Abstract Number: PB0728
Meeting: ISTH 2020 Congress
Theme: Fibrinolysis and Proteolysis » Fibrinogen and Factor XIII
Background: Plasma transglutaminase FXIII confers mechanical and biochemical stability to blood clots. Congenital or acquired FXIII deficiency occurs rarely but activity levels ≤ 30% may be associated with severe bleeding, therefore careful patient monitoring is recommended. There are several assays for the manual determination of FXIII, however there is still an unmet diagnostic need for a reliable high-throughput assay.
Aims: The aim of the study was to demonstrate the performance characteristics of an automated FXIII activity assay which is suitable for use in routine laboratories.
Methods: The assay principle is based on the use of a highly sensitive fluorogenic substrate in combination with a thrombin reagent. FXIII is activated by thrombin. FXIIIa cleaves a dark quenching molecule from the side chain of a modified peptide incorporating glycine methyl ester. Subsequently, the fluorescence intensity of an N-terminal coupled dye increases and is detected by the automated coagulation analyser.
Results: Linearity was shown using SSCLOT5 reference plasma diluted in FXIII depleted plasma ranging from 0.026 IU/mL to 0.77 IU/mL with a correlation of R2≥0.95. Recovery of samples in this range was between 95% und 105%. Analytical sensitivity of the assay showed a LoD of 0.004 IU/mL and a LoQ at 0.009 IU/mL of FXIII activity. Inter assay variation was determined with samples of different activity levels on various time points and with multiple reagent lots. Observed precision for normal plasma (0.77 IU/mL) was ≤3% and for plasma in the medical decision range (≤0.3 IU/mL) was ≤5%. Comparison with a manual chromogenic assay for FXIII activity using samples covering the whole assay range gave both a regression (Passing and Bablok) and correlation of ≥0.95.
Conclusions: We have demonstrated in our performance study that this reliable and robust automated assay fulfils the current diagnostic need for the determination of FXIII deficiency.
To cite this abstract in AMA style:
Leitner M, Pasternack R, Büchold C, Binder NB. Performance of a New Automated FXIII Activity Assay [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/performance-of-a-new-automated-fxiii-activity-assay/. Accessed March 21, 2024.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/performance-of-a-new-automated-fxiii-activity-assay/