High-density lipoprotein assay device and method
AssigneeCholestech Corporation
InventorsRonald M. Jones, Thomas E. Worthy, Anthony J. Nugent
Life of this patent
Estimating the term…
Abstract
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.
Claims28
An assay device for measuring serum cholesterol associated with high-density lipoproteins (HDL) in a blood fluid sample also containing low density lipoproteins (LDL) or very low density lipoproteins (VLDL), the device comprising:
- a sample distribution matrix effective to distribute a blood fluid sample from a sample application region within the matrix to one or more sample collection regions within the matrix;
- an HDL assay element, in which HDL concentration can be assayed, spaced apart from said sample distribution matrix,
- a reagent pad, disposed between said HDL assay element and said sample distribution matrix, and spaced apart from said matrix, said reagent pad containing a reagent effective to selectively remove non-HDL lipoproteins from the fluid sample, and
- mounting means effective (a) to maintain said device in a sample-distribution position, wherein said HDL assay element and reagent pad are spaced apart from said matrix, and (b) to transfer said device to a test position, whereby the HDL assay element is placed or maintained in contact with the reagent pad, and the reagent pad is, concurrent with or subsequent to said contact, brought into contact with said matrix.
A method of measuring serum cholesterol associated with high-density lipoproteins (HDL) in a blood fluid sample also containing low density lipoproteins (LDL) or very low density lipoproteins (VLDL), comprising
- (a) contacting the sample with an absorptive sample distribution matrix through which said sample is distributed to one or more sample collection sites;
- (b) bringing into contact with such a sample collection site, a first surface of a reagent pad, to which said sample is transferred, containing a reagent effective to selectively remove non-HDL lipoproteins from the fluid sample,
- wherein an opposite surface of said reagent pad is in simultaneous contact with an HDL assay element, containing assay reagents effective to produce an indication of HDL cholesterol concentration, such that successive sample volumes proceed from said reagent pad to said HDL assay element, and
- (c) determining the level of HDL cholesterol in said sample by detection at said HDL assay element.
Dependencies are inferred from the claim text.