Accuracy of rapid blood coagulation testing device FibCare® in a tertiary emergency department.

Abstract

FibCare® is a novel point-of-care testing device enabling prompt evaluation of fibrinogen levels. This study aimed to investigate the accuracy of FibCare® at a tertiary emergency department. Blood specimens obtained at a tertiary emergency medical center between October 1, 2021, and April 30, 2023, were evaluated. The correlation between the fibrinogen levels assessed via FibCare® and those via the Clauss method was evaluated using the Spearman's test. The discrepancy between the two measurement methods was assessed according to fibrinogen level and diagnosis. A total of 177 specimens from 147 patients were eligible for the analysis. The median age of the patients was 49 years, and 109 (61.6%) were men. The two measurements had statistically significant but moderate correlation (p < 0.001, ρ = 0.76). FibCare® missed 14 out of 35 cases from patients with hypofibrinogenemia (fibrinogen ≤150 mg/dL assessed by the Clauss method). The discrepancy between the two measurements was significantly greater in specimens with lower fibrinogen levels and those obtained from patients following trauma. FibCare®, a novel point-of-care testing device, can be compatible with the Clauss method. However, clinicians should be aware of the risk that FibCare® may underestimate fibrinogen reduction, especially in severe cases and trauma cases.