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Test Code RIVAR Rivaroxaban, Anti-Xa, Plasma


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


 



Specimen Required


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

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° C or, ideally, below -40 C degrees.

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.


Useful For

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

Method Name

Chromogenic Assay

Reporting Name

Rivaroxaban, Anti-Xa, P

Specimen Type

Plasma Na Cit

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

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

Reference Values

An interpretive report will be provided.

Interpretation

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.

Clinical Reference

1. Mueck W, Stampfuss J, Kubitza D, Becka M. Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clinical Pharmacokinetics. 2014;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/en/documents/product-information/xarelto-epar-product-information_en.pdf

3. EINSTEIN Investigators, Bauersachs R, Berkowitz SD, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;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;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;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;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;14(6):1308-1313

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

80299

LOINC Code Information

Test ID Test Order Name Order LOINC Value
RIVAR Rivaroxaban, Anti-Xa, P 74871-5

 

Result ID Test Result Name Result LOINC Value
RIVA1 Rivaroxaban, Anti-Xa, P 74871-5
RIVA2 Interpretation 69049-5
RIVA3 Cautions 62364-5