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Test ID: BDIAL
Bleeding Diathesis Profile, Limited

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

83094

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

Conditional

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

Detection of the more common potential causes of abnormal bleeding (eg, factor deficiencies/hemophilia, von Willebrand disease, factor-specific inhibitors) and a simple screen to evaluate for an inhibitor or severe deficiency of factor XIII (rare).

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 IDReporting NameAvailable SeparatelyAlways Performed
PTCProthrombin Time (PT), PYes, (order PT)Yes
APTTBActivated Partial Thrombopl Time, PYes, (order APT)Yes
TTThrombin Time (Bovine), PYesYes
DIRMD-Dimer, PYes, (order DDI)Yes
SFMSoluble Fibrin MonomerNoYes
FIBCFibrinogen, PYes, (order FIB)Yes
F8ACoag Factor VIII Activity Assay, PYesYes
VWAGvon Willebrand Factor Ag, PYesYes
VWFXvon Willebrand Factor Activity, PYesYes
FXIIIFactor XIII(13),ScrnNoYes
CCCSpecial Coagulation InterpretationNoYes

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 IDReporting NameAvailable SeparatelyAlways Performed
IBETHBethesda UnitsNoNo
F8ISCoag Factor VIII Assay Inhib Scrn,PNoNo
RISTRistocetin Cofactor, PNoNo
FACTVCoag Factor V Assay, PYesNo
F_7Coag Factor VII Assay, PYesNo
F_9Coag Factor IX Assay, PYesNo
F_10Coag Factor X Assay, PYesNo
F_11Coag Factor XI Assay, PYesNo
F_12Coag Factor XII Assay, PYesNo
RPTLReptilase Time, PYesNo
APSMAlpha-2 Plasmin Inhibitor, PYesNo
F_2Coag Factor II Assay, PYesNo
DRVTDilute Russells Viper Venom Time, PNoNo
F9_ISFactor IX Inhib ScrnNoNo
11_ISFactor XI Inhib ScrnNoNo
F2_ISFactor II Inhib ScrnNoNo
F5_ISFactor V Inhib ScrnNoNo
F7_ISFactor VII Inhib ScrnNoNo
10_ISFactor X Inhib ScrnNoNo
PNPPlatelet Neutralization ProcedureNoNo
PTMXPT Mix 1:1NoNo
APTTMAPTT Mix 1:1NoNo
DRVTMDRVVT MixNoNo
DRVTCDRVVT ConfirmationNoNo
STLAStaclot LA, PNoNo
VWFMvon Willebrand Factor Multimer, PYes, (order 8844)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, thrombin time (bovine), fibrinogen, D-dimer, soluble fibrin monomer, coagulation factor VIII activity assay, von Willebrand factor antigen, von Willebrand factor activity, factor XIII screen, and special coagulation interpretation.  

If PT is > or =14 seconds, PT mix will be performed.

If APTT is >36 seconds, APTT mix and DRVVT 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 APTT mix is >36 seconds with no evidence of heparin in samples, platelet neutralization procedure will be performed.

If thrombin time is >23 seconds, reptilase time will be performed.

If von Willebrand factor activity assay is <55%, von Willebrand factor ristocetin cofactor activity assay will be performed.  

If von Willebrand factor (VWF) antigen is <55%, the VWF activity is <55%, or the VWF activity:VWF antigen ratio is <0.8, VWF multimer analysis will be performed.

If appropriate, 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.

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

PTC/6599, PTMX/9053, APTTB/6548, APTTM/9118, TT/9059, FXIII/9068, RPTL/9078, DVRT/80340, DRVTM/32467, DRVTC/32468, STLA/82756: Clot-Based Assay

F_2/9121, FACTV/9054, F_7/9055, F_10/9066, F2_IS/7806, F5_IS/7808, F7_IS/7810, 10_IS/7812: Prothrombin Time Clot-Based Assay

F8A/9070, F_9/9065, F_11/9067, F_12/9069, F9_IS/7802, 11_IS/7804: Activated Partial Thromboplastin Time-Based Clotting Assay

PNP/8866: Activated Partial Thromboplastin Time (APTT) Mixing Test

RIST/9046: Ristocetin Induced Agglutination of Washed Normal Platelets

VWAG/9051, DIRM/6625: Automated Latex Immunoassay (LIA)

SFM/6600: Immunoturbidimetric

FIBC/80343: Clauss Methodology

APSM/9084: Amidolysis of Chromogenic Substrate

VWFM/31046: Agarose Gel Electrophoresis/Infrared Dye-Labeled Antibody Detection

VWFX/89792: Latex Particle Enhanced Immunoassay

IBETH/7288, F8IS/7289: Clot-Based Assay

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

Bleeding Diath Prof, Limited

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

Bleeding Diathesis Profile, Limited
Coag

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 vials

Specimen Volume: 5 mL in 5 plastic vials each containing 1 mL

Collection Instructions:

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

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

3. Send specimens in the same shipping container.

Additional Information:

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.

Forms: Coagulation Patient Information Sheet (Supply T675)

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.

Internal:
Two 4.5 mL 3.2% Sodium Citrate
External:
4 mL in 4 plastic vials, 1 mL each

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

Bleeding problems may be associated with a wide variety of coagulation abnormalities or may be due to problems not associated with coagulation (trauma and surgery as obvious examples). A partial listing of causes follows. 

 

-Deficiency or functional abnormality (congenital or acquired) of any of the following coagulation proteins: fibrinogen (factor I), factor II (prothrombin), factor V, factor VII, factor VIII (hemophilia A), factor IX (hemophilia B), factor X, factor XI (hemophilia C; bleeding severity not  always proportionate to factor level), factor XIII (fibrin-stabilizing factor), von Willebrand factor (VWF antigen and activity), and alpha-2 plasmin inhibitor and plasminogen activator inhibitor (PAI-I; severe deficiency in rare cases). Neither alpha-2 plasmin inhibitor nor PAI-I are included as a routine bleeding diathesis assay component, but either can be performed if indicated or requested.

-Deficiency (thrombocytopenia) or functional abnormality of platelets such as congenital (Glanzmann thrombasthenia, Bernard-Soulier syndrome, storage pool disorders, etc) and acquired (myeloproliferative disorders, uremia, drugs, etc) disorders. Platelet function abnormalities cannot be studied on mailed-in specimens.

 -Specific factor inhibitors (most commonly directed against factor VIII); factor inhibitors occur in 10% to15% of the hemophilia population and are more commonly associated with severe deficiencies of factor VIII or IX (antigen <1%). The inhibitor appears in response to transfusion therapy with factor concentrates with no correlation of occurrence and amount of therapy. Factor VIII inhibitors may occur spontaneously in the postpartum patient, with certain malignancies, in association with autoimmune disorders (eg, rheumatoid arthritis, systemic lupus erythematosus), in the elderly, and for no apparent reason.

-Other acquired causes of increased bleeding include paraproteinemia; other factor-specific inhibitors, including those against factor V, factor XI; or virtually any of the coagulation proteins.

-Acute disseminated intravascular coagulation/intravascular coagulation and fibrinolysis (DIC/ICF), which is a fairly common cause of bleeding. Bleeding can also occur in patients with chronic ICF.

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.

Interpretation Provides information to assist in interpretation of the test results

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

This test is not useful for assessing platelet function (eg, congenital or acquired disorders such as Glanzmann thrombasthenia, Bernard-Soulier syndrome, storage pool disease, myeloproliferative disease, associated platelet dysfunction), which requires fresh platelets.

 

Patient should not be receiving Coumadin or heparin. If the patient is currently on warfarin or heparin, this should be noted, as warfarin or heparin therapy can affect certain coagulation factors or assays, preclude their performance, or cause spurious results. Patient should also not be receiving fibrinolytic agents (streptokinase, urokinase, tissue plasminogen activator [tPA]).

 

If patient has been recently transfused, this should be noted; it is best to perform this study pretransfusion, if possible.

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

See individual unit codes.

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.

Varies

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

7 days, 21 days if multimers ordered

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 uses a reagent or kit labeled by the manufacturer as Research Use Only. 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 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-Coagulation factor VIII assay

85246-von Willebrand factor antigen

85291-Clot solubility factor XIII

85366-Soluble fibrin monomer

85379-D-dimer

85384-Fibrinogen

85390-26-Special coagulation interpretation

85397-von Willebrand factor activity

85610-PT

85670-Thrombin time

85730-APTT

85210-Factor II (if appropriate)                          

85220-Factor V (if appropriate)

85230-Factor VII (if appropriate)

85245-Ristocetin cofactor (if appropriate)

85247-von Willebrand factor multimer (if appropriate)

85250-Factor IX (If appropriate)

85260-Factor X (if appropriate)

85270-Factor XI (if appropriate)

85280-Factor XII (if appropriate)

85335-Bethesda units (if appropriate)

85335-Factor II inhibitor screen (if appropriate)

85335-Factor V inhibitor screen (if appropriate)

85335-Factor VII inhibitor screen (if appropriate)

85335-Factor VIII inhibitor screen (if appropriate)

85335-Factor IX inhibitor screen (if appropriate)

85335-Factor X inhibitor screen (if appropriate)

85335-Factor XI inhibitor screen (if appropriate)

85410-Alpha-2 plasmin inhibitor (if appropriate)

85597-Platelet neutralization for lupus inhibitor (if appropriate)

85598-Staclot LA (if appropriate)

85611-PT mix 1:1 (if appropriate)

85613-DRVVT (if appropriate)

85613-DRVVT mix (if appropriate)

85613-DRVVT confirm (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 IDReporting NameLOINC Code
APTTBActivated Partial Thrombopl Time, P14979-9
F8ACoag Factor VIII Activity Assay, P3209-4
FIBCFibrinogen, P3255-7
9068Factor XIII(13),ScrnIn Process
SFMSoluble Fibrin Monomer40702-3
TTThrombin Time (Bovine), P46717-5
VWAGvon Willebrand Factor Ag, P27816-8
VWFXvon Willebrand Factor Activity, P68324-3
7525Interpretation69049-5
DDMDRFibrinogen Equivalent Units (FEU)In Process
PR_TIProthrombin Time (PT), P5902-2
INR2INR6301-6
DDIMED-Dimer Units (DDU)In Process
7769Reviewed by:N/A