Description Enzyme immunoassay for the quantitative determination of D-dimer in human serum and plasma samples. Quality controls are included with the kit. Developed and manufactured in Europe by PromedeusLab. Summary D-dimer, the final degradation product of cross-linked fibrin, is typically elevated in patients with acute venous thromboembolism (1). D-dimer testing is an integral part of validated algorithms for the diagnosis of deep-vein thrombosis (DVT) and pulmonary embolism (PE) (2). Other Names D Dimer, D-dimer fibrin degradation product (FDP), D-dimer FDP Principle of Method The microtiter plate is coated with the antibody specifically binding the D-dimer. The human serum or plasma is incubated in the plate with the capture antibody. The specimen is washed out and the specifically bound protein is incubated with biotin-labelled detection antibody. Following another washing step, Streptavidin-HRP conjugate is added into the well. Unbound reagent is then washed out. Horseradish peroxidase (HRP) bound in the complex reacts with the chromogenic substrate (TMB) creating the blue colour. The reaction is stopped by addition of STOP solution (H2SO4). The absorbance values are measured at 450 nm (optionally 450/630 nm) and are proportional to the concentration of D-dimer in the specimen. The concentration of D-dimer in unknown samples is determined from the calibration curve which is created by plotting the absorbance values against the standard concentration values. Sample Types Serum, Plasma Typical Standard Curve Assay Range: 5 ng/mL - 160 ng/mL Sensitivity The limit of detection, defined as a concentration of human D-DIMER giving absorbance higher than absorbance of blank +3 standard deviations, is better than 1.25 ng/mL of sample. Precision Intra-Assay Test sample Mean (ng/mL) SD CV 1 75 5.1 7% 2 67 4.6 7% Inter-Assay (Run-to-Run) Test sample Mean (ng/mL) SD CV 1 18 0.8 4% 2 95 8.3 9% Accuracy Dilution Linearity: Test sample Dilution Measured Concentration (ng/mL) Expected Concentration (ng/mL) Yield 1 75 - - 1 2x 38 38 101% 1 4x 19 19 99% 1 8x 9 9 95% 2 66 - - 2 2x 34 33 102% 2 4x 16 17 95% 2 8x 8 8 98% Spiking Recovery: Test sample Spike (ng/mL) Measured Concentration (ng/mL) Expected Concentration (ng/mL) Yield 1 - 52 - - 1 120 147 172 86% 1 60 99 112 89% 1 30 68 82 84% Storage The kit must be stored at 2–8 °C. The opened components can be stored for one week at 2–8 °C. Usage This assay is for in vitro research use only and is not for use in diagnostic procedures. Resources Product Datasheet (PDS) Summary References Prisco D, Grifoni E. The role of D-dimer testing in patients with suspected venous thromboembolism. Semin Thromb Hemost. 2009 Feb;35(1):50-9. doi: 10.1055/s-0029-1214148. Epub 2009 Mar 23. PMID: 19308893. WELLS, P.S. (2007), Integrated strategies for the diagnosis of venous thromboembolism. Journal of Thrombosis and Haemostasis, 5: 41-50. https://doi.org/10.1111/j.1538-7836.2007.02493.x Ilex Life Sciences LLC is an authorized distributor of PromedeusLab.
