Varian, Inc.

Ansys Technologies, Inc.

Other

Ansys, Inc.

Roche Diagnostic Systems, Inc.

Steven S Bachand

Dennis D Blevins

Lawrence C McPhee

Geoffrey R Anderson

Robert Lee Grenz

Stephen Schultheis

Steven P Sidewell

Jane Tsai

John L Robertson

Stephen K Schultheis

Lee Huu Nguyen

John A Faux

R Keith Galloway

A method of producing a binding assay device provides a porous membrane comprising a material enabling capillary movement of a liquid sample from a first area on the membrane on a second area on the membrane. A detection site is disposed on the membrane between the first and second areas in a non-absorbent medium disposed on the membrane between the detection site and the membrane first area is attached by an adhesion with a dry reagent disposed between the medium and the membrane in order to enable mobilization of the reagent by passage of a liquid sample therepast.

Binding assay device with non-absorbent carrier material

A visual perception of a colored site in an immunoassay device comprising a strip for enabling capillary migration of a fluid sample therealong, a labeled reagent disposed on the strip and formulated for suspension in the sample migrating therepast and a captive reagent immobilized on the strip in a path of sample migration and formulated to bind to is enhanced by changing a color of the strip to the color which is complimentary to the colored site.

Method of detecting an analyte for lateral flow immunoassay tests

A binding assay device includes a porous membrane comprising a material enabling capillary movement of a liquid sample from a first area on the membrane on a second area on the membrane. A detection site is disposed on the membrane between the first and second areas in a non-absorbent medium disposed on the membrane between the detection site and the membrane first area is attached by an adhesion with a dry reagent disposed between the medium and the membrane in order to enable mobilization of the reagent by passage of a liquid sample therepast.

A multiple analyte assaying device includes a casing having a pocket portion adapted to capture or contain a predetermined volume of fluid specimen to be assayed. Disposed within the casing is a sample receiving pad and one or more reagent test strips. The pocket portion of the casing includes a feed element having multiple feed inlets, or alternatively, a single feed slot. The feed element provides pressure against the sample receiving pad. The pressure against the pad and a small size of the inlet or inlets are effective in controlling a rate of fluid release of the specimen to the sample receiving pad. The casing includes observation windows or alternatively a clear plastic view area for enabling observation of reagent zones of the test strips. The device is structured and adapted to enable a technician to capture the appropriate volume of fluid specimen in the pocket portion by submerging or dipping a portion of the device into a fluid-filled collection container for a brief period of time. The device includes a rail depending from the casing for elevating the dampened portion of the casing when the device is placed on a level surface.

Multiple analyte assaying device with a multiple sample introduction system

A lateral flow immunoassay device includes a membrane strip for enabling capillary migration of a sample therealong with a labeled reagent disposed on the membrane. The label reagent is formulated for suspension in the sample migrating therepast. A captive reagent is immobilized on the strip on a path of sample migration and the captive reagent is formulated to bind to the labeled reagent to form a visible colored site on the strip. An element is provided for changing the strip to a color which enhances visual perception of the colored site.

Color contrast system for lateral flow immunoassay tests

A saliva sampling device includes an expresser cup, an absorbent foam swab capable of absorbing a fluid specimen, and a flexible tether affixed to the foam swab. The foam swab is used to collect a sample of a fluid specimen such as saliva, and the tether is adapted to enable a user to sanitarily draw the saturated foam swab into the expresser cup in which the foam swab becomes compressed: and the absorbed fluid is expressed therefrom in a drop by drop fashion. The device also may include a platform having a reagent strip for absorbing the expressed fluid to reveal test results. The device may also include a divider for separating the expressed fluid into two or more aliquots prior to the testing thereof such that one of the aliquots may be used for confirmation or later testing of the fluid. In one embodiment, the expresser cup includes a conical cross section to effect gradual compression of the foam swab.

Saliva sampling device

A saliva testing and confirmation device generally includes an expresser cup adapted to receive and compress a foam collection swab pressed into the cup. The swab includes a sponge or foam portion capable of absorbing a fluid specimen such as saliva, and a generally rigid handle for facilitating manipulation thereof. The device also includes a testing and confirmation platform integral with the expresser cup. A channel or groove in the cup is provided for directing a flow of expressed fluid from the expresser into both a test well and a confirmation well. A lateral flow reagent test strip, in fluid communication with the test well may be encased in the platform and partially revealed for analysis of test results. The confirmation well includes a fluid tight cap having a tamper evident seal.

Saliva testing and confirmation device

A saliva testing and confirmation device generally includes an expresser cup adapted to receive and compress a foam collection swab capable of absorbing a fluid specimen such as saliva. The device also includes a testing and confirmation platform integral with the expresser cup. A channel or groove in the cup is provided for directing a flow of expressed fluid from the expresser into both a test well and a confirmation well. A lateral flow reagent test strip, in fluid communication with the test well may be encased in the platform and partially revealed for analysis of test results. The confirmation well includes a fluid tight cap having a tamper evident seal.

An assaying device and a method of manufacturing same are provided. The assaying device includes a unitary, absorbent membrane having multiple reagent stripes incorporated therein. The reagent stripes display an observable reaction if a sample component is present in a fluid sample being tested. The reagent stripes are deposited simultaneously on a continuous membrane ribbon and individual membranes are die cut therefrom. Each individual membrane includes commonly connected channels having die cut slots therebetween. The channels are preferably disposed perpendicularly with respect to the reagent stripes and provide means for causing contact between the fluid and reagent stripes. The present invention preferably includes a cassette for containing the membrane and for facilitating analysis of test results. During assembly of an assaying device, the unitary membrane is easily inserted into the cassette by engaging the slots with ridges in the cassette, thus minimizing a chance of error of alignment of the channels. The present invention is suitable for multiple component qualitative analysis as well as semi-quantitative analysis.

Method of manufacturing an assaying device

A urine collection cup device is provided including a clear plastic cup, a reagent strip disposed against an inner surface of the cup and adhered thereto by means of a plastic laminate or adhesive member. An aperture is provided in the adhesive member on a sample introduction end of the reagent strip to enable a fluid sample to be introduced onto the reagent strip. By capillary action the fluid migrates up the reagent strip and causes a visible indication of test validity and test results. A second aperture covered with a hydrophobic material is provided adjacent the reagent strip end to enable air to vent from the strip while preventing fluid specimen from entering therein.

Urine collection cup

Assaying device

Die cut reagent membrane, holder

An assaying device is provided for both collecting and analyzing a sample which includes a container and an opening for collecting the sample in a chamber for storing the sample. A cap is provided for sealing the container opening and at least one assay system is attached to the container for chemically analyzing the sample. A channel is provided for enabling a portion of the sample to enter the assay system upon a change of orientation of the container. A tamper-proof device is provided through the use of a releasable seal which permits the sample to enter the assay system only when desired.

Growing community of inventors

Laguna Niguel, CA, United States of America

Steven S Bachand