Test Catalog

Test Id : CH9

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Chromogenic 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

Monitoring coagulation factor replacement therapy of selected extended half-life coagulation factor replacements

 

Aiding in the diagnosis of hemophilia B using a 2-stage assay, especially when a 1-stage assay was normal

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

This assay is indicated in situations where there is a clinical suspicion of hemophilia B diagnosis, when the 1-stage assay is normal. However, this assay is also recommended for accurate classification of hemophilia B.

 

For more information see Hemophilia Testing Algorithm.

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

Chromogenic FIX, P

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

Chromogenic

Factor 9

Factor IX (rFIXFc)

Alprolix

Idelvion

Coagulation Factor IX (Recombinant), Fc Fusion Protein

Coagulation Factor IX (Recombinant), Albumin Fusion Protein

Coagulation Factor IX (Recombinant), glycoPEGylated

Extended Half-life

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

This assay is indicated in situations where there is a clinical suspicion of hemophilia B diagnosis, when the 1-stage assay is normal. However, this assay is also recommended for accurate classification of hemophilia B.

 

For more 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, ALBLD / Bleeding Diathesis Profile, Limited, Plasma is recommended.

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

Specimen Type: Platelet-poor plasma

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

Submission Container/Tube: Polypropylene vial preferred

Specimen Volume: 1 mL

Collection Instructions:

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

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

3. Aliquot plasma into a separate plastic vial leaving 0.25 mL in the bottom of centrifuged vial.

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

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 OK
Gross lipemia OK
Gross icterus OK

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

Monitoring coagulation factor replacement therapy of selected extended half-life coagulation factor replacements

 

Aiding in the diagnosis of hemophilia B using a 2-stage assay, especially when a 1-stage assay was normal

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

This assay is indicated in situations where there is a clinical suspicion of hemophilia B diagnosis, when the 1-stage assay is normal. However, this assay is also recommended for accurate classification of hemophilia B.

 

For more information see Hemophilia Testing Algorithm.

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

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

 

Typically, these patients are tested using a 1-stage clotting assay. However, new treatment options using long-acting glycoPEGylated replacement products are being approved for clinical use. Pharmacokinetic studies for these products indicate ideal monitoring of patients should be performed by the 2-stage chromogenic assay.

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.

65-140%

 

Chromogenic factor IX activity generally correlates with the one-stage FIX activity. In full term/premature neonates, infants, children, and adolescents the one-stage FIX activity* is similar to adults. However, no similar data for chromogenic FIX activity are available.(Appel IM, Grimminck B, Geerts J, Stigter R, Cnossen MH, Beishuizen A. Age dependency of coagulation parameters during childhood and puberty. J Thromb Haemost. 2012;10(11):2254-2263)

 

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

Interpretation
Provides information to assist in interpretation of the test results

Factor IX deficiency may be acquired (eg, vitamin K deficiency, warfarin anticoagulation effect, liver disease, or a consumptive coagulopathy) or congenital (hemophilia B).

 

Optimal laboratory monitoring of selected extended half-life factor IX replacement therapy (eg, glycoPEGylated factor FIX) may be achieved with the chromogenic factor IX assay. Elevated factor IX levels may be associated with acute or chronic inflammation, excess factor IX replacement therapy, or as a result of a rare genetic variant, factor IX Padua.

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

Excess heparin and dilution contamination due to improper specimen collection through an intravenous access device may result in artifactually decreased results.

 

The 1-stage and chromogenic factor IX (FIX) assay results should correlate in the normal population but may be discordant in the hemophilia population and when measuring factor replacement, especially with PEGylated recombinant FIX products.

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

1. Bowyer AE, Hillarp A, Ezban M, Persson P, Kitchen S. Measuring factor IX activity of noacog beta pegol with commercially available one-stage clotting and chromogenic assay kits: a two-center study. J Thromb Haemost. 2016;14(7 1428-1435. doi:10.1111/jth.13348

2. Kitchen S, Signer-Romero K, Key NS. Current laboratory practices in the diagnosis and management of haemophilia: a global assessment. Haemophilia. 2015;21(4)550-557

3. Sorensen MH, Anderson S, Ezban M. Factor IX-deficient plasma spiked with N9-GP behaves similarly to N9-GP post-administration clinical samples in N9-GP ELISA and FIX activity assays. Haemophilia. 2015;21(6):832-836

4. Dodt J, Hubbard AR, Wicks SJ, et al. Potency determination of factor VIII and factor IX for new product labelling and postinfusion testing: challenges for caregivers and regulators. Haemophilia. 2015;21(4):543-549

5. Wilmot HV, Hogwood J, Gray E. Recombinant factor IX: discrepancies between one-stage clotting and chromogenic assays. Haemophilia. 2014;20(6):891-897

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

The chromogenic factor IX assay is performed on the Instrumentation Laboratory ACL TOP Family using the Rossix ROX Factor IX kit. In this 2-stage assay, patient plasma is diluted and combined with reagents containing factors VIII, X, V, XIa, and II, fibrin inhibitor, calcium chloride, and phospholipids. The factor IX in the patient's plasma is activated to IXa, which then aids in the activation of factor X to factor Xa. After a specified incubation period, chromogenic substrate is added at which time, the factor Xa, present from the previous step, hydrolyzes the substrate into peptide and p-nitroaniline (pNA). The color produced by the release of pNA is measured photometrically at 405 nm and is proportional to the factor IX in the sample.(Package insert: ROX FACTOR IX kit. Rossix AB, Molndal, Sweden, Rev 04/2014)

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 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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It 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.

85130

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
CH9 Chromogenic FIX, P 88449-4
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.
CH9 Chromogenic FIX, P 88449-4

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