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Updated: Jun 27, 2026

The Nijmegen Hemostasis Assay: Simultaneous Fluorogenic Measurement of Thrombin and Plasmin Generation in a Single Well
Published on: February 27, 2026
Biological variation in tests of hemostasis.
Giuseppe Banfi1, Massimo Del Fabbro
1IRCCS Galeazzi, Milano, Italy. Banfi1@unimi.it
Understanding biological variation in hemostasis tests is key. Low variability in coagulation tests contrasts with high variability in fibrinolysis, impacting clinical interpretation and preoperative screening.
Area of Science:
- Clinical Biochemistry
- Hematology
- Laboratory Medicine
Background:
- Biological variability comprises interindividual and intraindividual components.
- Analysis of biological variation is essential for defining critical differences in laboratory results.
- Existing data on hemostasis test biological variation are outdated.
Purpose of the Study:
- To update and confirm biological variation data for hemostasis tests using modern automated methods.
- To assess the impact of biological variation on preoperative coagulation screening.
- To provide updated reference ranges for interpreting hemostasis parameters.
Main Methods:
- Utilized modern, fully automated analytical platforms.
- Quantified interindividual and intraindividual variability for various hemostasis parameters.
- Calculated the index of individuality to assess the influence of different variability components.
Main Results:
- Coagulation screening tests (prothrombin time, activated partial thromboplastin time) exhibit low biological variation.
- Thrombin time demonstrates very low within- and between-subject variability.
- Fibrinolytic parameters (PAI-1, fibrinopeptide A) show high biological variability.
- Index of individuality indicates preoperative screening is influenced by interindividual variability.
Conclusions:
- Updated biological variation data for hemostasis tests are now available.
- High variability in fibrinolytic parameters necessitates careful clinical interpretation.
- Interindividual variability significantly influences preoperative coagulation screening outcomes.
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