Abstract: An assay method and device can perform at least one (e.g., at least two) assays on a single aliquot of a sample liquid. The device can mix a sample liquid with assay reagents including magnetically susceptible particles. The device is configured to create a sample liquid-air interface with the sample liquid. The magnetically susceptible particles can be located (via an applied magnetic field) at the liquid-air interface when a second liquid contacts the interface to form a liquid-liquid interface. The magnetic particles travel across the liquid:liquid interface to the second liquid. The magnetically susceptible particles are configured to transport an analyte across the interface into the second liquid. An assay for the analyte is performed in the second liquid. An assay for another analyte can also be performed in the sample liquid.

Abstract: An electrochemical-based analytical test strip includes an electrically-insulating substrate, a patterned conductive layer disposed over the electrically-insulating substrate, a patterned insulating layer disposed over the patterned conductive layer, an enzymatic reagent layer disposed over the patterned conductive layer, a patterned adhesive layer disposed above the enzymatic reagent layer and a top layer disposed over the enzymatic reagent layer. In addition, the test strip has a sample-receiving chamber defined by the electrically-insulating substrate, the patterned conductive layer, the patterned insulating layer, the enzymatic reagent layer, the patterned adhesive layer and the top layer. The sample receiving chamber of the test strip has a working portion and a non-working portion and the top layer has a first portion and an opaque second portion.

Abstract: An assay method and device can perform at least one (e.g., at least two) assays on a single aliquot of a sample liquid. The device can mix a sample liquid with assay reagents including magnetically susceptible particles. The device is configured to create a sample liquid-air interface with the sample liquid. The magnetically susceptible particles can be located (via an applied magnetic field) at the liquid-air interface when a second liquid contacts the interface to form a liquid-liquid interface. The magnetic particles travel across the liquid:liquid interface to the second liquid. The magnetically susceptible particles are configured to transport an analyte across the interface into the second liquid. An assay for the analyte is performed in the second liquid. An assay for another analyte can also be performed in the sample liquid.

Abstract: A device includes a substrate that defines, at least in part, a microfluidic network including an inlet in communication with a first detection zone and with a second detection zone. A cobalt reagent and a nickel reagent are disposed within the microfluidic network. First electrodes are in communication with the first detection zone and second electrodes arc in communication with the second detection zone. The device is configured to receive a blood derived sample introduced to the inlet, partition the blood sample into first and second blood sample portions, form a first mixture including at least some of the first blood sample portion and at least some of the cobalt reagent, and form a second mixture including at least some of the second blood sample portion, at least some of the cobalt reagent and at least some of the nickel reagent.

Abstract: A method for determining an analyte (such a glucose) in a bodily fluid sample includes introducing a bodily fluid sample (e.g., a whole blood sample) into a sample-receiving chamber of an analytical test strip. The method also includes verifying that the bodily fluid sample has filled at least a working portion of the sample-receiving chamber by user visual observation of the working portion through a first portion of a top layer of the analytical test strip, while an opaque second portion of the top layer precludes user visual observation of a non-working portion of the sample-receiving chamber. Thereafter, in the method, the concentration of analyte in the bodily fluid sample is determined only if during the verifying step the user has verified that the bodily fluid sample has filled the working portion.

Abstract: An electrochemical-based analytical test strip includes an electrically-insulating substrate, a patterned conductive layer disposed over the electrically-insulating substrate, a patterned insulating layer disposed over the patterned conductive layer, an enzymatic reagent layer disposed over the patterned conductive layer, a patterned adhesive layer disposed above the enzymatic reagent layer and a top layer disposed over the enzymatic reagent layer. In addition, the test strip has a sample-receiving chamber defined by the electrically-insulating substrate, the patterned conductive layer, the patterned insulating layer, the enzymatic reagent layer, the patterned adhesive layer and the top layer. The sample receiving chamber of the test strip has a working portion and a non-working portion and the top layer has a first portion and an opaque second portion.

Abstract: A method for detecting an analyte can include binding an analyte with a first reagent which is associated with a magnetic particle, allowing analyte to interact with an excess amount of a second reagent capable of interacting with the analyte, and magnetically separating a portion of analyte-bound second reagent from excess second reagent. After the magnetic separation, the interaction of the analyte and the second reagent can be disrupted to produce a detectable form of the second reagent, which can be detected. A device and system suited to performing the method are also described.

Abstract: An assay device includes a first reagent including a magnetic particle and a second reagent including detectable component. The first and second reagent can each independently bind to an analyte in a sample. Applying a magnetic field can selectively concentrate the detectable component in a detection zone, where a detectable change ca be measured and related to the amount of analyte in the sample.