BackgroundWisteria floribunda agglutinin-positive Mac-2 binding protein (WFA-M2BP) is a protein with altered glycosylation that reacts with lectin, and was recently identified as a useful non-invasive biomarker for the diagnosis of liver fibrosis in patients with hepatitis C virus infection.This study aimed to evaluate the diagnostic efficacy of WFA-M2BP for liver fibrosis in the context of hepatitis B virus (HBV).MethodsWe enrolled 151 patients infected with HBV. Liver biopsy and elastography (Fibroscan) were performed during the initial visit. Fibrosis was graded according to the Knodell histologic activity index (F0–3). WFA-M2BP levels were determined with an automated immunoassay analyzer (M2BPGi, HISCL-5000, Sysmex, Japan). The diagnostic efficacy of WFA-M2BP was compared with those of various conventional or composite biomarkers, including enhanced liver fibrosis (ELF) score, Fibroscan, aspartate transaminase (AST)-to-platelet ratio index (APRI), and FIB-4, based on the area under the ROC curve (AUC) value.ResultsThe majority of patients were at fibrosis stages F1 and F2. The F2 and F3 AUC values for WFA-M2BP were similar to those for FIB-4, APRI, ELF, and Fibroscan, although the latter showed the best diagnostic efficacy. The diagnostic accuracy of all tested biomarkers for F2 and F3 was 60–70%. In multivariate analysis, WFA-M2BP, ELF, and platelet count significantly predicted stage ≥F2, whereas only platelet count significantly predicted F3.ConclusionsWFA-M2BP can support a diagnosis of liver fibrosis with similar diagnostic efficacy to other biomarkers, and predicted liver fibrosis stage ≥2 among patients with chronic hepatitis B.
INTRODUCTIONPre-transfusion compatibility testing is crucial to the transfusion process. Before red blood cell (RBC) transfusion, blood samples from donors and recipients are analyzed to determine their ABO and RhD blood typing, to look for unexpected RBC alloantibodies, and to con rm cross-match compatibility [1]. These tests are crucial for preventing transfusion of incompatible donor red cells that might cause a hemolytic reaction.Manual immunohematology testing has been performed by centrifuging RBCs and antibodies in test tubes, followed by a visual determination of the extent of RBC agglutination. Although the manual method is still considered the gold standard, this technique has inherent limitations. These include the elution of low af nity antibodies during washing, the variability in results due to differences in the cell-serum ratio, and the inconsistency in reporting due to inter-observer variability Background: An automated immunohematology analyzer, DAYMATE M (DAY Medical, Switzerland), has been recently developed. The potential of this analyzer to improve test results has been evaluated. Methods: A total of 300 blood samples from Seoul St. Mary's hospital and Incheon St. Mary's hospital were tested for ABO and RhD typing. In addition, 336 antibody screening test (AST) samples and 82 patients treated with hematopoietic stem cell transplantation (HSCT) were included. AST results by DAYMATE M were compared with those obtained by a manual method using DS-Screening II (Bio-Rad Laboratories, Switzerland) and red blood cells from Selectogen (Ortho-Clinical diagnostics Inc., USA). Results: Of the 300 patients enrolled, 87, 73, 79, and 61 had type A, B, O, and AB blood, respectively. The concordance rate was 99.9% for cell typing and 97.0% for serum typing. One discordant case was classified as type B instead of AB, and six discordant serum-typing cases were type A, but classified as type AB. Among the 336 AST samples, the concordance rate was 93.2%. From 136 positive cases, six were discordant. Within the 82 HSCT-treated patients, the concordance rate for ABO blood typing was 92.2%. Among the six discordant cases, DAYMATE M typed four cases as donor type where the standard method typed them as the recipient blood type. Conclusions: The DAYMATE M automated immunohematology analyzer performs reliably for ABO and RhD typing, as well as for ASTs and on samples from patients treated with HSCT.
The analytical performance and clinical application of measuring insulin and connecting peptide (C-peptide) by point of care (POC) assay were evaluated. A POC assay system (SelexOn, Osang Healthcare Inc., Anyang-si, Korea) was evaluated for precision, linearity, limit of blank (LOB), and limit of detection (LOD). Method comparison was performed with the Cobas Elecsys insulin and C-peptide assay (Roche Diagnostics GmbH, Mannheim, Germany) using 215 and 201 patient specimens for insulin and C-peptide, respectively. For clinical application, insulin resistance indices were studied. Homeostasis model assessment (HOMA) 1 and 2, Quantitative insulin sensitivity check index (QUIKI), fasting insulin resistance index (FIRI), and other indices were evaluated. The coefficient of variation (CV) of imprecision for low, medium, and high concentrations was 10.8%1, 15.99%, and 12.05%, respectively, for insulin and 9.21%, 13.51%, and 13.77%, respectively, for C-peptide. The linearity was validated to 839.78 pmol/L for insulin and to 17.30 nmol/L for C-peptide. LOB and LOD were 8.05 and 9.72 pmol/L for insulin and 0.05 and 0.08 nmol/L for C-peptide, respectively. For the method comparison, the regression equation was y ¼ 1.259x À 8.818 (r ¼ 0.957) for insulin and y ¼ 1.163x-0.088 (r ¼ 0.985) for C-peptide. The ROC value and overall accuracy were as follows:
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