Development of a Hand Held Molecular Point-Of-Care Test Device for Infectious Diseases

Development of a Hand Held Molecular Point-Of-Care Test Device for Infectious DiseasesPublic Health

ABOUT THE PROJECT

The project aims to develop a novel, single use, hand-held point-of-care test (POCT) device that addresses the program of lag in result turn-around times typically faced by remote facilities. The new POCT device will employ customizable assays providing diagnostics for a broad array of pathogens. The POCT device will house all of the reagents and components necessary to perform elution from the swab, pathogen lysis and release of nucleic acids, amplification of specific gene targets and detection providing results (positive or negative) displayed on the device within 20 minutes.

RESEARCH ABSTRACT

In most countries the diagnosis of infectious diseases is performed in hospital laboratories. Some facilities do not have the equipment or expertise on site and specimens must be sent to regional or public health laboratories resulting in a delay in getting results. This problem is aggravated in rural areas of remote mountainous locations. These delays can lead to misdiagnosis and improper treatment, putting patients at risk. Clearly, global healthcare would benefit from the availability of tools to shorten diagnostic times. New molecular diagnostics platforms developed for hospitals rely on expensive and complex benchtop instruments and are restricted to use in laboratories with trained personnel. These platforms fail to address the lag in result turn-around times faced by smaller facilities and do now allow diagnosis in remote areas. We are developing a novel, single use, hand-held point-of-care test (POCT) device that addresses this problem. Our POCT device will employ customizable assays providing diagnostics for a broad array of pathogens. The device utilizes a swab collected from a patient that is inserted into a self- contained and hand-held device that will be inexpensive and easy to use. No ancillary equipment will be needed. This system capitalizes on isothermal amplification that enables rapid detection of pathogens at a single temperature.

The POCT device will house all of the reagents and components necessary to perform elution from the swab, pathogen lysis and release of nucleic acids, amplification of specific gene targets and detection providing results (positive or negative) displayed on the device within 20 minutes.