Rapid Fibrinogen Assessment With the qLabs FIB Point-of-Care System: Results From a Multicenter Clinical Validation Study.

Abstract

Background: Acquired hypofibrinogenemia is frequently associated with major bleeding and requires prompt correction. Rapid and accurate quantification of fibrinogen is essential to guide hemostatic therapy and improve patient outcomes. The qLabs FIB system provides fibrinogen results within minutes at the bedside, supporting timely diagnostic assessment and therapeutic decision-making. This study aimed to validate the device analytical performance in a prospective, observational, multicenter setting by comparing whole-blood qLabs FIB results with lab-based plasma fibrinogen.

Methods: Fibrinogen concentrations from 463 citrated whole-blood samples were measured in parallel using the qLabs FIB and the Clauss method across 8 clinical sites.

Results: Overall, a strong correlation was observed between the qLabs FIB and the Clauss laboratory method (r = 0.94). The median of relative differences did not differ significantly between clinical sites. Receiver operating characteristic analysis showed sensitivities and specificities in the 90% range for identifying fibrinogen concentrations below the clinical decision thresholds of 1.5 and 2.0 g/L.

Conclusion: This study demonstrated a strong agreement of the qLabs FIB to the standard Clauss assay while providing rapid, near-patient fibrinogen measurements. This multicenter study confirms the initial performance of the system from a larger number of samples. The integration of qLabs FIB testing into routine clinical practice could support earlier, more targeted hemostatic interventions, thereby improving the safety and effectiveness of bleeding management.