Test Catalog

Test Id : FXCH

Coagulation Factor X Chromogenic Activity Assay, Plasma

Useful For
Suggests clinical disorders or settings where the test may be helpful

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).

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Chromogenic

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Factor X Chromogenic Activity Assay

Specimen Type
Describes the specimen type validated for testing

Plasma Na Cit

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

See Coagulation Guidelines for Specimen Handling and Processing in Special Instructions.

 

Patient Preparation: Fasting preferred

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

Submission Container/Tube: Polypropylene vial

Specimen Volume: 1 mL

Collection Instructions:

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

2. Freeze plasma immediately (no longer than 4 hours after collection) at -20 degrees C or, ideally, < or =-40 degrees 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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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).

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.

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 section in Coagulation Guidelines for Specimen Handling and Processing in Special Instructions.

Interpretation
Provides information to assist in interpretation of the test results

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.

Clinical Reference
Recommendations for 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

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

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 viper venom/calcium chloride reagent. The patient’s plasma factor X is activated in the presence of calcium by the activator Russell 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.,West Chester, OH, Rev 06/2006)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

85260

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
FXCH Factor X Chromogenic Activity Assay 33984-6
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
FXCH Factor X Chromogenic Activity Assay 33984-6

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports