Test Catalog

Test Id : RIVAR

Rivaroxaban, Anti-Xa, Plasma

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

Measuring rivaroxaban 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)

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

Rivaroxaban, Anti-Xa, P

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

Xarelto

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 rivaroxaban anti-Xa level to be falsely elevated.

 

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

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

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. 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 (preferred) 42 days

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

Measuring rivaroxaban 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

Rivaroxaban, an oral anticoagulant that directly inhibits factor Xa, has been approved by the FDA 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).

 

Plasma Concentrations of Rivaroxaban in Patient Populations Studied(1)

Patient population/clinical setting

Rivaroxaban dose

C-min (ng/mL)*
trough plasma conc (predose)

C-max (ng/mL)**
peak plasma conc
(2-4 hours postdose)

VTE prevention after total hip replacement surgery

10 mg once daily

9 (1-38)

125 (91-196)

DVT treatment (continued treatment)

20 mg once daily

26 (6-87)

270 (189-419)

Stroke prevention in patients with non-valvular AF (CR-CL > or =50 mL/min)

20 mg once daily

44 (12-137)

249 (184-343)

Stroke prevention in patients with non-valvular AF (CR-CL 30-49 mL/min)

15 mg once daily

57 (18-136)

229 (178-313)

Secondary prevention in patients with acute coronary syndrome

2.5 mg twice daily

17 (6-37)

46 (28-70)

 

Median (5th-95th percentile)

*Defined as samples collected 20-28 hours after dosing

**Defined as samples collected 2-4 hours after dosing

AF-atrial fibrillation, CR-CL-creatinine clearance, DVT-deep vein thrombosis, VTE-venous thromboembolism

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.

<4 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

The lower limit of detection of this assay is 4 ng/mL.

 

Therapeutic reference ranges have not been established. See Clinical Information section 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 rivaroxaban is not indicated. Therapeutic reference ranges have not been established, however, peak and trough levels observed in clinical trials at different dosing are available. Rivaroxaban concentration may be affected by drug interactions and liver or renal disease.

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

1. Mueck W, Stampfuss J, Kubitza D, Becka M: Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clinical Pharmacokinetics. 2014 Jan;53(1):1-16 doi: 10.1007/s40262-013-0100-7

2. Xarelto (rivaroxaban) Summary of Product Characteristics. Package insert. Bayer Pharma AG; 2013. Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf

3. EINSTEIN Investigators, Bauersachs R, Berkowitz SD, et al: Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-2510

4. EINSTEIN-PE Investigators, Buller HR, Prins MH, et al: Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-1297

5. Patel MR, Mahaffey KW, Garg J, et al: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-891

6. Siegal DM, Curnutte JT, Connolly SJ, et al: Andexanet alfa for reversal of factor Xa inhibitor activity. N Engl J Med. 2015 Dec 17;373:2413-2424

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 Jun;14(6):1308-1313

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 rivaroxaban, anti-Xa assay is performed on the Instrumentation Laboratory ACL TOP 700 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 rivaroxaban. Residual factor Xa is quantified with a synthetic chromogenic substrate. The paranitoaniline released is monitored kinetically at 405 nm and is inversely proportional to the rivaroxaban 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 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 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

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