Quantitative determination of the Thrombin/Antithrombin III-complex - in vitro ELISA-Assay
The conversion from prothrombin to thrombin is an essential incident in the coagulation cascade. Thrombin has effects on different physiological substrates and is inhibited by antithrombin III forming an inactive complex, the thrombin-antithrombin-III-complex (TAT).1
Persons predisposed to thrombosis, and disseminated intravascular Coagulation (DIC) patients, are found to have elevated concentrations of TAT.2, 3
Coagulation associated with blood contacting devices and materials occurs through the contact activation pathway, culminating in the formation of active thrombin which subsequently catalyses the formation of fibrin.
The presumption for testing medical devices is that appropriate materials and device designs should not be associated with excessive coagulation activity that could bring risk to the patient. High levels of coagulation activity may be an indicator of a higher tendency for the material or device to induce or be associated with acute thrombosis or thromboembolism. Thus increased TAT levels caused by blood material contact indicate an elevated thrombogenic potential.
A TAT-ELISA used for the quantitative determination of the thrombin-antithrombin III complex1 in human plasma therefore serves for the diagnosis of disturbances in blood coagulation, which are associated with changes in the activity of the coagulation system.
The TAT tests are performed in accordance with the ISO guidelines 10993-14, 10993-45 and 10993-126 at Eurofins BioPharma Product Testing Munich GmbH.
Procedure
Human whole blood samples are incubated with the test item. After Incubation the Plasma is gained from the blood samples and used to determine complement component concentration using an ELISA based method.
Historical Data
Historical data were generated from 2018 to 2021.
References
- Pelzer, H. et al.: Determination of Human Thrombin-Antithrombin III Complex in Plasma with an Enzyme-Linked Immunosorbent Assay, Thromb. Haemostasis 59, 101 (1988)
- Blanke, H. et al.: Die Bedeutung des Thrombin-Antithrombin III Komplexes in der Diagnostik der Lungenembolie und der tiefen Venenthrombose – Vergleich mit Fibrinopeptid A, Plättchenfaktor 4 und
ß-Thromboglobulin, Klin. 65, 757 (1987) - Hoek, J. A. et al.: Laboratory and Clinical Evaluation of an Assay of Thrombin-Antithrombin III Complexes,
Chem. 34 (10), 2058 (1988) - ISO 10993-1: “Evaluation and testing within a risk management process”
- ISO 10993-4: “Selection of tests for interactions with blood”
- ISO 10993-12: “Sample preparation and reference materials”
- Winter WE, Flax SD, Harris NS. Coagulation Testing in the Core Laboratory. Lab Med. 2017 Nov 8;48(4):295-313. doi: 10.1093/labmed/lmx050.
