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INNOVANCE Antithrombin AssayState-of-the-art antithrombin testing

INNOVANCE Antithrombin assay is a state-of-the-art, ready-to-use chromogenic reagent for automated measurement of antithrombin (AT) activity. It delivers exceptional precision even at low activity levels and high sensitivity for detecting both inherited and acquired antithrombin deficiencies. INNOVANCE Antithrombin assay was described for use in patients treated with QFITLIA (fitusiran) supporting the AT-based dosing regimen.12


INNOVANCE Antithrombin fitusiran testing

Benefits

The INNOVANCE Antithrombin assay is provided as a liquid, ready-to-use reagent, automated for multiple hemostasis systems from Siemens Healthineers. Through the precise combination of human factor Xa, standardized system settings, and a heparin concentration of 1500 IU/L it offers a robust and sensitive determination of AT activity. 

Economic stability icon
  • Good method correlation offers harmonized result interpretation.
  • High precision in the low range helps avoid the need for repeat testing, saving time and reagents.
  • Demonstrates excellent sensitivity to detect antithrombin mutations.1-10


Fast turnaround time
  • For reliable dose monitoring of QFITLIA (fitusiran), excellent precision is required in the clinical decision range of 15 – 35% antithrombin activity. With 5.5% CV or less, INNOVANCE Antithrombin assay has demonstrated precise results within the decision range when testing plasma pools.  
  • Available for any-sized lab on the CN-3000/6000,* CS-2500, CS-5100, CA-600, and BCS XP Systems from Siemens Healthineers. 


Patient outcomes
  • Efficient reagent management is accomplished by a convenient onboard stability. 
  • Available in different ready-to-use kit sizes and using multi-analyte calibrator and controls, reducing waste and providing cost and labor efficiencies.
Economic stability icon
  • Good method correlation offers harmonized result interpretation.
  • High precision in the low range helps avoid the need for repeat testing, saving time and reagents.
  • Demonstrates excellent sensitivity to detect antithrombin mutations.1-10


Technical Details

Technical Specifications

14 µL

Required sample volume, depending on system application

120 hours

Onboard stability on CS-5100 System†

100/130/400 tests per kit‡ 

3 kit configurations available to suit different volume needs

6–150% of norm

Measuring range on CS-5100 System

3.8%

Within-device/lab CV (%) with a plasma pool at 15.1% of norm (CS-5100 System)

4 weeks

Stability once opened at 2–8°C

99% AT type II HBS deficiencies correctly identified

Testing 643 patients with >10 different mutations2-11 

98% AT type I/II deficiencies correctly identified

Testing 954 patients with >45 different mutations2-11 


Assay performance can vary from country to country as well as with the system application of the respective assay. The values listed above are provided as examples only.

Evidence

Reliable performance across mutations and use for patients under QFITLIA treatment12

Proven sensitivity

In studies evaluating 643 individuals with type I/II mutations including more than 10 different heparin-binding-site (AT II-HBS) mutations, INNOVANCE Antithrombin assay identified 99% of patient samples, exceeding other FXa-based AT assays.1-11 It included AT Budapest III and AT Padua I (Rouen I) which have a high prevalence in Europe.1 Overall, in studies with AT type I/II mutations, INNOVANCE Antithrombin assay identified 98% of patient samples, equivalent to or exceeding other AT assays.1-11

Efficient therapy management

Because of its exceptional ability to measure within the therapeutic range, where others could not,16 the INNOVANCE Antithrombin assay was selected for clinical trials with the QFITLIA therapy in patients with hemophilia A or B with or without inhibitors.12-15 This assay was cleared as companion diagnostic for QFITLIA (fitusiran) in the U.S.§,12-15

Its clinical value is recognized worldwide.12-15 While intended use may vary by country, the assay uses consistent reagents globally.


Proven precision

The underlying study compared eight antithrombin activity assays used by 48 laboratories located across 16 countries worldwide regarding their accuracy and variability, particularly around or below 30% of norm in plasma samples. In this range highly relevant for the antithrombin-based dosing regimen with fitusiran, the authors found a higher variation of results. With decreasing AT activity levels, several assays displayed a variability up to 57.5% CV - but INNOVANCE Antithrombin assay remained precise.16

Monitoring

Clinical use

INNOVANCE Antithrombin assay can be used to support the following clinical applications:

  • Identify causes of thrombosis also in the presence of pregnancy complications:3,5-7,11 Detect antithrombin deficiency to guide appropriate anticoagulation strategies and support outcome-driven treatment decisions.

  • Ensure effective heparin therapy: Monitor AT activity levels to assess and ensure the efficacy of heparin-based anticoagulation.

  • Support treatment in complex conditions: Aid in managing patients with DIC, sepsis, or liver cirrhosis by evaluating antithrombin levels to tailor therapy.

  • NEW! Determine AT-levels in hemophilia A or B patients under QFITLIA therapy: INNOVANCE Antithrombin assay was found an ideal support for AT-based QFITLIA (fitusiran) dosing,12 even in patients with factor VIII or IX inhibitors.12-15 The assay’s high precision in low activity ranges16 was described as particularly effective for monitoring antithrombin levels critical to this treatment.12-15


Flexible, high-precision testing to match your lab’s workflow

The INNOVANCE Antithrombin assay offers automated, WHO-standardized quantification of FXa-based antithrombin activity. Flexible, high-precision testing with three kit sizes—small, medium, and large—designed to match your lab’s workflow and daily test volume, helping reduce waste and optimize efficiency. The assay is calibrated using Standard Human Plasma. For quality control, Control Plasma N and Control Plasma P are provided with assigned values.

Buffer

Substrate

Reagent

  1. INNOVANCE Antithrombin Buffer

    BUFFER

    A ready-to-use liquid buffer containing preservatives.

Use assays from Siemens Healthineers along the official ISTH testing workflow

A workflow for antithrombin testing has been proposed by the ISTH guideline on AT testing.16 A step-by-step approach is recommended to classify antithrombin (AT) deficiency, using two types of activity tests and an AT antigen test. Labs often don’t know if a patient is on anticoagulants, making it hard to choose the right AT test. One solution is to use both factor Xa and thrombin-based activity tests in a staggered approach, where needed (see below). The Atellica Data Manager can be set up to support this approach, including calculating the activity-to-antigen ratio.

Note: The overview below does not highlight clinical considerations concerning potential causes of acquired AT deficiency or the impact of a full-dose heparin therapy.

    Classifying antithrombin deficiencies

    AT defects are divided into type I and type II. While quantitative type I deficiency can be either acquired or hereditary, the qualitative type II deficiency is hereditary and characterized by a dysfunctional AT molecule. Type II defects are further divided into three subtypes, depending on the localization of the mutations.17 

    The correct classification of AT deficiency supports the correct therapy. While heterozygous HBS mutations, depending on the individual mutation may not necessarily be associated with an increased thrombotic risk, they can cause pregnancy complications.2-7 Discrimination among AT deficiency types is useful to adapt the therapy: anticoagulation or AT replacement.

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    1
    Rojnik T, et al. Comparison of antithrombin activity assays in detection of patients with heparin binding site antithrombin deficiency: systematic review and meta‑analysis. Nature Sc Rep. 2023;13:16734. https://doi.org/10.1038/s41598-023-43941-x.
    2
    Reda S, et al. Functional Characterization of Antithrombin mutations by monitoring of thrombin inhibition kinetics. Int J Mol Sci. 2021;22:2119. https://doi.org/10.3390/ijms22042119.
    3
    Gindele R, et al. Investigation of the differences in antithrombin to heparin binding among antithrombin Budapest 3, Basel, and Padua mutations by biochemical and in silico methods. Biomolecules 2021;11:544. https://doi.org/10.3390/biom11040544.  
    4
    Rühl H, et al. Activated factor X-based versus Thrombin-Based Antithrombin Testing in Thrombophilia Workup in the DOAC era. Thromb Haemost. 2018;118:381–7. https://doi.org/10.1160/TH17-08-0568.
    5
    Gindele R, et al. Clinical and laboratory characteristics of antithrombin deficiencies: a large cohort study from a single diagnostic center. Thromb Res. 2017;160:119-28.
    6
    Orlando C, et al. Antithrombin heparin binding site deficiency: a challenging diagnosis of a not so benign thrombophilia. Thromb Res. 2015;135:1179-85. https://doi.org/10.1016/j.thromres.2015.03.013.
    7
    Puurunen M, et al. Type II antithrombin deficiency caused by a founder mutation Pro73Leu in the Finnish population: clinical picture. J Thromb Haemost. 2013;11:1844–9. https://doi.org/10.1111/jth.12364.
    8
    Kovacs B, et al. The superiority of anti-FXa assay over anti-FIIa assay in detecting heparin-binding site antithrombin deficiency. Am J Clin Pathol. 2013;140(5):675-9. https://doi.org/10.1309/AJCPVY4Z9XZMFOTH.
    9
    Merz M, et al. Clinical multicenter evaluation of a new FXa-based Antithrombin assay. Int Jnl Lab Hem 2011;33:498-503. https://doi.org/10.1111/j.1751-553X.2011.01326.x.
    10
    Cooper PC, et al. The phenotypic and genetic assessment of antithrombin deficiency. Int. Jnl. Lab. Hem. 2011, 33, 227–37. https://doi.org/10.1111/j.1751-553X.2011.01307.x.
    11
    Javela K, et al. Great discrepancy in antithrombin activity measured using five commercially available functional assays. Thromb Res. 2013;132:132–7. http://dx.doi.org/10.1016/j.thromres.2013.05.012.
    12
    Young G, et al. Safety and efficacy of a fitusiran antithrombin-based dose regimen in people with hemophilia A or B: the ATLAS-OLE study. Blood 2025, published preprint on March 7, 2025. https://doi.org/10.1182/blood.2024027008.
    13
    Kenet G, et al. Fitusiran prophylaxis in people with hemophilia A or B who switched from prior BPA/CFC prophylasis: the ATLAS-PPX trial. Blood. 2024;143:2256-69. https://doi.org/10.1182/blood.2023021864.
    14
    Young G, et al. Efficacy and safety of fitusiran prophylaxis in people with haemophila A or haemophilia B with inhibitors (ATLAS-INH): a mutlicentre, open-label, randomized phase 3 trial. Lancet. 2023;401:1427-37. https://doi.org/10.1016/S0140-6736(23)00284-2.
    15
    Srivastava A, et al. Fitusiran prophylaxis in people with severe haemophilia A or haemophilia B without inhibitors (ATLAS-A/B): a multicentre, open-label, randomized, phase 3 trial. Lancet Haematol. 2023;10: e322-32. https://doi.org/10.1016/S2352-3026(23)00037-6.
    16
     Seth Chhabra E, et al. Global Comparative Antithrombin Field Study: Impact of Laboratory Assay Variability on the Assessment of Antithrombin Activity Measurement at Fitusiran Clinical Decision-Making Points. Haemophilia 2025;0:1-9. https://doi.org/10.1111/hae.70045  
    17
    Van Cott E, et al. Recommendations for clinical laboratory testing for antithrombin deficiency; communication from the SSC of the ISTH. J Thromb Haemost. 2020;18:17-22. https://doi.org/10.1111/jth.14648 
    *
    The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed. Not available for sale in the U.S.
    †
    Using reagent caps.
    ‡
    Dependent upon individual analyzer performance.
    §
    As of June 2025.
    **
    Optional, if patient’s anticoagulation is suspected or if AT deficiency type needs to be discriminated, respectively.
    ††
    Not available for sale in the U.S.
    All trademarks are the property of their respective owners. CN-3000 and CN-6000 Systems refer to Automated Blood Coagulation Analyzer CN-3000 and Automated Blood Coagulation Analyzer CN-6000 respectively.
    CN-3000 and CN-6000 Systems or CN-3000/6000 Systems refer to Automated Blood Coagulation Analyzer CN-3000 and Automated Blood Coagulation Analyzer CN-6000 respectively. CS-2500 and CS-5100 Systems refer to Automated Blood Coagulation Analyzer CS-2500 and Automated Blood Coagulation Analyzer CS-5100 respectively. CA-600 refers to Automated Blood Coagulation Analyzer CA-660 and CA-620 respectively.

    Product availability may vary from country to country and is subject to varying regulatory requirements. The products/features mentioned here are not commercially available in all countries. Their future availability cannot be guaranteed. Please contact your local representative for availability.
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