Resolving Bivalirudin Interference on Fibrinogen Testing by the Use of Activated Carbon
Methodology / laboratory published in J Clin Lab Anal (2026)
Abstract
BACKGROUND: Direct thrombin inhibitors may lead to falsely low fibrinogen results. The interference of bivalirudin on fibrinogen assays has not been thoroughly evaluated. This study investigates the interference of bivalirudin on fibrinogen detection and the potential use of activated carbon to address this issue. METHODS: Normal pooled plasma from 20 healthy subjects was spiked with increasing bivalirudin concentrations (0-6.4 μg/mL). Interference of bivalirudin on fibrinogen testing was evaluated by comparing three Clauss-method assays (HemosIL Fibrinogen-C XL; STA-Fibrinogen; Dade Thrombin) to an immunoassay (N Antiserum to Human Fibrinogen reagent, NAHF). Activated partial thromboplastin time (APTT) and fibrinogen results were analyzed before and after the addition of activated carbon (AC) to evaluate the absorption of bivalirudin by AC. RESULTS: The NAHF immunoassay remained unaffected by bivalirudin (p = 0.27). All three Clauss-methods assays showed a significant downward trend with the increase of bivalirudin concentration (STA-Fibrinogen: p = 0.012, Dade Thrombin: p < 0.001, Fibrinogen-C XL: p < 0.001). When compared to their respective baselines, STA-Fibrinogen exhibited a reduction of 16%, Dade Thrombin showed a reduction of 40%, and Fibrinogen-C XL displayed a decrease of up to 89%. Neither STA-Fibrinogen nor Dade Thrombin displayed a significant downward trend when the APTT ratio did not exceed 2.5. After the addition of AC, SynthASil APTT and HemosIL Fibrinogen-C XL levels of all samples containing varying concentrations of bivalirudin returned to near baseline. CONCLUSION: The influences of bivalirudin on fibrinogen assays vary significantly. Activated carbon can effectively remove bivalirudin from plasma, thereby eliminating its interference on fibrinogen testing.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
Laboratory methods paper resolving the pre-analytical interference of bivalirudin (a leech-derived direct thrombin inhibitor) with fibrinogen assays using activated-carbon pretreatment, allowing accurate hemostasis monitoring on therapy.
Por qué esto importa para la hirudoterapia
Este estudio investigó la interferencia de la bivalirudina en las pruebas de fibrinógeno utilizando plasma agrupado de 20 sujetos sanos enriquecido con concentraciones crecientes de bivalirudina (0–6,4 μg/mL), encontrando que los tres ensayos basados en el método de Clauss mostraron resultados de fibrinógeno falsamente bajos (reducciones del 16–89 %), mientras que un inmunoensayo no se vio afectado. El carbón activado eliminó eficazmente la bivalirudina del plasma, restaurando valores de APTT y fibrinógeno cercanos a los basales. El resumen no menciona en ningún momento la hirudina, las sanguijuelas ni la terapia con sanguijuelas, y no se puede establecer ninguna conexión defendible con la hirudoterapia o con el secretoma de la sanguijuela a partir de este texto. Por tanto, este estudio no es relevante para el dominio de ASH.
Citación
Resolving Bivalirudin Interference on Fibrinogen Testing by the Use of Activated Carbon.
Du J et al. · Journal of clinical laboratory analysis, 2026
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026