Test Catalog

Test Id : BIVAL

Bivalirudin, Ecarin, Plasma

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

Monitoring of bivalirudin therapy for patients with prolonged baseline activated partial thromboplastin time

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Chromogenic

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

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Bivalirudin, Ecarin, P

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

Angiomax

Bivalirudin

BIVAL

Specimen Type
Describes the specimen type validated for testing

Plasma Na Cit

Ordering Guidance

This test measures bivalirudin only. For measurement of argatroban direct thrombin inhibitor, order ARGAT / Argatroban, Ecarin, Plasma. For measurement of dabigatran direct thrombin inhibitor, order DABIE / Dabigatran, Ecarin, Plasma.

 

This test is not indicated for monitoring low molecular weight heparin (LMWH), unfractionated heparin (UFH), or oral direct anti-Xa inhibitors (eg, apixaban, rivaroxaban, edoxaban). For monitoring oral direct anti-Xa inhibitors, see APIXA / Apixaban, Anti-Xa, Plasma; EDOXA / Edoxaban, Anti-Xa, Plasma, or RIVAR / Rivaroxaban, Anti-Xa, Plasma.

Necessary Information

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

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Aliquot Tube, 5 mL (T465)

Specimen Type: Platelet-poor plasma

Collection Container/Tube: Light-blue top (3.2% sodium citrate)

Submission Container/Tube: Plastic vial (polypropylene preferred)

Specimen Volume: 1 mL

Collection Instructions:

1. Specimen should be collected 2 hours after initiation of continuous infusion of bivalirudin.

2. For complete instructions, see Coagulation Guidelines for Specimen Handling and Processing in Special Instructions.

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 degrees C or, ideally, < or =-40 degrees 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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

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

 Thawing Cold Reject; Warm reject
  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Plasma Na Cit Frozen (preferred) 42 days

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

Monitoring of bivalirudin therapy for patients with prolonged baseline activated partial thromboplastin time

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

Bivalirudin, a parenteral anticoagulant that directly inhibits thrombin (direct thrombin inhibitor, DTI) factor IIa. It is indicated for use in patients with unstable angina undergoing percutaneous coronary intervention (PCI), in those undergoing PCI with provisional use of glycoprotein IIb/IIIa inhibitor (GPI), or in those with, or at risk of, heparin- induced thrombocytopenia (HIT) or HIT and thrombosis syndrome (HITTS) undergoing PCI. In these indications it is intended for use with aspirin.

 

Frequently, bivalirudin is used for prevention of treatment of thrombosis in patients with HIT with or without thrombosis and with renal and/or hepatic dysfunction.

 

Bivalirudin is administered via continuous intravenous infusion, is removed by a combination of proteolytic cleavage by thrombin and renal clearance mechanisms, and can inhibit both soluble and clot-bound thrombin.

 

Bivalirudin's effect is typically monitored using the activated partial thromboplastin time (aPTT) test with a target aPTT ratio of 1.5 to 2.5 times the patient’s baseline value. However, in instances where patients have a prolonged baseline aPTT (eg, lupus anticoagulants and factor XII deficiency), aPTT monitoring of bivalirudin is not reliable and direct measurement of the effect of bivalirudin on factor IIa may be more reliable. For HIT, monitoring every 2 to 4 hours until in range and then once daily; for PCI, monitoring is unnecessary unless renal failure is present.

 

Internal laboratory validation demonstrates that plasma concentrations of bivalirudin from 0.25 to 2.00 mcg/mL correspond to an aPTT ratio of 1.5 to 3.0. Correlation of bivalirudin drug concentrations with aPTT ratios may vary with different aPTT reagents.

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.

<0.10 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

Therapeutic reference ranges have not been established. See Clinical Information for activated partial thromboplastin time correlative information.

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

The recommended monitoring per product guidelines is with the activated partial thromboplastin time  ratio, routine monitoring of bivalirudin drug levels is not indicated.

 

Bivalirudin concentration may be affected by drug interactions, liver, and renal disease.

 

Marked presence of hemolysis or bilirubin in the sample could falsely decrease bivalirudin levels. Marked presence of lipemia in the sample could falsely increase bivalirudin levels.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Linkins LA, Dans AL, Moores LK, et al: Treatment and prevention of heparin-induced thrombocytopenia: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e495S-e530s

2. Love JE, Ferrell C, Chandler WL: Monitoring direct thrombin inhibitors with a plasma diluted thrombin time. Thromb Haemost. 2007 Jul;98(1):234-242

3. Van Cott EM, Roberts AJ, Dager WE: Laboratory Monitoring of Parenteral Direct Thrombin Inhibitors. Semin Thromb Hemost. 2017 Apr;43(3):270-276

4. Gosselin RC, Douxfils J: Ecarin based coagulation testing. Am J Hematol. 2020 Apr;95(6). doi: 10.1002/ajh.25852

5. Gosselin RC, King JH, Janatpour KA, Dager WE, Larkin EC, Owings JT: Comparing direct thrombin inhibitors using aPTT, ecarin clotting times, and thrombin inhibitor management testing. Ann Pharmacother. 2004 Sep;38(9):1383-1388. doi:10.1345/aph.1D565

6. Beyer JT, Lind SE, Fisher S, Trujillo TC, Wempe MF, Kiser TH: Evaluation of intravenous direct thrombin inhibitor monitoring tests: Correlation with plasma concentrations and clinical outcomes in hospitalized patients. J Thromb Thrombolysis. 2020 Feb;49(2):259-267. doi: 10.1007/s11239-019-01961-3

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

The bivalirudin, ecarin chromogenic assay is performed on the Instrumentation Laboratory ACL TOP Family using the Diagnostica Stago ECA II kit. The STA ECA II kit is a chromogenic assay based on the cleavage of prothrombin by ecarin to meizothrombin, which then enzymatically cleaves the para-nitroaniline (pNA) from the chromogenic substrate resulting in a measurable colorimetric change.(Package insert: STA-ECA II. Diagnostica Stago S.A.S; Revision 09/2015)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 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
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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

CPT codes are provided by the performing laboratory.

80299

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports