Abstract: The present invention is directed to optical bio-discs, methods, and optical disc drives for clinical diagnostics. The present invention is further directed to methods for determining the quantity of a specific type of blood cell in a biological sample including on-disc sample preparation and processing, providing a pre-processed sample onto a capture zone, removing portions of the sample that are not bound in the capture zone, and counting bound cells. Also disclosed are fluidic circuits for processing blood samples for use in a cluster designation marker assay in the optical bio-disc.

Abstract: A manufacturing process for optical analysis discs including successive patterning operations and a related optical analysis discs thereby manufactured. The process includes providing a planar substrate layer, patterning on the planar substrate layer a spacing material forming a fluidic cavity configuration, and providing a cover layer bonded onto the planar substrate layer containing the fluidic cavity configuration. The optical analysis disc includes a planar substrate layer, a fluidic cavity configuration formed on the planar substrate layer by patterning a spacing adhesive material, and a cover layer bonded onto the planar substrate layer containing the fluidic cavity configuration.

Abstract: A process for manufacturing optical analysis discs with microfluidic structures and a disc made according thereto. The process includes the steps of providing a lens disc, patterning an intermediate adhesive layer with a pattern corresponding to predetermined microfluidic structures, providing a cover disc having molded microfluidic structures, and applying the cover disc onto the intermediate adhesive layer to match the molded microfluidic structures to the pattern to bond the cover disc onto the lens disc.

Abstract: The present invention relates to methods and apparatus for assays including optical bio-discs with spiral fluidic circuits and related detection systems. The optical bio-disc 110 includes a cap portion 116 having inlet and vent ports formed therein, a first channel layer 632 having cut-out portions, a second channel layer 634 having cut-out portions; a third channel layer 636 having cut-cut portions, a fourth channel layer 638 having cut-out portions, and a substantially circular substrate having a center and an outer edge. The cut-out portions are in register with each other such that when the bio-disc 110 is assembled a spiral fluidic circuit is formed having an inlet port, a mixing chamber 134, upper flow chambers 620, lower pass through chambers 622, inlet passages 626, outlet passages 628, a circumferential analysis chamber 618, and vent ports in fluid communication.

Abstract: Preparation and analysis of biomedical samples is performed using an optical bio-disc system. More specifically, chromatography, including for example, affinity, size exclusion, reverse phase, and ion exchange may be performed using an optical bio-disc system. Ion exchange chromatography may include anion exchange, cation exchange, cation exchange linked immunoassays (CELIA), and anion exchange linked immunoassays, in conjunction with calorimetric and/or fluorescent detection and quantization using an optical analysis disc or optical bio-disc. Improved methods for preparing assays, methods for depositing the reagents required for the assays, discs for performing assays, and detection systems are described herein.

Abstract: A process for manufacturing optical analysis discs with micro-fluidic structures and discs made according thereto. The process includes the steps of providing a lens disc, providing a cover disc having micro-fluidic structures having bonding grooves, dispensing adhesive material inside the bonding grooves, and applying the cover disc onto the lens disc to bond them together.

Abstract: The present invention is directed to optical bio-discs, methods, and optical disc drives for clinical diagnostics. The present invention is further directed to methods for determining the quantity of a specific type of blood cell in a biological sample including on-disc sample preparation and processing, providing a pre-processed sample onto a capture zone, removing portions of the sample that are not bound in the capture zone, and counting bound cells. Also disclosed are fluidic circuits for processing blood samples for use in a cluster designation marker assay in the optical bio-disc.