Adhered membranes retaining porosity and biological activity
First Claim
1. An assay device for measuring serum cholesterol associated with high-density lipoproteins (HDL) in a blood fluid sample containing lipoproteins other than HDLs, the device comprising:
- a sample distribution array;
a HDL test pad in which HDL concentration can be assayed; and
a reagent pad containing a binding reagent effective to selectively bind and remove non-HDLs from the fluid sample;
wherein said HDL test pad and said reagent pad are joined.
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Accused Products
Abstract
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.
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Citations
30 Claims
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1. An assay device for measuring serum cholesterol associated with high-density lipoproteins (HDL) in a blood fluid sample containing lipoproteins other than HDLs, the device comprising:
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a sample distribution array;
a HDL test pad in which HDL concentration can be assayed; and
a reagent pad containing a binding reagent effective to selectively bind and remove non-HDLs from the fluid sample;
wherein said HDL test pad and said reagent pad are joined. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method of preparing a device suitable for measuring serum cholesterol comprising:
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providing a reagent pad and an HDL test pad formed of an asymmetric polysulfone membrane having a small pore side and an open pore side;
orienting the reagent pad with the HDL test pad such that the small pore side of the reagent pad contacts the open pore side of the HDL test pad;
heating to adhere said HDL test pad and said reagent pad; and
applying (i) HDL test reagents to said HDL test pad, and (ii) a reagent effective to selectively bind and remove non-HDLs from a fluid sample to said reagent pad to form said device. - View Dependent Claims (16)
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17. A method of preparing a device suitable for measuring serum cholesterol comprising:
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coating a reagent pad with an acrylic acid copolymer;
applying (i) HDL test reagents to said HDL test pad, and (ii) a reagent effective to selectively bind and remove non-HDLs from a fluid sample to said reagent pad;
heating to adhere said HDL test pad and said reagent pad to form said device. - View Dependent Claims (18, 19, 20, 21, 22)
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23. A method of measuring serum cholesterol associated with high-density lipoproteins (HDL) in a blood fluid sample containing lipoproteins other than HDLs, comprising:
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contacting the sample with a laminate comprising (i) an HDL test pad having a detectable indicator of HDL cholesterol, (ii) a reagent pad containing a reagent effective to selectively bind and remove non-HDLs from the fluid sample;
wherein said blood fluid sample passes through said laminate by capillary action and/or gravity through said laminate to permit measurement of HDL concentration. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30)
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Specification