The INNOVANCE® Antithrombin assay is a state-of-the-art reagent for automated measurement of antithrombin activity levels. The ready-to-use reagent offers improved reagent management and shows excellent sensitivity for the detection of antithrombin deficiencies, congenital or acquired.
The INNOVANCE Antithrombin assay is provided as a liquid, ready-to-use reagent. The combination of human factor Xa, well-defined system settings, and a heparin concentration of 1500 IU/L results in a robust and sensitive determination of antithrombin activity. In studies evaluating 227 individuals with type I/II mutations including more than nine different heparin-binding-site (HBS) mutations, a sensitivity of 100% has been demonstrated, exceeding other FXa-based antithrombin assays.1-3, 9
The correct classification of antithrombin (AT) deficiency supports the correct therapy. While heterozygous HBS mutations are not necessarily associated with an increased thrombotic risk,7 discrimination among AT deficiency types is useful to adapt the therapy: antithrombin replacement or anticoagulation. 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.7 AT activity assays (e.g., INNOVANCE Antithrombin and Berichrom® Antithrombin III [A] assays) can detect both qualitative and quantitative deficiencies, while an AT antigen assay (e.g., Antiserum to Human Antithrombin III assay) measures quantitative defects only.
Good method correlation offers harmonized result interpretation and helps avoid the need for repeat testing, saving time and reagents.
Available in different ready-to-use kit sizes, reducing waste and providing cost and labor efficiencies.
Demonstrates excellent sensitivity to detect antithrombin mutations.4
Ready-to-use liquid reagent provides excellent precision and uses standard calibrators and controls for simplified system adaption.
Available for any-sized lab on the BCS® XP System, CA-600 and CS Systems and CN Systems.5
Efficient reagent management is accomplished by a convenient onboard stability combined with a kit size suited to individual lab needs.
10 µL Required sample volume, depending on system application
6–150% of norm Measuring range on CS-5100 System
120 hours Onboard stability on CS-5100 System*
2.3% Within-device/lab CV (%) on CS-5100 System
100/430 tests per kit6 Number of tests per kit for small/large kit configuration
4 weeks Stability once opened at 2–8°C
Using reagent caps
INNOVANCE Antithrombin Assay Kit Components
The INNOVANCE Antithrombin assay is an in vitro diagnostic reagent for the quantitative, WHO-standardized determination of antithrombin, as aid to diagnosis and monitoring of congenital or acquired antithrombin deficiencies in patients at risk for or suspected to have antithrombin deficiency in human sodium citrated plasma by means of automated, chromogenic methods. In addition, the INNOVANCE Antithrombin assay can be used for monitoring antithrombin substitution therapy.
The INNOVANCE Antithrombin assay is available in three different kit configurations for chromogenic, factor Xa-based measurement of antithrombin activity. Small, medium, and large kit sizes support a variety of system applications and daily consumptions of tests.
The INNOVANCE Antithrombin assay is calibrated using Standard Human Plasma. For quality control, Control Plasma N, Control Plasma P, Dade® Ci-Trol® Coagulation Control Level 1, and Dade® CiTrol® 1, are provided with assigned values.
A ready-to-use liquid buffer containing preservatives.
To identify a cause of thrombophilia and adapt treatment accordingly.
To ensure the efficiency of heparin treatment.
To determine the proper treatment in selected patients with, for instance, liver cirrhosis.
Perform Antithrombin (AT) Testing with Assays from Siemens Healthineers
A workflow for antithrombin testing has been proposed by the ISTH guideline on AT testing.7 A staggered approach for the classification of AT deficiency type is recommended, which includes two types of activity assays and an additional AT antigen assay. Laboratories often face the challenge of not being aware of an anticoagulant treatment. Thus it is difficult to determine the suitable AT assay in advance. A potential strategy might employ both factor Xa and a thrombin-based assay for AT activity testing, as proposed in an overview below. Atellica® Data Manager may be programmed to support such a testing scheme, including the calculation of the activity-to-antigen ratio.
The overview below does not highlight clinical considerations concerning potential causes of acquired AT deficiency or the impact of a full-dose heparin therapy.
Explore the Antithrombin Testing Portfolio
Siemens Healthineers is committed to developing assays that meet your needs. We offer both functional activity and antigen assays for the detection of congenital or acquired antithrombin deficiencies on a variety of automated coagulation analyzers: chromogenic activity methods targeting factors Xa or IIa, and an immunoassay for antigen quantitation.
Orlando C, Heylen O, Lillens W, et al. Antithrombin heparin binding site deficiency: a challenging diagnosis of a not so benign thrombophilia. Thromb Res. 2015;135:1179-85.
Kovacs B, Bereczky Z, Olah Z, 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.
Gindele R, Selmeczi A, Olah Z, et al. Clinical and laboratory characteristics of antithrombin deficiencies: a large cohort study from a single diagnostic center. Thromb Res. 2017;160:119-28.
More information on the assay’s sensitivity can be found in the brochure.
Not available for sale in the U.S.
Dependent upon individual analyzer performance.
Van Cott E, Orlando C, Moore GW, Cooper PC, Meijer P, Marlar R. Recommendations for clinical laboratory testing for antithrombin deficiency; communication from the SSC of the ISTH. J Thromb Haemost. 2020;18:17-22.
Rühl H, Reda S, Müller J, et al. Activated factor X-based versus Thrombin-Based Antithrombin Testing in Thrombophilia Workup in the DOAC era. Thromb Haemost. 2018;118:381–7.
Merz M, Böhm-Weigert M, Braun S, et al. Clinical multicenter evaluation of a new FXa-based Antithrombin assay. Int Jnl Lab Hem 2011;33:498-503.
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.
Product availability varies from country to country and is subject to varying regulatory requirements.
Atellica, Berichrom, BCS, INNOVANCE, PSI, 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.
CN Systems refers to Automated Blood Coagulation Analyzer CN-3000 and Automated Blood Coagulation Analyzer CN-6000. CN-3000 and CN-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-660 refers to Automated Blood Coagulation Analyzer CA-660.