D-dimer IVD, kit, immunochromatographic test (ICT), rapid
Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of D-dimer protein in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses as an aid in the diagnosis of conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), or disseminated intravascular coagulation (DIC). It is not intended to be used for self-testing.