• Pediatric Infection and Vaccine
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• 제14권1호
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• pp.91-96
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• 2007

목 적 : RSV 감염증 진단을 위한 여러 가지 신속 진단법이 이용되고 있다. 본 연구는 하기도 감염 소아의 비인두흡인물에서 RSV를 검출하는데 있어서 lateral-flow immunoassay 법을 이용하여 국내에서 개발된 RSV 조기 진단 kit인 바이오라인 알에스브이$^{TM}$(Standard Diagnostics, Inc., 용인, 대한민국)의 성적을 세포배양과 면역 형광법 결과와 비교 평가하기 위하여 수행되었다. 방 법 : 2002년 7월부터 2007년 2월까지 서울대학교 어린이병원의 응급실을 방문하거나 입원한 하기도 감염소아로부터 채취한 비인두 흡인물 319개를 대상으로 하여 RSV를 검출하는데 있어서 바이러스 배양과 면역 형광법을 기준으로 하여 바이오라인 알에스브이$^{TM}$ 검사의 성적을 평가하였다. 바이오라인 알에스브이$^{TM}$ 검사는 각 검체의 바이러스 배양과 면역 형광법 결과를 모르는 검사자에 의해서 두번 이상씩 시행되었다. 결 과 : 면역 형광법과 바이러스 배양이 모두 양성인 검체 110개 중 107개(97.3%), 면역 형광법만 양성인 검체 33개 중 29개(87.9%), 바이러스 배양법만 양성인 검체 26개 중 20개(76.9%)가 바이오라인 알에스브이$^{TM}$로 검사한 결과 양성으로 나타났으며, 두 가지 기준 검사에서 모두 음성인 검체 150개 중 140개(93.3%)가 바이오라인 알에스브이$^{TM}$ 검사 결과 음성이었다. 면역 형광법 또는 바이러스 배양법에 대한 바이오라인 알에스브이$^{TM}$ 검사의 민감도는 92.3%(156/169, 95% confidence interval[CI], 87.1-97.5%), 특이도는 93.3%(140/150, 95% CI, 88.4-98.2%), 양성 예측도는 94.0%(156/166, 89.5-98.5%), 음성 예측도는 91.5%(140/143, 95% CI, 86.0-97.0%), 일치도는 95.9%(306/319, 92.1-99.7%)이었다. 결 론 : 국내에서 개발된 RSV 감염 조기 진단 kit인 바이오라인 알에스브이$^{TM}$는 높은 민감도와 특이도를 보였다. 간단한 검사 방법과 신속한 결과라는 장점이 있어 향후 유행 시기에 유용한 진단법으로 사용될 수 있을 것으로 보인다.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제27권4호
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• pp.289-300
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• 2001

Telomerase is a ribonucleoprotein that synthesizes telomere repeats. It has been reported that activation of telomerase was associtated with immortalization, proliferative activity and carcinogenesis. Recently, telomerase activity has been extensively studied in many kinds of malignant tumors for clinical diagnostic and/or prognostic utilities. In neuroblastoma, breast carcinoma, gastric carcinoma, non-small cell lung carcinoma, close relationship has been reported between high telomerase activity and lymph node metastasis, tumor aggressiveness and poor prognosis. The purpose of this study is to investigate the clinical implication of telomerase activity assay as an adjunctive factor in decision-making on neck node management, speedy pre-operative judging on histologic malignancy grading. Thus we performed semi-quantitative assay of telomerase activity using Telomerase PCR ELISA $kit^{(R)}$(Boeringer Manheim, Germany) and evaluated correlation between telomerase activity and tumor size, neck node metastasis, Anneroth malignancy score and influence of pre-operative chemotherapy on its activity in 27 cases of oral squamous cell carcinomas and 18 cases of normal oral epithelium. Also, correlation between telomerase activities and PCNA indices was evaluated. The results were obtained as follows: 1. The telomerase activities were detected in 24 specimens out of 27 oral squamous cell carcinoma specimens (88.9%) and in 5 specimens out of 18 normal oral epithelium specimens (27.8%). The mean value of telomerase activities was $0.9793{\pm}0.3428$ in 24 oral squamous cell carcinoma specimens and $0.4855{\pm}0.1117$ in 5 normal oral epithelium specimens. The positivity rate and mean value of telomerase activities in oral squamous cell carcinoma specimens were significantly higher than those of normal oral epithelium specimens (p<0.05). 2. There was no significant correlation between total Anneroth malignancy score and telomerase activity (p>0.05), but points of mitosis index and depth of invasion were significantly correlated with telomerase activities (p<0.05). 3. The positive immunohistochemical staining for PCNA(proliferating cell nuclear antigen) was observed in 26 specimens out of 27 oral squamous cell carcinoma specimens and mean value of PCNA indices of 26 specimens was $53.67{\pm}26.46$. PCNA indices were significantly correlated with telomerase activities (p<0.05). 4. The mean value of telomerase activities was significantly higher in pathologic T3/T4 group than in T1/T2 group (p<0.01). There was no significant difference of mean value of telomerase activities between pathologic neck node positive group and negative group (p> 0.05). Pre-operative chemotherapy significantly lowered the telomerase activities (p<0.05). The above results suggested telomerase activity could be used as diagnostic marker and adjunctive parameter for judging on histologic malignancy in oral squamous cell carcinoma.

• Journal of Microbiology and Biotechnology
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• 제28권8호
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• pp.1376-1383
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• 2018

The hepatitis B virus (HBV) envelope contains small (S), middle (M), and large (L) proteins. PreS1 of the L protein contains a receptor-binding motif crucial for HBV infection. This motif is highly conserved among 10 HBV genotypes (A-J), making it a potential target for the prevention of HBV infection. In this study, we successfully generated a neutralizing human monoclonal antibody (mAb), 1A8 (IgG1), that recognizes the receptor-binding motif of preS1 using a phage-displayed human synthetic Fab library. Analysis of the antigen-binding activity of 1A8 for different genotypes indicated that it can specifically bind to the preS1 of major HBV genotypes (A-D). Based on Bio-Layer interferometry, the affinity ($K_D$) of 1A8 for the preS1 of genotype C was 3.55 nM. 1A8 immunoprecipitated the hepatitis B virions of genotypes C and D. In an in vitro neutralization assay using HepG2 cells overexpressing the cellular receptor sodium taurocholate cotransporting polypeptide, 1A8 effectively neutralized HBV infection with genotype D. Taken together, the results suggest that 1A8 may neutralize the four HBV genotypes. Considering that genotypes A-D are most prevalent, 1A8 may be a neutralizing human mAb with promising potential in the prevention and treatment of HBV infection.

• Tuberculosis and Respiratory Diseases
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• 제57권1호
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• pp.32-36
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• 2004

목 적 : 악성 흉막액의 진단을 위해서는 흉막액 세포진 검사, 흉막 생검 등이 이용되지만 위음성의 문제가 있어서 이를 보완하기 위해서 지금까지 여러 종양 표지자들이 흉막액에서 측정되어 왔다. 저자 등은 흉막액의 감별진단에 널리 알려진 CEA와 최근에 소개된 CYFRA 21-1의 진단적 유용성에 대해 알아보기 위해 본 연구를 시행하였다. 방 법 : 2002년 4월부터 2003년 11월까지 흉막액으로 내원한 222예(양성 150예, 폐암 57예, 전이성암 15예)를 대상으로 하여 전향적으로 혈청과 흉막액에서 CEA와 CYFRA 21-1를 각각 측정하였다. 결 과 : 양성 흉막액에 비해 악성 흉막액에서 유의하게 CEA와 CYFRA 21-1값이 높았으며, 특이도를 95%로 하였을 때 흉막액 CEA와 CYFRA 21-1의 cut off 값은 각각 5, 89 ng/ml 이었고 민감도는 각각 72%, 54%이었다. 흉막액에서 CEA와 CYFRA 21-1를 병용하여 검사했을 때의 민감도는 87%로 CEA나 CYFRA 21-1 단독검사에 비해 유의하게 높게 나타났다(p<0.05). 결 론 : 흉막액 CEA와 CYFRA 21-1 검사의 병용은 악성흉막액의 진단에 유용할 것으로 생각된다.

• Journal of Korean Medical Science
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• 제33권47호
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• pp.303.1-303.10
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• 2018

Background: Cell division cycle 6 (CDC6) is an essential regulator of DNA replication and plays important roles in the activation and maintenance of the checkpoint mechanisms in the cell cycle. CDC6 has been associated with oncogenic activities in human cancers; however, the clinical significance of CDC6 in prostate cancer (PCa) remains unclear. Therefore, we investigated whether the CDC6 mRNA expression level is a diagnostic and prognostic marker in PCa. Methods: The study subjects included 121 PCa patients and 66 age-matched benign prostatic hyperplasia (BPH) patients. CDC6 expression was evaluated using real-time polymerase chain reaction and immunohistochemical (IH) staining, and then compared according to the clinicopathological characteristics of PCa. Results: CDC6 mRNA expression was significantly higher in PCa tissues than in BPH control tissues (P = 0.005). In addition, CDC6 expression was significantly higher in patients with elevated prostate-specific antigen (PSA) levels (> 20 ng/mL), a high Gleason score, and advanced stage than in those with low PSA levels, a low Gleason score, and earlier stage, respectively. Multivariate logistic regression analysis showed that high expression of CDC6 was significantly associated with advanced stage (${\geq}T3b$) (odds ratio [OR], 3.005; confidence interval [CI], 1.212-7.450; P = 0.018) and metastasis (OR, 4.192; CI, 1.079-16.286; P = 0.038). Intense IH staining for CDC6 was significantly associated with a high Gleason score and advanced tumor stage including lymph node metastasis stage (linear-by-linear association, P = 0.044 and P = 0.003, respectively). Conclusion: CDC6 expression is associated with aggressive clinicopathological characteristics in PCa. CDC6 may be a potential diagnostic and prognostic marker in PCa patients.

• Korean Journal of Radiology
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• 제24권11호
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• pp.1102-1113
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• 2023

Objective: To elucidate the use of radiological studies, including nuclear medicine, and biopsy for the diagnosis and staging of prostate cancer (PCA) in clinical practice and understand the current status of PCA in Asian countries via an international survey. Materials and Methods: The Asian Prostate Imaging Working Group designed a survey questionnaire with four domains focused on prostate magnetic resonance imaging (MRI), other prostate imaging, prostate biopsy, and PCA backgrounds. The questionnaire was sent to 111 members of professional affiliations in Korea, Japan, Singapore, and Taiwan who were representatives of their working hospitals, and their responses were analyzed. Results: This survey had a response rate of 97.3% (108/111). The rates of using 3T scanners, antispasmodic agents, laxative drugs, and prostate imaging-reporting and data system reporting for prostate MRI were 21.6%-78.9%, 22.2%-84.2%, 2.3%-26.3%, and 59.5%-100%, respectively. Respondents reported using the highest b-values of 800-2000 sec/mm² and fields of view of 9-30 cm. The prostate MRI examinations per month ranged from 1 to 600, and they were most commonly indicated for biopsy-naïve patients suspected of PCA in Japan and Singapore and staging of proven PCA in Korea and Taiwan. The most commonly used radiotracers for prostate positron emission tomography are prostate-specific membrane antigen in Singapore and fluorodeoxyglucose in three other countries. The most common timing for prostate MRI was before biopsy (29.9%). Prostate-targeted biopsies were performed in 63.8% of hospitals, usually by MRI-ultrasound fusion approach. The most common presentation was localized PCA in all four countries, and it was usually treated with radical prostatectomy. Conclusion: This survey showed the diverse technical details and the availability of imaging and biopsy in the evaluation of PCA. This suggests the need for an educational program for Asian radiologists to promote standardized evidence-based imaging approaches for the diagnosis and staging of PCA.

• Asian Pacific Journal of Cancer Prevention
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• 제14권4호
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• pp.2383-2386
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• 2013

Senescence marker protein 30 (SMP30), a hepatocellular carcinoma (HCC) associated antigen, was earlier shown by our research group to be highly expressed in HCC paracancerous tissues, but have low levels in HCC tissues. In order to detect anti-SMP30 antibody in serum of HCC patients, we established pET30a-SMP30 and pColdIII-SMP30 expression systems in Escherichia coli. However, the expression product was mainly in the form of inclusion bodies. In this research, we used several combinations of chaperones, four molecular chaperone plasmids with pET30a-SMP30 and five molecular chaperone plasmids with pColdIII-SMP30 to increase the amount of soluble protein. Results showed that co-expression of HIS-SMP30 with pTf16, combined with the addition of osmosis-regulator, and a two-step expression resulted in the highest enhancement of solubility. A total of 175 cases of HCC serum were studied by ELISA to detect anti-SMP30 antibody with recombinant SMP30 protein. Some 22 were positive and x2 two-sided tests all showed P>0.05, although it remained unclear whether there was a relationship between positive cases and clinical diagnostic data.

• 한국산학기술학회논문지
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• 제14권7호
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• pp.3419-3424
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• 2013

B형간염표면 항원 및 항체(HBsAg와 anti-HBs)에 대한 검사 방법으로 화학발광면역검사법(CIA)을 포함한 면역검사법을 주로 사용하고 있으나 최근 간편한 면역크로마토그래피법(ICA)의 사용이 늘고 있는 추세이다. 본 연구에서는 CIA법을 이용한 정량검사법과 비교하여 신속검사인 ICA법의 민감도를 평가하고자 하였다. 대학병원에 간염검사를 의뢰한 검체 중 CIA법에서 양성 및 음성으로 나온 120 검체를 선정하여 ICA법으로 분석하였다. ICA법과 CIA법의 일치율은 항원 97%와 항체 90%로 나타났다. 항원검사의 ICA법 민감도, 특이도, 양성예측도, 음성예측도는 각각 97%, 100%, 100% 및 96.8%로 나타났으며, 항체검사는 각각 90%, 93.3%, 93.1% 및 90.3%로 나타났다. ICA법을 임상에서 사용 시 결과판독에 주의가 필요하며, 낮은 역가의 경우 검출되지 않는 제한점이 있으므로 예민도가 높은 다른 검사법을 이용하여 이중검사를 시행해야 할 것으로 사료된다.

• IMMUNE NETWORK
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• 제1권1호
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• pp.7-13
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• 2001

Currently 18 monoclonal antibodies were approved by FDA for inj ection into humans for therapeutic or diagnostic purpose. And 146 clinical trials are under way to evaluate the efficacy of monoclonal antibodies as anti-cancer agents, which comprise 9 % of clinical trials in cancer therapy field. When considering a lot of disappointment and worries existed in this field during the past 15 years, this boom could be called as resurrection. Antibodies have several merits over small molecule drug. First of all it is easier and faster in development, as proper immunization of the target proteins usually raises good antibody response. The side effects of antibodies are more likely to be checked out in immunohistomchemical staining of whole human tissues. Antibody has better pharmacokinetics, which means a longer half-life. And it is non-toxic as it is purely a "natural drug. Vast array of methods was developed to get the recombinant antibodies to be used as drug. The mice with human immunoglobulin genes were generated. Fully human antibodies can be developed in fast and easy way from these mice through immunization. These mice could make even human monoclonal antibodies against any human antigen like albumin. The concept of combinatorial library was also actively adopted for this purpose. Specific antibodies can be screened out from phage, mRNA, ribosomal library displaying recombinant antibodies like single chain Fvs or Fabs. Then the coding genes of these specific antibodies are obtained from the selected protein-gene units, and used for industrial scale production. Both $na\ddot{i}ve$ and immunized libraries are proved to be effective for this purpose. In post-map arena, antibodies are receiving another spotlight as molecular probes against numerous targets screened out from functional genomics or proteomics. Actually many of these antibodies used for this purpose are already human ones. Through alliance of these two actively growing research areas, antibody would play a central role in target discovery and drug development.

• 대한세포병리학회지
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• 제9권1호
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• pp.15-20
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• 1998

Mutant form of the p53 gene product is abnormally accumulated in the nuclei of the tumor cells due to prolonged half life, and readily detected by immunohistochemical methods. To determine the positivity rate of p53 in body cavity fluid according the primary site and histological types of tumors and the utility of p53 immunostaining as an adjunct in the diagnosis of malignancy, we reviewed 69 effusions, including pleural effusion, ascitic fluid, and pericardial fluid, that were diagnosed as overt malignancy and 21 effusions of suspicious malignancy, immunohistochemistry was performed on paraffin-embedded cell blocks using a monoclonal antibody to p53 supressor gene product(Clone DO7) and a standard avidin-biotin complex technique with a citrate buffer antigen retrieval solution. The results were as follows; of the 46 pleural effusions with overt malignancy, 22 were immunopositive for p53 protein; of the 21 ascitic fluids with overt malignancy, 5 were positive for p53. Positivity rates according to the primary sites of tumors were 18 of 34(52.9%), 8 of 21(38.1%), 1 of 9(11.1%) cases of the tumors of the lung, GI tract, and ovary, respectively. According to the histologic types of lung cancer, 11 cases(61.6%) were positive out of 18 adenocarcinomas, 2 of 5 large cell undifferentiated carcinomas, and 1 of 2 small cell undifferentiated carcinomas. Of 21 cases of suspicious malignancy, 6 were positive for p53 and all of them(6/6) were confirmed as adenocarcinoma of the lung or GI tract. These findings indicate that p53 immunostaining using paraffin embedded cell block is useful diagnostic and prognostic marker in body fluid cytology although negative immunostaining does not exclude malignancy.