Abstract: Methods of detecting compromise of at least one analyte reagent upon reaction with a test sample are disclosed. Also disclosed are reflectance spectroscopic diagnostic instruments that perform the method, and systems that contain same.

Abstract: Devices, kits, and methods for determining the presence or absence of at least one analyte in a liquid test sample.

Abstract: Methods of detecting compromise of at least one analyte reagent upon reaction with a test sample are disclosed. Also disclosed are reflectance spectroscopic diagnostic instruments that perform the method, and systems that contain same.

Abstract: In one aspect, the inventive concepts disclosed herein are directed to a lateral flow assay comprising: one or more chromatographic substrates, a sample application site, a first capture site, and a second capture site. The first capture site comprising an anti-hCG capture antibody with broad affinity for a group of multiple hCG variants and the second capture site comprising an anti-hCG capture antibody that is specific to a first variant of hCG. Additional aspects of the invention disclose using the later flow assay to determine a ratio of the first variant of hCG to the group of multiple hCG variants.

Abstract: Biological fluid samples are deposited by methods that produce a uniform layer of the sample over a reagent-containing surface. In one embodiment, a nozzle having multiple openings is used to deposit a sample over the reagent-containing surface simultaneously. In an alternative embodiment, single droplets of the sample are deposited in a pattern on the surface, preferably in a sequence of parallel lines. The reaction between the biological sample and the reagents is read from a spectrographic image of the reagent-containing surface obtained by optical methods.

Abstract: A method and device for carrying out immunoassays in which non analyte specific binding of heterophilic antibodies to a labeled antibody in a capture region produces an incorrect measure of the amount of an analyte attached to the antibody. Immunoglobulin from the same animal source as the labeled antibody is added to the sample fluid to prevent non-specific binding of the heterophilic antibodies in the capture region. One part of specific binding pair is added to said antibody or its label capable of binding to a second part of the binding pair immobilized in a control region downstream of said capture region for trapping the portion of the labeled anti-body which is not bound to the analyte. Preferably said binding pair is biotin/avidin or fluoroscein/anti-fluoroscein.

Abstract: A microfluidic device provides separation of particles in a liquid sample, particularly, separation of a sample of whole blood into its components for further analysis. Separation into red blood cells and plasma occurs within a few seconds after the blood sample has been transferred into a separation chamber with the application of centrifugal force of less than about five times gravity. With the application of greater force measurement of hematocrit is possible.

Abstract: A device for detecting an analyte in a fluid sample includes a liquid permeable composition for making a physical separation between compositions of the sample or for reacting with components. The liquid permeable composition has adhesive properties and can be used to make a multi-layered test strip or the composition can be used in the sample wells of microfluidic devices.

Abstract: Mixing of liquids in a microfluidic device is accomplished by dispensing the liquids into a first chamber to produce combined liquid. The liquids are thereafter discharged through at least one capillary from the first chamber into a second chamber for complete mixing.

Abstract: A microfluidic device provides separation of particles in a liquid sample, particularly, separation of a sample of whole blood into its components for further analysis. Separation into red blood cells and plasma occurs within a few seconds after the blood sample has been transferred into a separation chamber with the application of centrifugal force of less than one up to about five times gravity. With the application of greater force measurement of hematocrit is possible.

Abstract: A method and device for carrying out immunoassays in which non analyte specific binding of heterophilic antibodies to a labeled antibody in a capture region produces an incorrect measure of the amount of an analyte attached to the antibody. Immunoglobulin from the same animal source as the labeled antibody is added to the sample fluid to prevent non-specific binding of the heterophilic antibodies in the capture region. One part of specific binding pair is added to said antibody or its label capable of binding to a second part of the binding pair immobilized in a control region downstream of said capture region for trapping the portion of the labeled anti-body which is not bound to the analyte. Preferably said binding pair is biotin/avidin or fluoroscein/anti-fluoroscein.