PalmStat: a self-contained point of care diagnostic platform

DESCRIPTION (provided by applicant): Point of care testing is a test that is performed near or at the site of care. In addition it has come to imply a rapid turnaround time, ease of use and convenience for the patient. Traditional Point of Care single usecartridge tests are lateral flow immunoassay tests where the capture antibody is labeled with a chromagen, which allows for a positive reaction to be read as a color change on a strip. A novel Point of Care device the PalmStat has been invented which allows for the enhanced detection of targeted antigens. The unique elements of this self-contained hand-held device are its ability to concentrate antigen increasing assay sensitivity and specificity. The patented flow through design of the PalmStat device enables capture of greater quantities of antigen, removal of interfering substances and multiplexing of detection antigens. The first pathogen that will be targeted with the PalmStat device is Trichomonas vaginalis, a leading cause of sexually transmitted disease (STD) in women implicated in pre-term labor and urethritis in men. There are 3 to 5 million cases per year in North America and 180 million worldwide of T. vaginalis infection. Successful treatment of this infection, once diagnosed, can be performed using metronidazole or similar relatively low cost antimicrobial agents. Current methods of detection include culture and microscopy (wet mount) of vaginal samples. Molecular testing is not readily available but includes PCR and Transcription Mediated Amplification (TMA). Monoclonal antibodies for the detection of T. vaginalis in urine have been developed and characterized by Dr. John Aldrete of Washington State University (WSU) and will be utilized in the development of the PalmStat device. We will perform an optimization of these reagents and following this optimization we will fabricate and produce a prototype Trichomonas vaginalis PalmStat device, i.e. the TvPalmStat. Six functioning prototype TvPalmStat devices will be used for preliminary studies of thesensitivity and specificity of the TvPalmStat. In addition, these will be evaluated for ease of use and design considerations. The unique capabilities of this device which include a design which forces the correct sequence of the assay, the ability to testurine without a centrifugation step, and ease of use makes this device ripe for worldwide detection of T. vaginalis. A single use, inexpensive, disposable device, which can multiplex antigens for the detection of other STDs would have a significant impacton global health. PUBLIC HEALTH RELEVANCE: We propose the development of a new device, the PalmStat, that permits the enhanced detection of pathogens by Point of Care testing, i.e. a test performed near or at the site of clinical care. A diagnostictest for Trichomonas vaginalis, a sexually transmitted disease which infects 3 to 5 million people in the United States annually will be the first diagnostic test developed using the PalmStat device. The PalmStat can be adapted for the diagnosis of multiple sexually transmitted infections, providing a single use, inexpensive, disposable device for the detection of these diseases which would have a significant impact on global health.