Test Catalog

Test Id : F_11

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Coagulation Factor XI Activity Assay, Plasma

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Overview

Test Catalog

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

Diagnosing deficiency of coagulation factor XI

 

Investigating prolonged activated partial thromboplastin time

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

Optical Clot-Based

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

Coag Factor XI Assay, P

Aliases
Lists additional common names for a test, as an aid in searching

Factor XI Activity Assay

F11

Factor XI

Specimen Type
Describes the specimen type validated for testing

Plasma Na Cit

Ordering Guidance

Coagulation testing is highly complex, often requiring the performance of multiple assays and correlation with clinical information. For that reason, consider ordering a Coagulation Consultation.

Necessary Information

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

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

Specimen Type: Platelet-poor plasma

Patient Preparation: Patient must not be receiving Coumadin (warfarin) or heparin therapy.

Collection Container/Tube: Light-blue top (3.2% sodium citrate)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Specimen must be collected prior to factor replacement therapy.

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

3. Centrifuge, transfer all plasma into a plastic vial, and centrifuge plasma again.

4. Aliquot plasma into a plastic vial, leaving 0.25 mL in the bottom of centrifuged vial.

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

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. The minimum volume is sufficient for one attempt at testing.

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 14 days

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

Diagnosing deficiency of coagulation factor XI

 

Investigating prolonged activated partial thromboplastin time

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Factor XI is synthesized in the liver. Its biological half-life is 60 to 80 hours. Factor XI is a component of intrinsic coagulation pathway and, when activated, activates factor IX to IXa.

 

Factor XI deficiency may cause prolonged partial thromboplastin time. Deficiency is associated with mild bleeding diathesis, but there is poor correlation between activity level and clinical bleeding. A relatively high incidence of congenital deficiency occurs among individuals of Ashkenazi Jewish descent (hemophilia C).

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.

Adults: 55-150%

Normal, full-term newborn infants or healthy premature infants may have decreased levels (> or =10%), which may not reach adult levels for 180 or more days postnatal.*

*See Pediatric Hemostasis References section in Coagulation Guidelines for Specimen Handling and Processing.

Interpretation
Provides information to assist in interpretation of the test results

Acquired deficiency is associated with liver disease and rarely inhibitors.

 

Patients who are homozygous: <20% activity

 

Patients who are heterozygous: 20% to 60% activity

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Decreased plasma levels of factor XI do not correlate well with bleeding risk.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. He R, Chen D, He S. Factor XI: hemostasis, thrombosis, and antithrombosis. Thromb Res. 2012;129(5):541-550

2. Martin-Salces M, Jimenez-Yuste V, Alvarez MT, Quintana M, Hernandez-Navarro F. Review: Factor XI deficiency: review and management in pregnant women. Clin Appl Thromb Hemost. 2010;16(2):209-213

3. Seligsohn U. Factor XI in haemostasis and thrombosis: past, present and future. Thromb Haemost. 2007;98(1):84-89

4. Santoro R, Prejano S, Iannaccaro P. Factor XI deficiency: a description of 34 cases and literature review. Blood Coagul Fibrinolysis. 2011;22(5):431-435

5. Favaloro EJ, Lippi G, eds. Hemostasis and Thrombosis: Methods and Protocols. Humana Press; 2017

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

The factor XI assay is performed on the Instrumentation Laboratory ACL TOP using the activated partial thromboplastin time (aPTT) method and a factor-deficient substrate. Patient plasma is combined and incubated with a factor XI-deficient substrate (normal plasma depleted of factor XI by immunoadsorption) and an aPTT reagent. After a specified incubation time, calcium is added to trigger the coagulation process in the mixture. Then the time to clot formation is measured optically at a wavelength of 671 nm.(Owen CA Jr, Bowie EJW, Thompson JH Jr. Diagnosis of Bleeding Disorders. 2nd ed. Little, Brown and Company; 1975; Cielsa B. Defects of plasma clotting factors. In: Hematology in Practice. 3rd ed. FA Davis; 2019:chap 17)

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 Saturday

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 account representative. 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.

85270

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
F_11 Coag Factor XI Assay, P 3226-8
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.
F_11 Coag Factor XI Assay, P 3226-8

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