Epitope Limited

Orasure Technologies, Inc.

Hydradx, Inc.

Other

Andrew S Goldstein

Thomas R Thieme

Ronald William Mink

Stephen C Piacentini

Nanette M Klimkow

Robert C Bohannon

Stefan Gavojdea

David F Zogg

Frank Bellizzi

Denis R Burger

Jack H Fellman

Sharon L Livingood

Edward Anthony Bezek

Douglas Logan

Charles Edward Bergeron

Timed sensing of collection of saliva in a liquid collection element of predetermined volumetric capacity may be used to determine salivary secretion rate, as may be indicative of state of euhydration or dehydration. Sensing of salivary flow rate may be further augmented by sensing concentration of at least one analyte in saliva (e.g., with an immunochromatographic assay performed in a lateral flow device) in order to determine a state of euhydration or dehydration. Production of saliva may be stimulated, and collected saliva may be analyzed to generate an analyte detection signal that indicative of presence and/or correlative of concentration of at least one analyte in the collected saliva to sense a state of euhydration or dehydration.

Diagnostic device and method for sensing hydration state of a mammalian subject

A method for rapid collection and assay of oral fluids is disclosed. The method comprising the steps of: (a) placing an assay device into an oral cavity, (b) removing said assay device from said oral cavity; and (c) determining the presence or absence of at least one analyte. The assay device used in the method comprises: (i) an assay portion housing an immunochrornatographic lateral flow assay strip, the lateral flow assay strip containing at least one reagent selected from an antigen and an antibody that is used to detect one of the presence or absence of at least one analyte in a fluid; (ii) a neck portion extending from the assay portion, the neck portion forming a channel for delivery of fluid to said assay strip and the channel being defined by a first, narrow part proximal to the assay portion and a second part including an opening for receiving the oral fluid, wherein the second part includes a channel width that is substantially wider than the channel width at the narrow end; (iii) a collection strip in fluid communication with the lateral flow assay strip, the collection strip having a first portion disposed within the channel and a second portion protruding outwardly from the neck portion opening; and (iv) a blocking strip coupled between and in flow communication with the lateral flow assay strip and the collection strip.

Device for collection and assay of oral fluids

This invention provides for a rapid and convenient method of simultaneous collection of both genomic and diagnostic information from a single sample on a bibulous pad by differential extraction of the diagnostic information from the genomic information. It is a surprising discovery of this invention that a PCR assay on the contents of the bibulous pad provides results comparable in reliability, specificity, and sensitivity to the best available serum (blood) based assays. The assays of this invention can be used to confirm each other, either by detecting the genomic information leading to the diagnostic information, or by detecting in the genomic information, a predisposition to a disease and confirming the presence of the disease through diagnostic testing.

Simultaneous collection of DNA and non-nucleic analytes

A device for collecting and transporting aqueous fluid from the oral cavity to a lateral chromatographic strip for test is disclosed. The lateral chromatographic strip is placed within and extend along a cavity defined in a housing. At least one inspection site to the lateral chromatographic strip is provided to enable inspection of selected sites on the lateral chromatographic strip for test results. A porous wick material protrudes from the housing to a collection site exterior of the housing at one end and communicates to the lateral chromatographic strip at the other end. The porous wick material has particulate construction, the particles adsorbing aqueous oral fluid to transport the fluid from the mouth to the lateral chromatographic strip without substantial absorption. The particles of the porous wick material are bound together to define a continuous interstitial volume for the flow of oral fluid to be transported and are treated to be hydrophilic to the adsorbed oral fluids. The porous wick material readily releases oral fluid to the lateral chromatographic strip. Prevention of reverse flow to the oral cavity from the lateral chromatographic strip naturally occurs due to the circuitous flow path of the porous wick material. A bite plate is coupled to the housing and insertable between the teeth of the patient to position the porous wick in the oral cavity for collecting the oral fluid. The bite plate is typically held in place by the occlusal force of the teeth, preferably the molars and/or the bicuspids, to position the porous wick in the buccal space. By observing the lateral chromatographic strip while the test device is in the mouth immediate test results are obtained.

An apparatus and process for transporting and discharging biohazardous materials is disclosed. A vial is provided having an interior for receiving biohazardous contents. The vial is sealed at one end by a frangible tip for forming an opening in the vial upon breaking of the frangible tip. The vial includes a cap at the opposite end of the vial for sealing the vial when a biohazardous sample contained in a porous absorbent member is placed interior of the vial. A centrifuge tube is provided with an upper opening having a dimension to be plugged when the vial is placed into the centrifuge tube. The centrifuge tube has flexible sidewalls to permit digital manipulation of the frangible tip of the vial by the sidewalls of the centrifuge tube. The vial is placed within the centrifuge tube to plug the tube. Once the vial is within the tube, the tube is digitally manipulated to break the frangible tip of the vial by compressing sidewalls of the centrifuge tube to break the frangible tip of the vial interior of the centrifuge tube. Thereafter, centrifuging the centrifuge tube and vial with broken frangible tip occurs. This causes the biohazardous material to discharge from the porous absorbent member and vial into the centrifuge tube for further processing.

Flexible centrifuge tube having bio-containment function

A device for collecting substances for testing comprises a vial having a first, generally open end, engageable by a removable closure member, and a second, generally closed end. A removable closure member is provided having first and second ends. The first and second ends of the closure member are engageable with the first end of the vial. An absorbent member is preferably attached to the removable closure member and is receivable in the vial whereby the absorbent member is located outside of the vial prior to use, with the first end of the vial being secured to the second end of the closure member to provide a handle, and after use, the second end of the closure member is removed from the first end of the vial, the closure member is inverted, the absorbent member is inserted into the vial and the first end of the closure member is removably engaged to the first end of the vial.

Device for collecting substances for testing

A device for obtaining oral fluid containing substances for testing. In one embodiment, the device includes a syringe having a plunger at the end of which an absorbent pad is attached. A test assembly containing the device is also disclosed.

Oral collection device and kit

A substitute oral fluid standard for testing, calibration, and standardization of devices and methods for collection, storage, and analysis of oral fluids. The oral fluid standard comprises a mucin and a protease inhibitor.

Synthetic oral fluid standard

A substitute saliva standard for use in testing, calibration, and standardization of devices and methods for collecting and analyzing oral fluids.

Growing community of inventors

Portland, OR, United States of America

Andrew S Goldstein