Test Catalog

Test Id : APIXA

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Apixaban, Anti-Xa, Plasma

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Overview

Test Catalog

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

Measuring apixaban concentration in selected clinical situations (eg, renal insufficiency, assessment of compliance, periprocedural measurement of drug concentration, suspected overdose, advanced age, and extremes of body weight)

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

Apixaban, Anti-Xa, P

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

Eliquis

Specimen Type
Describes the specimen type validated for testing

Plasma Na Cit

Ordering Guidance

This assay is not indicated for monitoring low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) concentrations. The presence of UFH and LMWH will cause the apixaban anti-Xa level to be falsely elevated.

 

This assay is optimized to measure apixaban concentration in presence of coagulation factor Xa recombinant, inactivated-zhzo (andexanet alfa, Andexxa).

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 to 4 hours (peak) after a dose or just prior (trough) to the next dose for apixaban concentrations.

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

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. A 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

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 42 days

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

Measuring apixaban concentration in selected clinical situations (eg, renal insufficiency, assessment of compliance, periprocedural measurement of drug concentration, suspected overdose, advanced age, and extremes of body weight)

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

Apixaban, an oral anticoagulant that directly inhibits factor Xa, has been approved by the US Food and Drug Administration for prophylaxis of thrombosis in atrial fibrillation and surgical patients and treatment of venous thromboembolism (VTE). Unlike warfarin, it does not require routine therapeutic monitoring. However, in selected clinical situations, measurement of drug level would be useful (eg, renal insufficiency, assessment of compliance, periprocedural measurement of drug concentration, suspected overdose, advanced age, and extremes of body weight).

 

Table. Predicted Apixaban Steady-State Exposure Concentrations(1)

Dosage

Apixaban

C-min (ng/mL)

trough plasma concentration (predose)

Apixaban C-max (ng/mL)

peak plasma concentration
(2-4 hours postdose)

Prevention of VTE: elective hip or knee replacement surgery

 

 

2.5 mg twice daily

51 (23-109)

77 (41-146)

Prevention of stroke and systemic embolism: NVAF

 

 

2.5 mg twice daily

79 (34-162)

123 (69-221)

5 mg twice daily

103 (41-230)

171 (91-321)

Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE)

 

 

2.5 mg twice daily

32 (11-90)

67 (30-153)

5 mg twice daily

63 (22-177)

132 (59-302)

10 mg twice daily

120 (41-335)

251 (111-572)

 

Median (5th-95th percentile)

Abbreviations not previously defined:

Nonvalvular atrial fibrillation (NVAF)

Deep vein thrombosis (DVT)

Pulmonary embolism (PE)

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

The lower limit of detection of this assay is 10 ng/mL.

 

Therapeutic reference ranges have not been established. See Clinical Information for peak and trough drug concentrations observed from clinical trials.

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

Routine monitoring of apixaban is not indicated. Therapeutic reference ranges have not been established, however, peak and trough levels observed in clinical trials at different dosing are available. Apixaban concentration may be affected by drug interactions and liver or renal disease.

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

1. Eliquis (apixaban). Package insert. Bristol-Meyers Squibb Company; Revised 11/2019

2. Hurst KV, O'Callaghan JM, Handa A. Quick reference guide to apixaban. Vasc Health Risk Manag. 2017;13:263-267

3. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patient with atrial fibrillation. N Engl J Med. 2011;365(11):981-992

4. Frost C, Nepal S, Wang J, et al. Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects. Br J Clin Pharmocol. 2013;76:(5):776-786

5. Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369(9):799-808

6. Siegal DM, Curnutte JT, Connolly SJ, et al. Andexanet alfa for reversal of factor Xa inhibitor activity. N Engl J Med. 2015;373(25):2413-2424

7. Martin K, Beyer-Westendorf J, Davidson BL, Huisman MV, Sandset PM, Moll S. Use of the direct oral anticoagulants in obese patients: guidance from the SSC of the ISTH. J Thromb Haemost. 2016;14(6):1308-1313

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

The apixaban, anti-Xa assay is performed on the Instrumentation Laboratory ACL TOP Family using the HemosIL Liquid Anti-Xa kit. The liquid Anti-Xa kit is a 1-stage chromogenic assay based on a synthetic chromogenic substrate and on factor Xa inactivation. Factor Xa is neutralized directly by apixaban. Residual factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the apixaban in the sample.(Package insert: HemosiL Liquid Anti-Xa kit. Instrumentation Laboratory Company; Rev. 06/2017)

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 account representative. 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 has been modified from the manufacturer's instructions. 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 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
APIXA Apixaban, Anti-Xa, P 74214-8
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.
APIX1 Apixaban, Anti-Xa, P 74214-8
APIX2 Interpretation 69049-5
APIX3 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 | PHP Pdf | CMS 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