Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A sample collection device for a fluid sample includes: a body including a capillary channel having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; an air vent located in the vicinity of the second end and in fluid communication with the capillary channel; a barrier positioned within the capillary channel to prevent flow of the fluid by capillary action thereacross; and features on opposing sides of the body to form an axis of rotation, which is substantially perpendicular to the overall direction of the capillary channel from the first end to the second end. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a sample manipulation device to bring the first end into position with the sample manipulation device.

Abstract: 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.

Abstract: A sample collection device for a fluid sample includes: a body including a capillary channel having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; an air vent located in the vicinity of the second end and in fluid communication with the capillary channel; a barrier positioned within the capillary channel to prevent flow of the fluid by capillary action thereacross; and features on opposing sides of the body to form an axis of rotation, which is substantially perpendicular to the overall direction of the capillary channel from the first end to the second end. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a sample manipulation device to bring the first end into position with the sample manipulation device.

Abstract: 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.

Abstract: A lateral flow device for use in a mainframe or point-of-care clinical analyzer, in which the lateral flow device includes a planar support having at least one sample addition area and at least one reaction area disposed thereon. The sample addition area and reaction area are fluidly interconnected to one another and form at least one lateral fluid flow path. The lateral flow device is sized for retention within a storage cartridge of the analyzer defined by a hollow interior and having a plurality of lateral flow assay devices retained in stacked relation therein.

Abstract: A sample collection device for a fluid sample includes: a body including a capillary channel having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; an air vent located in the vicinity of the second end and in fluid communication with the capillary channel; a barrier positioned within the capillary channel to prevent flow of the fluid by capillary action thereacross; and features on opposing sides of the body to form an axis of rotation, which is substantially perpendicular to the overall direction of the capillary channel from the first end to the second end. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a sample manipulation device to bring the first end into position with the sample manipulation device.

Abstract: A lateral flow device for use in a mainframe or point-of-care clinical analyzer, in which the lateral flow device includes a planar support having at least one sample addition area and at least one reaction area disposed thereon. The sample addition area and reaction area are fluidly interconnected to one another and form at least one lateral fluid flow path. The lateral flow device is sized for retention within a storage cartridge of the analyzer defined by a hollow interior and having a plurality of lateral flow assay devices retained in stacked relation therein.

Abstract: 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.

Abstract: 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.

Abstract: A lateral flow device for use in a mainframe or point-of-care clinical analyzer, in which the lateral flow device includes a planar support having at least one sample addition area and at least one reaction area disposed thereon. The sample addition area and reaction area are fluidly interconnected to one another and form at least one lateral fluid flow path. The lateral flow device is sized for retention within a storage cartridge of the analyzer defined by a hollow interior and having a plurality of lateral flow assay devices retained in stacked relation therein.

Abstract: 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.

Abstract: A lateral flow device for use in a mainframe or point-of-care clinical analyzer, in which the lateral flow device includes a planar support having at least one sample addition area and at least one reaction area disposed thereon. The sample addition area and reaction area are fluidly interconnected to one another and form at least one lateral fluid flow path. The lateral flow device is sized for retention within a storage cartridge of the analyzer defined by a hollow interior and having a plurality of lateral flow assay devices retained in stacked relation therein.

Abstract: 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.

Abstract: An assay device includes: a liquid sample zone; a reagent zone downstream and in fluid communication with the sample addition zone containing a reagent material; a detection zone in fluid communication with the reagent zone. The detection zone 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 capillary space between the projections capable of generating capillary flow parallel to the substrate surface. The device is capable of creating a reagent plume in the detection zone that includes liquid sample and dissolved reagent, where the width of the reagent plume extends substantially across the width of the detection zone, The device further includes a wicking zone in fluid communication with the detection zone having a capacity to receive liquid sample flowing from the detection zone.