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Establishing a reference range for thrombin generation using a standard plasma significantly improves assay
1Department of Haematology, Glasgow Royal Infirmary, Glasgow, UK.
Thrombosis Research
|May 10, 2015
Summary
Standardizing thrombin generation assays is crucial for clinical use. Establishing a reference range for NIBSC reference plasma (TGT-RP) as an internal quality control (IQC) significantly reduces inter-assay variability, ensuring accurate results.
Area of Science:
- Coagulation science
- Clinical diagnostics
- Biomedical assay development
Background:
- Thrombin generation assays are effective for assessing plasma coagulation potential.
- Standardization is required for routine clinical adoption of these assays.
Purpose of the Study:
- To establish a reference range for NIBSC reference plasma (TGT-RP).
- To implement TGT-RP as an internal quality control (IQC) for thrombin generation assays.
Main Methods:
- Measured thrombin generation in TGT-RP across 153 experiments under 4 conditions (1 pM or 5 pM tissue factor +/- thrombomodulin).
- Calculated an acceptance range (+/- 2 SD) for TGT-RP.
- Tested healthy volunteer plasma, using TGT-RP for normalization and result exclusion.
Main Results:
- Established acceptance ranges for TGT-RP under all tested conditions.
- Normalizing results from a healthy volunteer significantly reduced inter-assay variability (ETP, Peak).
- Excluding results when TGT-RP fell outside the acceptance range also significantly reduced inter-assay variability for raw data.
Conclusions:
- This study advances the standardization of thrombin generation assays.
- Implementing an IQC with a reference range improves accuracy and reproducibility.
- The established IQC allows for reporting of raw data while ensuring data quality.
