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An automated hepatitis C virus (HCV) antigen (Ag) assay was evaluated with clinical samples. Determination of HCV Ag and RNA levels in 282 subjects using Abbott HCV Ag and Roche Cobas TaqMan assays revealed that these two tests were highly correlated (r = 0.9464). Thus, the HCV Ag assay could be an alternative test to quantitative reverse transcription-PCR.

Human epididymis protein 4 (HE4) is a new biomarker for the detection of ovarian cancer. We evaluated the analytical performance of a novel automated HE4 assay and established reference ranges of HE4 and CA125. We also compared the diagnostic performance of both biomarkers for ovarian cancer. Precision performances and linearity of the HE4 assay were assessed. Serum samples from 2,182 healthy and 72 pregnant women were also assayed for HE4 and CA125, and the 95%, 97.5% and 99% reference limits f

Infection with high-risk (HR) human papillomavirus (HPV) genotypes is an important risk factor for cervical cancers. We evaluated the clinical performances of two new real-time PCR assays for detecting HR HPVs compared to that of the Hybrid Capture 2 test (HC2). A total of 356 cervical swab specimens, which had been examined for cervical cytology, were assayed by Abbott RealTime HR and Roche Cobas HPV as well as HC2. Sensitivities and specificities of these assays were determined based on the cr

CONTEXT: Some tumor markers, including carcinoembryonic antigen (CEA) and cytokeratin 19 fragment (CYFRA 21-1), are used for the detection of lung cancer; however, their use is limited because of low sensitivities and high false-positive rates. OBJECTIVES: To investigate the usefulness of an anti-p53 assay in detecting lung cancer and to compare the anti-p53 to CEA and CYFRA 21-1 tumor markers. DESIGN: Serum samples were collected from 82 patients with lung cancer. Sera were also collected from

We investigated soluble human leukocyte antigen-G (sHLA-G) expression according to the phases of hepatitis B virus (HBV) infections and hepatocellular carcinoma (HCC). A total of 267 sera from anti-HBs positive healthy individuals (n = 50), chronic HBV carriers (n = 45), as well as patients with active hepatitis B (n = 46), liver cirrhosis (LC, n = 46) and early stage HCC (n = 80) were collected and assayed for sHLA-G. Relationships between sHLA-G levels and clinicopathologic parameters includin

BACKGROUND: This study was performed to investigate the prevalence of qnr genes in clinical isolates of Escherichia coli from Korea that produce extended-spectrum beta-lactamases (ESBLs). METHODS: During the period of May to June 2005, we collected clinical isolates of E. coli that were intermediate or resistant to ceftazidime and/or cefotaxime from 11 Korean hospitals. Antimicrobial susceptibility was determined by the disk diffusion and agar dilution methods. ESBL production was confirmed phen

We evaluated quantitative hepatitis B surface antigen (qHBsAg) assays and a hepatitis B virus (HBV) core-related antigen (HBcrAg) assay. A total of 529 serum samples from patients with hepatitis B were tested. HBsAg levels were determined by using the Elecsys (Roche Diagnostics, Indianapolis, IN) and Architect (Abbott Laboratories, Abbott Park, IL) qHBsAg assays. HBcrAg was measured by using Lumipulse HBcrAg assay (Fujirebio, Tokyo, Japan). Serum aminotransferases and HBV DNA were respectively q

BACKGROUND: Traditional culture methods are time-consuming, making it difficult to utilize the results in the early stage of urinary tract infection (UTI) management, and automated urinalyses alone show insufficient performance for diagnosing UTIs. Several models have been proposed to predict urine culture positivity based on urinalysis. However, most of them have not been externally validated or consisted solely of urinalysis data obtained using one specific commercial analyzer. METHODS: A tota

BACKGROUND: This study investigated the outcomes of kidney transplantation (KT) over a 16-year period in Korea and identified risk factors for graft failure using a nationwide population-based cohort. METHODS: We investigated the Korean National Health Insurance Service-National Health Information Database. Health insurance claims for patients who underwent KT between 2002 and 2017 were analyzed. RESULTS: The data from 18,331 patients who underwent their first KT were reviewed. The percentage of

We evaluated analytic performances of an automated treponemal test and compared this test with the Venereal Disease Research Laboratory test (VDRL) and fluorescent treponemal antibody absorption test (FTA-ABS). Precision performance of the Architect Syphilis TP assay (TP; Abbott Japan, Tokyo, Japan) was assessed, and 150 serum samples were assayed with the TP before and after heat inactivation to estimate the effect of heat inactivation. A total of 616 specimens were tested with the FTA-ABS and

A novel multiplex real-time PCR assay for concurrent detection of hepatitis viruses was evaluated for its clinical performance in screening patients with acute hepatitis. A total of 648 serum samples were collected from patients with acute symptoms of hepatitis. Concurrent detection of nucleic acids of HAV, HBV and HCV was performed using the Magicplex™ HepaTrio Real-time Detection test. Serum nucleic acid levels of HBV and HCV were also quantified by the Cobas® AmpliPrep/Cobas® TaqMan® (CAP/CTM

BACKGROUND: Anti-HCV assays are widely used as a screening tool for HCV infection. However, diagnostic performances and effective signal-to-cut-off ratios (S/COs) for predicting true HCV infections would vary according to the assays used. Thus, we evaluated the diagnostic performances of the new Elecsys Anti-HCV assay. METHODS: A total of 41 694 cases tested by the Elecsys Anti-HCV II assay (Roche Diagnostics, Germany) during January 2013 to December 2015 were retrospectively analyzed by compari

Advances in patient care and immunosuppressive drugs have improved graft survival, resulting in an increase in kidney transplantation (KT); however, persistent immunosuppression is thought to cause late occurrence of cancer. This population-based study consisted of a total of 14,842 patients whose data from the years 2002 to 2017 were collected from the National Health Information Database in South Korea. Malignancies occurred in 7.6% of the total KT patients. Prostate and thyroid cancers were t

The human leukocyte antigen (HLA)-G is a nonclassical major histocompatibility complex class I molecule with relatively limited polymorphism. The differences in allele frequency according to ethnicity and country have not been studied enough, so far. Therefore, fundamental data including allele frequencies and polymorphism are needed for studies on immunological function of HLA-G in each population. We investigated allele frequencies and 14-bp polymorphism of the HLA-G in Koreans. HLA-G alleles