Abstract Number: PB0666
Meeting: ISTH 2020 Congress
Background: In Clauss fibrinogen assay excess thrombin is added to the plasma to measure the time until clot is formed and convert it to the concentration of fibrinogen in comparison with the standard. Clauss assay generally shows a good agreement with antigen testing, but the presence of thrombin inhibitors such as heparin affects the outcome. In addition, in the aspect of reagent stability and standardization thrombin reagent has limitations. Recently, we developed a new fibrinogen assay reagent using recombinant batroxobin.
Aims: We evaluated the performance of the new fibrinogen assay reagent using recombinant batroxobin, ANYFIB.C (NC bit Inc., Seongnam, Korea).
Methods: ANYFIB.C (NC bit Inc.) reagent was evaluated for its precision, lower detection limit, interference, and stability and compared to HemosIL fibrinogen-C for clinical samples using ACL TOP 700 coagulation analyzer (Instrumentation Laboratory, Lexington, MA, USA).
Results: Within-run, between-run, and total coefficients of variation for ANYFIB.C were 1.14%, 0.07%, and 4.62% at the low level (mean, 71.4 mg/dL), respectively, 0.60%, 1.40%, and 3.59% at the mid-level (mean, 292.4 mg/dL), respectively, and 0.73%, 0.96%, and 4.29% at the high level (mean, 561.2 mg/dL), respectively. Lower detection limit was measured to be 46.4 mg/dL as the mean value of 20 repeated measurements. The presence of hemoglobin 500 mg/dL, bilirubin 40 mg/dL, or heparin 10U/mL in a specimen did not affect the fibrinogen concentration. Lot 1 and 2 ANYFIB.C reagents were shown to be stable keeping their activity at least more than one week in room temperature. Regression analysis between ANYFIB.C and HemosIL fibrinogen-C showed an excellent correlation (R2=0.991).
Conclusions: A new fibrinogen assay reagent, NCbit ANYFIB.C is considered to replace Clauss assay fibrinogen reagents.
To cite this abstract in AMA style:
Park R, Song J. Performance Evaluation of a New Fibrinogen Assay Reagent Using Recombinant batroxobin [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/performance-evaluation-of-a-new-fibrinogen-assay-reagent-using-recombinant-batroxobin/. Accessed March 21, 2024.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/performance-evaluation-of-a-new-fibrinogen-assay-reagent-using-recombinant-batroxobin/