SBIR-STTR Award

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.

Thesaurus Terms:
ABO(H) blood groups, biomedical equipment development, blood group incompatibility, blood test, erythrocyte, immunohematology agglutinin, blood transfusion, cell differentiation human tissue

This is a Phase II STTR application for funds to build, test, and optimize a full-size prototype of RAFT (Rapid Automated Flow cytometric Testing), a novel device for rapid, automated blood typing and compatibility testing. Phase I Aims of performing blood bank testing with inert filter membranes have been exceeded using RAFT in the manual format. RAFT is 1) accurate, sensitive, rapid, and capable of both batch and "stat" testing, 2) protected under patents pending, and 3) capable of being fully automated. For complete "walk away" automation, RAFT will require the assembly of 4 major component systems: 1) robotic liquid handling system, 2) proprietary RAFT reaction chamber module, 3) flow cytometric analysis station, and 4) computer software package to control sample processing and data interpretation. Proof-of-concept for components of the automated RAFT workstation has been achieved. The Phase II Specific Aims are: 1) To fabricate and assemble a fully-automated immunohematology workstation integrating the proprietary RAFT filter and vacuum particle exclusion technology, and 2) To optimize the clinical performance of the automated RAFT platform sufficiently to begin a multi-center clinical investigation. The results of the multi-center trial (to be completed during Phase Ill) will lead to an FDA 510(k) application.

Thesaurus Terms:
ABO(H) blood groups, biomedical automation, biomedical equipment development, blood group incompatibility, blood test, erythrocyte, flow cytometry, immunohematology agglutinin, blood transfusion, cell differentiation clinical research, human tissue