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Siemens Healthineers Hemostasis INNOVANCE Anti-Xa assay

INNOVANCE Anti-Xa assay

Simplify your anticoagulant testing with one streamlined, ready-to-use assay for heparin and direct oral anticoagulant (DOAC) testing

The INNOVANCE® Anti-Xa assay1 is an automated chromogenic assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) as well as rivaroxaban and apixaban concentrations in citrated human plasma. The INNOVANCE Anti-Xa assay1 combines a truly ready-to-use liquid reagent for heparin and DOAC testing, allowing 24/7 access to rapid, specific testing for anticoagulants. Unlike most commercially-available solutions, this assay requires no manual preparation or waiting time.

Features & Benefits

Stable reagents

Economical testing outcomes

Anticoagulant testing, simplified

  • Liquid reagents require no manual preparation or reconstitution, allowing staff to concentrate on high-value tasks.
  • Combined testing solution reduces handling, material, and ordering complexity for the lab.
  • Single calibration curve for both types of heparin (UFH and LMWH) streamlines result interpretation and eliminates the risk of evaluation on the wrong curve.
Stable reagents

Accelerate your lab's testing workflow

Available without the wait

  • 24/7 access to rapid, specific testing for anticoagulants supports timely patient treatment.
  • Robust assay design reduces susceptibility to interferences.

Validated diagnostic

Consistent patient results over time

Improved diagnostic accuracy in heparin and

DOAC testing

  • Drug-specific standards sets for the DOACs rivaroxaban and apixaban allow for accurate measurement of drug concentrations in ng/mL.
  • Broad and consistent assay range of 0.10 to 1.50 IU/mL for UF and LMW heparin
  • High lot-to-lot consistency that helps ensure consistent patient results over time

Technical Specifications

One solution for streamlined, ready-to-use anti-Xa testing

The INNOVANCE Anti-Xa assay1 offers robust performance across all parameters. With its compact and ready-to-use configuration, the INNOVANCE Anti-Xa assay1 supports improved laboratory outcomes.It builds on the proven performance of the INNOVANCE Heparin assay and leverages the same proven components, but now also includes DOAC testing capabilities.

No waiting time
Liquid, ready-to-use reagent requires no manual preparation or standing time

0.10–1.50 IU/mL
Consistent measuring range for UFH and LMWH

20–350 ng/mL
Measuring range for rivaroxaban and apixaban

Up to 700 ng/mL

DOAC measuring range extendable by dilution

1.0%
Within-device/lab CV of INNOVANCE Heparin LMW Control 1

2.48%

Within-device/lab CV of INNOVANCE Apixaban Control 11

2.13%

Within-device/lab CV of INNOVANCE Rivaroxaban Control 11

8 weeks

Stability once opened at 2–8°C

Within-device/lab CV (%) indicated for Sysmex® CS-2500 System. Assay performance can vary from country to country as well as corresponding to the system application of the respective assay. The values listed above are provided as examples only.

Learn more about the individual INNOVANCE Anti-Xa assay components 

By combining heparin and DOAC testing into one simple and easy-to-use assay, the INNOVANCE Anti-Xa assay1 streamlines handling, reduces order complexity, and offers labs an economical testing outcome.

    Siemens-Healthineers-Hemostasis-reagent-portfolio-cover

    Availability on Siemens Healthineers and Sysmex Systems

    For details on available assay applications or ordering information, download a copy of the hemostasis reagent portfolio catalogue.

    Clinical Use

    Why your lab should perform anti-Xa testing for anticoagulants

    To monitor and manage bleeding risks, labs are asked to safeguard anticoagulant therapies such as heparin or direct oral anticoagulants (DOACs) by testing patients for a growing number of agents.

    Why accurate DOAC assessment is imperative

    Direct oral anticoagulants such as rivaroxaban and apixaban are direct anti-Xa inhibitor drugs that have evolved over time because of their convenient dosing and short half-life. Though the medication usually does not require monitoring, DOAC testing is needed to properly manage individuals with bleeding conditions, emergency situations that require unplanned surgery, and relevant comorbidities (e.g., renal insufficiency).

    Why anti-Xa is the better choice for heparin testing

    Heparin is a traditional anticoagulant drug and exists in two forms—UFH and LMWH—both of which considerably accelerate the inactivation of coagulation factor Xa by antithrombin. Clinical data shows that monitoring heparin with an anti-Xa assay has several advantages over APTT testing:2-6 

    •  A smoother dose-response curve 
    •  More-stable heparin levels during therapy 
    •  Fewer blood samples required 
    •  Fewer dosage adjustments

    Thank you for your interest in Siemens Healthineers and Sysmex hemostasis testing solutions.

    1

    Not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements.

    2
    Vandiver JW, Vondracek TG. Antifactor Xa levels versus activated partial thromboplastin time for monitoring unfractionated heparin. Pharmacotherapy. 2012;32(6):546-58.
    3

    Vandiver JW, Vondracek TG. A comparative trial of anti-factor Xa levels versus the activated partial thromboplastin time for heparin monitoring. Hosp Pract. 2013;41(2):16-24.33  

    4

     Liveris A, Bello RA, Friedmann P, Duffy MA, Manwani D, Killinger JS, Rodriquez D, Weinstein S. Anti-factor Xa assay is a superior correlate of heparin dose than activated partial thromboplastin time or activated clotting time in pediatric extracorporeal membrane oxygenation. Pediatr Crit Care Med. 2014;15(2):e72-9.

    5

    Adatya S, Uriel N, Yarmohammadi H, Holley CT, Feng A, Roy SS, Reding MT, John R, Eckman P, Zantek ND. Anti-factor Xa and activated partial thromboplastin time measurements for heparin monitoring in mechanical circulatory support. JACC Heart Fail. 2015;3(4):314-22.

    6

    van Roessel S, Middeldorp S, Cheung YW, Zwinderman AH, de Pont AC. Accuracy of aPTT monitoring in critically ill patients treated with unfractionated heparin. Neth J Med. 2014;72(6):305-10. Free access: http://www.njmonline.nl/getpdf.php?id=1463

    INNOVANCE and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. Sysmex is a trademark of Sysmex Corp. All other trademarks and brands are the property of their respective owners. 


     Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.