Test Catalog

Test Id : F_9

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Coagulation Factor IX Activity Assay, Plasma

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Overview

Test Catalog

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

Diagnosing deficiencies, particularly hemophilia B (Christmas disease)

 

Assessing the impact of liver disease on hemostasis

 

Investigation of a prolonged activated partial thromboplastin time

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For information see Hemophilia Testing Algorithm

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 IX Assay, P

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

Factor IX Activity Assay

Hemophilia B

Factor IX

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For information see Hemophilia Testing Algorithm

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

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 deficiencies, particularly hemophilia B (Christmas disease)

 

Assessing the impact of liver disease on hemostasis

 

Investigation of a prolonged activated partial thromboplastin time

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For information see Hemophilia Testing Algorithm

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

Factor IX is a vitamin K-dependent serine protease synthesized in the liver and participates in the intrinsic coagulation pathway. Its biological half-life is 18 to 24 hours.

 

Congenital deficiency is inherited as an X-linked recessive bleeding disorder (hemophilia B). Severe deficiency (<1%) is characterized by hemarthroses, deep tissue bleeding, excessive bleeding with trauma, and ecchymoses.

 

Acquired deficiency is associated with liver disease, vitamin K deficiency, warfarin therapy, and inhibitors (rare).

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 =6 months: Normal, full-term newborn infants or healthy premature infants may have decreased levels (> or =20%), which may not reach adult levels for 180 or more days postnatal.* (Literature derived)

>6 months: 65-140%

*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 more common than congenital.

 

Mild hemophilia B: 5% to 50% activity

 

Moderate hemophilia B: 1% to 5% activity

 

Severe hemophilia B: <1% activity

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

Liver disease, warfarin therapy, or vitamin K deficiency may decrease factor IX levels.

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

1. Barrowcliffe TW, Raut S, Sands D, Hubbard AR. Coagulation and chromogenic assays of factor VIII activity: general aspects, standardization, and recommendations. Semin Thromb Hemost. 2002;28(3):247-256

2. Franchini M, Lippi G, Favaloro EJ. Acquired inhibitors of coagulation factors: part II. Semin Thromb Hemost. 2012;38(5):447-453

3. Carcao MD. The diagnosis and management of congenital hemophilia. Semin Thromb Hemost. 2012;38(7):727-734

4. 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 IX 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 IX-deficient substrate (normal plasma depleted of factor IX 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.

85250

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_9 Coag Factor IX Assay, P 3187-2
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_9 Coag Factor IX Assay, P 3187-2

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 | PHP Pdf | CMS 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