Chromogenic FVIII Inhibitor Profile

Test Code

11871

CPT Codes
85130, 85335, 85390<br>Limited Access Code

Preferred Specimen

2 mL serum collected in a 3.2% sodium citrate (light blue-top) tube - See Instructions

Minimum Volume

1 mL

Instructions

1.) Specimen must be collected prior to factor replacement therapy.
2.) If collecting sample through a port/line, be sure to waste the appropriate amount prior to collection.
3.) For complete instructions, see Coagulation Guidelines for Specimen Handling and Processing in Special Instructions.
4.) Centrifuge, transfer all plasma into a plastic vial, and centrifuge plasma again.
5.) Aliquot plasma (1 mL per aliquot) into 2 separate plastic vials leaving 0.25 mL in the bottom of centrifuged vial.
6.) 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.

Shipping Instructions: Send all vials in the same shipping container.

Transport Container

Plastic vials (x2)

Transport Temperature

Frozen

Specimen Stability

Room temperature: Not acceptable
Refrigerated: Not acceptable
Frozen: 14 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Gross hemolysis; Gross lipemia; Gross icterus; IV heparin contamination

Methodology
Chromogenic

FDA Status
This test was developed and its performance characteristics 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.

Setup Schedule

Set up: Mon-Fri; Report available: 2-3 days

Reference Range

See Laboratory Report

Clinical Significance

Factor VIII (FVIII) inhibitors are IgG antibodies directed against coagulation FVIII that typically result in development of potentially life-threatening hemorrhage. These antibodies may be alloimmune: developing in patients with congenital FVIII deficiency (hemophilia A) in response to therapeutic infusions of factor VIII concentrate or autoimmune: occurring in patients without hemophilia (not previously factor VIII deficient) either spontaneously, during pregnancy, or in association with autoimmune diseases.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.