Next Article in Journal
Preventive Effect of Canstatin against Ventricular Arrhythmia Induced by Ischemia/Reperfusion Injury: A Pilot Study
Next Article in Special Issue
Factor XIII-A in Diseases: Role Beyond Blood Coagulation
Previous Article in Journal
Relevance of Peroxisome Proliferator Activated Receptors in Multitarget Paradigm Associated with the Endocannabinoid System
Previous Article in Special Issue
Carboxypeptidase U (CPU, TAFIa, CPB2) in Thromboembolic Disease: What Do We Know Three Decades after Its Discovery?
 
 
Article

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

1
Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, Brunner Str. 67, 1230 Vienna, Austria
2
Zedira GmbH, Roesslerstrasse 83, D 64293 Darmstadt, Germany
3
Department of Haematology, Specialist Haemostasis Unit, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge CB2 0QQ, UK
4
Faculty of Science and Technology, Middlesex University, The Burroughs, Hendon, London NW4 4BT, UK
*
Authors to whom correspondence should be addressed.
Int. J. Mol. Sci. 2021, 22(3), 1002; https://doi.org/10.3390/ijms22031002
Received: 22 December 2020 / Revised: 14 January 2021 / Accepted: 18 January 2021 / Published: 20 January 2021
(This article belongs to the Special Issue Fibrinogen/Fibrin, Factor XIII and Fibrinolysis in Diseases)
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® FXIII Activity, a functional ammonia release assay, and the HemosIL 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. View Full-Text
Keywords: automation; bleeding disorder; blood coagulation; clinical validation; diagnostic assay; factor XIII; isopeptidase; transglutaminase automation; bleeding disorder; blood coagulation; clinical validation; diagnostic assay; factor XIII; isopeptidase; transglutaminase
Show Figures

Figure 1

MDPI and ACS Style

Leitner, M.; Büchold, C.; Pasternack, R.; Binder, N.B.; Moore, G.W. Clinical Validation of an Automated Fluorogenic Factor XIII Activity Assay Based on Isopeptidase Activity. Int. J. Mol. Sci. 2021, 22, 1002. https://doi.org/10.3390/ijms22031002

AMA Style

Leitner M, Büchold C, Pasternack R, Binder NB, Moore GW. Clinical Validation of an Automated Fluorogenic Factor XIII Activity Assay Based on Isopeptidase Activity. International Journal of Molecular Sciences. 2021; 22(3):1002. https://doi.org/10.3390/ijms22031002

Chicago/Turabian Style

Leitner, Martina, Christian Büchold, Ralf Pasternack, Nikolaus B. Binder, and Gary W. Moore. 2021. "Clinical Validation of an Automated Fluorogenic Factor XIII Activity Assay Based on Isopeptidase Activity" International Journal of Molecular Sciences 22, no. 3: 1002. https://doi.org/10.3390/ijms22031002

Find Other Styles
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Back to TopTop