NOVEL DEVICES FOR RAPID BLOOD COMPATIBILITY TESTING

The primary objective of these studies is to develop a novel device for rapid, cost-effective, and completely automated pretransfusion compatibility testing. This device will be of interest to Transfusion Medicine services and Blood Banks because it will improve testing throughput while cutting costs. Furthermore, applications are possible in other areas including platelet crossmatching and serological assays. The studies in this Phase I application will demonstrate proof of principle through development of prototypes incorporating our novel, proprietary technologies: DFS-columns and MCD-minidiscs. In the first studies, DFS-column design will be optimized for reproducible differentiation of agglutinated vs. non-agglutinated RBCs. Initial investigations clearly demonstrate the feasibility and likelihood of success with these studies. In the next investigations, MD Works, Inc. will develop MCD-minidiscs incorporating DFS technology (DFS/MCD-minidiscs). Extensive studies will be performed in the laboratory of the PI to compare optimized DFS/MCD-minidiscs with currently marketed testing devices for ABO/Rh(D) typing, antibody screens, and crossmatching. These studies will use both testing reagents and authentic clinical samples to demonstrate the advantages of immunohematology testing with the DFS/MCD-minidisc platform. After feasibility is demonstrated, Phase II funding will be sought to incorporate the DFS/MCD-minidisc prototype into a fully automated testing platform, and to initiate multicenter clinical trials. PROPOSED COMMERCIAL APPLICATIONS: The devices described in this application will be of interest to all blood banks. since this instrumentation will allow for rapid, inexpensive, and completely automated "walk-away" pretransfusion blood compatibility testing. Furthermore, modifications are envisioned for using the device for ELISA-type assays, or other assays which currently require a centrifugation step.