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HelpTest Code LAB15668 Coagulation Factor VIII Activity Assay, Plasma
Reporting Name
Coag Factor VIII Activity Assay, PUseful For
Diagnosing hemophilia A
Diagnosing von Willebrand disease when measured with the von Willebrand factor (VWF) antigen and VWF activity
Diagnosing acquired deficiency states
Investigation of prolonged activated partial thromboplastin time
Monitoring infusions of factor VIII replacement during interventional procedures and prophylactic infusions
This test is not useful for inferring carrier status in suspected female carriers of hemophilia A, unless it is 50% of normal (<28% activity in adults).
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
Plasma Na CitOrdering 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 |
Special Instructions
Reference Values
Adults: 55-200%
Normal, full-term newborn infants or healthy premature infants typically have levels greater than or equal to 40%.*
*See Pediatric Hemostasis References 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
85240
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| F8A | Coag Factor VIII Activity Assay, P | 3209-4 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| F8A | Coag Factor VIII Activity Assay, P | 3209-4 |
Clinical Information
Factor VIII is synthesized in the liver and, perhaps, in other tissues. It is a coagulation cofactor that circulates bound to von Willebrand factor and is part of the intrinsic coagulation pathway. The biological half-life is 9 to 18 hours (average is 12 hours).
Congenital factor VIII deficiency is the cause of hemophilia A, which has an incidence of 1 in 10,000 and is inherited in a recessive sex-linked manner on the X chromosome. Severe deficiency (<1%) characteristically demonstrates as hemarthrosis, deep-tissue bleeding, excessive bleeding with trauma, and ecchymoses.
Factor VIII may be decreased in von Willebrand disease. Acquired deficiency states also occur.
Antibodies specific for factor VIII are the most commonly occurring specific inhibitors of coagulation factors and can produce serious bleeding disorders (acquired hemophilia).
Spuriously decreased results may occur, as factor VIII is highly susceptible to proteolytic inactivation.
Interpretation
Mild hemophilia A: 5% to 50% activity
Moderate hemophilia A: 1% to 5% activity
Severe hemophilia A: <1% activity
Congenital deficiency may also occur in combined association with factor V deficiency.
Liver disease usually causes an increase of factor VIII activity.
Acquired deficiencies of factor VIII have been associated with myeloproliferative or lymphoproliferative disorders (acquired von Willebrand disease: VWD), inhibitors of factor VIII (autoantibodies, postpartum conditions, etc), and intravascular coagulation and fibrinolysis.
Levels may be decreased with von Willebrand factor in VWD.
Cautions
Factor VIII is a labile protein. Improper handling of a specimen may give a false result.
Factor VIII is highly susceptible to proteolytic inactivation, with the potential for spuriously decreased assay results. Normal results can be regarded as reliable, but decreased results need to be correlated with other clinical and laboratory information. Repeat testing may be necessary.
Factor VIII activity in frozen-thawed plasma specimens may be 10% to 20% lower than if assayed in fresh specimens, even under optimum conditions of processing and transportation, and may be even lower if these conditions are suboptimal.
Factor VIII activity rises in response to a number of factors, including pregnancy, estrogen therapy, stress, disease, etc.
Once artefactual reduction of factor VIII is excluded, it is important to measure von Willebrand factor levels to ensure that the patient does not have von Willebrand disease.
Clinical Reference
1. Spreafico M, Peyvandi F. Combined FV and FVIII deficiency. Haemophilia. 2008;14(6):1201-1208
2. 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
3. Franchini M, Lippi G, Favaloro EJ. Acquired inhibitors of coagulation factors: part II. Semin Thromb Hemost. 2012;38(5):447-453
4. Carcao MD. The diagnosis and management of congenital hemophilia. Semin Thromb Hemost. 2012;38(7):727-734
5. Favaloro EJ, Lippi G, eds. Hemostasis and Thrombosis: Methods and Protocols. Humana Press; 2017
Method Description
The factor VIII 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 VIII-deficient substrate (normal plasma depleted of factor VIII 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 daysSpecimen Retention Time
7 daysReject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
NY State Approved
YesTesting Algorithm
For information see Hemophilia Testing Algorithm.
Method Name
Optical Clot-Based
Forms
If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.
Disease States
- Hemophilia A