Abstract: When the quantification of an analyte is based on a color change detected by a change in the amount of light transmitted or reflected, undiluted samples often saturate the detection range of the assay. Thus, very often, the sample needs to be diluted for reliable quantification. Disclosed are systems and method, including various configurations of fluidic circuits for us on an optical bio-disc, that advantageously allow the use of undiluted and/or whole blood samples for colorimetric assays on optical bio-disc is described.

Abstract: Methods for decreasing non-specific bindings of beads in dual bead assays and related optical bio-discs and disc drive systems. Methods include identifying whether a target agent is present in a biological sample and mixing capture beads each having at least one transport probe affixed thereto, reporter beads each having at least one signal probe affixed thereto, and a biological sample. Mixing is performed under binding conditions to permit formation of a dual bead complex if the target agent is present in the sample. The reporter bead and capture bead each are bound to the target agent. Denaturing the target agent and keeping it in the denatured form by use of a specialized hybridization buffer is also provided. A denaturing agent is guanidine isothiocynate.

Abstract: The invention provides compositions and methods for determining whether a target agent is present in a biological sample. The invention provides a sensitive and consumer friendly system for performing biological assays. More particularly, the invention is directed to the use of a biodisc in a dual bead assay designed to identify the presence of a target molecule. The invention further provides methods to optimize the selection of a suitable solid phase for use in a dual bead assay.

Abstract: Personal diagnostic devices including diagnostic patches (bio-patches) and interactive medical bracelets (bio-bracelets) are provided with a skin/patch interface, at least one analysis layer, a signal processing layer, and a user output interface. Embodiments of the interactive diagnostic devices may include micro-fluidic circuits with reaction chambers, analysis chambers, mixing cambers, and various pre-disposed chemistries or reagents for performing a wide verity of tests by trans-dermal transport of blood or perspiration. Sample collection chambers for the fluidic circuit may include minimally invasive tubules that penetrate the skin surface to acquire blood samples from capillaries near the epidermis. Alternate implementations of the personal diagnostic device may be equipped with logic processing, input/output devices, acoustic microphones, cryogenic circuits, embedded processors, electrical control circuitry, and battery current sources or photovoltaic sources of electrical power.

Abstract: Methods for deceasing non-specific bindings of beads in dual bead assays and related optical bio-discs and disc drive systems. The methods include determining the suitability of a test solid phase for purposes of use in a dual bead assay. The method also includes identifying whether a target agent is present in a biological sample and involves mixing capture beads, reporter beads, and a biological sample. The mixing is performed under binding conditions to permit formation of a dual bead complex if the target agent is present in the sample. The reporter bead and capture bead are each bound to the target agent. Cleavable spacers or displacement linkers may be used in forming the dual bead complexes. The methods also include placing the capture beads and the reporter beads spatially proximally, performing a ligation reaction employing a ligase, and isolating the dual bead complex from the mixture to obtain the isolate.

Abstract: Methods and apparatus for conducting differential cell counts including leukocytes and use of optical bio-discs for performing such cell counts is disclosed. The bio-disc includes a substantially circular substrate having a center and an outer edge, an active layer associated with the substrate; a target zone disposed between the center and the outer edge; and a plurality of capture antibodies bound to the active layer such that the antibodies are immobilized on the active layer in the target zone.

Abstract: A wide variety of current diagnostic and other biochemical tests employ a substance, such as a chromagen, that undergoes a detectable color development or change of fluorescent emission in the presence of the analyte of interest. The intensity of the color or fluorescence developed may be time dependent and proportional to the concentration of the analyte of interest. Systems, methods, and components usable for quantifying the concentration of an analyte of interest in a biological sample on optical biodiscs are disclosed herein. Analytes may include, for example, glucose, cholesterol, and triglycerides. In one embodiment, reagents are immobilized on the optical disc prior to the assay.