Abstract: 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.

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: The present disclosure is directed to a thin-film element that enables analytes to be analyzed on separate surfaces. In an example, a thin-film element includes a first layer for processing a fluid sample to generate a first analyte and a second analyte. The thin-film element also includes a second layer configured to be impermeable to the first analyte to enable the first analyte to be retained by the first layer and permeable to the second analyte to enable the second analyte to pass through the second layer. The thin-film element further includes a third layer configured to retain the second analyte. The second layer includes a first reflective surface and a second reflective surface to provide reflectance signals indicative of analytes present in the first and third layers to sensors located on opposite sides of the thin-film element.

Abstract: The invention relates generally to both a method and apparatus for the creation of full resolution color digital images of diagnostic cassettes or objects of interest using a gray-scale digital camera or sensor combined with time sequential illumination using additive primary colors followed by post exposure digital processing. Such procedures and equipment is of significant economic value when employed in situations such as diagnostic clinical analyzers where space is limited and image quality requirements are high.

Abstract: A test element for an assay includes: a cartridge having a housing which includes a priming pad capable of containing a liquid fluid, a wash port having an opening in the housing, and an opening for directly or indirectly applying a sample; and an assay device positioned within the cartridge in fluid communication with the wash port containing an analytical reagent.

Abstract: An antigen with an increased half-life is provided for the formulation of more stable and consistent clinical diagnostic immunoassay controls and calibrators. An antigen analogue comprises a first and a second polypeptide which is identical or similar to corresponding terminal amino acid sequences of an antigen. The first and second polypeptides are connected with a PEG chain. Also provided are methods of calibrating assays using a compound disclosed herein.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A method to normalize at least one of a population of subordinate clinical diagnostic analyzer to a master clinical diagnostic analyzer such that an assay result from a subordinate clinical diagnostic analyzer can be converted to the equivalent result of the master clinical diagnostic analyzer by using a simple multiplicative factor when the assay executed on each analyzer uses a common fluorescently labeled dye. Also a method to re-normalize a subordinate clinical diagnostic analyzer assay result to a master clinical diagnostic analyzer assay result by using a simple multiplicative factor when the assay executed on the subordinate clinical diagnostic analyzer uses a different fluorescently labeled dye than the assay executed on the master clinical diagnostic analyzer.

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 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.

Abstract: A test element for an assay includes: a cartridge having a housing which includes a priming pad capable of containing a liquid fluid, a wash port having an opening in the housing, and an opening for directly or indirectly applying a sample; and an assay device positioned within the cartridge in fluid communication with the wash port containing an analytical reagent.

Abstract: The present disclosure provides methods for the detection of multiple analytes using a single solid phase. The present disclosure also relates to the preparation of solid phases that include receptacles having affixed thereto antibodies directed to at least two different analytes. The methods of the present disclosure can be used, for example, for the quantitative detection of analytes in a sample and the measurement thereof.

Abstract: Modified hepatitis C virus polypeptides are described. The polypeptides include the HCV NS4a domain and modified NS3 domain. The polypeptides retain conformational epitopes. HCV immunoassays including the polypeptides are also described.

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: An article of manufacture composed of tray-like packaging unit characterized by a first section designed to hold a sample analysis slide and a second section designed to hold a sample collection device. Molded into the tray-like packaging unit are a thermoformed well designed to accept a patient's liquid sample from a pipette or syringe, a splash wall formed between the first section and the second section designed to contain the patient's liquid sample in the thermoformed well, and an overflow reservoir designed to hold excess patient sample placed in the thermoformed well. Also molded into the sidewalls of tray-like packaging unit are projections designed to allow the sample analysis slide and the sample collection device to be snapped into the packaging unit resulting in a secure configuration for transport.

Abstract: A lateral flow diagnostic assay device is defined by a substrate having a top surface that further includes a sample addition zone for receiving a sample, a transport and reaction zone, and a wicking zone. Each of the sample addition zone, reaction and transport zone and wicking zone are disposed on the top surface of the substrate and fluidically interconnected by means that permit lateral capillary flow along at least one fluid flow path from the sample addition zone to the wicking zone. The assay device further includes a capillary vent disposed in relation to the wicking zone, the capillary vent having an overall length and cross sectional area that creates a backpressure so as to control the flow rate of a sample applied to the assay device.