Clinical Validation of an Automated Fluorogenic Factor XIII Activity Assay Based on Isopeptidase Activity

Hereditary factor XIII (FXIII) deficiency is a rare autosomal bleeding disorder which can cause life-threatening bleeding. Acquired be immune-mediated or due to increased consumption reduced synthesis. The most commonly used screening test insensitive, and widely quantitative assays have analytical limitations. present study sought validate Technofluor FXIII Activity, the first isopeptidase-based assay available on routine coagulation analyser, Ceveron s100. Linearity was evidenced throughout measuring range, with correlation coefficients of >0.99, variation for repeatability reproducibility were <5% <10%, respectively. A normally distributed reference range 47.0–135.5 IU/dL derived from 154 normal donors. Clinical samples Activity results between 0 167.0 assayed Berichrom® functional ammonia release assay, HemosIL™ antigen generating correlations 0.950 0.980, Experiments transglutaminase inhibitor showed that detect inhibition enzymatic activity. No interference exhibited by high levels haemolysis lipaemia, bilirubin evident at 18 mg/dL, level commensurate severe liver disease. rapid, accurate precise suitable diagnostic use fewer interferents than activity assays.