Objective: Based on the Liver Imaging Reporting and Data System version 2018 (LI-RADS, v2018), this study aimed to analyze LR-5 diagnostic performance for hepatocellular carcinoma (HCC) when threshold growth as a major feature is replaced by a more HCC-specific ancillary feature, as well as the frequency of threshold growth in HCC and non-HCC malignancies and its association with tumor size. Materials and Methods: This retrospective study included treatment-naive patients who underwent gadoxetate disodiumenhanced MRIs for focal hepatic lesions and surgery between January 2009 and December 2016. The frequency of major and ancillary features was evaluated for HCC and non-HCC malignancies, and the LR-category was assessed. Ancillary features that were significantly more prevalent in HCC were then used to either replace threshold growth or were added as additional major features, and the diagnostic performance of the readjusted LR category was compared to the LI-RADS v2018. Results: A total of 1013 observations were analyzed. Unlike arterial phase hyperenhancement, washout, or enhancing capsule which were more prevalent in HCCs than in non-HCC malignancies (521/616 vs. 18/58, 489/616 vs. 19/58, and 181/616 vs. 5/58, respectively; p < 0.001), threshold growth was more prevalent in non-HCC malignancies than in HCCs (11/23 vs. 17/119; p < 0.001). The mean size of non-HCC malignancies showing threshold growth was significantly smaller than that of non-HCC malignancies without threshold growth (22.2 mm vs. 42.9 mm, p = 0.040). Similar results were found for HCCs; however, the difference was not significant (26.8 mm vs. 33.1 mm, p = 0.184). Additionally, Fat-in-nodule was more frequent in HCCs than in non-HCC malignancies (99/616 vs. 2/58, p = 0.010). When threshold growth and fat-in-nodule were considered as ancillary and major features, respectively, LR-5 sensitivity (73.2% vs. 73.9%, p = 0.289) and specificity (98.2% vs. 98.5%, p > 0.999) were comparable to the LI-RADS v2018. Conclusion Threshold growth is not a significant diagnostic indicator of HCC and is more common in non-HCC malignancies. The diagnostic performance of LR-5 was comparable when threshold growth was recategorized as an ancillary feature and replaced by a more HCC-specific ancillary feature.

Objective: Based on the Liver Imaging Reporting and Data System version 2018 (LI-RADS, v2018), this study aimed to analyze LR-5 diagnostic performance for hepatocellular carcinoma (HCC) when threshold growth as a major feature is replaced by a more HCC-specific ancillary feature, as well as the frequency of threshold growth in HCC and non-HCC malignancies and its association with tumor size. Materials and Methods: This retrospective study included treatment-naive patients who underwent gadoxetate disodiumenhanced MRIs for focal hepatic lesions and surgery between January 2009 and December 2016. The frequency of major and ancillary features was evaluated for HCC and non-HCC malignancies, and the LR-category was assessed. Ancillary features that were significantly more prevalent in HCC were then used to either replace threshold growth or were added as additional major features, and the diagnostic performance of the readjusted LR category was compared to the LI-RADS v2018. Results: A total of 1013 observations were analyzed. Unlike arterial phase hyperenhancement, washout, or enhancing capsule which were more prevalent in HCCs than in non-HCC malignancies (521/616 vs. 18/58, 489/616 vs. 19/58, and 181/616 vs. 5/58, respectively; p < 0.001), threshold growth was more prevalent in non-HCC malignancies than in HCCs (11/23 vs. 17/119; p < 0.001). The mean size of non-HCC malignancies showing threshold growth was significantly smaller than that of non-HCC malignancies without threshold growth (22.2 mm vs. 42.9 mm, p = 0.040). Similar results were found for HCCs; however, the difference was not significant (26.8 mm vs. 33.1 mm, p = 0.184). Additionally, Fat-in-nodule was more frequent in HCCs than in non-HCC malignancies (99/616 vs. 2/58, p = 0.010). When threshold growth and fat-in-nodule were considered as ancillary and major features, respectively, LR-5 sensitivity (73.2% vs. 73.9%, p = 0.289) and specificity (98.2% vs. 98.5%, p > 0.999) were comparable to the LI-RADS v2018. Conclusion Threshold growth is not a significant diagnostic indicator of HCC and is more common in non-HCC malignancies. The diagnostic performance of LR-5 was comparable when threshold growth was recategorized as an ancillary feature and replaced by a more HCC-specific ancillary feature.

Antigens, Nuclear ; Arthritis, Rheumatoid ; Autoantibodies ; Diagnosis ; Enzyme-Linked Immunosorbent Assay ; Fluorescence ; Humans ; Immunoenzyme Techniques ; Lupus Erythematosus, Systemic ; Rheumatic Diseases ; Sensitivity and Specificity

Background/Aims: To investigate whether serum Wisteria floribunda agglutinin-positive human Mac-2-binding protein (WFA+-M2BP) can predict the recurrence of hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after curative resection. Methods: Patients with chronic hepatitis B (CHB) who underwent curative resection for HCC between 2004 and 2015 were eligible for the study. Recurrence was sub-classified as early (<2 years) or late (≥2 years). Results: A total of 170 patients with CHB were selected. During the follow-up period (median, 22.6 months), 64 (37.6%) patients developed recurrence. In multivariate analyses, WFA+-M2BP level was an independent predictor of overall (hazard ratio [HR]=1.490), early (HR=1.667), and late recurrence (HR=1.416), together with male sex, des-gamma carboxyprothrombin level, maximal tumor size, portal vein invasion, and satellite nodules (all P<0.05). However, WFA+- M2BP level was not predictive of grade B-C posthepatectomy liver failure. The cutoff value that maximized the sum of sensitivity (30.2%) and specificity (90.6%) was 2.14 (area under receiver operating characteristic curve=0.632, P=0.010). Patients with a WFA+-M2BP level >2.14 experienced recurrence more frequently than those with a WFA+-M2BP level ≤2.14 (P=0.011 by log-rank test), and had poorer postoperative outcomes than those with a WFA+-M2BP level ≤2.14 in terms of overall recurrence (56.0 vs. 34.5%, P=0.047) and early recurrence (52.0 vs. 20.7%, P=0.001). Conclusions WFA+-M2BP level is an independent predictive factor of HBV-related HCC recurrence after curative resection. Further studies should investigate incorporation of WFA+-M2BP level into tailored postoperative surveillance strategies for patients with CHB.

BACKGROUND: The interferon-gamma (IFN-γ) releasing assay (IGRA) is widely used for latent tuberculosis infection (LTBI) diagnosis. We evaluated the analytical performance of a new automated chemiluminescent immunoanalyzer-based IGRA (CLIA-IGRA), AdvanSure I3 (LG Life Sciences, Seoul, Korea) and compared it with that of the QuantiFERON-TB Gold In-Tube (QFT-GIT) assay. METHODS: Repeatability and reproducibility were evaluated at four levels. Detection capability, including limit of blank (LoB), limit of detection (LoD), and limit of quantification (LoQ), was evaluated using IFN-γ standard material (National Institute for Biological Standards and Control code: 87/586). Agreement between the results of two assays was evaluated using 341 blood samples from healthcare workers and patients at a tertiary care hospital. To determine the cut-off value of CLIA-IGRA for diagnosing LTBI, the ROC curve was analyzed. RESULTS: Repeatability and reproducibility were 4.86–7.00% and 6.36–7.88% CV, respectively. LoB, LoD, and LoQ were 0.022, 0.077, and 0.249 IU/mL, respectively. IFN-γ values between CLIA-IGRA and QFT-GIT showed a strong correlation within the analytical measurable range of both assays, especially when the value was low. Qualitative comparison of the two assays yielded a 99.1% overall agreement (kappa coefficient=0.98). A cut-off value of 0.35 IU/mL was appropriate for diagnosing LTBI. CONCLUSIONS CLIA-IGRA is a reliable assay for LTBI diagnosis, with performance similar to that of QFT-GIT.

PURPOSE: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) to antiepileptic drug (AED), are rare, but result in significant morbidity and mortality. We investigated the major culprit drugs, clinical characteristics, and clinical course and outcomes of AED-induced SCARs using a nationwide registry in Korea. METHODS: A total of 161 patients with AED-induced SCARs from 28 referral hospitals were analyzed. The causative AEDs, clinical characteristics, organ involvements, details of treatment, and outcomes were evaluated. We compared the clinical and laboratory parameters between SJS/TEN and DRESS according to the leading causative drugs. We further determined risk factors for prolonged hospitalization in AED-induced SCARs. RESULTS: Carbamazepine and lamotrigine were the most common culprit drugs causing SCARs. Valproic acid and levetiracetam also emerged as the major causative agents. The disease duration and hospital stay in carbamazepine-induced SJS/TEN were shorter than those in other AEDs (P< 0.05, respectively). In younger patients, lamotrigine caused higher incidences of DRESS than other drugs (P= 0.045). Carbamazepine, the most common culprit drug for SCARs, was associated with a favorable outcome related with prolonged hospitalization in SJS (odds ratio, 0.12; 95% confidence interval, 0.02-0.63, P= 0.12), and thrombocytopenia was found to be a risk factor for prolonged hospitalization in DRESS. CONCLUSION: This was the first large-scale epidemiological study of AED-induced SCARs in Korea. Valproic acid and levetiracetam were the significant emerging AEDs causing SCARs in addition to the well-known offending AEDs such as carbamazepine and lamotrigine. Carbamazepine was associated with reduced hospitalization, but thrombocytopenia was a risk factor for prolonged hospitalization. Our results suggest that the clinical characteristics and clinical courses of AED-induced SCARs might vary according to the individual AEDs.
Anticonvulsants ; Carbamazepine ; Cicatrix ; Drug Hypersensitivity Syndrome ; Epidemiologic Studies ; Hospitalization ; Humans ; Incidence ; Korea ; Length of Stay ; Mortality ; Referral and Consultation ; Risk Factors ; Stevens-Johnson Syndrome ; Thrombocytopenia ; Valproic Acid

BACKGROUND/AIMS: Liver stiffness (LS) was assessed using transient elastography, and the enhanced liver fibrosis (ELF) test was performed to accurately assess fibrotic burden. We validated the LS-ELF algorithm and investigated whether the sequential LS-ELF algorithm performs better than concurrent combination of these analyses in chronic hepatitis B (CHB) patients. METHODS: Between 2009 and 2013, 222 CHB patients who underwent liver biopsy (LB), as well as LS measurement and the ELF test, were enrolled. RESULTS: Advanced fibrosis (≥F3) and cirrhosis (F4) were identified in 141 (63.6%) and 118 (53.2%) patients, respectively. Areas under receiver operating characteristic curve for LS predictions of ≥F3 (0.887 vs 0.703) and F4 (0.853 vs 0.706) were significantly higher than the ELF test (all p < 0.001). Based on the LS-ELF algorithm, 60.4% to 71.6% and 55.7% to 66.3% of patients could have avoided LB to exclude ≥F3 and F4, respectively, whereas 68.0% to 78.7% and 63.5% to 66.1% of patients could have avoided LB to confirm ≥F3 and F4, respectively. When confirmation and exclusion strategies were applied simultaneously, 69.4% to 72.5% and 60.8% to 65.3% of patients could have avoided LB and been diagnosed as ≥F3 and F4, respectively. The proportion of patients who correctly avoided LB for the prediction of ≥F3 (69.4% to 72.5% vs 42.3% to 59.0%) and F4 (60.8% to 65.3% vs 23.9% to 49.5%) based on the sequential LS-ELF algorithm was significantly higher than the concurrent combination (all p < 0.05). CONCLUSIONS: The sequential LS-ELF algorithm conferred a greater probability of avoiding LB in CHB patients to diagnose advanced fibrosis and cirrhosis, and this test performed significantly better than the concurrent combination.
Biopsy ; Elasticity Imaging Techniques* ; Fibrosis ; Hepatitis B ; Hepatitis B, Chronic* ; Hepatitis, Chronic* ; Humans ; Liver Cirrhosis* ; Liver* ; ROC Curve

BACKGROUND: Epstein-Barr Virus (EBV) is one of the most prevalent causes of viral infection in humans. EBV infection stage (acute, past, or absent infection) is typically determined using a combination of assays that detect EBV-specific markers, such as IgG and IgM antibodies against the EBV viral capsid antigen (VCA) and IgG antibodies against the EBV nuclear antigen (EBNA). We compared the diagnostic performance and agreement of results between three commercial EBV antibody assays using an EBV performance panel (SeraCare Life Science, Milford, MA, USA) as a reference. METHODS: EBV antibody tests of EBV VCA IgM, VCA IgG, and EBNA IgG antibodies were performed by the Architect (Abbott Diagnostics, Wiesbaden, Germany), Liaison (DiaSorin, Saluggia, Italy), and Platelia (Bio-Rad, Marnes-la-Coquette, France) assays. Agreement between the three assays was evaluated using 279 clinical samples, and EBV DNA and antibody test results were compared. RESULTS: The three EBV antibody assays showed good diagnostic performance with good and excellent agreement with the performance panel (kappa coefficient, >0.6). The overall VCA IgM positivity rate was higher in EBV DNA-positive samples than in EBV DNA-negative samples for all three EBV antibody assays (P=0.02). The three EBV antibody assays exhibited good agreement in results for the clinical samples. CONCLUSIONS: The diagnostic performance of the three EBV antibody assays was acceptable, and they showed comparable agreement in results for the clinical samples.
Antibodies ; Biological Science Disciplines ; Capsid ; DNA ; Epstein-Barr Virus Infections ; Herpesvirus 4, Human* ; Humans ; Immunoglobulin G ; Immunoglobulin M ; Immunoglobulins

BACKGROUND: Conventional IgG assays require costly equipment and skilled experts. Semiquantitative measurement of total IgG using point-of-care testing devices may be the solution for these limitations. This study evaluated the reproducibility of the ImmuneCheck™ IgG assay (ProteomeTech Inc., Korea) and the correlation of its results with conventional laboratory IgG results in the serum and whole blood. METHODS: Both the serum and whole blood samples from 120 patients were used. To evaluate the intra-test reproducibility and inter-test correlation, intraclass correlation coefficient (ICC) analysis was used. RESULTS: The concentration of serum total IgG measured by cobas® 6000 (Roche Diagnostics, Switzland) ranged from 690.4 to 2,756.4 mg/dL. The intra-test reproducibility of ImmuneCheck™ IgG was high (Serum ICC=0.724, P < 0.001; Whole blood ICC=0.843, P < 0.001). The inter-test correlation between the ImmuneCheck™ IgG and cobas® 6000 results was very good (Serum ICC=0.805, P < 0.001; Whole blood ICC=0.842, P < 0.001). Because there were no samples with a total IgG level lower than 600 mg/dL, the pre-existing serum samples were diluted and then the linearity tests were conducted. The intra-test reproducibility for the diluted serum samples was almost perfect (ICC=0.995, P < 0.001), and the inter-test correlation between the ImmuneCheck™ IgG and cobas® 6000 results was also strong (ICC=0.992, P < 0.001). CONCLUSIONS: The ImmuneCheck™ IgG assay is reproducible and highly correlated with the conventional IgG assay for the serum and whole blood. It could be applied for the rapid detection of total IgG.
Humans ; Immunoglobulin G* ; Point-of-Care Testing