A bicentric pilot study of apixaban and rivaroxaban quantification using a novel Point-Of-Care system in the emergency department
Year: 2026
Type: article
Abstract: BackgroundDirect Oral AntiCoagulants (DOAC) do not require routine monitoring; however, rapid assessment of drug concentrations may be needed in critical situations. Laboratory-based anti-Xa assays are recommended but are not consistently available with turnaround-times compatible with emergency care.ObjectivesTo evaluate analytical performance, agreement at clinical thresholds, precision, and turnaround-time of a whole-blood point-of-care (POC) system for measuring apixaban and rivaroxaban.MethodsA preliminary laboratory study and a prospective bicentric pilot study in emergency departments were performed on DOAC treated patients. Paired samples were analyzed using the POC system and a laboratory anti-Xa assay (STA-R® Max3). Agreement within the analytical measuring range (23–200 ng/mL) was assessed using Passing–Bablok regression and Bland–Altman analysis. Concordance at 30, 50, and 100 ng/mL was evaluated using Cohen’s kappa (κ) and prevalence and bias-adjusted kappa (PABAK). Precision and time-to-result were also assessed.ResultsExcellent agreement was observed in both the preliminary laboratory study (r = 0.978, slope = 0.994, median bias = −5.5 ng/mL) and the ER study in the 69 analyzed patients (r = 0.965, slope = 1.013, median bias = −10.5 ng/mL). Agreement increased with higher cut-offs (κ: 0.62, 0.89, 0.94; PABAK: 0.83, 0.89, 0.94 at 30, 50, and 100 ng/mL). Precision was acceptable (SD ≤ 6 ng/mL; CV < 6%). Median time-to-result was shorter with the POC (14 min vs 73 min).ConclusionsThe POC system shows a high level of agreement with a laboratory anti-Xa assay and reduced turnaround time, supporting its potential use in the emergency setting.
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,250
OpenAlex ID: W7221802342