Chemical Warfare Agent (CWA) Lightweight Field-Portable (Hand-Held) Medical Diagnostic Tool

The U.S. Army Medical Research Acquisition Activity at Fort Detrick, MD awarded an SBIR Phase I contract to Rapid Pathogen Screening, Inc. (RPS) in May 2006. The overall objective of this SBIR topic is to develop a lightweight field-portable (i.e., hand-held) device that fulfills a two-fold purpose as follows: (1) it will detect/identify Chemical Warfare Nerve Agents (CWNAs) of operational concern and (2) it will be used as a diagnostic tool by appropriate medical professionals to rapidly screen for and to identify those individuals who have been exposed to CWNAs and determine those individuals who require treatment. The primary purpose of this device will be diagnostic testing of biomedical samples (e.g., urine) for the presence of nerve agent metabolites. The Phase I focus and objective was to develop a detailed plan which articulated an effective strategy to formulate a diagnostic tool with the capability to detect/identify CWNAs. In accomplishing the objective of this Phase I project, six sub-objectives (tasks) were achieved. They were the following: (1) define the operational and technical (analytical) requirements for a CWNA medical diagnostic tool; (2) select target CWNA metabolites for detection; (3) develop technical specifications and quality control (QC) procedures to verify the function of the diagnostic tool against the technical specifications; (4) research and identify biological reagents for CWNA detection; (5) select measures for target pre-concentration and/or derivatization; and, (6) develop detection strategy and prototype design for the CWNA medical diagnostic device. The technical objective of the SBIR Phase II program will be to produce a proof-of-concept medical diagnostic tool that can demonstrate the capability to detect/identify multiple agents in the nerve agent class. In addition, an automatic reader and communications device will be demonstrated that presents the test results of the device. Integral to this overall objective of the SBIR Phase II effort will be the evaluation of the device for sensitivity and specificity by the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD).