Abstract: The invention relates to antibody characteristics used to design a whole blood Point of Care Thyroid Stimulating Hormone (TSH) immunoassay using an ELISA sandwich assay lacking one or more wash steps between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: The described invention provides a method for detecting a target analyte that exhibits protease enzyme activity. The described method includes contacting a sample with a hybrid oxidase enzyme engineered to exhibit increased catalytic activity over that of a starting oxidase enzyme upon cleavage of a mutated protease cleavage recognition sequence. The mutated protease cleavage recognition sequence is a recognition sequence specific for the target analyte. The described method further includes contacting a substrate with the engineered hybrid oxidase enzyme. The substrate comprises a cognate composition of matter to the engineered hybrid oxidase enzyme, and the engineered hybrid oxidase enzyme is configured to catalyze conversion of the cognate composition of matter into a detectable product upon proteolytic cleavage of the mutated protease cleavage recognition sequence by the target analyte.

Abstract: The present invention relates to ellagic acid formulations for performing coagulation assays that are highly stable for long term storage and reduce assay time. Particularly, aspects of the present invention are directed to a composition and method of preparing ellagic acid in a highly soluble format for use in a coagulation assay. For example, the ellagic acid may be solubilized in one or more of sodium hydroxide, methanol, a polyether compound, particularly polyethylene glycol, polyethylene oxide, or polyoxyethylene, and a cyclodextrin guest-host complex.

Abstract: Provided herein is technology relating to testing biological samples and particularly, but not exclusively, to devices, systems, and kits for performing multiple, simultaneous real-time assays on a sample in a single-use disposable format. For example, the technology relates to an apparatus that finds use, for example, for point-of-care diagnostics, including use at accident sites, emergency rooms, in surgery, in intensive care units, as well as for non-medical applications.

Abstract: A composition of matter for use in an immunoassay devices and method comprising a signal antibody, e.g., FAB fragment, covalently linked to a first nucleotide; and one or more signal elements, e.g., signal enzymes such as ALP or fluorescent dyes, each covalently linked to a second nucleotide, wherein the first nucleotide has one or more repeated sequences, and the second nucleotide is bound to one of the one or more repeated sequences on said first nucleotide, and wherein the ratio of the signal antibody to the signal element is controlled by the number of repeated sequences.

Abstract: The described invention provides a method of generating a catalytically active oxidase enzyme preparation. The described invention also provides a means of generating reagents for a protease detection sensor which can use colorimetric, fluorescent, or electrochemical detection. Further, the invention describes a system for a protease detecting sensor.

Abstract: A composition of matter for use in an immunoassay devices and method comprising a signal antibody, e.g., FAB fragment, covalently linked to a first nucleotide; and one or more signal elements, e.g., signal enzymes such as ALP or fluorescent dyes, each covalently linked to a second nucleotide, wherein the first nucleotide has one or more repeated sequences, and the second nucleotide is bound to one of the one or more repeated sequences on said first nucleotide, and wherein the ratio of the signal antibody to the signal element is controlled by the number of repeated sequences.

Abstract: The invention relates to low wash Thyroid Stimulating Hormone (TSH) immunoassays using an ELISA sandwich assay having limited or no wash step between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: The invention relates to antibody characteristics used to design a whole blood Point of Care Thyroid Stimulating Hormone (TSH) immunoassay using an ELISA sandwich assay lacking one or more wash steps between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: The invention is directed to enzyme immobilization compositions comprising: one or more enzymes, a humectant, an acrylic-based monomer, a water-soluble organic photo-initiator and a water-soluble acrylic-based cross-linker in a substantially homogeneous aqueous mixture. The invention is also directed to methods for forming sensors comprising such compositions and to apparati for forming arrays of immobilized layers on an array of sensors by dispensing such compositions onto a substrate.

Abstract: Provided herein is technology relating to testing biological samples and particularly, but not exclusively, to methods for performing multiple, simultaneous real-time assays on a sample in a single-use disposable format. For example, the technology relates to methods employing an apparatus that finds use, for example, for point-of-care diagnostics, including use at accident sites, emergency rooms, in surgery, in intensive care units, as well as for non-medical applications.

Abstract: Thyroid Stimulating Hormone (TSH) immunoassays are performed using an ELISA sandwich assay that employs scavenging or sacrificial beads for reducing interference caused by cross-reacting endocrine glycoprotein hormone analogs such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: The invention is directed to enzyme immobilization compositions comprising: one or more enzymes, a humectant, an acrylic-based monomer, a water-soluble organic photo-initiator and a water-soluble acrylic-based cross-linker in a substantially homogeneous aqueous mixture. The invention is also directed to methods for forming sensors comprising such compositions and to apparati for forming arrays of immobilized layers on an array of sensors by dispensing such compositions onto a substrate.

Abstract: The present invention relates to methods for the extraction of nucleic acids from cells, the amplification of segments of nucleic acid and the detection of nucleic acids, all in a convenient and portable manner. In one embodiment, a sample comprising cells containing nucleic acid is exposed to an aqueous mixture comprising a lytic reagent and one or more beads capable of binding the nucleic acid released from said cells to form a nucleic acid-bead complex. The nucleic acid-bead complex is passed through an immiscible liquid layer to separate the nucleic acid from the aqueous mixture. The one or more beads are magnetic, and the nucleic acid-bead complex is passed through and separated from the immiscible liquid layer with an applied magnetic field. The invention is particularly suited for use in point-of-care medical diagnostics testing.

Abstract: Provided herein is technology relating to testing biological samples and particularly, but not exclusively, to devices, systems, and kits for performing multiple, simultaneous real-time assays on a sample in a single-use disposable format. For example, the technology relates to an apparatus that finds use, for example, for point-of-care diagnostics, including use at accident sites, emergency rooms, in surgery, in intensive care units, as well as for non-medical applications.

Abstract: The present invention relates to automated devices and methods for the extraction of nucleic acids from cells, the amplification of segments of nucleic acid and the detection of nucleic acids, all in a convenient and portable manner. The invention is particularly suited for use in point-of-care medical diagnostic testing.

Abstract: The described invention provides a method of generating a catalytically active oxidase enzyme preparation. The described invention also provides a means of generating reagents for a protease detection sensor which can use colorimetric, fluorescent, or electrochemical detection. Further, the invention describes a system for a protease detecting sensor.

Abstract: The present invention is directed to methods and devices for amending undiluted and partially diluted urine samples in a manner suitable for performing immunoassays for target analytes, for example NGAL. Generally, the urine sample is treated with reagents including at least one of buffer materials, water soluble proteins, urease, and other interferent mitigants. These reagents control the pH of the urine sample in a manner suitable for immuno-binding reactions and ameliorate interferences, particularly during the detection step.

Abstract: The present invention is directed to methods and devices for amending undiluted and partially diluted urine samples in a manner suitable for performing immunoassays for target analytes, for example NGAL. Generally, the urine sample is treated with reagents including at least one of buffer materials, water soluble proteins, urease, and other interferent mitigants. These reagents control the pH of the urine sample in a manner suitable for immuno-binding reactions and ameliorate interferences, particularly during the detection step.

Abstract: This invention relates to mutagenized redox oxidase enzymes used to design enzyme electrodes with improved interference characteristics in the presence of mediator and oxygen in the assay. This recombinant modified enzyme has enhanced capability to transfer electrons to redox mediator instead of its natural electron acceptors such as O2, NAD, NADP, etc., which will improve the assay performance with less interference and higher sensitivity.