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ProC Global: the first functional screening assay for the complete protein C pathway
Insights
A new screening test, ProC Global, effectively detects hereditary thrombophilia, including factor V Leiden mutation and deficiencies in protein C or S. This assay aids in assessing thrombotic risk, complementing existing coagulation tests.
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.
Abstract:
In clinical practice, venous thromboembolic complications are much more frequent than bleeding disorders. In fact, disturbances within the protein C pathway due to coagulation factor V (FV) Leiden mutation and deficiency of protein C or protein S are the most frequent abnormalities in hereditary thrombophilia. Furthermore, acquired dysfunctions of the protein C system may predispose the single individual to an increased thrombotic risk. A routine-suited screening assay that would allow the monitoring of the proper interplay of factors in the protein C pathway could add an important factor to the basic coagulation profile. This consists of the prothrombin time and of the activated partial thromboplastin time, which currently allow only a screening for increased risk for bleeding but not for venous thromboembolism. A new functional screening test for the protein C system such as the presented ProC Global should therefore facilitate detection of FV Leiden as well as deficiency of protein C and protein S. The results of the present evaluation indicate that ProC Global is highly sensitive to activated protein C resistance/FV Leiden (100%) and protein C deficiency (90%) and sensitive to protein S deficiency (63%). Furthermore, the assay gives a quantitative measure of the net potential of the protein C pathway in relation to the intrinsic procoagulant system. The use of this assay for a prospective assessment of thromboembolic risk is the subject of current studies.