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Test ID: F8A
Coagulation Factor VIII Activity Assay, Plasma

Secondary ID A test code used for billing and in test definitions created prior to November 2011

9070

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

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

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

Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test

Method Name A short description of the method used to perform the test

Activated Partial Thromboplastin Clot-Based Assay

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Coag Factor VIII Activity Assay, P

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

Coagulation Factor VIII Activity Assay, Plasma
Factor VIII - Off hours order 399
Factor VIII Activity Assay
Hemophilia A

Specimen Type Describes the specimen type needed for testing

Plasma Na Cit

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

See Coagulation Studies in Special Instructions.

 

Specimen Type: Platelet-poor plasma

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

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Spin down, remove plasma, and spin plasma again.

2. Freeze specimen immediately at < or =-40 degrees C, if possible.

Additional Information:

1. Double-centrifuged specimen is critical for accurate results as platelet contamination may cause spurious results.

2. Patient must not be receiving Coumadin or heparin therapy.

3. Each coagulation assay requested should have its own vial.

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

5. Not offered for detection of hemophilia carrier.

6. Coagulation testing is highly complex, often requiring the performance of multiple assays and correlation with clinical information. For that reason, we suggest ordering Coagulation Consultations.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.5 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
Plasma Na CitFrozen14 days

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

Factor VIII is synthesized in the liver, and perhaps in other tissues. It is a coagulation cofactor which 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 decrease 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).

 

Factor VIII is highly susceptible to proteolytic inactivation, with the potential for spuriously decreased assay results.

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.

Adults: 55-200%

Normal, full-term newborn infants or healthy premature infants usually have normal or elevated factor VIII.*

*See Pediatric Hemostasis References in Coagulation Studies in Special Instructions.

Interpretation Provides information to assist in interpretation of the test results

See Cautions.

 

Mild hemophilia A: 5% to 50%

 

Moderate hemophilia A: 1% to 5%

 

Severe hemophilia A: <1%

 

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, post-partum conditions, etc.), and intravascular coagulation and fibrinolysis.

 

May be decreased with von Willebrand factor in VWD

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

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 result needs 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, or maybe even lower if these conditions are suboptimal.

 

Factor VIII rises in response to a number of factors, including pregnancy, estrogen therapy, stress, disease, etc.

 

Not useful for inferring carrier status in suspected female carriers of hemophilia A, unless it is below 50% of normal.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Spreafico M, Peyvandi F: Combined FV and FVIII deficiency. Haemophilia 2008 Nov;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 Jun;28(3):247-256

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

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

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

The factor VIII assay is performed on the Beckman Coulter 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. At which time, 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. Second edition. Boston, MA, Little, Brown and Company, 1975)

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Friday

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

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 The location of the laboratory that performs the test

Rochester

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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

85240

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
F8ACoag Factor VIII Activity Assay, P3209-4