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Updated: Jun 22, 2026
12:43
On-Chip Endothelial Inflammatory Phenotyping
Published on: July 21, 2012
Biological variation in inflammatory and hemostatic markers
G Rudez1, P Meijer, H M H Spronk
1Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Journal of Thrombosis and Haemostasis : JTH
|July 2, 2009
Summary
Understanding biological variation in inflammatory and hemostatic markers is key. This study determined optimal measurements for fibrinogen, CRP, and others, providing crucial data for assay quality specifications.
Area of Science:
- Clinical Chemistry
- Hematology
- Immunology
Background:
- Biological variation, the natural change in analyte concentrations within an individual over time, influences inflammatory and hemostatic markers.
- Understanding this variability is crucial for accurate interpretation of diagnostic and monitoring tests.
Purpose of the Study:
- To determine the number of repeated measurements required to establish an individual's true habitual concentration for key markers.
- To define recommended analytical imprecision, bias, and assess the contribution of analytical imprecision to overall test result variability.
- To investigate the index of individuality, reference change value, and seasonal variation for selected markers.
Main Methods:
- Collected 520 blood samples from 40 healthy individuals over one year.
- Assessed between-subject, within-subject, and seasonal variation for fibrinogen, C-reactive protein (CRP), platelet aggregation, thrombin generation, and prothrombin time (PT).
Main Results:
- One to two measurements sufficed for most markers, but 4+ for platelet aggregation and 9+ for thrombin generation were needed.
- Recommended analytical CVs for diagnosis ranged from 4%-27% (except CRP at 77.7%), with monitoring CVs being ~3% lower.
- Seasonal variation impacted fibrinogen and thrombin generation, explaining ~11% of their total variability.
Conclusions:
- This research offers critical insights into the biological variability of inflammatory and hemostatic markers.
- Findings aid in calculating appropriate sample sizes for studies.
- Provides data for establishing robust analytical quality specifications for laboratory assays.
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