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Anticoagulant response to activated protein C: method validation and assay comparison
T Calkins1, J Greengard, J H Griffin
1Scripps Reference Laboratory, San Diego, CA 92121, USA.
Journal of Clinical Laboratory Analysis
|January 1, 1995
Summary
Activated protein C (APC) resistance, a common issue in thrombophilia, is often due to factor V mutations. This study validated an assay for APC resistance, finding differences in response based on sex and age.
Area of Science:
- Biochemistry
- Hematology
- Clinical Diagnostics
Background:
- Activated protein C (APC) resistance affects 20-60% of thrombophilic patients.
- The common cause is the factor V Arg506Gln mutation, confirmed by DNA sequencing.
- Understanding APC resistance is crucial for diagnosing thrombotic disorders.
Purpose of the Study:
- To validate an in-house assay for detecting APC resistance.
- To compare the in-house assay with a commercial kit.
- To investigate demographic differences in APC response.
Main Methods:
- Validated an in-house assay for APC resistance at Scripps Reference Laboratory (SRL).
- Studied 80 healthy subjects (40 males, 40 females, aged 21-60).
- Compared SRL assay results with a commercial kit (Chromogenix, Coatest).
Main Results:
- Significant differences in APC response were observed between adult males and females.
- APC response increased with age in normal individuals.
- The SRL assay showed a greater difference in normal ranges between sexes compared to the commercial kit.
- 44% of thrombophilic patients were identified as APC-resistant.
- Individuals with the factor V Arg506Gln mutation showed low APC response in both assays.
Conclusions:
- The validated SRL assay effectively identifies APC resistance.
- Demographic factors like sex and age influence APC response.
- APC resistance testing aids in diagnosing thrombosis and assessing familial risk.