Back to Search
Start Over
Clinical Validation of an Automated Fluorogenic Factor XIII Activity Assay Based on Isopeptidase Activity.
- Source :
-
International journal of molecular sciences [Int J Mol Sci] 2021 Jan 20; Vol. 22 (3). Date of Electronic Publication: 2021 Jan 20. - Publication Year :
- 2021
-
Abstract
- Hereditary factor XIII (FXIII) deficiency is a rare autosomal bleeding disorder which can cause life-threatening bleeding. Acquired deficiency can be immune-mediated or due to increased consumption or reduced synthesis. The most commonly used screening test is insensitive, and widely used quantitative assays have analytical limitations. The present study sought to validate Technofluor FXIII Activity, the first isopeptidase-based assay available on a routine coagulation analyser, the Ceveron s100. Linearity was evidenced throughout the measuring range, with correlation coefficients of >0.99, and coefficients of variation for repeatability and reproducibility were <5% and <10%, respectively. A normally distributed reference range of 47.0-135.5 IU/dL was derived from 154 normal donors. Clinical samples with Technofluor FXIII Activity results between 0 and 167.0 IU/dL were assayed with Berichrom <superscript>®</superscript> FXIII Activity, a functional ammonia release assay, and the HemosIL <superscript>™</superscript> FXIII antigen assay, generating correlations of 0.950 and 0.980, respectively. Experiments with a transglutaminase inhibitor showed that Technofluor FXIII Activity can detect inhibition of enzymatic activity. No interference was exhibited by high levels of haemolysis and lipaemia, and interference by bilirubin was evident at 18 mg/dL, a level commensurate with severe liver disease. Technofluor FXIII Activity is a rapid, accurate and precise assay suitable for routine diagnostic use with fewer interferents than ammonia release FXIII activity assays.
- Subjects :
- Automation, Laboratory standards
Bilirubin metabolism
Blood Coagulation Tests standards
Chromogenic Compounds standards
Factor XIII metabolism
Factor XIII Deficiency blood
Fluorometry methods
Fluorometry standards
Hemolysis
Humans
Immunologic Tests methods
Immunologic Tests standards
Reproducibility of Results
Transglutaminases metabolism
Automation, Laboratory methods
Blood Coagulation Tests methods
Carbon-Nitrogen Lyases metabolism
Factor XIII analysis
Factor XIII Deficiency diagnosis
Fluorescent Dyes standards
Subjects
Details
- Language :
- English
- ISSN :
- 1422-0067
- Volume :
- 22
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- International journal of molecular sciences
- Publication Type :
- Academic Journal
- Accession number :
- 33498248
- Full Text :
- https://doi.org/10.3390/ijms22031002