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Sources of variability in coagulation factor assays
S G Thompson1, J C Martin, T W Meade
1MRC Epidemiology, Northwick Park Hospital, Harrow, Middlesex, UK.
Thrombosis and Haemostasis
|December 18, 1987
Summary
This study quantifies variation in coagulation factor assays, finding significant inter-individual differences. These estimates are crucial for understanding arterial disease and designing future research on blood coagulation factors.
Area of Science:
- Hematology
- Clinical Chemistry
- Biostatistics
Background:
- Understanding biological variation is key for interpreting laboratory results.
- Coagulation factors are increasingly implicated in arterial disease pathogenesis.
- Limited data exists on the components of variation for coagulation assays.
Purpose of the Study:
- To estimate the components of variation for several coagulation factor assays.
- To compare these variations with other hematological and biochemical variables.
- To provide data for interpreting relationships and planning future studies.
Main Methods:
- Longitudinal study design with 14 volunteers.
- Bi-monthly blood sample collection over three years.
- Analysis of variance components for coagulation factor assays.
Main Results:
- Between-batch variation was a small component of total variation.
- Inter-individual variation ranged from 15% (antithrombin III) to 85% (cholesterol, hemoglobin).
- Factor VII activity and fibrinogen showed over 70% inter-individual variation.
Conclusions:
- Significant inter-individual variation exists for coagulation factors like factor VII and fibrinogen.
- These estimates are essential for accurate interpretation of coagulation data in arterial disease research.
- The findings inform sample size calculations for future clinical studies.