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Test Code FXCH Coagulation Factor X Chromogenic Activity Assay, Plasma

Reporting Name

Factor X Chromogenic Activity Assay

Useful For

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

 

This assay should not be used for monitoring heparin, or oral direct factor Xa inhibitors such as rivaroxaban (Xarelto), apixaban (Eliquis), or edoxaban (Savaysa).

Method Name

Chromogenic

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Plasma Na Cit


Specimen Required


Patient Preparation: Fasting preferred

Collection Container/Tube: Light-blue top (citrate)

Submission Container/Tube: Polypropylene vial

Specimen Volume: 1 mL

Collection Instructions:

1. For complete instructions see Coagulation Guidelines for Specimen Handling and Processing

2. Spin down, remove plasma, and spin plasma again.

3. Freeze plasma immediately (no longer than 4 hours after collection) at -20° C or, ideally, at or below -40° C.

Additional Information:

1. Double-centrifuged specimen is critical for accurate results as platelet contamination may cause spurious results.

2. Each coagulation assay requested should have its own vial.

3. If priority specimen, mark request form, give reason, and request a call-back.


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma Na Cit Frozen 14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Reference Values

≥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 section in Coagulation Guidelines for Specimen Handling and Processing.

Day(s) Performed

Monday through Friday

CPT Code Information

85260

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FXCH Factor X Chromogenic Activity Assay 33984-6

 

Result ID Test Result Name Result LOINC Value
FXCH Factor X Chromogenic Activity Assay 33984-6

Clinical Information

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; under medicating 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.

Interpretation

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

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.

Method Description

The chromogenic factor X assay is performed on the Instrumentation Laboratory ACL TOP. In this 2-stage assay, an incubated dilution of the patient's plasma is combined in equal volumes with a chromogenic substrate and a Russell's viper venom/calcium chloride reagent. The patient's plasma factor X is activated in the presence of calcium by the activator Russell's viper venom, which then hydrolyzes the chromogenic substrate creating 2 products, peptide and pNA (paranitroaniline). The pNA is then measured at 405 nm and is proportional to the amount of factor X in the patient's plasma.(Package insert: Diapharma Factor X Kit. DiaPharma Group, Inc., Rev 06/2006)

Report Available

1 to 3 days

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.