Fibrinogen/Fibrin Degradation Products Assay

A Fibrinogen / Fibrin Degradation Products (FDP) assay is a diagnostic laboratory test that quantifies the concentration of fibrin fragments present in a blood sample. This measurement reflects the activity of the body’s intrinsic fibrinolytic system in breaking down blood clots. Increased levels of FDP may indicate the presence of conditions such as disseminated intravascular coagulation (DIC), deep vein thrombosis, or pulmonary embolism, which are characterized by abnormal clot formation and subsequent degradation.

A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).

Intended Use: The kit is an immuno-turbidimetric assay for quantitative determination of D-dimer in venous plasma, used in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism and deep venous thrombosis in outpatients suspected of PE(pulmonary embolism ) or DVT(deep venous thrombosis) It measures D-Dimer in human citrated plasma.

Device Description: The D-Dimer Reagent is a suspension of polystyrene latex particles coated with a monoclonal antibody specific for the D-Dimer domain in fibrin-soluble derivatives. This method allows for more precise detection of D-Dimer, avoiding interference from endogenous factors like the Rheumatoid Factor. When a plasma containing D-Dimer is mixed with the Latex Reagent and Reaction Buffer, the coated latex particles agglutinate, which is directly proportional to the concentration of D-Dimer in the sample. The D-Di kit includes Tris buffer and a suspension of microlatex particles coated with two different mouse monoclonal anti-human D-dimer antibodies. The test principle involves an antigen-antibody reaction, leading to an agglutination of the latex particles, increasing turbidity and absorbance, which is measured photometrically.

• Expected value and range.
• Precision/Reproducibility
• Detection studies
• Linearity/assay reportable range
• Analytical Specificity/Interference
• Traceability (controls, calibrators, or method)
• Recovery
• Analytical Sensitivity

The same is applicable for CE Marking under IVDR also.

Clinical Testing is mandatory for 510k submission and IVDR CE Marking