Related Experiment Video
Updated: May 13, 2026

The Nijmegen Hemostasis Assay: Simultaneous Fluorogenic Measurement of Thrombin and Plasmin Generation in a Single Well
Published on: February 27, 2026
Regulation in hemostasis and thrombosis: part I-in vitro diagnostics
Emmanuel J Favaloro1, Mario Plebani, Giuseppe Lippi
1Department of Haematology, Institute of Clinical Pathology and Medical Research ICPMR, Pathology West, Westmead Hospital, Westmead, New South Wales 2145, Australia. emmanuel.favaloro@swahs.health.nsw.gov.au
Abstract:
The diagnostic or test-performance process, as associated to the evaluation or diagnosis of hemostasis and thrombosis and related disorders, is influenced or controlled by the activity of a large number of professional, expert, and government organizations. These may be involved in driving standardization or harmonization, providing professional or expert guidelines, or in regulation of therapeutic products and diagnostic products such as in vitro diagnostic devices or reagents (IVDs). Although all organizations involved in this activity would propose an intention to drive improvements in diagnostics and human health and although there are benefits to the overall process of standardization and regulation for tests of hemostasis and thrombosis, it should also be recognized there are several specific problems and limitations to this process. As highlighted in this report, which specifically relates to the regulation of IVDs, several case studies are used as examples to show that regulation, aimed to reduce risks associated with the implementation of diagnostic testing, may instead encourage the adverse outcome of locking out clinically useful, new, and improved technologies and locking in old and outdated technologies. This has a potential for significant adverse outcomes related to the clinical diagnosis and management of hemostasis and thrombosis-related disorders.
Related Concept Videos
Anticoagulant Drugs: Low-Molecular-Weight Heparins
Extrinsic and Intrinsic Pathways of Hemostasis
The Extrinsic Pathway
The extrinsic pathway of coagulation is typically initiated by tissue damage that exposes blood to tissue factor (TF), a protein released by the damaged tissue cells outside the blood vessels—this interaction with TF triggers biochemical reactions involving specific clotting factors. The key player here is Factor VII, which forms a...
Introduction to Hemostasis
The three phases of hemostasis involve many clotting factors present in plasma and several substances released by platelets and injured tissue cells. It is a fast, localized, and...
Disorders of Hemostasis
Thromboembolic Disorders
Two factors primarily cause thromboembolic conditions.
Venous Thrombosis III: Interprofessional Care
Anticoagulant Drugs: Vitamin K Antagonists and Direct Oral Anticoagulants
Warfarin, a prominent vitamin K antagonist family member, exerts its effect by inhibiting the enzyme VKORC1 (vitamin K epoxide reductase complex 1). By hindering this enzyme, warfarin...

