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.

Fonctionnalités et avantages

Stable reagents

Economical testing outcomes

  • 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

  • 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

  • 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

Spécifications techniques

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

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.

  1. Siemens Healthineers INNOVANCE Rivaroxaban Standards

    Description: INNOVANCE Rivaroxaban Standards1 are used for calibration of the INNOVANCE Anti-Xa assay1 for the quantitative determination of the concentration of rivaroxaban in citrated human plasma. The Standards set consists of a Standard 0 without rivaroxaban and a Standard 1 with ~420 ng/mL rivaroxaban.

    SMN/Catalog no.: 10873677/OPPT03

    Package size: 2 x 2 x for 1 mL

  2. Siemens Healthineers INNOVANCE Rivaroxaban Controls

    Description: INNOVANCE Rivaroxaban Controls1 are used for quality control of the INNOVANCE Anti-Xa assay1 for the quantitative determination of rivaroxaban in citrated human plasma. They include two levels of rivaroxaban controls: Control 1 ~70 ng/mL; Control 2 ~250 ng/mL.

    SMN/Catalog no.: 10873676/OPPS03

    Package size: 2 x 5 x for 1 mL

  3. Siemens Healthineers INNOVANCE Heparin UF Control 2

    Description: INNOVANCE Heparin UF Control 2 is used for quality control of the INNOVANCE Heparin/INNOVANCE Anti-Xa1 assays for the quantitative determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in citrated human plasma. Concentration of heparin ~0.7 IU/mL.

    SMN/Catalog no.: 10873451/OPOD03

    Package size: 5 x for 1 mL

  4. INNOVANCE Heparin UF Control 1

    Description: INNOVANCE Heparin UF Control 1 is used for quality control of the INNOVANCE Heparin/INNOVANCE Anti-Xa1 assays for the quantitative determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in citrated human plasma. Concentration of heparin ~0.3 IU/mL.

    SMN/Catalog no.: 10873452/OPOC03

    Package size: 5 x for 1 mL

  5. Siemens Healthineers INNOVANCE Heparin LMW Control 2

    Description: INNOVANCE Heparin LMW Control 2 is used for quality control of the INNOVANCE Heparin/INNOVANCE Anti-Xa1 assays for the quantitative determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in citrated human plasma. Concentration of heparin ~1.0 IU/mL

    SMN/Catalog no.: 10873449/OPOE03

    Package size: 5 x for 1 mL

  6. Siemens Healthineers INNOVANCE Heparin LMW Control 1

    Description: INNOVANCE Heparin LMW Control 1 is used for quality control of the INNOVANCE Heparin/INNOVANCE Anti-Xa1 assays for the quantitative determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in citrated human plasma. Concentration of heparin ~0.4 IU/mL.

    SMN/Catalog no.: 10873449/OPOE03

    Package size: 5 x for 1 mL

  7. Siemens Healthineers INNOVANCE Apixaban Standards

    Description: INNOVANCE Apixaban Standards1 are used for calibration of the INNOVANCE Anti-Xa assay1 for the quantitative determination of the concentration of apixaban in citrated human plasma. The Standards set consists of a Standard 0 without apixaban and a Standard 1 with ~420 ng/mL apixaban.

    SMN/Catalog no.: 10873673/OPPW03

    Package size: 2 x 2 x for 1 mL

  8. Siemens Healthineers INNOVANCE Apixaban Controls

    Description: INNOVANCE Apixaban Controls1 are used for quality control of the INNOVANCE Anti-Xa assay1 for the quantitative determination of apixaban in citrated human plasma. They include two levels of apixaban controls: Control 1 ~70 ng/mL; Control 2 ~250 ng/mL.

    SMN/Catalog no.: 10873672/OPPV03

    Package size: 2 x 5 x for 1 mL

  9. Siemens Healthineers INNOVANCE Anti-Xa reagent

    Description: The INNOVANCE Anti-Xa1 reagent is an in vitro diagnostic reagent for the quantitative, WHO-standardized determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) activity for monitoring patients under UFH or LMWH therapy in human sodium citrated plasma by means of automated, chromogenic methods. The assay employs ready-to-use liquid reagents and a single hybrid calibration curve for LMWH and UFH. In addition, the INNOVANCE Anti-Xa1 reagent is an in vitro diagnostic reagent for the quantitative determination of the direct factor Xa inhibitors rivaroxaban and apixaban as an aid in detecting the anticoagulant status in patients under therapy with these factor Xa inhibitors in human sodium citrated plasma by means of automated, chromogenic methods.

    SMN/Catalog no.: 10873681/OPPU05

    Package size: Kit

  10. Siemens Healthineers INNOVANCE Heparin Calibrator

    Description: For calibration of the INNOVANCE Heparin/INNOVANCE Anti-Xa1 assays for the quantitative determination of the activity of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in citrated human plasma using a hybrid calibration curve. The calibrators are traceable to the WHO Standards for LMWH and UFH.

    SMN/Catalog no.: 10873453/OPOB03

    Package size: 5 x 1 x for 1 mL

Siemens-Healthineers-Hemostasis-reagent-portfolio-cover

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

Approche clinique

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

1

2

3

4

5

6