Intended use: HemosIL D-Dimer HS is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP* for use, in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE).
Principle: Suspension of polystyrene latex particles of uniform size coated with the F (ab') 2 fragment of a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. The use of the F (ab') 2 fragment allows a more specific D-Dimer detection, avoiding the interference of some endogenous factors like the Rheumatoid Factor. When a plasma containing D-Dimer is mixed with the Latex Reagent and the Reaction Buffer, the coated latex particles agglutinate.
Vials and volumes:
- 3 x 2 mL Latex Reagent (lyo)
- 3 x 8 mL Reaction Buffer (liq)
- 2 x 1 mL D-Dimer Calibrator (lyo)
*ACL, ACL TOP, and HemosIL are trademarks of Instrumentation Laboratory.