Abstract: A compact, microprocessor-controlled instrument for fluorometric assays in liquid samples has a floating stage with docking bay for receiving a microfluidic cartridge and a scanning detector head with on-board embedded microprocessor controlled by an optical data acquisition and processing daemon within the detector head for controlling source LEDs, emission signal amplification and filtering in an isolated, low noise, high-gain environment within the detector head. Multiple optical channels may be incorporated in the scanning head. The assay ma be validated using dual channel optics for monitoring a first fluorophore associated with a target analyte and a second fluorophore associated with a control. Molecular biological assays use PCR amplification of target nucleic acids and fluorometric assays, which may require temperature control during detection.

Abstract: Microfluidic cartridges or devices for serum separation and blood cross-match analysis are provided. The devices may include a serum separation subcircuit alone or in combination with a solute mixing subcircuit. The serum separation subcircuit promotes on-cartridge clotting of a blood sample and manipulates the flow of the separated serum sample for subsequent cross-match analysis with a second blood sample, for example. The solute mixing subcircuit includes at least two intake channels, one for a whole blood sample from, for example, a blood donor and the other for the separated serum sample from, for example, a transfusion recipient. The solute mixing subcircuit further includes a serpentine mixing channel conjoined to a downstream channel. Under vacuum generated by a conjoined finger pump, the two input streams fill the serpentine mixing and downstream channels due to capillary action, enabling visualization of an agglutination reaction.

Abstract: The present invention provides a rapid and highly effective method for the preparation of biological samples for detection of both DNA and RNA target molecules. The method comprises treatment of the sample with a clay mineral followed by lysis of the sample with an alkaline solution. The method is particularly suited for preparing complex biological samples, such as blood or plasma, for the simultaneous detection of DNA and RNA targets. Samples prepared by the method of the invention may be directly used as targets in PCR amplification. The method of the invention may conveniently be coupled with further steps and devices to perform molecular analyses for diagnostic and other applications.

Abstract: Microfluidic cartridges for agglutination reactions are provided. The cartridges include a microfluidic reaction channel with at least two intake channels, one for an antigen-containing fluid and the other for an antibody-containing fluid, conjoined to a reaction channel modified by incorporation of a downstream flow control channel. At low Reynolds Number, the two input streams layer one on top of the other in the reaction channel and form a flowing, unmixed horizontally-stratified laminar fluid diffusion (HLFD) interface for an extended duration of reaction. Surprisingly, the design, surface properties, and flow regime of microfluidic circuits of the present invention potentiate detection of antibody mediated agglutination at the stratified interface. Antigen:antibody reactions involving agglutination potentiated by these devices are useful in blood typing, in crossmatching for blood transfusion, and in immunodiagnostic agglutination assays, for example.

Abstract: An integrated “lab-on-a-chip” microfluidic device performs nucleic acid sample preparation and diagnostic analysis from test samples containing cells and/or particles. The device analyzes DNA or RNA targets, or both, from a common test sample. Dried and/or liquid reagents necessary for nucleic acid sample preparation and analysis are contained on the device, such that the device only requires addition of test sample. Clay mineral and alkaline buffer reagents are employed for overcoming the problems of nucleic acid degradation and contamination during sample preparation. The device may include a composite filter to separate plasma or serum from other blood constituents when the test sample is a blood product. The microfluidic device utilizes a plurality of microfluidic channels, inlets, valves, membranes, pumps, and other elements arranged in various configurations to manipulate the flow of the liquid sample, in particular, in order to prepare nucleic acids and perform further diagnostic analysis.

Abstract: Fluidic cartridges, and manufacture thereof, having a plurality of circuit element subtypes containing pneumatically operated diaphragm members, where the diaphragm materials are selected for yield point, chemical resistance, breathability and other properties individually according to the fluidic element subtype are provided. A process of in-situ edge-bonded decoupage for forming diaphragm members inside a cartridge, and fluidic circuits having diaphragm members as active and passive circuit elements, including pumps, valves, vents, waste receptacles, reagent reservoirs, and cuvettes with optical windows, where the material composition of each individual diaphragm member may be selected from an assortment of materials during manufacture are also provided.

Abstract: Manufacturing methods and compositions are described for production of self-contained microfluidic cartridge devices with on-board reagents for molecular biological testing. Sensitive reagents are stored in dry form without lyophilization or freezing, and reconstituted at the point of use with either a biological sample or a sample eluate at the point of use. Manufacturing methods include sheet and roll fabrication processes where the reagents are printed in place and sealed within individual microfluidic cartridges before gel vitrification.

Abstract: A microfluidic cartridge and methods for performing a diagnostic, molecular or biochemical assay thereon, where all dried and/or liquid reagents necessary for the assay are contained in the cartridge and the assay requires only the addition of sample. Pneumohydraulic features, chamber and diaphragm technologies are introduced for overcoming the problems of bubble interference and reagent washout during operation of a microfluidic cartridge. The cartridges are inserted into a host instrument for performance of an assay and the cartridge is supplied as a consumable.

Abstract: Disclosed herein is a device comprising a pair of bellows pumps configured for efficient mixing at a microfluidic scale. By moving a fluid sample and particles in suspension through an aperture between the paired bellows pump mixing chambers, molecular collisions leading to binding between the particles and ligands in the sample are enhanced. Such devices provide an alternative for mixing that does not use a vent and can be used with a variety of particles in suspension such as magnetic beads to capture or purify useful cells and molecules.

Abstract: Disclosed is a compact, microprocessor-controlled instrument for fluorometric assays in liquid samples, the instrument having a floating stage with docking bay for receiving a microfluidic cartridge and a scanning detector head with on-board embedded microprocessor operated under control of a ODAP daemon resident in the detector head for controlling source LEDs, emission signal amplification and filtering in an isolated, low noise, high-gain environment within the detector head. Multiple optical channels may be incorporated in the scanning head. In a preferred configuration, the assay is validated using dual channel optics for monitoring a first fluorophore associated with a target analyte and a second fluorophore associated with a control. Applications include molecular biological assays based on PCR amplification of target nucleic acids and fluorometric assays in general, many of which require temperature control during detection.

Abstract: Microfluidic cartridges for agglutination reactions are provided. The cartridges include a microfluidic reaction channel with at least two intake channels, one for an antigen-containing fluid and the other for an antibody-containing fluid, conjoined to a reaction channel modified by incorporation of a downstream flow control channel. At low Reynolds Number, the two input streams layer one on top of the other in the reaction channel and form a flowing, unmixed horizontally-stratified laminar fluid diffusion (HLFD) interface for an extended duration of reaction. Surprisingly, the design, surface properties, and flow regime of microfluidic circuits of the present invention potentiate detection of antibody mediated agglutination at the stratified interface. Antigen:antibody reactions involving agglutination potentiated by these devices are useful in blood typing, in crossmatching for blood transfusion, and in immunodiagnostic agglutination assays, for example.

Abstract: A microfluidic cartridge and methods for performing a diagnostic, molecular or biochemical assay thereon, where all dried and/or liquid reagents necessary for the assay are contained in the cartridge and the assay requires only the addition of sample. Pneumohydraulic features, chamber and diaphragm technologies are introduced for overcoming the problems of bubble interference and reagent washout during operation of a microfluidic cartridge. The cartridges are inserted into a host instrument for performance of an assay and the cartridge is supplied as a consumable.

Abstract: A compact device for operatively coupling a solid planar substrate, for example a glass slide, to a microfluidic circuit and performing a reaction or reactions on organic matter bound to the face of the planar substrate. Typical reactions include binding, staining and/or labeling reactions. In use, a sealed reaction chamber is formed, the chamber enclosing the organic matter and at least a part of the solid substrate. Headspace in the sealed chamber between the solid substrate is generally of microfluidic dimensions, and diaphragm pump members are used to inject, exchange and/or mix the fluids in the chamber.

Abstract: Manufacturing methods and compositions are described for production of self-contained microfluidic cartridge devices with on-board reagents for molecular biological testing. Sensitive reagents are stored in dry form without lyophilization or freezing, and reconstituted at the point of use with either a biological sample or a sample eluate at the point of use. Manufacturing methods include sheet and roll fabrication processes where the reagents are printed in place and sealed within individual microfluidic cartridges before gel vitrification.

Abstract: The present invention relates to microfluidic devices and methods for manipulating and analyzing fluid samples. The disclosed microfluidic devices utilize a plurality of microfluidic channels, inlets, valves, filter, pumps, liquid barriers and other elements arranged in various configurations to manipulate the flow of a fluid sample in order to prepare such sample for analysis.

Abstract: An instrument for fluorometric assays in liquid samples is disclosed. The instrument may include multiple optical channels for monitoring a first fluorophore associated with a target analyte and a second fluorophore associated with a control. The disclosed instrument finds utility in any number of applications, including microfluidic molecular biological assays based on PCR amplification of target nucleic acids and fluorometric assays in general.

Abstract: Formulations for dry storage of PCR reagents are described. These formulations find use in manufacture of self-contained microfluidic card devices for PCR clinical testing in which the reagents are reconstituted at the point of testing. In these cards, TAQ polymerase is stored “on-board” in vitrified dry form without lyophilization or freezing, and is reconstituted by either the sample or a sample eluate during the assay.

Abstract: Integrated microfluidic cartridges for nucleic acid extraction, amplification, and detection from clinical samples are disclosed. The devices are single-entry, sanitary, and disposable. The devices enable simplex or multiplex nucleic acid target detection, as for example: assay panels for multiple infectious agents, or assay panels for cancerous cell types. Methods for use of microfluidic cartridges in a fully automated, pneumatically controlled apparatus are also disclosed.

Abstract: A microfluidic cartridge including on-board dry reagents and microfluidic circuitry for determining a clinical analyte or analytes from a few microliters of liquid sample; with docking interface for use in a host workstation, the workstation including a pneumatic fluid controller and spectrophotometer for monitoring analytical reactions in the cartridge.

Abstract: An instrument for fluorometric assays in liquid samples is disclosed. The instrument may include multiple optical channels for monitoring a first fluorophore associated with a target analyte and a second fluorophore associated with a control. The disclosed instrument finds utility in any number of applications, including microfluidic molecular biological assays based on PCR amplification of target nucleic acids and fluorometric assays in general.