ProC Global: the first functional screening assay for the complete protein C pathway

Area of Science:

• Hematology
• Clinical Coagulation
• Thrombophilia Diagnostics

Background:

• Venous thromboembolic complications are more prevalent than bleeding disorders.
• Hereditary thrombophilia often involves protein C pathway abnormalities like factor V Leiden mutation or deficiencies in protein C or S.
• Acquired protein C system dysfunctions also elevate thrombotic risk.

Purpose of the Study:

• To evaluate a new functional screening assay, ProC Global, for monitoring the protein C pathway.
• To assess the utility of ProC Global in detecting factor V Leiden, protein C deficiency, and protein S deficiency.
• To determine if ProC Global can provide a quantitative measure of protein C pathway function relative to the procoagulant system.

Main Methods:

• Evaluation of the ProC Global assay's performance.
• Assessment of sensitivity for activated protein C resistance/factor V Leiden.
• Assessment of sensitivity for protein C and protein S deficiencies.

Main Results:

• ProC Global demonstrated 100% sensitivity for activated protein C resistance/factor V Leiden.
• The assay showed 90% sensitivity for protein C deficiency and 63% sensitivity for protein S deficiency.
• The assay provides a quantitative measure of the protein C pathway's net potential.

Conclusions:

• ProC Global is a highly sensitive screening test for key thrombophilia abnormalities.
• The assay can facilitate the detection of factor V Leiden, protein C, and protein S deficiencies.
• Further studies are investigating the use of ProC Global for prospective thromboembolic risk assessment.