Ortho-clinical Diagnostics, Inc

Other

Zhong Ding

Edward R Scalice

David Angelo Tomasso

Daniel P Salotto

James Ellis Robinson

Philip C Hosimer

Raymond Francis Jakubowicz

Merrit Nyles Jacobs

Timothy C Warren

Andrew M Kirsch

James D Kanaley

Kory Adam Gunnerson

William Franklin Gottermeier

Aaron Michael Swick

David Allen Heavner

Susan Danielson

Amy M Wilson-Colley

Dale Robert Ryan

Mark Sawczuk

Joseph John Dambra

Randy Kristopher Bower

Ronald F Brookes

James D Shaw

Muhidin A Lelic

Theodore J DiMagno

David Bergman

Ed Graham

Benjamin Wojtasiewicz

Michael W Sundberg

Scott Steams

Scott Stearns

Philip C Hosmier

Johanna Julia-Trecaso Miller

Robert Seth Jones

Dave Heavner

Described herein are clinical diagnostics and more specifically to a lateral-flow assay devices.

Lateral-flow assay device with filtration flow control

A lateral-flow assay device includes a substrate having a sample addition zone and a wash addition zone downstream thereof along a fluid flow path through which a sample flows. The fluid flow path is configured to receive a wash fluid in the wash addition zone. A hydrophilic surface is arranged in the wash addition zone. Flow constriction(s) are spaced apart from the fluid flow path and arranged to define, with the hydrophilic surface, a reservoir configured to retain the wash fluid by formation of a meniscus between the hydrophilic surface and the flow constriction(s). The fluid flow path draws the wash fluid from the reservoir by capillary pressure. Apparatus for analyzing a fluidic sample and methods of displacing a fluidic sample in a fluid flow path of an assay device are also described.

Lateral-flow assay device having flow constrictions

Disclosed is an assay device which comprises a liquid sample addition zone, a reagent zone, a detection zone, and a wicking zone, all defining a fluid flow path. The device further comprises a reagent addition zone along and in fluid communication with the fluid flow path downstream of the sample addition zone and upstream of the detection zone. An interrupting wash is added at this reagent addition zone in accordance with the method of the subject invention to control sample volume. The interrupting wash fluid is added at a predetermined fill volume on the chip device and also serves to wash the detection channel and fill the remaining chip volume.

Assay device having controllable sample size

The present disclosure is directed to a method and apparatus for locating a target location on a reaction cell and using the target location to perform an assay. In an example embodiment, a method of performing at least one assay includes obtaining at least one image of a fluid sample located on a reaction cell and creating a set of derivative data including a plurality of derivative data points based on the at least one image. The method also includes determining an image gradient data point for each of the plurality of derivative data points and determining a target location of the fluid sample in the reaction cell based on the image gradient data points. The method further includes performing at least one assay using the target location of the fluid sample in the reaction cell.

Method and apparatus for selecting slide media image read location

The present disclosure is directed to a method and apparatus for performing an assay on a dry slide or other solid media using a reduced reading window. In an embodiment, method of performing at least one assay comprises obtaining an image of a fluid sample located on a dry slide, positioning a reading window to correspond to an area of the fluid sample in the image, determining an interference area within the reading window based on light intensity, reducing the reading window to eliminate the interference area from the reading window, and performing at least one assay using the reduced reading window.

Dry slide assay using reduced reading window

A method for performing an assay on a liquid sample for the detection of one or more analytes of interest in an assay device having a flow path which includes a sample zone and detection zone thereon includes: dispensing the sample onto the sample zone; combining the sample and a reagent, wherein the sample and reagent may be combined prior to addition of the sample to the sample zone or on the assay device, flowing the combined sample/reagent by capillary action into and through the detection zone having capture elements bound thereto, wherein a signal at least partially representative of the presence or concentration of analyte(s) is produced and detected; determining a reaction time or reaction volume; and determining the concentration of the analyte by using both the detected signal and the reaction time or reaction volume.

Calibrating assays using reaction time

A lateral-flow assay device includes a substrate with a sample addition zone and a fluid flow path. A cover supports a filter having a portion contacting the substrate to create a contact area that at least partly overlaps the sample addition zone. Another portion extends from the contact portion to the supported periphery of the filter to define with the substrate a reservoir configured to retain the filtrate by capillary pressure between the substrate and the extending portion. The reservoir volume is based on an acute angle formed between the substrate and the extending portion of the filter and on a fluid meniscus of the filtrate. The filter and sample addition zone are configured to provide capillary pressure drawing the filtrate from the reservoir to the sample addition zone. Methods for controlling flow characteristics in a lateral-flow assay device are also described.

A sample collection device for a fluid includes: a substantially disk-shaped body having a periphery; a capillary channel extending through the body and bounded by the periphery, having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; a sample collection well located in the vicinity of the second end and in fluid communication with the capillary channel; and an axis of rotation extending through the center of the disk and which is substantially perpendicular to the major surface of the disk-shaped body. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk is rotated in a first position.

Rotatable disk-shaped fluid sample collection device

Disclosed is method of improving flow of a liquid sample in an assay device, as well as a method of performing an assay on a liquid sample for the detection of one or more analytes of interest. The methods use the addition of a reagent, such as a wash reagent, to wet the fluid flow path of a sample prior to sample addition, thereby improving flow of the sample through the fluid flow path that has been wetted as opposed to flow of the sample through the fluid flow path that has not been wetted. The reagent wets the fluid flow path between the sample addition zone and the wicking zone.

Method of improving liquid sample flow in assay device

A method for providing quality control on a lateral flow assay device or for triggering a process-related step, the device including a substrate having at least one sample receiving area, at least one reagent zone downstream and in fluid communication with the at least one sample receiving area, at least one detection zone downstream and in fluid communication with the at least one reagent zone and at least one wicking zone downstream of the at least one detection zone, each fluidly interconnected therewith along at least one fluid flow path. The detection material provided in the at least one reagent zone produces a detectable signal that can be tracked and monitored prior to the completion of at least one test being performed on the lateral flow assay device.

Quality/process control of a lateral flow assay device based on flow monitoring

An assay device includes: a detection zone which includes a first set of projections which are capable of generating capillary flow. A wicking zone (WZ) has a capacity to receive liquid sample flowing from the detection zone and includes a second set of projections which are capable of generating capillary flow. The WZ is rectangular in shape and the longer side of the rectangle extends in the direction of flow to thereby reduce the pressure gradient in the assay device which increases the total flow time of liquid sample compared to a WZ having equal length sides and same volume. At least a portion of the second set of projections have at least one dimension selected from a diameter, a center-to-center spacing, or a gap between projections that is different from the first set of projections, and is selected to increase the total flow time of the sample.

Controlling fluid flow through an assay device

A lateral flow assay device includes a substrate having a top surface, as well as a sample receiving area disposed upon the top surface. At least one fluid flow path extends along the substrate from the sample receiving area, wherein the sample receiving area can be placed in contact with a peripheral reservoir formed at a sample addition area to draw sample therefrom in a controlled manner. The device can further include a reagent area that is designed to promote uniform dissolution of a deposited detection material by a sample moved through the device along the fluid flow path as well, as a flow channel configure to promote mixing of sample and reagent and an absorbing or wicking zone configured to affect various flow characteristics.

Lateral flow assay device

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Pittsford, NY, United States of America

Zhong Ding