NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Evaluating patients with thrombosis or hypercoagulability states
Detecting a lupus-like anticoagulant; dysfibrinogenemia; disseminated intravascular coagulation/intravascular coagulation and fibrinolysis
Detecting a deficiency of antithrombin, protein C, or protein S
Detecting activated protein C resistance (and the factor V R506Q [Leiden] mutation if indicated)
Detecting the prothrombin G20210A mutation
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
|Test ID||Reporting Name||Available Separately||Always Performed|
|PTC||Prothrombin Time (PT), P||Yes, (order PT)||Yes|
|APTTB||Activated Partial Thrombopl Time, P||Yes, (order APT)||Yes|
|DRVT||Dilute Russells Viper Venom Time, P||No||Yes|
|TT||Thrombin Time (Bovine), P||Yes||Yes|
|FIBC||Fibrinogen, P||Yes, (order FIB)||Yes|
|DIRM||D-Dimer, P||Yes, (order DDI)||Yes|
|SFM||Soluble Fibrin Monomer||No||Yes|
|ATTF||Antithrombin Activity, P||Yes||Yes|
|CFX||Protein C Activity, P||Yes||Yes|
|PSF||Protein S Ag, Free, P||Yes, (order PSTF)||Yes|
|PTNT||Prothrombin G20210A Mutation, B||Yes||Yes|
|APCRV||Activated Protein Resistance V, P||Yes||Yes|
|CCC||Special Coagulation Interpretation||No||Yes|
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
|Test ID||Reporting Name||Available Separately||Always Performed|
|F8IS||Coag Factor VIII Assay Inhib Scrn,P||No||No|
|ATTI||Antithrombin Antigen, P||Yes||No|
|FACTV||Coag Factor V Assay, P||Yes||No|
|F_7||Coag Factor VII Assay, P||Yes||No|
|F_9||Coag Factor IX Assay, P||Yes||No|
|F_10||Coag Factor X Assay, P||Yes||No|
|F_11||Coag Factor XI Assay, P||Yes||No|
|F_12||Coag Factor XII Assay, P||Yes||No|
|F8A||Coag Factor VIII Activity Assay, P||Yes||No|
|RPTL||Reptilase Time, P||Yes||No|
|PSGN||Plasminogen Activity, P||Yes||No|
|F_2||Coag Factor II Assay, P||Yes||No|
|PCAG||Protein C Ag, P||Yes||No|
|S_FX||Protein S Activity, P||Yes||No|
|F5DNA||Factor V Leiden (R506Q) Mutation, B||Yes||No|
|PNP||Platelet Neutralization Procedure||No||No|
|PTMX||PT Mix 1:1||No||No|
|APTTM||APTT Mix 1:1||No||No|
|PST||Protein S Ag, Total, P||No||No|
|STLA||Staclot LA, P||No||No|
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
Initial testing includes: prothrombin time (PT); activated partial thromboplastin time (APTT); dilute Russells viper venom time (DRVVT); thrombin time (bovine); fibrinogen; D-dimer; soluble fibrin monomer; antithrombin activity; protein C activity; protein S antigen, free; prothrombin G20210A mutation; activated protein resistance V; and, if appropriate, special coagulation interpretation.
If PT is > or =14 seconds, PT mix will be performed.
If APTT is >36 seconds, APTT mix will be performed.
If APTT mix is >36 seconds with no evidence of heparin in samples, platelet neutralization procedure will be performed.
If DRVVT ratio is > or =1.2, DRVVT mix will be performed.
If DRVVT mix ratio is > or =1.2, DRVVT confirmation will be performed.
If thrombin time is >23 seconds, reptilase time will be performed.
If protein S antigen, free is <65% for males and females > or =50 years of age and <50% for females <50 years of age, protein S antigen, total will be performed.
If protein C activity is <70% with no evidence for an acquired decrease in protein C activity, protein C antigen may be performed.
If antithrombin activity is <80% with no evidence of an acquired decrease in antithrombin activity, antithrombin antigen will be performed.
If activated protein C resistance (APC) ratio is <2.3 or baseline APC APTT is prolonged, factor V leiden (R506Q) mutation analysis will be performed.
If appropriate, protein S activity, plasminogen, coagulation factor assays, or Staclot LA will be performed at an additional charge to clarify significant abnormalities in the screening clotting times.
If factor VIII result is <55%, the factor VIII inhibitor screen may be performed along with the Bethesda titering assay, if inhibitor screen is positive.
See Thrombophilia Profile algorithm in Special Instructions.
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
PTC, PTMX, APTTB, APTTM, DRVT, TT, STLA, APCRV, DRVTM, DRVTC: Clot-Based Assay
FIBC: Clauss Methodology
DIRM, PSF, PST: Automated Latex Immunoassay (LIA)
ATTF, CFX: Chromogenic Assay
PTNT: Direct Mutation Analysis
PNP: Activated Partial Thromboplastin Time (APTT) Mixing Test
IBETH, F8IS: Clot-Based Assay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
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.
1. Coagulation Patient Information Sheet (Supply T675) in Special Instructions
2. New York Clients-Informed consent is required. Please document on the request form or electronic order that a copy is on file. An Informed Consent for Genetic Testing (Supply T576) is available in Special Instructions.
Blood and plasma are required.
Specimen Type: Whole blood
Preferred: Yellow top (ACD)
Acceptable: EDTA, sodium citrate
Specimen Volume: 6 mL
1. Invert several times to mix blood.
2. Do not transfer blood to other containers.
3. Label specimen as whole blood.
Specimen Type: Platelet-poor plasma
Collection Container/Tube: Light-blue top (citrate)
Submission Container/Tube: Plastic vials
Specimen Volume: 6 mL in 6 plastic vials each containing 1 mL
1. Specimen must be drawn prior to factor replacement therapy.
2. Spin down, remove plasma, and spin plasma again.
3. Freeze specimens immediately at < or =-40 degrees C, if possible.
4. Label specimens as plasma.
5. Send specimens in the same shipping container.
1. Double-centrifuged specimen is critical for accurate results as platelet contamination may cause spurious results.
2. Patient should not be receiving Coumadin or heparin.
3. If priority specimen, mark request form, give reason, and request a call-back.
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.
Whole Blood: 3 mL/Plasma: 5 mL in 5 plastic vials each containing 1 mL
Mild OK; Gross reject
Mild OK; Gross reject
Mild OK; Gross reject
Green top (heparin) tube
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Plasma Na Cit||Frozen||14 days|
|Whole blood||Ambient (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Thrombophilia is defined as an acquired or familial disorder associated with thrombosis. The clinical presentation of an underlying thrombophilia may include venous thromboembolism (deep vein thrombosis, pulmonary embolism, superficial vein thrombosis), recurrent miscarriage, and complications of pregnancy (eg, severe preeclampsia, abruptio placentae, intrauterine growth restriction, stillbirth). Other possible clinical presentation includes arterial thrombosis (especially among patients <50 years of age with no other risk factors for atherosclerotic arterial occlusive disease (diabetes mellitus, hypercholesterolemia, hypertension, or tobacco smoking) and aseptic necrosis of bone (eg, femoral head mandible). Demographic or environmental exposures that compound the risk of venous thromboembolism among persons with a thrombophilia include increasing age, male gender, obesity, surgery, trauma, hospitalization for medical illness, malignant neoplasm, prolonged immobility during travel (eg, prolonged airplane travel), oral contraceptive use, estrogen therapy (both oral and transdermal), tamoxifen and raloxifene therapy, and infertility drugs. Central venous catheters and transvenous pacemaker wires increase the risk for upper extremity deep vein thrombosis; this risk is unrelated to thrombophilia.
Inherited thrombophilias include:
-Deficiency due to reduced plasma protein level or dysfunctional protein of:
- Protein C
- Protein S
-Activated protein C resistance due to the factor V R506Q (Leiden) mutation
-Prothrombin G20210A mutation
Acquired thrombophilias include a lupus-like anticoagulant (antiphospholipid antibodies) and disseminated intravascular coagulation/intravascular coagulation and fibrinolysis (DIC/ICF). DIC/ICF may cause thrombotic as well as hemorrhagic events. Positive tests for DIC/ICF can also occur as consequences of thrombosis.
Acquired deficiencies of fibrinogen, protein C, protein S, and antithrombin may be found in conjunction with liver disease (they are produced by the liver) or DIC/ICF and are of uncertain significance with respect to thrombosis risk.
Acquired deficiencies of protein C and protein S are also found in liver patients treated with oral anticoagulants (eg, warfarin, Coumadin) since both of these proteins are dependent upon the action of vitamin K for normal function.
Acquired protein S deficiency also occurs in thrombotic thrombocytopenic purpura, pregnancy or estrogen therapy, nephrotic syndrome, and sickle cell anemia. In acute illness, the level of acute-phase reactants rise (including C4b binding protein, which binds and inactivates protein S in the plasma) and the portion of bound protein S also rises leaving a lower proportion of free protein S. The significance of acquired protein S deficiency with respect to thrombosis risk is unknown.
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.
An interpretive report will be provided.
An interpretive report will be provided.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
To obtain the most useful information, this testing is best performed in medically-stable patients who are not receiving oral vitamin K inhibitor (eg, warfarin, Coumadin), heparin, low-molecular-weight heparin, hirudin (Refludan), argatroban, fibrinolytic agents (eg, streptokinase, tissue plasminogen activator), or platelet GPIIbIIIa (alpha IIb beta3) inhibitors (abxicimab [ReoPro], tirofiban, aggrastat). However, useful information can be obtained in patients receiving anticoagulation therapy.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
College of American Pathologists Consensus Conference XXXVI: diagnostic issues in thrombophilia. Arch Pathol Lab Med. 2002;126:1277-1433
Method Description Describes how the test is performed and provides a method-specific reference
See individual test IDs.
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
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
7 days for plasma, 1 month for whole blood
Performing Laboratory Location The location of the laboratory that performs the test
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.
81240-F2 (prothrombin, coagulation factor II) (eg, hereditary hypercoagulability) gene analysis, 20210G->A variant
85303-Protein C activity
85306-Protein S antigen, free
85307-Activated protein resistance V
85366-Soluble fibrin monomer
85390-26-Special coagulation interpretation
81241-F5 (coagulation factor V) (eg, hereditary hypercoagulability) gene analysis, Leiden variant (if appropriate)
85210-Factor II (if appropriate)
85220-Factor V (if appropriate)
85230-Factor VII (if appropriate)
85240-Factor VIII (if appropriate)
85250-Factor IX (if appropriate)
85260-Factor X (if appropriate)
85270-Factor XI (if appropriate)
85280-Factor XII (if appropriate)
85301-Antithrombin antigen (if appropriate)
85302-Protein C antigen (if appropriate)
85305-Protein S antigen, total (if appropriate)
85306-Protein S activity (if appropriate)
85335-Bethesda titer (if appropriate)
85335-Factor VIII inhibitor screen (if appropriate)
85420-Plasminogen activity (if appropriate)
85597-Platelet neutralization for lupus inhibitor (if appropriate)
85598-Staclot LA (if appropriate)
85611-PT mix 1:1 (if appropriate)
85613-DRVVT mix (if appropriate)
85613-DRVVT confirmation (if appropriate)
85635-Reptilase time (if appropriate)
85732-APTT mix 1:1 (if appropriate)
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 ID||Reporting Name||LOINC Code|
|APTTB||Activated Partial Thrombopl Time, P||14979-9|
|ATTF||Antithrombin Activity, P||27811-9|
|CFX||Protein C Activity, P||27818-4|
|PSF||Protein S Ag, Free, P||27821-8|
|SFM||Soluble Fibrin Monomer||40702-3|
|TT||Thrombin Time (Bovine), P||46717-5|
|DDMDR||Fibrinogen Equivalent Units (FEU)||In Process|
|RVVR||DRVVT Screen Ratio||15359-3|
|PR_TI||Prothrombin Time (PT), P||5902-2|
|21803||Prothrombin G20210A Mutation, B||24475-6|
|DDIME||D-Dimer Units (DDU)||In Process|
|21806||PTNT Reviewed By||In Process|