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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.

Insights

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.

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