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Test ID F_11 Coagulation Factor XI Activity Assay, Plasma

Reporting Name

Coag Factor XI Assay, P

Useful For

Diagnosing deficiency of coagulation factor XI

 

Investigating prolonged activated partial thromboplastin time

Specimen Type

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


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° 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.


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

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

Reference Values

Adults: 55-150%

Normal, full-term newborn infants or healthy premature infants may have decreased levels (≥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.

Day(s) Performed

Monday through Saturday

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.

CPT Code Information

85270

Clinical Information

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).

Interpretation

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

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

Clinical Reference

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

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)

Report Available

1 to 3 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

NY State Approved

Yes

Method Name

Optical Clot-Based