Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

Abstract: A fluidics-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes a self-calibrated magnetic binding assay format (e.g., sandwich, competitive, etc.) that includes detection probes capable of generating a detection signal (e.g., fluorescent non-magnetic particles) and calibration probes capable of generating a calibration signal (e.g., fluorescent magnetic particles). The amount of the analyte within the test sample is proportional (e.g., directly or inversely) to the intensity of the detection signal calibrated by the intensity of the calibration signal. It has been discovered that the fluidics-based device of the present invention provides an accurate, inexpensive, and readily controllable method of determining the presence of an analyte in a test sample.

Abstract: There is provided a rough microfluidic channel for use, for example, in a lateral flow assay device. The rough microfluidic channel has a roughness greater than a similar channel that is smooth, as measured by a Reynolds number for flow under otherwise identical conditions, which is at least 50 percent greater than the Reynolds number for the smooth channel. Alternatively, the roughness may be greater than a similar channel that is smooth, as measured by the fill time which is at least 25 percent lower for said rough channel than said smooth channel.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

Abstract: A system that employs transmission-based detection techniques to determine the presence or concentration of an analyte within a test sample is provided. Specifically, the optical detection system contains an assay device that is positioned in the electromagnetic radiation path defined between an illumination source and solar panel. To enhance the sensitivity and signal-to-noise ratio of the system without significantly increasing costs, the distance between the illumination source and/or solar panel and the assay device is minimized. The illumination source and/or solar panel may also be positioned directly adjacent to the assay device. In addition, the system may be selectively controlled to reduce reliance on external optical components, such as optical filters or diffusers.

Abstract: A blood sampling device includes a lancet having a skin piercing member disposed at an end thereof. The lancet is slidable within and releasably engaged with an elongated lancet guide that remains stationary with use of the device. A shell is axially movable relative to the lancet guide between a rest position and an actuate position, with the lancet being spring loaded within the lancet guide by movement of the shell from the rest position to the actuate position.

Abstract: A method for controlling fluid flow in an assay device that employs a membrane is provided. Specifically, one or more recessed regions are formed in the membrane by applying a solvent treatment thereto. The solvent treatment is selected based on its particular dissolving capacity for the material used to form the membrane. For example, an alcohol-based solvent, such as methanol, may be used as a solvent for nitrocellulose membranes. Upon contact with the solvent treatment, a recessed region is formed that may serve a variety of different functions relating to flow control. In one particular embodiment, the recessed region may function as a metering channel that is capable of delivering a controlled volume of the test sample to a detection zone upon initiation of the assay.

Abstract: A finger cover, such as a finger wipe that can fit onto a human finger, is provided with an improved seam structure. The cover includes a pocket member having an open end for the insertion of a finger. The pocket member is formed by a first panel attached to a second panel along a flush outwardly facing circumferential edge seam. The seam is less than about 1 millimeter (mm) in width and about 1 mm in height. Additional reinforcing weld points may be provided at various locations along the seam.

Abstract: A diagnostic test kit for detecting an analyte residing in a test sample is provided. The kit employs a lateral flow device that contains a membrane. A metering channel is formed in the membrane that is capable of delivering a controlled volume of the test sample to a detection zone upon initiation of the assay. Such a metering channel is particularly effective for embodiments in which the test sample has a relatively low volume, such as less than about 100 microliters, in some embodiments less than about 25 microliters, and in some embodiments, less than about 10 microliters. For example, whole blood drops obtained from patients with a lancet from low-pain areas (due to reduced nerve endings than finger), such as the forearm, thigh, or other alternate sites, may have a volume of from about 0.1 to about 5 microliters. Despite their low volume, the present inventors have discovered that the blood drops may still be accurately analyzed for the presence of an analyte using lateral flow detection techniques.

Abstract: There is provided a lateral flow assay device for detecting the presence or quantity of an analyte residing in a test sample where the lateral flow assay device has a porous membrane in communication with a wicking pad. The porous membrane has a detection zone which has a chromophore configured to chemically react with an analyte or a secondary trigger or a reaction product from the analyte and a trigger generating reagent(s), to generate a visually detectible signal. Additional chrmophore zones may be located downstream from the first chrmophore zone to generate signals of varying color. Scavenging zones may be included between chromophore zones to attenuate the signal by reacting with the analyte without generating a visually detectable signal.

Abstract: A microfluidic assay device for determining the presence or absence of an analyte within a fluid test sample is provided. The present invention provides a technique for achieving continuous flow in a microfluidic device by using at least one input channel, an analysis zone, and a plurality of wicking channels disposed about the perimeter of the analysis zone. In one embodiment, for example, the wicking channels extend radially from the analysis zone. As a result of the particular configuration of the microfluidic device, an assay may performed in a “single step” without the need for active forces, such as a pressure source, electrokinetic force, etc., to induce flow of the fluid test sample through the device. Likewise, flow rate is controlled so that the dwell time of the fluid test sample within the analysis zone is long enough to allow for the desired reactions and/or detection.

Abstract: There is provided a lateral flow assay device for detecting the presence or quantity of an analyte residing in a test sample where the lateral flow assay device has a porous membrane in communication with a conjugate pad and a wicking pad. The porous membrane has a detection zone which has an immobilized first capture reagent configured to bind to at least a portion of the analyte and analyte-conjugate complexes to generate a detection signal. A control zone may be located downstream from the detection zone on the porous membrane and has a second capture reagent immobilized within the control zone. The conjugate pad is located upstream from the detection zone, and has detection probes with specific binding members for the analyte. The sample is deposited between the control and detection zones. A buffer release zone is located upstream of the conjugate pad and provides for buffer addition to the device, the buffer serving to move the detection probes to the detection and control zones.

Abstract: A luminescent detection system that employs transmission-based detection is provided for use with a chromatographic-based assay device. Unlike conventional systems, the detection system of the present invention is portable, simple to use, and inexpensive. For example, the system may be selectively controlled to reduce reliance on expensive optical components, such as monochromators or narrow emission bandwidth optical filters. In addition, the detection system is also capable of eliminating background interference from many sources, such as scattered light and autofluorescence, which have often plagued conventional fluorescent detection systems.

Abstract: A system that employs transmission-based detection techniques to determine the presence or concentration of an analyte within a test sample is provided. Specifically, the optical detection system contains a chromatographic-based assay device that is positioned in the electromagnetic radiation path defined between an illumination source and detector. To enhance the sensitivity and signal-to-noise ratio of the system without significantly increasing costs, the distance between the illumination source and/or detector and the assay device is minimized. The illumination source and/or detector may also be positioned directly adjacent to the assay device. In addition, the system may be selectively controlled to reduce reliance on external optical components, such as optical filters or diffusers.

Abstract: A flow-through assay device capable of detecting the presence or quantity of an analyte of interest is provided that is accurate, reliable, and easy-to-use. The device contains a substrate printed with a channel to facilitate the flow of a test sample to a detection working electrode. The detection working electrode communicates with affinity reagents, such as redox mediators and capture ligands. For instance, capture ligands that are specific binding members for the analyte of interest are applied to the detection electrode to serve as the primary location for detection of the analyte.

Abstract: The premature rupture of amniotic fluid (PROM) may be discovered through a number of inventive means. Methods of evaluating whether PROM is present include; a) through the testing of the pH of vaginal fluids using an irreversible pH test; b) through the detection of analytes (e.g. enzymes) specific to amniotic fluid in the vaginal fluids; c) though the detection of hydrogen peroxide (H2O2) in the vaginal fluid; and d) through the detection of cholesterol in vaginal fluid. While individually indicative of PROM, it is desirable to combine at least two of these techniques to yield a powerful tool of even greater reliability. Test devices and feminine hygiene pads into which the test methods may be incorporated are also included herein.

Abstract: A fluidics-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes a self-calibrated magnetic binding assay format (e.g., sandwich, competitive, etc.) that includes detection probes capable of generating a detection signal (e.g., fluorescent non-magnetic particles) and calibration probes capable of generating a calibration signal (e.g., fluorescent magnetic particles). The amount of the analyte within the test sample is proportional (e.g., directly or inversely) to the intensity of the detection signal calibrated by the intensity of the calibration signal. It has been discovered that the fluidics-based device of the present invention provides an accurate, inexpensive, and readily controllable method of determining the presence of an analyte in a test sample.