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

Various methods and techniques have been developed in the laboratory for the detection and identification of exposure to chemical warfare nerve agents (CWNAs). A broad range of analytical methods is available to screen urine, blood or body tissues for traces of CWNAs or their breakdown products. Laboratory-based methods allow the differentiation between CWNAs and non-CWNAs that are used in agricultural applications. These laboratory-based methods also demonstrate detection sensitivities down to the pg/ml level. Laboratory-based medical diagnostic systems for CWNAs have several limitations. Sample preparation and analysis phases are relatively time and labor intensive which make it difficult to use the technology in acute exposure cases for immediate countermeasures or treatment of patients. Furthermore, laboratory instruments require certain environmental conditions, external power supply, warm-up time, regular maintenance cycles and calibra-tion routines. These requirements make it nearly impossible to use these instruments in a less controlled or field environment. The overall objective of this small business innovation research (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 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 the device will be diagnostic testing of biomedical samples (e.g., urine) for the presence of nerve agent metabolites. A potential solution for meeting the overall objective of this SBIR topic is leveraging the patented lateral flow immunoassay technology of Rapid Pathogen Screening (RPS), in combination with appropriate integrated modules for sample collection and sample preparation, to produce a powerful tool for rapid field diagnosis and detection of CWNAs. The objective of this SBIR Phase I effort will be to develop a detailed plan which articulates an effective strategy to formulate a diagnostic tool with the capability to detect/identify CWNAs. The Phase I effort will provide focus for DoD regarding what type of strategy should be implemented to formulate a medical diagnostic tool that is lightweight and field-portable with the capability to detect/identify CWNAs.