Ortho-Clinical Diagnostics, Inc

Eastman-Kodak Company

James D Kanaley

Zhong Ding

Edward R Scalice

David Angelo Tomasso

Philip C Hosimer

Timothy C Warren

David A Tomasso

Daniel P Salotto

David Allen Heavner

Susan Danielson

Geraldine Ann Pelanek

Robert W Zercie

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

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

An assay device includes: a liquid sample zone; a reagent zone downstream and in fluid communication with the sample zone containing a reagent material; a detection zone in fluid communication with the reagent zone having capture elements bound thereto; and a wicking zone in fluid communication with the capture zone having a capacity to receive liquid sample flowing from the detection zone. The sample receiving zone, the reagent zone, the detection zone and the wicking zone define a fluid flow path and at least a part of the fluid flow path has a substrate and projections which extend substantially vertically from the substrate, wherein the projections have a height, cross-section and a distance between one another that defines a space between the projections capable of generating capillary flow parallel to the substrate surface. In addition, the fluid flow path having projections includes a corner section which changes the direction of the flow path. The projections in or around the corner section are modified to maintain the configuration of the flow front of the sample flowing through the flow path after the corner is substantially the same configuration as before the corner.

Assay device having uniform flow around corners

A buffered composition includes whole chlamydial or gonococcal organisms or an antigen thereof, and a nonionic fluorinated surfactant in an amount of at least about 0.05 weigh percent. This composition is useful in a positive control test used in diagnostic assays for chlamydial or gonococcal organisms. It is particularly useful when coated in an article used in such assays, such as disposable test devices having nonionic polyamide filtration membranes in the bottom of test wells.

Buffered composition, coated article test device and a method for their

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Honeoye Falls, NY, United States of America

James D Kanaley