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INNOVANCE DTI Assay

A reliable dabigatran assay for when specific circumstances require specific testing

The INNOVANCE® DTI Assay provides specific, reliable dabigatran results and is available for use with no waiting time and minimal preparation. Its long onboard stability allows testing to occur when needed.

Features & Benefits

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  • Shows excellent correlation between Siemens Healthineers and Sysmex systems.
  • Shows strong correlation to liquid chromatography-tandem mass spectrometry.
  • Is highly specific due to chromogenic assay principle.
  • Is not susceptible to interference from therapeutic doses of heparins.
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  • Has a broad measuring range of 20–500 ng/mL (extensible up to 1000 ng/mL by sample predilution).
  • Remains stable for 8 weeks after opening to facilitate economical reagent use.
  • Offers excellent lot-to-lot consistency.

Technical Specifications

25 μL 

 Required sample volume 

120 tests

Number of tests per kit* 

54 hours
Onboard stability on the CS-5100 System

20-500% ng/mL
Measuring range (extensible up to 1000 ng/mL by sample predilution)

4.54%
Within-device/lab CV of Dabigatran Control L on the CS-5100 System

8 weeks
Stability after reconstitution at 2–8°C

Assay claims may vary depending on system utilized. The values listed above are provided as examples only.

INNOVANCE DTI Assay Kit Components

Reagent

INNOVANCE DTI Assay kit

Diluent

Substrate

  1. INNOVANCE DTI Assay Kit

    INNOVANCE DTI Assay kit

    SMN/Catalog no.: 10873467/OPOH03

    Package size: 4 x 5 mL Reagent, 4 x 2 mL Substrate, 4 x 5.5 mL Diluent
    Intended use: The INNOVANCE DTI Assay is an in vitro diagnostic reagent for the quantitative determination of the direct thrombin inhibitor (DTI) dabigatran concentration to aid in the detection of dabigatran and quantification of the anticoagulant status in patients under therapy with dabigatran in human sodium citrated plasma by means of automated, chromogenic methods. For determination of dabigatran, no international reference preparation or method is available.


Sysmex CN-3000/6000 Systems
Available on CN-3000/6000 Systems.1

Available on a broad range of analyzers 

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

Clinical Use

Why your lab should perform DTI testing for anticoagulants

To monitor and manage bleeding risks, labs are asked to help 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

DOACs are available in two main forms: direct inhibitors of factor Xa (such as rivaroxaban and apixaban) or direct inhibitors of thrombin (e.g., dabigatran). Though the medication usually does not require monitoring, DOAC testing is needed to properly manage individuals with bleeding conditions, in emergency situations that require unplanned surgery, and with relevant comorbidities (e.g., renal insufficiency).

Why the INNOVANCE DTI Assay is the better choice for dabigatran testing

The INNOVANCE DTI Assay provides specific, reliable dabigatran results you can trust, showing great correlation to liquid chromatography-tandem mass spectrometry (LC-MS/MS) by using an automated chromogenic method principle. It is available for use with no wait time and minimal preparation. Due to the composition of the reagent, the assay is not influenced by the presence of therapeutic doses of unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). Its long onboard stability allows testing to occur when needed, and the extended, once-opened stability of its components makes the assay cost-effective, with minimal waste. Get the reliable, timely dabigatran testing you need.  

1.

Not available for sale in the U.S. 

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local Siemens Healthineers organization for further details.

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