INNOVANCE Antithrombin AssayState-of-the-art antithrombin testing
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.
Features & Benefits
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.
Efficient testing
- 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
Excellent precision
- 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
Stable reagents
- Efficient reagent management is accomplished by a convenient onboard stability combined with a kit size suited to individual lab needs.
Technical Specifications
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.
BUFFER
A ready-to-use liquid buffer containing preservatives.
Clinical Use
- 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.