Measuring FVIII Activity and Thrombin Generation Simultaneously With a Novel Point of Care Platform (EnzySystem HemA): Qualitative Usability Evaluation.

ABSTRACT:

Background

Hemophilia A is an inherited bleeding disorder with an increased risk of excessive bleeding. People affected by hemophilia A with a severe bleeding phenotype are treated prophylactically with hemostatic agents. Monitoring treatment and adjusting it to the individual patient's needs is complicated by the scarcity of laboratories equipped to perform relevant coagulation assays and the absence of point-of-care testing platforms. A novel near-patient testing platform called the EnzySystem HemA aims to address this issue by measuring factor VIII (FVIII) activity and thrombin generation within 1 hour of 100 µL of whole blood.

Objective

This study assessed the usability of the EnzySystem HemA by health care professionals without prior training and gathered information on

SUBMITTER: Bavinck A 

PROVIDER: S-EPMC12530449 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature