Quantitative analysis of a biological sample of unknown quantity

• US 7,569,184 B2
• Filed: 11/05/2004
• Issued: 08/04/2009
• Est. Priority Date: 04/23/2002
• Status: Active Grant

• Current Assignee: Pwnhealth Chicago LLC
• Original Assignee: Home Access Health Corp. (Everly Well, Inc.)
• Inventors: Bervig, Troy, Wandell, Michael, Godsey, Barbara, Vinogradov, Ilia
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): JARRETT, LORE RAMILLANO
• Application Number:
  US10/982,199
• Publication Number:
  US 20050209532A1
• Time in Patent Office: 1,733 Days
• Field of Search: 422/61, 436/71, 436/16, 436/17, 436/19, 436/66
• US Class Current: 422/404
• CPC Class Codes: G01N 2333/91188 transferring nitrogenous groups (2.6)
• CPC Class Codes: G01N 33/57434 of prostate
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/107497 Preparation composition [e.g., lysing or precipitation, etc.]
• CPC Class Codes: Y10T 436/109163 Inorganic standards or controls

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.

Claims

1. 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 at least one 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 the level of said normalizing analyte in said solution, wherein, in determining the analyte level in the blood from which said blood fluid specimen was collected, a recovery delta is added to the analyte level of the analyte level in said solution to provide a recovery delta corrected solution analyte level, and the analyte level in the blood from which said blood fluid specimen was collected is determined as a function of said recovery delta corrected solution analyte level and on the level of said normalizing analyte, wherein said recovery delta is a positive value, wherein said recovery delta is determined as a function of the time elapsed since said blood fluid specimen was collected.

2. A method according to claim 1, wherein said recovery delta is determined in accordance with the function:

A+B (time) wherein A is 0, a positive value, or a negative value, and B is a positive or negative non-zero value.

3. A method according to claim 2, wherein B is determined based on climactic conditions.

4. A method according to claim 1, said analyte being selected from the group consisting of total cholesterol, HDL, LDL, and TG.

5. A method according to claim 1, said normalizing analyte including sodium.

6. A method according to claim 1, said normalizing analyte including chloride.

7. 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 at least one 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 the level of said normalizing analyte in said solution, wherein, in determining the analyte level in the blood from which said blood fluid specimen was collected, a recovery delta is added to the analyte level of the analyte level in said solution to provide a recovery delta corrected solution analyte level, and the analyte level in the blood from which said blood fluid specimen was collected is determined as a function of said recovery delta corrected solution analyte level and on the level of said normalizing analyte, wherein said recovery delta is a negative value, wherein said recovery delta is determined as a function of the time elapsed since said blood fluid specimen was collected.

8. 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 at least a first normalizing analyte; and

determining an analyte level in the blood from which said blood fluid specimen was collected based on said analyte level in said solution and on the level of said first normalizing analyte in said solution, wherein the calculation of analyte level in the blood from which said blood fluid specimen was taken includes a predetermined nonlinear first analyte correction factor, measuring the level of at least a second normalizing analyte in said solution, wherein the level of analyte in the blood from which said blood fluid specimen was collected is determined based on the level of said second normalizing analyte and on the corrected first analyte level.

9. A method according to claim 8, wherein a first blood analyte level is determined based on the levels in solution of said analyte and said chloride normalizing analyte;

a second blood analyte level is determined based on the levels in solution of said analyte and said second normalizing analyte; and

the level of analyte in the blood from which said blood fluid specimen was collected is determined by calculating the mean average of said first and second blood analyte levels.

10. A method according to claim 9, said first normalizing analyte comprising chloride.

11. A method for reporting a test result, comprising:

receiving an incoming inquiry from a user;

prompting said user for a test number;

retrieving a test result from a database of test numbers and test results; and

reporting said test result to said user, said test result comprising an analyte level having been determined according to 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 at least one 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 the level of said normalizing analyte in said solution, wherein, in determining the analyte level in the blood from which said blood fluid specimen was collected, a recovery delta is added to the analyte level of the analyte level in said solution to provide a recovery delta corrected solution analyte level, and the analyte level in the blood from which said blood fluid specimen was collected is determined as a function of said recovery delta corrected solution analyte level and on the level of said normalizing analyte.

12. A method for reporting a test result, comprising:

receiving an incoming inquiry from a user;

prompting said user for a test number;

retrieving a test result from a database of test numbers and test results; and

reporting said test result to said user, said test result comprising an analyte level having been determined according to 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 at least a first 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 the level of said first normalizing analyte in said solution, wherein the calculation of analyte level in the blood from which said blood fluid specimen was taken includes a predetermined nonlinear first analyte correction factor.