Cholestech Corporation

Alere San Diego, Inc.

Ronald M Jones

Thomas E Worthy

Anthony Joseph Nugent

Jeffrey Shindelman

Gary E Hewett

Neal F Bellet

George E Withers, Iii

Eric G Barr

An assay device and method for measuring the concentration of HDL-associated cholesterol in a blood-fluid sample are described. The assay design prevents interference by reagents used for such removal with the HDL quantification reaction or with other assays carried out on the same sample. If desired, removal of non-HDL lipoproteins and assay of HDL cholesterol can be carried out without interruption of the assay.

High-density lipoprotein assay device and method

An assay device and method for measuring the concentration of LDL-associated cholesterol in a blood-fluid sample are described. The method employs selective precipitation of VLDL and chylomicrons and immunoseparation of HDL from a blood fluid sample. The assay device allows the assay to be performed entirely in a flow strip format.

Assay device for direct measurement of LDL cholesterol

An assay device and method for measuring the concentration of HDL-associated cholesterol in a blood-fluid sample are described. The assay design is such that removal of non-HDL lipoproteins from a sample and assay of HDL cholesterol in the sample occur without interruption of the assay. The device also prevents interference by reagents used for the HDL assay with other assays carried out on the same sample.

An assay pad for measuring the concentration of HDL-associated cholesterol in a sample, a method for using the pad, and a diagnostic assay device for carrying out the method are described. The assay pad includes a polymer adhesive or heat laminate bond. The assay design prevents interference by reagents used for such removal with the HDL quantification reaction or with other assays carried out on the same sample. If desired, removal of non-HDL lipoproteins and assay of HDL cholesterol can be carried out without interruption of the assay.

Adhered membranes retaining porosity and biological activity

The invention relates to an immunoassay cassette useful for carrying out multistage immunoassays in an automated manner. In operation, the cassette assumes different operational positions in which solutions are transferred sequentially across an absorbent pathway containing assay reagents.

Automated immunoassay cassette

An assay device for measuring the concentration of HDL-associated cholesterol in a blood-fluid sample is disclosed. The device includes a glass-fiber sieving matrix capable of separating soluble and precipitated material migrating through the matrix, and a reagent reservoir in the matrix, for releasing a reagent effective to selectively precipitate LDL and VLDL particles, while permitting soluble HDL to migrate through the matrix. The glass fibers are coated with a polymer coating to prevent binding of HDL to the fibers in the presence of the precipitating reagent.

High-density lipoprotein solid-phase precipitation assay device

An assay device and method for measuring the concentration of HDL-associated cholesterol in a blood-fluid sample. The device includes a glass-fiber sieving matrix capable of separating soluble and precipitated material migrating through the matrix, and a reagent reservoir in the matrix, for releasing a reagent effective to selectively precipitate LDL and VLDL particles, while permitting soluble HDL to migrate through the matrix. The glass fibers are coated with a polymer coating to prevent binding of HDL to the fibers in the presence of the precipitating reagent.

High-density lipoprotein solid-base assay device

An improved method for measuring the concentration of HDL-associated cholesterol in a blood-fluid sample. The method includes (a) adding a volume of the sample to an absorptive matrix (i) formed of glass fibers and (ii) effective to separate soluble from precipitated blood through the matrix from a sample-application site to a sample-collection site in the matrix, (b) releasing into the matrix, dextran sulfate and magnesium ions in an amount effective to selectively precipitate LDL and VLDL in the fluid sample, and (c) assaying fluid sample which has migrated through the matrix for the presence of lipoprotein-bound cholesterol. The improvement in the method comprises treating the glass fibers by reaction with bis(hydroxyethyl)aminopropyltriethoxy silane or by coating the fibers with polyvinyl alcohol, thereby affording substantially 100% recovery of HDL applied to the matrix.

High-density lipoprotein solid-base precipitation assay method

An assay device for measuring the concentration of a soluble analyte, such as HDL-associated cholesterol, in a fluid sample containing interfering compounds, such as LDL-or VLDL-associated cholesterol, which can be selectively precipitated. The device includes a sieving matrix capable of separating soluble and precipitated material migrating through the matrix, and a reservoir which holds a precipitating agent which is effective, within a given concentration range, to selectively precipitate the interfering compounds. The reservoir is designed to delay the release of agent, on contact with the fluid sample, to maintain the concentration of precipitating agent in contact with the fluid sample within the given concentration range.

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Mountain View, CA, United States of America

Ronald M Jones