quality Control. To apply Westgard Multi-Rules in quality control, credible quality control substance and target value are required. However, as physical examinations commonly use quality control substances provided within the test kit, there are many difficulties presented in the calculation of target value in relation to frequent changes in concentration value and insufficient credibility of quality control substance. This study attempts to improve the professionalism and credibility of quality control by applying Westgard Multi-Rules and calculating credible target value by using a commercialized quality control substance. Materials and Methods : This study used Immunoassay Plus Control Level 1, 2, 3 of Company B as the quality control substance of Total T3, which is the thyroid test implemented at the relevant hospital. Target value was established as the mean value of 295 cases collected for 1 month, excluding values that deviated from ${\pm}2SD$. The hospital quality control calculation program was used to enter target value. 12s, 22s, 13s, 2 of 32s, R4s, 41s, $10\bar{x}$, 7T of Westgard Multi-Rules were applied in the Total T3 experiment, which was conducted 194 times for 20 days in August. Based on the applied rules, this study classified data into random error and systemic error for analysis. Results: Quality control substances 1, 2, and 3 were each established as 84.2 ng/$dl$, 156.7 ng/$dl$, 242.4 ng/$dl$ for target values of Total T3, with the standard deviation established as 11.22 ng/$dl$, 14.52 ng/$dl$, 14.52 ng/$dl$ respectively. According to error type analysis achieved after applying Westgard Multi-Rules based on established target values, the following results were obtained for Random error, 12s was analyzed 48 times, 13s was analyzed 13 times, R4s was analyzed 6 times, for Systemic error, 22s was analyzed 10 times, 41s was analyzed 11 times, 2 of 32s was analyzed 17 times, $10\bar{x}$ was analyzed 10 times, and 7T was not applied. For uncontrollable Random error types, the entire experimental process was rechecked and greater emphasis was placed on re-testing. For controllable Systemic error types, this study searched the cause of error, recorded the relevant cause in the action form and reported the information to the Internal Quality Control committee if necessary. Conclusions : This study applied Westgard Multi-Rules by using commercialized substance as quality control substance and establishing target values. In result, precise analysis of Random error and Systemic error was achieved through the analysis of 12s, 22s, 13s, 2 of 32s, R4s, 41s, $10\bar{x}$, 7T rules. Furthermore, ideal quality control was achieved through analysis conducted on all data presented within the range of ${\pm}3SD$. In this regard, it can be said that the quality control method formed based on the systematic application of Westgard Multi-Rules is more effective than the Levey-Jennings chart and can maximize error detection.

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Field Assessment of Sanitation Management for School Foodservice Suppliers in the Seoul Area (서울지역 학교급식 식재료 납품업체 위생관리 실태 평가)

  • Lee, Kyung-Mi;Ryu, Kyung
    • Korean journal of food and cookery science
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    • 제23권5호
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    • pp.650-663
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    • 2007
  • The purpose of this study was to identify the sanitation management items of school foodservice suppliers that require improvement, by assessing their sanitation practices with food commodities. Our field assessment was performed using a total of 20 vendors supplying agricultural products, meat products, seafoods and processed products; all were located in the Seoul and Gyeonggi areas. The assessment tool for sanitation management was composed of 93 checklist items and was used to evaluate seven different categories; the facility and environment, management of the facility and equipment, food materials management, process control, water management, personal hygiene management, and laboratory instrument management. A score of two was given for "satisfactory", one for "fair", and zero for "unsatisfactory". The overall average supplier score was 1.7/2.0 (85.8%). The score of the seafood vendors was highest at 1.9 (95.4%), while the lowest score of 1.3 (65.7%) occurred with the processed product suppliers. Among the sanitation management categories, water management was scored at 2.0, while inspection management was lowest at 1.4. The subcategories indicating needed improvements for the processed product suppliers were raw materials, storage, transport and recall. For the agricultural product suppliers it was preparation management. furthermore, one item within the laboratory instrument management category was unsatisfactory for both the agricultural and processed product suppliers. In conclusion, these results can be used to develop sanitation management procedures for suppliers, as well as by administration agencies to evaluate and guide those suppliers.

A Study on Contents of Trace Metal of the Agricultural Products around Mines Located in Chollanam-Do (전라남도 광산 주변에서 수확한 농산물의 미량금속 조사)

  • 박정숙;김충모;이미경
    • The Korean Journal of Food And Nutrition
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    • 제14권2호
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    • pp.132-137
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    • 2001
  • To know a degree of pollution in agricultural products cultivated around 4 unworked mines located in Chollanam-Do, we investigated a concentration of trace metal to provide the basic data for its residual limits. 28 samples of seven kinds of agricultural products (lettuce, onion. potato, radish, pepper. pumpkin, bean) collected from 4 unworked mines located in Chollanam-Do in 1999 were analyzed by Mercury Analyzer for mercury and Atomic Absorption spectrophotometer for Pb, As, Cd. Cu, Mn, and Zn. Hg contents were detected N.D. ∼trace level (0.01 ppm and less) and As contents were detected N.D. ∼ 0.038 ppm but most of samples were not detected. Cd contents were detected N.D∼0.101 ppm. The results of Hg, As, Pb and Cd content showed that for all the 7 species of agricultural products studied, none have accumulated levels dangerous enough to pose health problems. The average contents of Cu were 4.356∼10.624 rpm in bean. the Mn were 4.332∼24.385 ppm in lettuce and the Zn were 4.072 ∼ 20.715 ppm in bean, respectively.

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Effect of Multifaceted Interventions for Ward Nurses on the Storage, Conditions, and Transportation of Specimens for Microbial Culture (병동 간호사 대상의 다각적 중재가 배양검사 검체의 보관과 상태 및 운송에 미치는 영향)

  • Cho, Min Jung;Jeong, Jae Sim;Kim, Yoon Hee
    • Journal of Korean Biological Nursing Science
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    • 제24권2호
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    • pp.95-103
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    • 2022
  • Purpose: The purpose of this study was to provide multifaceted interventions for nurses and to confirm changes in their knowledge, perception, and actual practice on the adequate storage, conditions, and transportation of culture specimens. Methods: A one-group pretest-posttest experimental design was conducted with 41 nurses in two general wards of a tertiary acute care hospital in Seoul. Multifaceted interventions including education, feedback, posting guidelines and reminders, and improvement in specimen management accessibility were provided from May 2019 to January 2020. Outcomes were measured before and after the interventions. Knowledge and perception of the nurses were evaluated using self-reported questionnaires and actual practice by observation. Results: After the interventions, the average knowledge score on transportation time was significantly increased (Z= -4.89, p< .001). However, the knowledge score on storage methods was not significantly increased. The perception score was significantly increased (t= -3.19, p= .003). The proportion of specimen storage times, places, and conditions managed properly was significantly increased from 43.0% (46/107) to 77.1% (84/109) (p< .001). The average transportation time of blood samples to the laboratory significantly decreased from 3 hours 36 minutes (± 1 hour 52 minutes) to 3 hours 1 minute (± 1 hour 41 minutes) (t= 2.51, p= .013). The percentage of blood culture specimens arriving within 2 hours was increased significantly from 22.9% to 39.2% (χ2= 6.90, p= .009). Conclusion: The interventions were effective. However, some specimens remained in the ward longer than expected after the interventions. This requires further interventions.

Epidemiology and Clinical Characteristics of Enterovirus Infections in Children: A Single Center Analysis from 2006 to 2010 (2006-2010년 단일기관 소아에서의 엔테로바이러스 감염 역학 및 임상 양상에 관한 연구)

  • Park, In-Soo;Lee, Hae Sung;Choi, Soo-Han;Kim, Hye Jin;Hwang, Seo Yeon;Cheon, Doo-Sung;Chang, Jin-Keun
    • Pediatric Infection and Vaccine
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    • 제20권2호
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    • pp.81-88
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    • 2013
  • Purpose : This study was performed to investigate the epidemiology of enterovirus (EV) infections in children at a secondary hospital during recent 5 years. Methods : We collected the cerebrospinal fluid, stool and throat swab samples from the pediatric patients with suspected EV infections in KEPCO Medical Center, Seoul, Korea from July 2006 to September 2010. EV detection and genotype identification were performed by RT-PCR at Korea Centers for Disease Control and Prevention. Results : A total of 386 samples were collected from 277 patients during study period. Ninety-eight patients (35.4%) were diagnosed with EV infections. The RT-PCR positive rate was the highest in throat swab samples (48.3%). The median age of patient was 4.7 years (range, 0.1-12.5 years). Aseptic meningitis (50, 51.0%) was the most common clinical manifestation; herpangina (22, 22.4%) and hand-foot-mouth disease (18, 18.4%). One hundred EVs were isolated from 98 patients and 20 genotypes of EV were identified; Echovirus 30 (28 cases, 28%), Enterovirus 71 (12 cases, 12%), Echovirus 25 (10 cases, 10%), Echovirus 9 (9 cases, 9%) and Coxsackievirus A6 (8 cases, 8%). Aseptic meningitis caused by Echovirus 30 was the most common manifestation in 2008. There was no complicated case caused by Enterovirus 71. Conclusion : This study showed the epidemiology of confirmed EV infection in children from 2006 to 2010. There is a need for continuous surveillance of EV infections and its clinical manifestations.

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Survey of Contaminants of Bound 3-MCPD in Food (식품 중 결합형 3-MCPD 오염실태조사)

  • Kong, Young-Woon;Park, Sung-Kug;Seo, Jung-Heok;Kim, Dong-Sul
    • Journal of Food Hygiene and Safety
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    • 제25권4호
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    • pp.289-293
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    • 2010
  • 3-MCPD created in manufacture process was regulated in our country about soy sauce and HVP. The latest paper reported that Bound 3-MCPD is created as intermediate. Germany common risk assesment reported that Bound 3-MCPD must be reduced because Bound 3-MCPD can be created in estimation circle when this is hydrolyzed in human body, but the data about the toxity of Bound 3-MCPD is lack. Therefore, We analysis about 209 items food such as soy sauce, seasoning food and meat-eating manufactured goods using bound 3-MCPD analysis method developed recently. As result of survey, bound 3-MCPD detected in 8 items among 44 traditional sauce (0.02~0.28ppm), 8 of soup 12 items (0.01~0.96ppm), in 22 items of sauce 60 items (0.01~0.55ppm), in 16 items of meat-eating manufactured foods 30 items (0.04~0.18ppm), in 20 items of snack cookies 28 items (0.09~1.43ppm), in 8 in roasted oil foods 10 items (0.04~1.22ppm), in 6 items of peanut processed food 10 items (0.06~0.25ppm), in 1 of vegetable cream 15 items (0.05ppm). Detected level was lower than the result of monitored by other countries.

Quality Tests for the Knee-Orthosis Velcro and Locking System (무릎보조기 벨크로 및 잠금장치에 대한 품질시험 연구)

  • Jung, Se-Wook;Seo, Won-San;Cho, KiHun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • 제17권5호
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    • pp.275-283
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    • 2016
  • In this study, three knee-orthoses (dial lock type, medium size, right side) were used for a quality level test (static bending test and solidity test of the locking system) of the knee-orthosis locking system. In the static bending test, a smaller maximum load was observed in samples A and C compared to the reference standard value (KS P 8408 standard value: 1000 N, sample A: 865 N, sample C: 833 N). In addition, in the solidity test of the locking system, a smaller maximum load was observed in the all samples compared to the referenced standard value (KS P 8411 standard value: 200 N, sample A: 41 N, sample B: 97 N, sample C: 54 N). Korean industrial standards for knee-orthoses and systematic test methods are lacking. Therefore, a systematic management plan for knee-orthoses is required. The result of the current study showed that a systematic management plan for the knee-orthosis locking system is required. In particular, the development of a quantitative and objective test method is needed. The findings of the current study may be useful for monitoring the quality of the knee-orthosis locking system and may provide foundational information for the development of a quantitative and objective test method.