Rickettsiae Detection Dipstick

To address the Army need for a handheld, field-usable assay capable of diagnosing rickettsial disease in soldiers to aid early treatment, Physical Optics Corporation (POC) proposes to develop a new Rickettsiae Detection Dipstick (RDD). The RDD is based on a combination of lateral flow immunochromatography technology and lab-on-chip principles. The RDD assay will rapidly (10 min) differentiate between spotted fever group (SFG) and typhus group (TG) Rickettsiae by detecting rickettsial antigens in blood. The RDD will be inexpensive, not require power or special storage conditions, and have at least 85% of the sensitivity and specificity of current gold-standard assays. All that is necessary to perform the assay is prepackaged in a kit. The one-step assay protocol is easy to perform and the results are easily interpreted by minimally trained personnel. In Phase I, POC will demonstrate RDD feasibility by fabricating the dipstick and demonstrating its capability to identify inactivated SFG and TG Rickettsiae in blood, as well as provide 100 assays for testing at NMRC. In Phase II, POC plans to optimize the RDD design and performance parameters, and perform extensive testing to provide the required level of sensitivity and specificity, and pursue FDA approval in Phase III.