This assay is highly sensitive and specific for inherited activated protein C (APC) resistance, most commonly due to the factor V Leiden mutation, but it will not detect patients with acquired APC resistance. Persons with acquired APC resistance are at similar risk for venous thromboembolism.
Preanalytical conditions of the patient and the blood specimen are extremely important for reliable performance and interpretation of testing for APC resistance. Plasmas demonstrating prolongation of clotting times (prothrombin time, activated partial thromboplastin time) for reasons other than anticoagulant effects (eg, lupuslike anticoagulants or specific coagulation factor inhibitors) generally cannot be reliably tested for the presence or absence of APC resistance. Proper preparation of the blood (plasma) specimen is extremely important to help insure accuracy of results and interpretation.
The activated protein C resistance ratio (APCRV) assay has greater than 99% sensitivity for detecting the presence of a factor V Leiden mutation. Discrepant results of plasma-based APCRV and DNA-based factor V Leiden testing may occur in recipients of liver or allogeneic hematopoietic stem cell transplants; or due to anticoagulant effects such as excess heparin; direct thrombin inhibitors argatroban (Acova), bivalirudin (Angiomax), or dabigatran (Pradaxa); or direct factor Xa inhibitors rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa); or a sample mix-up. Clinical correlation is suggested. If clinically indicated, consider follow-up repeat APCR testing or direct DNA-based testing for the factor V Leiden (R506Q) mutation (F5DNA / Factor V Leiden [R506Q] Mutation, Blood).