• Journal of Veterinary Science
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• 제21권4호
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• pp.68.1-68.8
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• 2020

A fluorescent microsphere-based immunochromatographic strip test (FICT) was developed for the rapid, sensitive, and quantitative detection of porcine reproductive and respiratory syndrome virus (PRRSV) antibodies at the pen-side. The assay was based on the formation of a sandwich immune-complex (anti-pig IgG-PRRSV antibodies-NSP7/N), which was validated by a comparison with IDEXX-ELISA using 3325 clinical specimens. The diagnostic specificity, sensitivity, and accuracy of FICT were 97.28, 93.41, and 94.95%, respectively. FICT showed a good correlation with the virus neutralization assay. Overall, a promising pen-side diagnostic tool was developed for the rapid and quantitative detection of PRRSV antibodies within 15 min.

• Annals of Laboratory Medicine
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• 제38권6호
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• pp.578-584
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• 2018

Background: Accurate, rapid, and cost-effective screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection may be useful in laboratories that cannot afford automated chemiluminescent immunoassays (CLIAs). We evaluated the diagnostic performance of a novel rapid automated fluorescent lateral flow immunoassay (LFIA). Methods: A fluorescent LFIA using a small bench-top fluorescence reader, Automated Fluorescent Immunoassay System (AFIAS; Boditech Med Inc., Chuncheon, Korea), was developed for qualitative detection of hepatitis B surface antigen (HBsAg), antibody to HBsAg (anti-HBs), and antibody to HCV (anti-HCV) within 20 minutes. We compared the diagnostic performance of AFIAS with that of automated CLIAs-Elecsys (Roche Diagnostics GmbH, Penzberg, Germany) and ARCHITECT (Abbott Laboratories, Abbott Park, IL, USA)-using 20 seroconversion panels and 3,500 clinical serum samples. Results: Evaluation with the seroconversion panels demonstrated that AFIAS had adequate sensitivity for HBsAg and anti-HCV detection. From the clinical samples, AFIAS sensitivity and specificity were 99.8% and 99.3% for the HBsAg test, 100.0% and 100.0% for the anti-HBs test, and 98.8% and 99.1% for the anti-HCV test, respectively. Its agreement rates with the Elecsys HBsAg, anti-HBs, and anti-HCV detection assays were 99.4%, 100.0%, and 99.0%, respectively. AFIAS detected all samples with HBsAg genotypes A-F and H and anti-HCV genotypes 1, 1a, 1b, 2a, 2b, 4, and 6. Cross-reactivity with other infections was not observed. Conclusions: The AFIAS HBsAg, anti-HBs, and anti-HCV tests demonstrated diagnostic performance equivalent to current automated CLIAs. AFIAS could be used for a large-scale HBV or HCV screening in low-resource laboratories or low-to middle-income areas.

• 대한임상검사과학회지
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• 제54권1호
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• pp.49-60
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• 2022

본 연구는 COVID-19 시대에서 빠르고 정확한 진단검사를 위해 임상병리사의 역할을 파악하고, 효율적으로 대응할 수 있는 체계적인 시스템 마련을 위한 기초자료를 제공하고자 하였다. 연구 방법은 15개 의료기관을 대상으로 설문조사 및 초점 집단 면담을 통한 분석을 하였다. 검체 채취 기관(11개)을 분석한 결과, 선별검사소 운영 기관은 7개, 임상병리사 10.4명, 채취 소요시간 2.1분, 검사소요시간 5.4시간, 검사건수 9,670건, 검사인력 6.2명으로 조사되었다. 초점 집단 면담 분석결과, COVID-19검사와 관련하여 검체 채취자 및 검사자를 보호하기 위한 근무시간, 근무장소, 근무환경이 포함된 표준화된 지침은 없었다. 그리고 감염사고 발생 시 법적인 보호 조치가 미흡하며, COVID-19와 관련한 인력에 관한 규정이 마련되어 있지 않았다. 또한, 신뢰도 있는 COVID-19 검사를 위해 검체 채취자 및 분자진단 검사자의 전문적인 교육이 요구되었다. 결론적으로 COVID-19와 같은 긴급상황 감염병 발생 시 대처할 수 있는 특수검사 단기수련기관 등을 통한 전문교육의 시행과 안정적인 인력공급 할 수 있는 법적인 체계마련이 필요할 것으로 사료된다.

• 대한유전성대사질환학회지
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• 제13권1호
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• pp.1-19
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• 2013

Inherited metabolic disorders are individually rare but as a whole, they are nor rare. Since Archibald Garrod introduced a concept of "inborn error of metabolism" or "chemical individuality", more than 600 diseases are currently known, affecting approximately one in 500 newborns cumulatively. They frequently manifest with acute, life-threatening crisis that requires immediate specific intervention or they present with insidious diverse symptoms and signs involving multiple visceral organs or tissues as well as central nervous system, hampering a correct diagnosis. In addition, many pediatricians are not familiar with all diagnostic and therapeutic strategies for diverse inherited metabolic disorders. However, the prognosis of affected children are heavily dependent on rapid and effective treatment. In this lecture, practical guidelines for the specific diagnosis based on diverse clinical features of inherited metabolic disorders will be described. Many sophisticated laboratory tests are available for the confirmatory diagnosis of each disease, which is challenging to general pediatricians with respect to knowledge about biochemical metabolite assay test, enzymatic test and DNA diagnostic tests. Sample collections, indications, methods and interpretation of results in varying laboratory tests will be listed as well.

• 대한임상검사과학회지
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• 제55권1호
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• pp.45-51
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• 2023

개 파보바이러스(canine parvovirus type 2, CPV-2)와 코로나바이러스(canine coronavirus, CCoV)는 개에서 위장관염을 일으키는 주요 병원체이다. 두 바이러스는 전염성과 이환율이 높고 특정한 치료법이 없어 신속 정확한 진단이 필요하다. 동물용 신속진단키트 (rapid diagnostic test, RDT)는 빠르고, 간편하여 진료현장에서 널리 활용되고 있다. 이에 본 연구에서는 성능평가를 통해 CPV-2/CCoV RDT의 임상적 유용성을 확인하고자 하였다. 성능평가 항목으로 최소검출한계(limit of detection, LoD), 교차반응, 간섭, 민감도, 특이도, 음성우도비(negative likelihood ratio, NLR), 카파통계량(kappa value, κ) 등을 확인하였다. 성능평가 결과, LoD는 CPV-2 9.7×10 50% tissue culture infections dose (TCID₅₀)/mL, CCoV 2.5×10² TCID₅₀/mL로 나타났다. 병원체 9종에 의한 교차반응과 간섭물질에 대한 간섭은 관찰되지 않았다. RDT는 두 바이러스의 검출에 있어 민감도 90.0%, 특이도 100.0%, NLR=0.1, κ=0.90으로 나타났다. 결론적으로 CPV-2/CCoV RDT는 높은 민감도, 특이도, κ와 낮은 NLR을 보여 선별검사로써 유용할 것으로 생각된다.

• Parasites, Hosts and Diseases
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• 제56권1호
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• pp.71-74
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• 2018

Soluble antigens from an axenic culture of Entamoeba histolytica were used to develop a commercial ELISA kit to quantify anti-E. histolytica antibodies in sera of patients with extraintestinal amebiasis in non-endemic settings. The diagnostic specificity and sensitivity of the test were assessed retrospectively using 131 human serum samples with amoebic serologic status available. They were selected according to their results in immunofluorescence (IFAT) and were separated in 2 sample categories: 64 sera with positive results by IFAT and 67 with negative results by IFAT. The sensitivity and specificity of the ELISA kit were assessed at 95.0% and 94.0% compared to the IFAT. The test can be useful to exclude a potential diagnosis of amebiasis and could be used as a screening method since ELISA is an automated technique.

• 한국동물위생학회지
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• 제35권4호
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• pp.269-273
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• 2012

A confirmatory serological test, the standard tube agglutination test (STAT) is evaluated for the diagnostic efficiency in brucellosis Korea. A total of 345 bovine samples were collected from regional veterinary branch under national brucellosis monitoring program from January 2010 to June 2012 in Korea. These samples were diagnosed as suspected serum and brucellosis positive by the Rose Bengal test (RBT) and the STAT, respectively. The STAT was compared and evaluated with three serological test such as the indirect-enzyme linked immunosorbent assay (I-ELISA), competitive-enzyme linked immunosorbent assay (C-ELISA) and fluorescence polarisation assay (FPA) prescribed for international trade by OIE. Among the 345 bovine serum samples, 302 (87.5%) were diagnosed as positive in the STAT, while 215 (62.3%), 223 (64.6%) and 194 (56.2%) serum samples were diagnosed as positive for brucellosis in the I-ELISA, C-ELISA and FPA, respectively. The STAT showed quite high positive results as compared with three prescribed tests of OIE. FPA, I-ELISA and C-ELISA have shown 60.6%, 64.9% and 67.2% correlation, respectively as compared to the STAT. However correlations of three prescribed tests ranged high 84.1~97.7%. Especially, correlation between I-ELISA and C-ELISA is quite high, 97.7%. These results suggest that the STAT has shown many false-positive reactions. Therefore, additional serological test, such as ELISAs and FPA, would be necessary to adopt as a confirmatory test in the national surveillance program of bovine brucellosis in Korea.

• 대한수의학회지
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• 제49권2호
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• pp.121-125
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• 2009

Paratuberculosis caused by Mycobacterium avium subspecies paratuberculosis (Mpt) is a chronic infectious enteric disease with deleterious impact on the performance in ruminants. In Korea, ELISA has been introduced to detect antibodies to Mpt in individual cattle. However, comparison study with ELISA has not been studied until now. In total, a panel of 899 serum samples obtained from dairy cattle was analyzed with two commercial ELISAs for Mpt to assess the performance. Two ELISAs employed in this study were both licensed worldwide. Two ELISAs applied onto same serum samples showed the moderate agreement (kappa value = 0.60). There was non-significant McNemar test (p = 0.0614) between two ELISA results indicating that each proportion detected by two kits did not differ. In addition, the percent agreement between two ELISA results was turned out to be 96.8% which interpreted excellent reproducibility. It was shown from this study that two ELISAs revealed moderate kappa agreement performance. The implication raised is that when ELISAs as diagnostics are used to detect Mpt in individual cattle, positive reaction by either ELISA should be interpreted as serologically Mpt positive due to presumed low sensitivity of ELISAs and their test agreement being less than 100%.

• 대한임상검사과학회지
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• 제44권1호
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• pp.7-16
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• 2012

The Korean GDP per capita doubled during the last 10 years. As the GDP increases, Korean health behaviors such as, eating, drinking, smoking, and exercise habits changed as well. Compared to the remarkably advanced diagnostic technologies and therapeutics during the last decade, the leading causes of death in Korea scarcely changed. Among the leading causes of death, cerebrovascular disease, heart disease, diabetes, liver disease and hypertension are closely related to health behaviors. Using the database of medical check-up between 2001 and 2010, the authors performed a longitudinal study for the prevalence rates and the trends of major chronic adult diseases among the 2,721 workers along with their health behavior. Among the diagnostic test items, fasting blood sugar, cholesterol and BMI levels showed steady increase and these three test items all showed linear trends (p<0.001). The average blood sugar and cholesterol levels were near worrying levels. Moreover, the average BMI of males was found to be at the overweight level, intimating the possibility reaching thee Obese Class I level soon if there are no aggressive counter measures. Fasting blood sugar and cholesterol levels were higher in a drinking group as compared to a non-drinking group, and the BMI levels were also higher in the drinking group and the smoking group as compared to the non-drinking and the non-smoking group (p<0.001). Finally, the authors believe that the fasting blood sugar, cholesterol and BMI levels should be designated as target monitoring test items in the medical check-up for Korean employees.

• Korean Journal of Radiology
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• 제22권7호
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• pp.1213-1224
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• 2021

Objective: To develop a machine learning (ML) pipeline based on radiomics to predict Coronavirus Disease 2019 (COVID-19) severity and the future deterioration to critical illness using CT and clinical variables. Materials and Methods: Clinical data were collected from 981 patients from a multi-institutional international cohort with real-time polymerase chain reaction-confirmed COVID-19. Radiomics features were extracted from chest CT of the patients. The data of the cohort were randomly divided into training, validation, and test sets using a 7:1:2 ratio. A ML pipeline consisting of a model to predict severity and time-to-event model to predict progression to critical illness were trained on radiomics features and clinical variables. The receiver operating characteristic area under the curve (ROC-AUC), concordance index (C-index), and time-dependent ROC-AUC were calculated to determine model performance, which was compared with consensus CT severity scores obtained by visual interpretation by radiologists. Results: Among 981 patients with confirmed COVID-19, 274 patients developed critical illness. Radiomics features and clinical variables resulted in the best performance for the prediction of disease severity with a highest test ROC-AUC of 0.76 compared with 0.70 (0.76 vs. 0.70, p = 0.023) for visual CT severity score and clinical variables. The progression prediction model achieved a test C-index of 0.868 when it was based on the combination of CT radiomics and clinical variables compared with 0.767 when based on CT radiomics features alone (p < 0.001), 0.847 when based on clinical variables alone (p = 0.110), and 0.860 when based on the combination of visual CT severity scores and clinical variables (p = 0.549). Furthermore, the model based on the combination of CT radiomics and clinical variables achieved time-dependent ROC-AUCs of 0.897, 0.933, and 0.927 for the prediction of progression risks at 3, 5 and 7 days, respectively. Conclusion: CT radiomics features combined with clinical variables were predictive of COVID-19 severity and progression to critical illness with fairly high accuracy.