Comparison of Fibrinogen Concentrations Determined by the Clauss Method with Prothrombin-Derived Measurements on an Automated Coagulometer.

ABSTRACT

BACKGROUND: This research aims to compare fibrinogen results, obtained from the Clauss and PT-derived method on the Cobas t511 analyzer, in patients with specific categories of disease. A second aim was to determine the reference range for these 2 methods. METHODS: We retrospectively compared fibrinogen concentrations of 914 patients obtained by the Clauss and PT-derived methods on the Cobas t511 coagulation analyzer from the laboratory information system. Fibrinogen data was segregated into a healthy outpatient population and those populations with possible fibrinogen abnormalities including pregnancy, chronic illness, liver disease, heart and vascular diseases, and clinical suspicion of COVID-19. All data were analyzed using Passing-Bablok regression and Bland-Altman analysis. Reference ranges were determined from fibrinogen results of the healthy outpatient population who presented for a clinic check-up. RESULTS: All fibrinogen results were grouped and compared according to fibrinogen values (low, normal, and high), international normalized ratio (INR) values (<1.2, 1.2-2.0, and >2.0), and diagnosis. There were statistically significant positive correlations in all groups (P < 0.05), except for low fibrinogen values (P = 0.96). Results with INR value <1.2 had the highest correlation between 2 methods. CONCLUSION: The PT-derived method can be used alone in the Cobas t511 analyzer, especially in patients with an INR <1.2. Reported new reference ranges of the PT-derived method could help to determine and compare the clinical significance of fibrinogen methods. Further studies must be focused on the conditions in which PT-derived fibrinogen results should be directed to the Clauss test.