Clinical Evaluation of Thromboembolic Samples with the New HemosIL™ D-Dimer HS and the HemosIL™ D-Dimer Assays on the ACL TOP

Abstract number: P0285

Morelli¹ B, Stefanin¹ C, Sales² M, Arza² B, Spagnotto³ M

¹¹Hematology Laboratory, Legnano Hospital, Italy, ¹¹Hematology Laboratory, Legnano Hospital, Italy, ²²Biokit, Barcelona, Spain, ³³Instrumentation Laboratory, Milano, Italy

For clinical purposes D-Dimer determination can be used to rule out the diagnosis of thromboembolic disease, thereby avoiding the unnecessary exposure of many patients to invasive tests and anticoagulant therapy. The last developments in D-Dimer test are focused on latex agglutination assays because they are fast and easy to perform. The HemosIL™ D-Dimer and the HemosIL™ D-Dimer HS are latex enhanced turbidimetric immunoassays from Instrumentation Laboratory (IL). The last one is specially designed to work on the ACL TOP automated coagulation analyzer from IL using the 671 nm wavelength channel. The reagent consists of a latex suspension coated with the F(ab')₂ fraction of a specific monoclonal antibody directed against D-Dimer. The purpose of this study was to compare the results obtained with the HemosIL™ D-Dimer HS to those obtained with the HemosIL™ D-Dimer on the ACL TOP, using well characterized samples. To this end 166 patient samples including 32 disseminated intravascular coagulation, 11 deep venous thrombosis and 17 pulmonar embolism were evaluated with both reagents on the ACL TOP. All these positive diagnosed samples were clearly positive with D-Dimer HS and the D-Dimer and both reagents compared well (r= 0.961, y = 1.05x - 4.3 by Passing and Bablok). In addition other 20 Rheumatoid Factor (RF)-positive samples were separately tested. As expected, no RF interference was obtained with the new HemosIL™ D-Dimer HS. To conclude, this study confirms the clinical usefulness of HemosIL™ D-Dimer and HemosIL™ D-Dimer HS in the safe and rapid diagnosis of venous thromboembolism and deep venous thrombosis.