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ABSTRACT: BACKGROUND: Serologic tests are widely used for the diagnosis of syphilis. However, conventional methods require well-trained technicians to produce reliable results. We compared automated nontreponemal and treponemal tests with conventional methods. METHODS: The HiSens Auto Rapid Plasma Reagin (AutoRPR) and Treponema Pallidum Particle Agglutination (AutoTPPA) tests, which utilize latex turbidimetric immunoassay, were assessed. A total of 504 sera were assayed by AutoRPR, AutoTPPA, conventional VDRL and FTA-ABS. Among them, 250 samples were also tested by conventional TPPA. RESULTS: The concordance rate between the results of VDRL and AutoRPR was 67.5%, and 164 discrepant cases were all VDRL reactive but AutoRPR negative. In the 164 cases, 133 showed FTA-ABS reactivity. Medical records of 106 among the 133 cases were reviewed, and 82 among 106 specimens were found to be collected from patients already treated for syphilis. The concordance rate between the results of AutoTPPA and FTA-ABS was 97.8%. The results of conventional TPPA and AutoTPPA for 250 samples were concordant in 241 cases (96.4%). AutoRPR showed higher specificity than that of VDRL, while VDRL demonstrated higher sensitivity than that of AutoRPR regardless of whether the patients had been already treated for syphilis or not. Both FTA-ABS and AutoTPPA showed high sensitivities and specificities greater than 98.0%. CONCLUSIONS: Automated RPR and TPPA tests could be alternatives to conventional syphilis tests, and AutoRPR would be particularly suitable in treatment monitoring, since results by AutoRPR in cases after treatment became negative more rapidly than by VDRL.
Clinical biochemistry 02/2013; · 2.02 Impact Factor
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ABSTRACT: BACKGROUND: We evaluated recently introduced automated immunoassay analyzer LUMIPULSE G1200 (Fujirebio, Inc., Tokyo, Japan) for detecting serologic hepatitis B virus (HBV) markers by comparison with the results by ARCHITECT i4000SR (Abbott, Abbott Park, IL). METHODS: Precision performance was evaluated over 20 days. HBV surface antigen (HBsAg), HBV e antigen (HBeAg), antibodies to HBV core antigen (anti-HBc), antibodies to HBeAg (anti-HBe), and antibodies to HBsAg (anti-HBs) in a total of 1,000 serum samples were assessed by the two analyzers. Discrepant results were retested by COBAS e411 (Roche Diagnostics, Mannheim, Germany). RESULTS: LUMIPULSE showed excellent precision performance of total imprecision less than 3.5% coefficient of variation. The qualitative results between the two analyzers were agreed with each other in 92.0-99.8% of the specimens according to the different HBV markers. The degrees of reactions for HBeAg were moderately correlated between the two analyzers (r = 0.60), and those of other HBV markers were well correlated (r = 0.80 or greater). However, there were 183 discrepancies among 1,000 cases, and most of them showed degree of reaction around the cutoff values. CONCLUSIONS: LUMIPULSE G1200 showed well-concordant results with ARCITHECT for hepatitis B serologic tests. However, results near the cutoff values would need to be retested with other immunoassay or molecular methods, when the serological profiles of HBV markers are unusual or are not correlated to the clinical conditions of the patient, due to discrepancies between the immunoassay analyzers.
Journal of Clinical Laboratory Analysis 02/2013; · 1.38 Impact Factor
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ABSTRACT: BACKGROUND: The enhanced liver fibrosis (ELF) value is a non-invasive serum marker used for assessing liver fibrosis in chronic liver disease. To use the ELF value for the purpose of screening the general population and selecting subpopulations at high risk, it is important to know the normal range of ELF values as a prerequisite. AIMS: We aimed to define the normal range of ELF values by recruiting apparently healthy subjects and investigating factors influencing ELF values in subjects with minimal fibrotic burden. METHODS: ELF values were determined in a cohort of healthy subjects who underwent a health check-up and in healthy living liver donors who were screened for transplantation. None of subjects suffered from chronic heart disease, diabetes mellitus, metabolic syndrome, hepatitis B, hepatitis C, or human immunodeficiency virus infection, systemic autoimmune disease or liver dysfunction. RESULTS: Among 183 subjects analyzed, the normal ELF 5th through 95th percentile range was 5.95-8.73. Body mass index (P = 0.014) and male gender (P = 0.015) showed significant positive correlations with ELF value, whereas age did not. In multivariate linear regression analysis, platelet count was identified as the only independent factor influencing the ELF value (β=-0.006, P = 0.016). When considering the difference in ELF values between genders, the normal range of men was defined to be 6.72-8.93, this was slightly higher than that of women, 5.69-8.67. CONCLUSIONS: We identified the normal range of ELF values and found that it can be significantly influenced by platelet count even in the healthy population.
Liver international: official journal of the International Association for the Study of the Liver 02/2013; · 3.82 Impact Factor
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ABSTRACT: Adiponectin is found to associate with diabetes in studies apart from cohort studies. This prospective cohort study is to evaluate the predictive role of adiponectin in diabetes among participants with impaired fasting glucose (IFG). A total of 42,845 participants who visited 7 health examination centers located in Seoul and Kyunggi province, South Korea, during 2004-2008 were first included. Of the 42,845 participants, 5,085 participants had IFG. IFG was categorized as stage 1 (fasting glucose 100-109 mg/dL) or stage 2 (110-125 mg/dL). The incidence rates of diabetes were followed up to December, 2011. Hazard ratios (HRs) and 95 % confidence intervals (CI) were performed by Cox proportional hazard model. Of the 5,085 participants, 652 participants developed diabetes during a mean follow-up of 4.4 years. Low adiponectin was associated with diabetes among men with stage 2 IFG (HR, 1.78; 95 %CI, 1.33-2.38) while it was associated with diabetes among women with stage 1 IFG (HR, 2.64; 95 %CI, 1.38-5.03) and stage 2 IFG (HR, 2.17; 95 %CI, 1.07-4.42). When combined men and women, the association between adiponectin and diabetes was statistically significant in stage 2 IFG with an increase of about 82 % (HR, 1.82; 95 %CI, 1.40-2.39) after adjusting for age, sex, body mass index, waist circumference, and fasting serum glucose. There was an interaction by sex and stage 1 IFG in the association between adiponectin and risk of diabetes (P < 0.001). Adiponectin was independently associated with diabetes among participants with IFG. This association was apparent in stage 2 IFG. Adiponectin may be used as a predictor of diabetes in patients having IFG.
Endocrine 02/2013; · 1.42 Impact Factor
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ABSTRACT: In hepatitis C Virus (HCV) high-risk groups, HCV-specific T cell responses have been detected in seronegative, aviremic persons who have no evidence of HCV infection. Herein, we investigated functional profiles of HCV-specific T-cell responses in seronegative, aviremic patients of a HCV high-risk group. Seventy seven hemodialysis patients with chronic renal disease were analyzed by IFN-γ ELISpot assays, and eight of 71 (11.3%) seronegative, aviremic patients displayed HCV-specific T-cell responses. Their HCV-specific memory T cells were characterized by assessing cytokine polyfunctionality, known to provide antiviral protection. By intracellular staining of IFN-γ, TNF-α, IL-2 and MIP-1β, we identified two distinct populations in the seronegative, aviremic patients: polyfunctional responders and TNF-α-predominant responders. In further analysis, occult HCV infection was excluded as a cause of the HCV-specific T cell response via secondary nested RT-PCR of HCV RNA in peripheral blood mononuclear cell samples. HCV-specific T cells targeted multiple epitopes including non-structural proteins in a single patient, implying that their T cells might have been primed by HCV proteins synthesized within the host. We conclude that HCV-specific memory T cells of seronegative, aviremic patients arise from authentic HCV replication in the host, but not from current occult HCV infection. By functional pattern of HCV-specific T cells, there are two distinct populations in these patients: polyfunctional responders and TNF-α-predominant responders.
PLoS ONE 01/2013; 8(4):e62319. · 4.09 Impact Factor
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ABSTRACT: The relationship between cytokines and responses to peginterferon alpha-2a treatment in chronic hepatitis B patients has not yet been fully elucidated. We analyzed the serum levels of interleukin (IL)-1alpha, IL-1beta, IL-2, IL-4, IL-6, IL-8, IL-10, vascular endothelial growth factor, interferon-gamma, tumor necrosis factor-alpha, monocyte chemotactic protein-1 (MCP1) and epidermal growth factor during the treatment with peginterferon alpha-2a.
Ninety-three serum samples from 20 chronic hepatitis B patients were collected before, during and after 48 weeks of peginterferon therapy and were assayed for 12 cytokines. The patients were categorized as either virologic responders (VRs) or non-responders (NRs) according to their HBV DNA levels taken at 6th month during treatment. The Evidence Investigator (Randox, Antrim, UK), a protein chip analyzer, was used to quantify cytokines.
Among the 12 cytokines, the levels of MCP1 were increased and the levels of IL-4 were decreased during the treatment in VRs. However these cytokines were not significantly changed in NRs in the treatment phases. Area under the receiver operating characteristic curve (AUROC) value of HBV DNA measured before the treatment was 0.81 in predicting VRs, and that of the baseline MCP1 was 0.76. IL-6 levels at 3rd and 6th months during the treatment also showed AUROC values 0.85 and 0.78 respectively in predicting sustained VRs.
Serum cytokine levels reflect the pathological differences of individual treatment phases and could also be useful in monitoring responses to peginterferon treatment in chronic hepatitis B patients.
Hepatobiliary & pancreatic diseases international: HBPD INT 10/2012; 11(5):499-506. · 1.08 Impact Factor
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ABSTRACT: Five assays for the detection of human papillomavirus (HPV) with different assay principles were evaluated. A total of 230 cervical swab specimens were collected from subjects according to the cytologic results. All specimens were tested by the following assays: hybrid capture 2 (HC2), two real-time PCR assays (Abbott RealTime HR and AdvanSure RealTime), liquid beads microarray (GeneFinder) and peptide nucleic acid-based array (PANArray). The HPV DNA of 99 samples was sequenced to identify genotypes. Concordance rates between the results for the identification of 14 high risk HPV genotypes by any two of the evaluated assays, except for AdvanSure RealTime, ranged from 83.0% to 88.3%, and those for the identification of genotypes 16 and 18, except for HC2, were 93.0% and 96.1%, respectively. The results for the evaluation of high risk HPV genotypes by HC2 agreed with those of the other assays in 76.5-86.5% of cases. Identification of HPV genotype by GeneFinder and PANArray corresponded with that by direct sequencing in 88.9% and 84.8% of sequenced samples. This study demonstrated that HC2 and the two real-time PCR assays could be used for routine HPV screening, and the other genotyping assays can be applied for epidemiologic surveillance.
Journal of virological methods 09/2012; · 2.13 Impact Factor
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ABSTRACT: BACKGROUND: We compared the diagnostic utilities of CYFRA 21-1, nuclear matrix protein-22 (NMP22), urinary bladder cancer antigen (UBC), and fibrin/fibrinogen degradation products (FDP) for detecting urinary bladder cancer. METHODS: We assayed CYFRA 21-1, NMP22, UBC and FDP from urine samples for 250 subjects. Among them, 54 were diagnosed as bladder cancer, and the remaining 196, which consisted of healthy individuals and patients with hematuria, inflammation/infection, or benign prostate hyperplasia, were assigned to the control group. RESULTS: Urinary levels of all 4 markers were higher in the bladder cancer group than the control group. The areas under the receiver operating characteristic curves (ROC-AUCs) of CYFRA 21-1, NMP22, UBC and FDP, corrected with urine creatinine concentrations, were 0.90, 0.89, 0.80 and 0.77, respectively, for discriminating bladder cancer from controls. The ROC-AUCs for the combinations of the markers were not significantly higher than those with CYFRA 21-1 or NMP22. NMP22 was the only independent variable for predicting bladder cancer among the four markers in the multivariate analysis. CONCLUSIONS: All 4 tumor biomarkers exhibited diagnostic utility for predicting bladder cancer. Among them, CYFRA 21-1 and NMP22 were the most effective at predicting bladder cancer.
Clinica chimica acta; international journal of clinical chemistry 08/2012; 414C:93-100. · 2.54 Impact Factor
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ABSTRACT: Anaphylactic transfusion reactions are rare complications of blood transfusions. Anhaptoglobinemia, a condition that has high incidence in Asia, can cause allergic transfusion reactions or anaphylaxis in severe cases. A 50-yr-old Korean woman was diagnosed with relapsed acute promyelocytic leukemia. She developed thrombocytopenia during chemotherapy and an anaphylactic transfusion reaction on the 4th and 5th platelet transfusions immediately after the transfusion of the platelet concentrates was initiated. Blood analysis showed no detectable serum haptoglobin. We examined her genetic phenotype and detected anhaptoglobinemia, which occurs because of an allelic deletion in the Hp gene cluster. The presence of an antibody against haptoglobin was detected by performing ELISA. To prevent anaphylactic reactions, apheresis platelets were transfused after washing. Consequently, anaphylactic transfusion reactions did not develop. Here, we report the first case of anhaptoglobinemia causing anaphylactic transfusion reaction in Korea.
Annals of laboratory medicine. 07/2012; 32(4):304-6.
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ABSTRACT: Early biomarkers for acute kidney injury after kidney transplantation have been studied because delayed graft function (DGF) is associated with increased risk of acute rejection and graft loss. We investigated the usefulness of serum neutrophil gelatinase-associated lipocalin (NGAL) and interleukin-18 (IL-18) for the prediction of DGF after kidney transplantation.
Fifty-nine kidney transplant recipients were included and they were separated into DGF and immediate graft function (IGF) groups. Serum samples were collected on the preoperative day as well as days 1, 5, and 14 after the transplantation, and assayed for NGAL and IL-18.
After transplantation, serum levels of NGAL were significantly higher at any time in patients with DGF compared to those with IGF. Serum concentrations of IL-18 were not different between both groups. The receiver operating characteristics(ROC)-area under the curve (AUC) values of NGAL, IL-18, and creatinine on day 1 for the discrimination of DGF from IGF were 0.86, 0.63, and 0.65. On POD1, the sensitivities of NGAL and creatinine were respectively 78.6%, and 50.0% at 77.8% specificity, and the AUC values for any combinations including NGAL and that for NGAL alone were higher than that of creatinine.
Serum NGAL is an early and sensitive marker of graft dysfunction in kidney transplantation, while serum IL-18 showed limited values.
Journal of Clinical Laboratory Analysis 07/2012; 26(4):295-301. · 1.38 Impact Factor
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ABSTRACT: We compared the diagnostic utilities of procalcitonin (PCT) and C-reactive protein (CRP) for predicting bacteremia diagnosed by blood cultures. PCT was also evaluated as a parameter for differentiating true bacteremia from culture contamination.
We analyzed a total of 3343 patients in which PCT, CRP, and blood cultures were concurrently requested for detecting bacteremia from January 2010 to December 2011. PCT concentrations were measured by the VIDAS® Brahms PCT assay, and CRP concentrations were determined by a turbidimetric assay using CA-400 analyzer.
The PCT concentrations of bacteremia cases (n=331) were significantly higher than those of non-bacteremia (n=2856) (median: 3.2 ng/ml vs. 0.4 ng/ml, P<0.0001). The correlation coefficient between the PCT and CRP concentrations was 0.51. The areas under the receiver operating characteristic curves (ROC-AUCs) of PCT and CRP for discriminating bacteremia from non-bacteremia were 0.76 and 0.64, respectively. The ROC-AUC of PCT for differentiating true bacteremia from contamination was 0.86, while that of CRP was 0.65.
PCT concentration by single testing was more useful for predicting bacteremia than CRP. PCT also exhibited diagnostic utility for ruling out blood culture contamination. Thus, PCT could be helpful in the accurate diagnosis of bacteremia.
Clinica chimica acta; international journal of clinical chemistry 06/2012; 413(21-22):1731-6. · 2.54 Impact Factor
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ABSTRACT: Tumor marker concentrations in a given specimen measured by different analyzers vary according to assay methods, epitopes for antibodies used, and reagent specificities. Although great effort in quality assessment has been instituted, discrepancies among results from different analyzers are still present. We evaluated the assay performance of the UniCel™ DxI 800 automated analyzer in measuring the alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen (CA) 125, CA 15-3 and CA 19-9 tumor markers.
The linearity and precision performance of the five tumor marker assays were evaluated, and concentrations of the respective markers as measured by DxI were compared to those measured by other conventional analyzers (ADVIA Centaur™ and Vitros™ ECi) using 200 specimens collected from 100 healthy persons and 100 patients with respective cancers.
The linear fits for all five tumor markers were statistically acceptable (F=4648 for AFP, F=15846 for CEA, F=6445 for CA 125, F=2285 for CA 15-3, F=7459 for CA 19-9; p<0.0001 for all). The imprecision of each tumor marker assay was less than 5% coefficient of variation, except for low and high concentrations of AFP. The results from UniCel™ DxI 800 were highly correlated with those from other analyzers.
Our results demonstrate that UniCel™ DxI 800 has good linearity and precision performance for the tumor markers assayed in this study. However, there were discrepancies between assaying methods. Efforts to standardize tumor marker assays should be undertaken, and the redetermination of cut-off levels is necessary when developing methods of analyzing tumor markers.
Yonsei medical journal 05/2012; 53(3):557-64. · 0.77 Impact Factor
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ABSTRACT: 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 quantified by using the Hitachi 7600 analyzer (Hitachi High-Technologies, Tokyo, Japan) and the Cobas AmpliPrep/Cobas TaqMan test (Roche). Precision of the qHBsAg and HBcrAg assays was assessed, and linearity of the qHBsAg assays was verified. All assays showed good precision performance with coefficients of variation between 4.5% and 5.3% except for some levels. Both qHBsAg assays showed linearity from 0.1 to 12,000.0 IU/mL and correlated well (r = 0.9934). HBsAg levels correlated with HBV DNA (r = 0.3373) and with HBcrAg (r = 0.5164), and HBcrAg also correlated with HBV DNA (r = 0.5198; P < .0001). This observation could provide impetus for further research to elucidate the clinical usefulness of the qHBsAg and HBcrAg assays.
American Journal of Clinical Pathology 05/2012; 137(5):770-7. · 2.60 Impact Factor
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ABSTRACT: PurposeThis study was designed to assess anti-Saccharomyces cerevisiae antibody positive rate in Behçet’s disease and intestinal Behçet’s disease and to evaluate whether anti-Saccharomyces cerevisiae antibody expression is associated with clinical findings at diagnosis and clinical course of intestinal Behçet’s disease.
MethodsOne hundred six patients with intestinal Behçet’s disease, 30 patients with Behçet’s disease, and 45 healthy control subjects
were included. Anti-Saccharomyces cerevisiae antibody was detected by indirect immunofluorescence assay. According to anti-Saccharomyces cerevisiae antibody expression, the various parameters at diagnosis, cumulative relapse rates, and cumulative probabilities of operation
were analyzed.
ResultsAnti-Saccharomyces cerevisiae antibody positive rate was 44.3 percent in intestinal Behçet’s disease, 3.3 percent in Behçet’s disease, and 8.8 percent
in healthy control subjects. In patients with intestinal Behçet’s disease, age, gender, distribution of Behçet’s disease subtype,
symptoms, laboratory tests, and colonoscopic findings at diagnosis were not different according to anti-Saccharomyces cerevisiae antibody expression. Cumulative probability of a first operation was significantly higher in anti-Saccharomyces cerevisiae antibody (+) intestinal Behçet’s disease than in anti-Saccharomyces cerevisiae antibody (−) intestinal Behçet’s disease: 44.8 and 17.2 percent at one year, and 53 and 24.3 percent at two years after diagnosis,
respectively (P = 0.006). The number of patients who underwent two or more operations was higher in anti-Saccharomyces cerevisiae antibody (+) intestinal Behçet’s disease than in anti-Saccharomyces cerevisiae antibody (−) intestinal Behçet’s disease (21.3 vs. 8.5 percent). The cumulative relapse rates were not different between the two groups.
ConclusionsAnti-Saccharomyces cerevisiae antibody positive rate was 44.3 percent in intestinal Behçet’s disease. Clinical findings at diagnosis and cumulative relapse
rates of intestinal Behçet’s disease were not found to be associated with anti-Saccharomyces cerevisiae antibody expression. However, patients with anti-Saccharomyces cerevisiae antibody (+) intestinal Behçet’s disease were more likely to receive surgical treatment.
Diseases of the Colon & Rectum 04/2012; 49(12):1849-1859. · 3.13 Impact Factor
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ABSTRACT: 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 criteria that concordant results among the three assays were regarded as true-positive or -negative and that the results of genotyping and sequencing were considered true findings when the HPV assays presented discrepant results. The overall concordance rate among the results for the three assays was 82.6%, and RealTime HR and Cobas HPV assays agreed with HC2 in 86.1% and 89.9% of cases, respectively. The two real-time PCR assays agreed with each other for 89.6% of the samples, and the concordance rate between them was equal to or greater than 98.0% for detecting HPV type 16 or 18. HC2 demonstrated a sensitivity of 96.6% with a specificity of 89.1% for detecting HR HPVs, while RealTime HR presented a sensitivity of 78.3% with a specificity of 99.2%. The sensitivity and specificity of Cobas HPV for detecting HR HPVs were 91.7% and 97.0%. The new real-time PCR assays exhibited lower sensitivities for detecting HR HPVs than that of HC2. Nevertheless, the newly introduced assays have an advantage of simultaneously identifying HPV types 16 and 18 from clinical samples.
Journal of clinical microbiology 04/2012; 50(7):2359-65. · 4.16 Impact Factor
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ABSTRACT: A newly developed and totally automated Luminex-based assay, the BioPlex™ 2200 system, is able to detect various autoantibodies simultaneously from a single sample. We compared the BioPlex™ 2200 system with ELISA for the detection of six autoantibodies.
A total of 127 serum samples from the patients with systemic rheumatic diseases were collected and assayed with the BioPlex™ 2200 system (Bio-Rad, USA) and conventional ELISA (INOVA Diagnostics, USA) for 5 anti-extractable nuclear antigens. Additionally, relative sensitivity of the BioPlex™ 2200 system for detecting anti-dsDNA was evaluated with 79 specimens from SLE patients, which were positive for anti-dsDNA by ELISA.
The concordance rates between ELISA and the BioPlex ranged from 88.1% for anti-RNP to 95.2% for anti-Scl-70, and the kappa coefficients between the results by the two assays were from 0.48 to 0.67. Among the 79 anti-dsDNA positive specimens by ELISA, seventy-eight (98.7%) showed positive results for anti-dsDNA by the BioPlex.
The BioPlex™ 2200 system showed comparable results with those by conventional ELISA for detecting autoantibodies, and this automated assay could measure multifarious autoantibodies concurrently in a single sample. It could be effectively used in clinical laboratories for screening autoimmune diseases.
Clinica chimica acta; international journal of clinical chemistry 01/2012; 413(1-2):308-11. · 2.54 Impact Factor
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Beom Kyung Kim,
Seung Up Kim, Hyon Suk Kim,
Jun Yong Park,
Sang Hoon Ahn,
Chae Yoon Chon,
In Rae Cho,
Dong-Hoo Joh,
Young Nyun Park,
Kwang-Hyub Han,
Do Young Kim
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ABSTRACT: Diagnostic values of FibroTest (FT) for hepatic fibrosis have rarely been assessed in Asian chronic hepatitis B (CHB) patients. We aimed to validate its diagnostic performances in comparison with liver stiffness (LS).
From 2008 to 2010, 194 CHB patients who underwent liver biopsies along with FT and transient elastography were prospectively enrolled. Fibrosis stage was assessed according to the Batts and Ludwig system.
To predict significant fibrosis (F≥2), advanced fibrosis (F≥3), and cirrhosis (F = 4), areas under receiver operating characteristic curves (AUROCs) of FT were 0.903, 0.907, and 0.866, comparable to those of LS (0.873, 0.897, and 0.910, respectively). Optimized cutoffs of FT to maximize sum of sensitivity and specificity were 0.32, 0.52, and 0.68 for F≥2, F≥3, and F = 4, while those of LS were 8.8, 10.2, and 14.1 kPa, respectively. According to FT and LS cutoffs, 123 (63.4%) and 124 (63.9%) patients were correctly classified consistent with histological fibrosis (F1, F2, F3, and F4), respectively. Overall concordance between each fibrosis stage estimated by FT and LS was observed in 111 patients, where 88 were correctly classified with histological results. A combination formula adding LS to FT (LS+FT) showed similar AUROC levels (0.885, 0.905, and 0.915), while another multiplying LS by FT (LS×FT) showed the best AUROCs (0.941, 0.931, and 0.929 for F≥2, F≥3, and F4, respectively).
FT provides good fibrosis prediction, with comparable outcomes to LS in Asian CHB patients. FT substantially reduces need for liver biopsy, especially when used in combination with LS.
PLoS ONE 01/2012; 7(4):e35825. · 4.09 Impact Factor
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ABSTRACT: Liver stiffness measurement (LSM) and FibroTest (FT) are frequently used as non-invasive alternatives for fibrosis staging to liver biopsy. However, to date, diagnostic performances of Enhanced Liver Fibrosis (ELF) test, which consists of hyaluronic acid, aminoterminal propeptide of procollagen type-III, and tissue inhibitor of matrix metalloproteinases-1, have not been compared to those of LSM and FT in Asian chronic hepatitis B (CHB) patients.
Between June 2010 and November 2011, we prospectively enrolled 170 CHB patients who underwent liver biopsies along with LSM, FT, and ELF. The Batts system was used to assess fibrosis stages.
Areas under receiver operating characteristic curves (AUROCs) to predict significant fibrosis (F≥2), advanced fibrosis (F≥3), and cirrhosis (F = 4) were 0.901, 0.860, and 0.862 for ELF, respectively; 0.937, 0.956, and 0.963 for LSM; and 0.896, 0.921, and 0.881 for FT. AUROCs to predict F≥2 were similar between each other, whereas LSM and FT had better AUROCs than ELF for predicting F≥3 (both p<0.05), and LSM predicted F4 more accurately than ELF (p<0.05). Optimized cutoffs of ELF to maximize sum of sensitivity and specificity were 8.5, 9.4, and 10.1 for F≥2, F≥3, and F = 4, respectively. Using suggested ELF, LSM and FT cutoffs to diagnose F1, F2, F3, and F4, 91 (53.5%), 117 (68.8%), and 110 (64.7%) patients, respectively, were correctly classified according to histological results.
ELF demonstrated considerable diagnostic value in fibrosis staging in Asian CHB patients, especially in predicting F≥2. However, LSM consistently provided better performance for predicting F≥3 and F4.
PLoS ONE 01/2012; 7(7):e41964. · 4.09 Impact Factor
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ABSTRACT: High mobility group box 1 protein (HMGB1), a nuclear protein, can be translocated to the cytoplasm and secreted in colon cancer cells. However, the diagnostic significance of HMGB1 has not been evaluated in colorectal carcinomas. For this purpose, we have screened the expression and secretion of HMGB1 in 10 colon cancer cell lines and 1 control cell line and found that HMGB1 was detected in the culture medium. To evaluate the diagnostic value of HMGB1, we performed an enzyme-linked immunosorbent assay to measure HMGB1 levels and compared them to carcinoembryonic antigen (CEA) levels in the serum samples of 219 colorectal carcinoma patients and 75 healthy control subjects. We found that the serum HMGB1 level was increased by 1.5-fold in patients with colorectal carcinoma compared to those in healthy controls. When HMGB1 and CEA levels were compared, HMGB1 had similar efficacy as CEA regarding cancer detection (the sensitivity was 20.1% for HMGB1 vs. 25.6% for CEA, and the specificity was 96% for HMGB1 vs. 90.7% for CEA). Moreover, the diagnostic accuracy of HMGB1 for stage I cancer was significantly higher than that of CEA (sensitivity: 41.2% vs. 5.9%; specificity: 96% vs. 90.7). When we combined HMGB1 and CEA, the overall diagnostic sensitivity was higher than that of CEA alone (42% vs. 25.6%), and the diagnostic sensitivity for stage I was also elevated (47% vs. 5.9%). However, the prognosis of patients was not related with serum HMGB1 concentrations. Our findings indicate that serum HMGB1 levels are increased in a subset of colorectal carcinomas, suggesting their potential utility as a supportive diagnostic marker for colorectal carcinomas.
PLoS ONE 01/2012; 7(4):e34318. · 4.09 Impact Factor
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ABSTRACT: 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) HBV and HCV tests. Patients' medical records were also reviewed. Concordance rates between the results from the HepaTrio and the CAP/CTM tests for the detection of HBV and HCV were 94.9% (k = 0.88) and 99.2% (k = 0.98), respectively. The cycle threshold values with the HepaTrio test were also correlated well with the levels of HBV DNA (r = -0.9230) and HCV RNA (r = -0.8458). The sensitivity and specificity of the HepaTrio test were 93.8% and 98.2%, respectively, for detecting HBV infection, and 99.1% and 100.0%, respectively, for HCV infection. For the HepaTrio test, 21 (3.2%) cases were positive for both HBV and HCV. Among the positive cases, 6 (0.9%) were true coinfections. This test also detected 18 (2.8%) HAV positives. The HepaTrio test demonstrated good clinical performance and produced results that agreed well with those of the CAP/CTM assays, especially for the detection of HCV. This assay was also able to detect HAV RNA from anti-HAV IgM-positive individuals. Therefore, this new multiplex PCR assay could be useful for the concurrent detection of the three hepatitis viruses.
PLoS ONE 01/2012; 7(11):e49106. · 4.09 Impact Factor
