Calibrator composition based upon dialyzed blood serum

Claim 1

In a calibrator composition for use in calibrating an analytical system in which an aqueous albumin-containing liquid is assayed for one or more non-proteinaceous analytes contained therein by an indicator that binds to albumin having free sites, said composition comprising, in admixture a pre-selected amount of such analytes and a blood serum matrix comprising albumin having free-binding sites; the improvement wherein said composition contains a compatible, organic, albumin site-binding material in an amount sufficient to reduce the bias arising from the presence of said free-binding sites.

Claim 9

A method of preparing a reduced bias calibrator composition for calibrating an analytical system for the assay of non-proteinaceous analytes by an indicator that binds to albumin having free sites, comprising the steps of (a) dialyzing a blood serum matrix to separate albumin from molecules at least as small as those having a molecular weight of about 1,000; and (b) adding to said albumin, in either order, a pre-selected amount of a non-proteinaceous analyte and a compatible organic, albumin site-binding material in an amount sufficient to reduce the bias of the composition arising from the presence of free-binding sites.

Claim 10

A method of preparing a reduced bias calibrator composition for calibrating an analytical system for the assay of non-proteinaceous analytes by an indicator that binds to albumin having free sites, comprising the steps of (a) dialyzing a blood serum matrix to separate albumin from molecules at least as small as those having a molecular weight of about 1,000; and (b) adding to said albumin, in either order, a pre-selected amount of a non-proteinaceous analyte and a compatible organic, albumin site-binding material in an amount sufficient to reduce the bias of the composition arising from the presence of free-binding sites.

Claim 11

A method of calibrating an analytical system for the assay of a predetermined analyte, using a substrate capable of generating a dye in response to the analyte, said dye being capable of binding with albumin having free sites, the method comprising the steps of (a) adding to successive test compositions at least two samples of a calibrator composition comprising at least two different pre-selected amounts of said analyte, a blood serum matrix including albumin having free-binding sites, and an amount of a compatible, organic albumin site-binding material sufficient to bind to said free-binding sites and to reduce the bias arising from the presence of free-binding sites; (b) measuring the density of said dye in the test composition; and (c) thereafter attributing the density measured to the pre-selected analyte amounts, wherein a calibration curve can be established for density measurements other than those detected in said measuring step.

Claim 12

A method of calibrating an analytical system for the assay of a predetermined analyte, using a substrate capable of generating a dye in response to the analyte, said dye being capable of binding with albumin having free sites, the method comprising the steps of (a) adding to successive test compositions at least two samples of a calibrator composition comprising at least two different pre-selected amounts of said analyte, a blood serum matrix including albumin having free-binding sites, and an amount of a compatible, organic albumin site-binding material sufficient to bind to said free-binding sites and to reduce the bias arising from the presence of free-binding sites; (b) measuring the density of said dye in the test composition; and (c) thereafter attributing the density measured to the pre-selected analyte amounts, wherein a calibration curve can be established for density measurements other than those detected in said measuring step.