Abstract: Methods, devices, and reagents are described for performing ratiometric assays for hemoglobin A1c. The methods involve a direct ratio determination between Hb A1c and normalized total hemoglobin utilizing a saturating amount of hemoglobin so that Hb A1c binds proportionately to a substrate. In some applications, the assay utilizes a proximity label system for signal generation and/or labeled magnetic beads. The methods can be configured as homogeneous or heterogeneous assays.

Abstract: Disclosed herein are methods of detecting a coronavirus, e.g., SARS-CoV-2, using a sandwich assay.

Abstract: Methods, devices, and reagents are described for performing ratiometric assays for hemoglobin A1c. The methods involve a direct ratio determination between Hb A1c and normalized total hemoglobin utilizing a saturating amount of hemoglobin so that Hb A1c binds proportionately to a substrate. In some applications, the assay utilizes a proximity label system for signal generation and/or labeled magnetic beads. The methods can be configured as homogeneous or heterogeneous assays.

Abstract: Methods, devices, and reagents are described for performing ratiometric assays for hemoglobin A1c. The methods involve a direct ratio determination between Hb A1c and normalized total hemoglobin utilizing a saturating amount of hemoglobin so that Hb A1c binds proportionately to a substrate. In some applications, the assay utilizes a proximity label system for signal generation and/or labeled magnetic beads. The methods can be configured as homogeneous or heterogeneous assays.

Abstract: Methods, devices, and reagents are described for performing assays for hemoglobin Ale, glycated albumin, and other glycated proteins. The methods involve a ratio determination between glycated protein and non-glycated protein. In some applications, the assay utilizes LOCI for signal generation. This invention is directed to assays and corresponding devices and reagents for detection of glycated protein, particularly including glycated hemoglobin. As is generally understood, such detection is useful in the management of blood glucose levels in diabetic patients and for monitoring the status of pre-diabetic individuals.

Abstract: Methods, devices, and reagents are described for performing ratiometric assays for hemoglobin A1c. The methods involve a direct ratio determination between Hb A1c and normalized total hemoglobin utilizing a saturating amount of hemoglobin so that Hb A1c binds proportionately to a substrate. In some applications, the assay utilizes LOCI or other proximity label for signal generation and/or labeled magnetic beads. The methods can be configured as homogeneous or heterogeneous assays.

Abstract: Methods, devices, and reagents are described for performing assays for hemoglobin Ale, glycated albumin, and other glycated proteins. The methods involve a ratio determination between glycated protein and non-gtycated protein. In some applications, the assay utilizes LOCI for signal generation. This invention is directed to assays and corresponding devices and reagents for detection of glycated protein, particularly including glycated hemoglobin. As is generally understood, such detection is useful in the management of blood glucose levels in diabetic patients and for monitoring the status of pre-diabetic individuals.

Abstract: Dry, pelletized reagents are described which rapidly reconstitute into active reagent solutions when contacted with an appropriate liquid sample or other appropriate solution, including heterogeneous reagent pellets made from two or more separate reagent solutions in such manner that components in the separate reagent solutions which will normally react with each other in solution do not substantially react. Also described are reagent dispenser packages and assay devices containing dry pelletized reagents.

Abstract: An assay system including reagents and devices for conducting rapid, high sensitivity analyte assays, including multiplexed assays, is described. The reagents and devices are adapted for performing time-resolved signal detection with low background due to non-specific binding. Also described are apparatus for use in measuring a luminescent property of a sample. The apparatus can use light emitting diodes for emitting radiation to excite the sample, under the control of a control signal. A signal generator generates the control signal for modulating the intensity of the emitted radiation. The control signal has a first component at a first frequency with a period that is less than, or of the same order as, an expected characteristic time constant of the luminescent property. The control signal has a second component at a second frequency with a period that is greater than the expected characteristic time constant of the luminescent property.

Abstract: A method is described for obtaining antibodies binding specifically to an epitope resulting from in vivo modification of a biomolecule or biomolecular complex, where the in vivo modification results from expression of a transgene in an animal. An example of such a biomolecule or biomolecular complex is LDL and an example of such a transgene is human myeloperoxidase. Resulting antibodies and methods of using the antibodies are also described.

Abstract: Methods and apparatus for conducting analyte assays, including multiplexed assays are described. Such methods include assays adapted for low volume assay devices in which assays can be performed using undiluted biological liquid samples by exchanging binding medium with detection medium, using layered labels, and/or using droplet based mixing in an assay device.

Abstract: Compositions and processes for qualitative or quantitative one-step, two-site, tag/anti-tag or competitive non-bibulous lateral flow (immunochromatographic) assays for analytes in body fluids including chemically modified proteins as blocking and/or dispersing agents in conjunction with additives eliminating non-specific interference with the detection agents and/or binding partner caused by endogenous polypeptide constituents. Composition of the chemically modified proteins can be albumins. Composition of the chemically modified albumins can have altered charge and/or molecular weight. Process for composition of the chemically modified proteins can be prepared by modification of the nucleophilic groups. The chemical modification of nucleophilic groups in albmins can be introduced by anhydrides, alkyl acetimidates, methylating and/or cross-linking agents. The additives eliminating non-specific interference can be chemically modified albumins, heterophilic blockers and chaotropic agents.

Abstract: A microfluidic separation system for separating fluid sample medium from cells provided in a sample, for example, a sample of bodily fluid which is to be subjected to further analysis. The system may include a microfluidic structure and a cell aggregation agent. The microfluidic structure may include one or more microfluidic channels operable to separate aggregated cells from fluid sample medium by size exclusion.

Abstract: The present invention concerns a composition comprising an aqueous medium, a reagent for assessing fibrinogen biological activity and a reagent for assessing the activity of a reagent used for determining platelet count. In one particular embodiment the composition comprises an aqueous medium, an antibody for fibrinogen and fixed platelets substantially free of fibrinogen antibody binding sites. Also disclosed is a method for conducting a control for an assay for platelet function activity and a control for the platelet count assay. The method comprises utilizing a common control for the assays wherein the control does not cross-react with itself or with reagents for conducting the assays. In a particular embodiment the common control comprises an aqueous medium, a reagent for assessing fibrinogen biological activity and a reagent for binding to the reagent used for determining platelet count. Also disclosed are kits for carrying out methods in accordance with the present invention.

Abstract: The present invention provides a filter for effectively removing substances from a sample of bodily fluid which can interfere with the results of an assay. The filter includes a solid phase support and an active chemical component for binding to the interfering substance. The active chemical component is insoluble in the sample and is immobilized on the solid phase support. The present invention also includes a filter device, transport matrix, assay device, and method for removing substances which interfere with determining the presence of one or more analytes in a sample.