Coagulation Factor X Chromogenic Activity Assay, Plasma
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
The antithrombotic effect of oral vitamin K antagonists (eg, warfarin) is mediated by reduction in the plasma activity of vitamin K-dependent procoagulant factors II (prothrombin) and X. The intensity of oral anticoagulation therapy with vitamin K antagonists must be monitored and adjusted to a narrow therapeutic range; undermedicating increases the risk of thrombosis, while overmedicating increases the risk of bleeding. Such therapy typically is monitored with the prothrombin time/international normalized ratio (INR) system.
Lupus anticoagulants (LAC) are autoantibodies that interfere with phospholipid-dependent clotting tests and most commonly cause prolongation of the activated partial thromboplastin time (APTT). LAC can be associated with a prothrombotic disorder termed the antiphospholipid syndrome. LAC occasionally may cause prolongation of the baseline prothrombin time, rendering the INR system inaccurate for monitoring the intensity of oral anticoagulant therapy. LAC-induced prolongation of the prothrombin time is most commonly seen with recombinant human tissue factor thromboplastins (ie, prothrombin time reagents) with a low international sensitivity index (ISI) such as Innovin or RecombiPlasTin 2G (ISI = 1.0). The chromogenic factor X activity is an alternative assay for monitoring oral anticoagulant therapy. This assay is unaffected by LAC because the assay end point is not a phospholipid-dependent clotting time.
Argatroban is a parenteral direct thrombin inhibitor that is approved for treatment of heparin-induced thrombocytopenia (HIT), an antibody-mediated prothrombotic disorder. Argatroban therapy prolongs the prothrombin time, which also renders the INR inaccurate for monitoring the warfarin effect while transitioning from Argatroban to oral anticoagulant therapy. The chromogenic coagulation factor X activity assay may be used as an alternative to the INR for monitoring and adjusting the warfarin dose during this transition.
Monitoring warfarin anticoagulant therapy, especially in patients whose plasma contains lupus anticoagulants that interfere with baseline prothrombin time/international normalized ratio and in patients receiving the drug Argatroban who are being transitioned to warfarin
A chromogenic factor X activity of approximately 20% to 40% corresponds to the usual warfarin international normalized ratio range (ie, 2.0-3.0).
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Liver disease and vitamin K deficiency may lower factor X levels. If factor X deficiency is suspected, order F_10 / Coagulation Factor X Activity Assay, Plasma.
This assay should not be used for monitoring heparin, or oral direct factor Xa inhibitors such as rivaroxaban (Xarelto), apixaban (Eliquis)or edoxaban (Savaysa).
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
> or =18 years of age: 60%-140%
Chromogenic Factor X activity generally correlates with the one-stage factor X activity. In full term or premature neonates, infants, and children, the one-stage factor X activity* is lower than adult reference range and progressively rises to the adult reference range by adolescence. However, no similar data for the chromogenic factor X activity have been published.
*See Pediatric Hemostasis References in Coagulation Studies in Special Instructions.
Clinical References Provides recommendations for further in-depth reading of a clinical nature
1. Austin JH, Stearns CR, Winkler AM, et al: Use of the chromogenic factor X assay in patients transitioning from Argatroban to warfarin therapy. Pharmacotherapy 2012;32(6):493-501
2. McGlasson DL, Romick BG, Rubal BJ: Comparison of a chromogenic factor x assay with international normalized ratio for monitoring oral anticoagulation therapy. Blood Coagul Fibrinolysis 2008;19:513-517
3. Moll S, Ortel TL: Monitoring warfarin therapy in patients with lupus anticoagulants. Ann Intern Med 1997;127:177-185
4. Robert A, Le Querrec A, Delahousse B, et al: Control of oral anticoagulation in patients with antiphospholipid syndrome--influence of the lupus anticoagulant on International Normalized Ratio. Thromb Haemost 1998;80:99-103