Quantitative analysis of a biological sample of unknown quantity
AssigneeHome Access Health Corporation
InventorsMichael Wandell, Ilia Vinogradov
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Abstract
Disclosed is a method for testing a modified specimen such as a dried blood spot, plasma or serum specimen, for an analyte of interest, such as cholesterol. In accordance with the disclosed subject matter, the level of the analyte of interest in the medium from which the modified specimen was obtained (e.g., from a patient's blood) is determined based on the level of an analyte in a solution formed from the modified specimen and on the level of at least one normalizing analyte. The analyte and normalizing analyte each may be an ion, compound, biochemical entity, or property of the specimen. Also disclosed are a fluid collector and a fluid collection device.
Claims74
A method for determining the level of an analyte in blood from a solution formed from a dried blood fluid specimen, said blood fluid specimen being a plasma or serum specimen, comprising:
- in either order, measuring the analyte level in said solution and measuring the level of a normalizing analyte;
- and
- determining the analyte level in the blood from which said blood fluid specimen was collected based on said analyte level in said solution and on said level of said normalizing analyte in said solution.
A method for determining the concentration of an analyte in blood from a solution formed from a dried blood fluid specimen, comprising:
- in either order, measuring the analyte level in said solution and measuring the level of a normalizing analyte;
- and
- determining the analyte level in the blood from which said blood fluid specimen was collected based on said analyte level in said solution and on said level of said normalizing analyte in said solution;
- said normalizing analyte being selected from the group consisting of sodium, chloride, and osmolality.
A method for determining the concentration of an analyte from a solution formed from a dried blood fluid specimen, comprising:
- in any order, measuring the level of an analyte in said solution, measuring the level of a first normalizing analyte in said solution, and measuring the level of a second normalizing analyte in said solution;
- determining the analyte level in the blood from which said blood fluid specimen was collected based on said analyte level in said solution, the level of said first normalizing analyte in said solution, and the level of said second normalizing analyte in said solution.
A method for preparing a database for use in determining an analyte level in blood based upon measurements of the analyte in a solution formed from a blood fluid specimen and based upon the measurement of first and second normalizing analytes in said solution, comprising:
- providing a plurality of blood samples each having a known blood analyte level;
- for each of said blood samples, preparing a blood fluid specimen thereby yielding a plurality of blood fluid specimens;
- for each of said blood fluid specimens, forming a solution;
- for each of said solutions, measuring the levels of said analyte, a first normalizing analyte, and a second normalizing analyte in said solution;
- and
- recording in a database record the known blood analyte level, the level of analyte measured in said solution, the level of first normalizing analyte measured in said solution and the level of said second normalizing analyte measured in said solution.
The method according to claim 43, said analyte being ALT.
The method according to claim 53, said algorithm being first order with respect to said solution analyte level.
A computer readable medium containing the computer file prepared in accordance with the method of claim 56.
A method for determining the concentration of an analyte in a body fluid specimen from a solution formed from an modified specimen, comprising:
- in any order, measuring the level of an analyte in said solution, measuring the level of a first normalizing analyte in said solution, and measuring the level of a second normalizing analyte in said solution;
- determining the analyte level in the specimen from which said modified specimen was collected based on said analyte level in said solution, the level of said first normalizing analyte in said solution, and the level of said second normalizing analyte in said solution.
A fluid collector comprising:
- an absorbent substrate coated with a saccharide polymer, said substrate permitting at least substantial separation of serum from red blood cells via differential wicking.
A method for determining the level of an analyte in a fluid based on measurement of said analyte in a modified fluid specimen to be analyzed, comprising in any appropriate order:
- providing a plurality of fluid specimens having a known measurable analyte level;
- preparing a modified fluid specimen from each of said fluid specimens;
- in either order, measuring the level of said analyte and at least one normalizing analyte in each of said modified fluid specimens thereby generating a data set;
- using said data set, deriving an algorithm for determining the level of analyte as a function of analyte level measured in a modified specimen and normalizing analyte measured in a modified specimen;
- determining the levels of said analyte and said normalizing analyte in said modified fluid specimen to be analyzed;
- and
- calculating the level of said analyte in the fluid from which said modified specimen was obtained based on said algorithm.
Dependencies are inferred from the claim text.