Key result
The chromogenic ecarin assay demonstrated high linearity (R2=0.989) and accuracy (R2=0.985) for measuring dabigatran concentrations between 18 and 470 ng/mL.
Why the study?
Does the chromogenic ecarin assay reliably measure dabigatran concentrations compared to dilute thrombin time methods and mass spectrophotometry?
Does the chromogenic ecarin assay reliably measure dabigatran concentrations compared to dilute thrombin time methods and mass spectrophotometry?
The chromogenic ecarin assay provides a reliable and accurate method for quantifying dabigatran concentrations, which may aid in clinical management during suspected accumulation or bleeding.
May support dabigatran monitoring in bleeding or accumulation; leaves open prospective validation against reference methods.
BACKGROUND: Clinicians managing patients receiving the direct thrombin inhibitor dabigatran may benefit in being able to determine the amount of drug present in selected situations. This may include assessment of accumulation, concurrent drug interactions, or adequate removal from circulation. The ability to estimate the amount of dabigatran present using the chromogenic ecarin assay (ECA) requires further clarification. OBJECTIVE: To describe the reliability of dabigatran measurements using a chromogenic ECA. METHODS: This was an evaluation of the ECA method that incorporated assessment of imprecision, linearity, accuracy, carryover, and lower limits of detection or blank. Pooled normal plasma enriched with dabigatran at concentrations of 0, 25, 50, 75, 100, 125, 150, 200, 300, 400, and 500 ng/mL were sent blinded to 3 laboratories in the United States to compare our ECA results with those of laboratories reporting dilute thrombin time methods (HEMOCLOT thrombin inhibitor assay) for measuring dabigatran. Trough and peak levels from 35 patients were also compared with mass spectrophotometry for assessing ECA accuracy. RESULTS: The within-run or day-to-day imprecision was less than 10%, with high linearity (R (2) = 0.989) and high degree of accuracy (R (2) = 0.985; slope = 0.908) for levels ranging between 18 and 470 ng/mL and no carryover at 0 ng/mL noted. The ECA approach appeared to be more reliable at lower dabigatran concentrations. CONCLUSIONS: The chromogenic ECA appears to be an effective approach to determine the amount of dabigatran present. Further insights are necessary to determine how it can be used to reduce thromboembolic or bleeding complications in patients receiving dabigatran.
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Gosselin et al. (2013) studied Patients receiving dabigatran (n=35). Chromogenic ecarin assay (ECA) vs. Mass spectrophotometry and dilute thrombin time methods was evaluated on Imprecision, linearity, and accuracy of dabigatran measurements. The chromogenic ecarin assay demonstrated high linearity (R2=0.989) and accuracy (R2=0.985) for measuring dabigatran concentrations between 18 and 470 ng/mL.