DIN/TR 13284:2025-03

In vitro diagnostic medical devices (IVD) in the field of coagulation are designed to help physicians to evaluate the patients' hemostatic balance, identify patients at risk of bleeding or thrombosis or to monitor pro- or anticoagulant therapy. Typically, this can be done by using semi-global assays including the prothrombin time (PT) and the activated partial thrombopastin time (aPTT) as well as specific assays looking at individual components, either procoagulant or anticoagulant. These IVD however do not provide a holistic picture of the patient’s status which results in the combination of counteracting pro- and anticoagulant factors. An ideal global assay in coagulation would integrate the complex interplay of pro- and anticoagulant activities, thus, reflecting the haemostatic balance of an individual and providing an accurate and clinically more relevant information in a single measurement as compared to a panel of specific assays. This technical report describes thrombin generation assays (TGA) as one of such assays, summarizing several options offered to properly run TGA, including a review of preanalytical and analytical items, performance, interpretation, and applications in physiology research, pharmacy and patient management. This technical report is a summarized, purely informative status report on requirements and recommendations made elsewhere in the technical literature, which are reproduced here for information purposes. This document does not contain any requirements or recommendations made of its own. This document has been prepared by Working Committee NA176-08-04 AA "Hämostaseologie" ("Haemostaseology") at DIN Standards Committee Health Technologies (NAGesuTech).