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Louisirirotchanakul S.,Siriraj Hospital | Khupulsup K.,Ramathibodi Hospital | Akraekthalin S.,Phyathai Hospital | Chan K.P.,Singapore General Hospital | And 5 more authors.
Journal of Medical Virology | Year: 2010

South East Asia has some of the highest prevalence rates of hepatitis B virus (HBV) infection (≥8%) in the world, and the emergence of hepatitis B surface antigen (HBsAg) mutant strains is a growing problem. Assays with the highest levels of sensitivity, including mutant detection, should be used for routine HBsAg screening. In this large multicenter study, the clinical and technical performance of the fully automated Elecsys HBsAg II assay was compared with the Architect, AxSYM, and Advia Centaur HBsAg assays for HBsAg screening. Nine laboratories (three each from Thailand, Korea, and Singapore) compared the Elecsys HBsAg II assay with their routine HBsAg screening assay against a range of stored and routine clinical samples, including recombinant mutants. The Elecsys HBsAg II assay demonstrated equivalent sensitivity and specificity to the Architect HBsAg assay. However, the ElecsysHBsAg II assay recognized a native mutant sample (L94S, L97V, L98V, T123A) that the Architect HBsAg assay failed to detect. The AxSYM and Advia Centaur HBsAg assays appeared less sensitive for the detection of early HBV infection and also failed to detect some of the recombinant mutant strains. There was almost complete agreement between the Elecsys HBsAg II assay and comparator assays with respect to routine serum samples. The results of this study demonstrate that the Elecsys HBsAg II assay is a highly sensitive and specific screening assay for HBsAg and detects reliably the most important and clinically relevant HBV mutants and genotypes. It is suitable for routine HBsAg screening in Asia. © 2010 Wiley-Liss, Inc.

Han H.J.,Yonsei University | Kim J.R.,Cheil General Hospital | Nam H.R.,Sungkyunkwan University | Keum K.C.,Yonsei University | And 2 more authors.
Radiation Oncology Journal | Year: 2014

Purpose: To evaluate non-sentinel lymph node (LN) status after sentinel lymph node biopsy (SNB) in patients with breast cancer and to identify the predictive factors for disease failure. Materials and Methods: From January 2006 to December 2007, axillary lymph node (ALN) dissection after SNB was performed for patients with primary invasive breast cancer who had no clinical evidence of LN metastasis. A total of 320 patients were treated with breast-conserving surgery and radiotherapy. Results: The median age of patients was 48 years, and the median follow-up time was 72.8 months. Close resection margin (RM) was observed in 13 patients. The median number of dissected SNB was two, and that of total retrieved ALNs was 11. Sentinel node accuracy was 94.7%, and the overall false negative rate (FNR) was 5.3%. Eleven patients experienced treatment failure. Local recurrence, regional LN recurrence, and distant metastasis were identified in 0.9%, 1.9%, and 2.8% of these patients, respectively. Sentinel LN status were not associated with locoregional recurrence (p > 0.05). Close RM was the only significant factor for disease-free survival (DFS) in univariate and multivariate analysis. The 5-year overall survival, DFS, and locoregional DFS were 100%, 96.8%, and 98.1%, respectively. Conclusion: In this study, SNB was performed with high accuracy and low FNR and high locoregional control was achieved. © 2014. The Korean Society for Radiation Oncology.

Kim J.S.,Chonbuk National University | Bae C.-W.,Kyung Hee University | Lee K.-Y.,Catholic University of Korea | Park M.S.,Ajou University | And 17 more authors.
Human Vaccines and Immunotherapeutics | Year: 2012

Rotavirus (RV) infection is the primary cause for childhood gastroenteritis worldwide. In Korea, RV infection is most common among children less than 5 y of age. This post-licensure study was conducted to further evaluate the RV vaccine (RIX4414) to provide additional local clinical data to the Korean Food and Drug Association. Healthy infants aged 6-12 weeks were enrolled to receive two doses of either RIX4414 or placebo as per 0, 1-2 mo schedule. Blood samples were collected before dose-1 and one month post-dose-2 of RIX4414/placebo to assess serum anti-RV IgA antibody concentrations using ELISA . Gastroenteritis stool samples were tested for the presence of RV using ELISA . RV positive samples were subjected to further analysis for G and P typing. Among 684 infants enrolled and vaccinated, 432 infants (RIX4414 = 318; placebo = 114) were included in the according-to-protocol cohort for immunogenicity. The anti-RV IgA antibody seroconversion rates in the RIX4414 group following one month post-dose-2 were 88.1% (95% CI: 84.0-91.4) and the corresponding geometric mean concentration in the RIX4414 group was 208.5 U/ml (95% CI: 174.2-249.5). Occurrence of solicited and unsolicited adverse events were similar in both, RIX4414 and placebo groups. None of the gastroenteritis stool samples tested positive for RV and no fatal SAE s were reported in either groups. The two-dose regimen of RIX4414 was observed to be immunogenic with a similar safety profile as compared with the placebo group, when administered to healthy Korean infants. © 2012 Landes Bioscience.

Lee T.S.,Boramae Medical Center | Lee J.-Y.,Seoul National University | Kim J.-W.,Seoul National University | Oh S.,Boramae Medical Center | And 6 more authors.
Gynecologic Oncology | Year: 2013

Objective The aim of this study was to evaluate the impact of ovarian preservation on the recurrence and survival rates of premenopausal women with early-stage endometrial cancer. Methods Using medical records of premenopausal women who received primary surgical treatment for stage I-II endometrial cancer, the demographics and survival rates were compared retrospectively for patients who had ovarian preservation and those who underwent bilateral salpingo-oophorectomy. Cox proportional hazards models with inverse probability of treatment weighting (IPTW) based on propensity score were performed to adjust for selection bias between the two groups. Results A total of 495 women were identified, including 176 patients who had ovarian preservation. The ovarian preservation group was younger (P < 0.001) and had an earlier year of diagnosis (P = 0.014), a lower prevalence of lymphadenectomy (P < 0.001), and a marginally significant association with lower tumor grade (P = 0.052). The Kaplan-Meier curve and the log rank test showed no difference in either recurrence-free survival (P = 0.742) or overall survival (P = 0.462) between the two groups. In a multivariate Cox model adjusted by IPTW and covariates, ovarian preservation had no effect on either recurrence (hazard ratio [HR], 0.73; 95% CI, 0.29-1.81) or overall survival (HR, 1.33; 95% CI, 0.43-4.09). Conclusions Ovarian preservation does not appear to be associated with an adverse impact on the outcomes of premenopausal women with early-stage endometrial cancer. The present study has useful implications for physicians counseling young women who want to preserve their ovaries. © 2013 Elsevier Inc.

Kwak H.-S.,Cheil General Hospital | Kang Y.-S.,Cheil General Hospital | Han K.-O.,Cheil General Hospital | Moon J.-T.,Ilsan Jeil Womens Hospital | And 7 more authors.
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | Year: 2010

This paper reports the development and validation of an improved assay for quantitation of fatty acid ethyl esters (FAEEs) in human meconium using liquid chromatography/tandem mass spectrometry (LC-MS/MS). FAAEs (ethyl laurate, ethyl myristate, ethyl palmitate, ethyl palmitoleate, ethyl stearate, ethyl oleate, ethyl linoleate, ethyl linolenate, and ethyl arachidonate) and the internal standard (I.S.), ethyl heptadecanoate, were separated by reverse phase HPLC and quantified by MS/MS using electrospray ionization (ESI) and multiple reaction monitoring (MRM) in the positive ionization mode. The absolute recovery of FAEEs varied from 55 ± 10% for 0.33 nmol/g (100 ng/g) of ethyl linoleate up to 86 ± 8% for 1.55 nmol/g (500 ng/g) of ethyl miristate. The LODs and LOQs varied from 0.01 to 0.08 nmol/g and from 0.02 to 0.27 nmol/g, respectively. The assay has been successfully applied to examine the FAEE levels in 81 meconium samples from babies born to mothers reporting alcohol consumption, to varying degrees, during pregnancy. © 2010 Elsevier B.V. All rights reserved.

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