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Test ID 9INHE Factor IX Inhibitor Evaluation, Plasma


Advisory Information


This test is for factor IX inhibitors only. If the presence or type of inhibitor is unknown, order APROL / Prolonged Clot Time Profile, Plasma first, except for when screening studies are needed for patients with known hemophilia A or B.



Shipping Instructions


Send all vials in the same shipping container.



Necessary Information


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

Specimen Required


Patient Preparation:

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

2. Fasting preferred

Specimen Type: Platelet-poor plasma

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

Submission Container/Tube: 3 Plastic vials

Specimen Volume: 3 mL in 3 plastic vials, each containing 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 in Special Instructions.

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

4. Aliquot plasma (1-2 mL per aliquot) into 3 separate plastic vials, 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, ≤-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.


Useful For

Detection and titering of coagulation inhibitor to the specific factor requested, primarily factor IX in patients with hemophilia B

 

This test is not useful for the detection of a lupus-like circulating anticoagulant inhibitor, a nonspecific circulating anticoagulant, or other inhibitors that are not specific for coagulation factors.

Profile Information

Test ID Reporting Name Available Separately Always Performed
9INHT FIX Inhib Profile Tech Interp No Yes
F_9 Coag Factor IX Assay, P Yes Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
9AINH FIX Inhib Profile Prof Interp No No
9BETH FIX Bethesda Units, P No No
F9_IS Factor IX Inhib Scrn No No

Testing Algorithm

Testing begins with coagulation factor IX activity assay with dilutions to evaluate assay inhibition; if the factor IX activity assay is normal or increased, then a technical interpretation will be provided.

 

If the factor IX activity assay is decreased, then an inhibitor screen will be performed at an additional charge to look for specific factor IX inhibition and a professional interpretation will be provided. If specific inhibition is apparent, the titer of the inhibitor will be determined.

Method Name

Optical Clot-Based

Reporting Name

Factor IX Inhib Profile, P

Specimen Type

Plasma Na Cit

Specimen Minimum Volume

2 mL plasma in 2 plastic vials, 1 mL each

Specimen Stability Information

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

Reference Values

FACTOR IX ACTIVITY ASSAY

Adults: 65-140%

Normal, full-term newborn infants or healthy premature infants may have decreased levels (≥20%), which may not reach adult levels for ≥180 days postnatal.*

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

Day(s) and Time(s) Performed

Monday through Friday

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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 U.S. Food and Drug Administration.

CPT Code Information

85390-Factor IX Tech Interp

85250-Factor IX activity assay

85335-Bethesda titer (if appropriate)

85335-Factor IX inhibitor screen (if appropriate)

85390-Factor IX Professional Interp (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
9INHE Factor IX Inhib Profile, P In Process

 

Result ID Test Result Name Result LOINC Value
9INHT FIX Inhib Profile Tech Interp 69049-5
F_9 Coag Factor IX Assay, P 3187-2

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.