Test Catalog

Test Id : ARGAT

Argatroban, Ecarin, Plasma

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

Measuring argatroban concentration in plasma

 

This assay is not useful for measurement of other direct thrombin inhibitors eg, dabigatran or bivalirudin.

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 Assay

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

Argatroban, Ecarin, P

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

ARGATROBAN

Acova

Specimen Type
Describes the specimen type validated for testing

Plasma Na Cit

Ordering Guidance

This test measures argatroban only. For measurement of dabigatran direct thrombin inhibitor, see 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

Specimen Type: Platelet-poor plasma

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

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

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

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

Forms

If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.

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

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

Measuring argatroban concentration in plasma

 

This assay is not useful for measurement of other direct thrombin inhibitors eg, dabigatran or bivalirudin.

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

Argatroban, a parenteral direct thrombin inhibitor (DTI) that directly inhibits factor IIa, is indicated for use in patients with heparin-induced thrombocytopenia (HIT). Argatroban is administered via continuous infusion, is eliminated by the liver, and can inhibit both soluble and clot-bound thrombin. Argatroban effect is typically monitored using activated partial thromboplastin time (APTT) measurements with a target of 1.5 to 3.0 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 argatroban is not reliable and measurement of argatroban's effect on factor IIa may be more reliable.

 

There are no clinical studies directly correlating argatroban concentration to clinical outcomes. The available data suggest that plasma concentrations of argatroban 1.2 to 2.3 mcg/mL correspond to an APTT ratio of 1.5 to 3.0.(1)

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

Routine monitoring of argatroban drug levels is not indicated, the recommended monitoring per product guidelines is with the activated partial thromboplastin time.

 

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

 

Marked presence of lipemia or bilirubin in the sample could falsely decrease argatroban levels.

Supportive Data

The lower limit of detection of this assay is 0.10 mcg/mL.

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

1. Ahmad S, Iqbal O, Ahsan A, et al: Clinical laboratory monitoring of a synthetic antithrombin agent, argatroban, using high performance liquid chromatography and functional methods. Int Angiol. 1999;18:198-205

2. Argatroban Injection. Package insert: Sandoz, Inc; 2019

3. Van Cott EM, Roberts AJ, Dager WE: Laboratory monitoring of parenteral direct thrombin inhibitors. Semin Thromb Hemost. 2017;43: 270-276

4. Gosselin RC, King JH, Janatpour KA, et al: Comparing direct thrombin inhibitors using aPTT, Ecarin clotting times, and thrombin inhibitor management testing. Ann Pharmacother. 2004;38:1383-1388

5. Gosselin RC, Adcock DM, Bates SM, et al: International Council for Standardization in Haematology (ICSH) recommendations for laboratory measurement of direct oral anticoagulants. Thromb Haemost. 2018 Mar;118(3):437-450

6. Lind SE, Boyle ME, Fisher S, Ishimoto J, Trujillo TC, Kiser TH: Comparison of the aPTT with alternative tests for monitoring direct trombin inhibitors in patient samples. Am J Clin Pathol. May 2014;141:665-674

7. Curvers J, van de Kerkhof D, Stroobants AK, van den Dool EJ, Scharnhorst V: Measuring direct thrombin inhibitors with routine and dedicated coagulation assays.  Am J Clin Pathol. 2012;138: 551-558

8. Seidel H, Kolde HJ: Monitoring of argatroban and lepirudin: what is the input of laboratory values in "real life"?  Clin Appl Thromb Hemost .2018 Mar;24(2):287-294

9. Fenyvesi T, Jorg I, Harenberg J: Monitoring of anticoagulant effects of direct thrombin inhibitors. Semin Thromb Hemost. 2002;28(4):361-368

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 argatroban, ecarin chromogenic assay is performed on the Instrumentation Laboratory ACL TOP 700 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 paranitroanaline (pNA) from the chromogenic substrate resulting in a measureable colorometric 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

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
ARGAT Argatroban, Ecarin, P 55363-6
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
ARGA1 Argatroban, Ecarin, P 55363-6
ARGA2 Interpretation 69049-5
ARGA3 Cautions 62364-5

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 | Create a 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