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.
